Catalyst Pharmaceutical Partners Inc.
As filed with the Securities and Exchange Commission on
September 1, 2006
Registration No. 333-136039
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
Amendment No. 1
to
FORM S-1
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
CATALYST PHARMACEUTICAL PARTNERS, INC.
(Exact name of registrant as specified in its charter)
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Delaware |
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2834 |
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76-0837053 |
(State or other jurisdiction of
incorporation or organization) |
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(Primary Standard Industrial
Classification Code Number) |
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(I.R.S. Employer
Identification Number) |
220 Miracle Mile
Suite 234
Coral Gables, Florida 33134
(305) 529-2522
(Name, address, including zip code, and telephone number,
including area code, of registrants principal executive
offices)
Patrick J. McEnany
Chief Executive Officer
Catalyst Pharmaceutical Partners, Inc.
220 Miracle Mile
Suite 234
Coral Gables, Florida 33134
(305) 529-2522
(Name, address, including zip code, and telephone number,
including area code,
of agent for service)
Copies To:
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Philip B. Schwartz, Esq.
Akerman Senterfitt
One Southeast Third Avenue
Miami, Florida 33131
(305) 374-5600 |
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Donald J. Murray, Esq.
Dewey Ballantine LLP
1301 Avenue of the Americas
New York, New York 10019-6092
(212) 259-8000 |
Approximate date of commencement of proposed sale to
public: As soon as practicable after this registration
becomes effective
If any of the securities being registered on this Form are to be
offered on a delayed or continuous basis pursuant to
Rule 415 under the Securities Act, check the following
box: o
If this Form is used to register additional securities for an
offering pursuant to Rule 462(b) under the Securities Act,
check the following box and list the Securities Act registration
number of the earlier effective registration statement for the
same
offering: o
If this Form is a post-effective amendment filed pursuant to
Rule 462(c) under the Securities Act, check the following
box and list the Securities Act registration statement number of
the earlier effective registration statement for the same
offering: o
If this Form is a post-effective amendment filed pursuant to
Rule 462(d) under the Securities Act, check the following
box and list the Securities Act registration number of the
earlier effective registration statement for the same
offering: o
The registrant hereby amends this registration statement on
such date or dates as may be necessary to delay its effective
date until the registrant shall file a further amendment which
specifically states that this registration statement shall
become effective in accordance with Section 8(a) of the
Securities Act of 1933 or until the registration statement shall
become effective on such date as the Commission, acting pursuant
to Section 8(a), may determine.
The information
in this preliminary prospectus is not complete and may be
changed. We may not sell these securities until the registration
statement filed with the Securities and Exchange Commission is
effective. This preliminary prospectus is not an offer to sell
these securities and is not soliciting an offer to buy these
securities in any state where the offer or sale is not
permitted.
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SUBJECT TO COMPLETION, DATED
SEPTEMBER 1, 2006
Common Stock
Shares
This is the initial public offering of our common stock and no
public market currently exists for our shares. We expect that
the public offering price will be between
$ and
$ per
share.
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The Offering |
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Per Share |
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Total |
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Public Offering Price
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$ |
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Underwriting Discounts and Commissions
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$ |
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$ |
Proceeds, Before Expenses, to Catalyst
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$ |
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$ |
We have applied to have our common stock included for quotation
on the Nasdaq Global Market under the symbol CPRX.
Investing in our common stock involves a high degree of
risk.
See Risk Factors beginning on page 10.
Neither the Securities and Exchange Commission nor any state
securities commission has approved or disapproved of these
securities or determined if this prospectus is truthful or
complete. Any representation to the contrary is a criminal
offense.
We have granted the underwriters the right to purchase up
to additional
shares from us within 30 days after the date of this
prospectus to cover over-allotments, if any. The underwriters
expect to deliver shares of common stock to purchasers on or
about ,
2006.
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First Albany Capital |
Stifel Nicolaus |
The date of this prospectus
is ,
2006
You should rely only on the information contained in this
prospectus. We have not, and the underwriters have not,
authorized anyone to provide you with different information. If
anyone provides you with different or inconsistent information,
you should not rely on it. We are not, and the underwriters are
not, making an offer to sell these securities in any
jurisdiction where the offer and sale is not permitted. You
should assume that the information in this prospectus is
accurate as of the date on the front cover of this prospectus
only. Our business, financial condition, results of operations
and prospects may have changed since that date.
Sabril is a registered trademark of Sanofi-Aventis.
TABLE OF CONTENTS
2
PROSPECTUS SUMMARY
The following summary is qualified in its entirety by the
more detailed information appearing elsewhere in this
prospectus. Individuals who participate in this offering are
urged to read this prospectus in its entirety. An investment in
the shares offered hereby involves a high degree of risk. This
prospectus contains forward-looking statements that involve
risks and uncertainties. Our actual results may differ
significantly from the projected results discussed in these
forward-looking statements. Factors that may cause such a
difference include, but are not limited to, those discussed in
Risk Factors. We, our,
ours, us, or the company
when used herein, refers to Catalyst Pharmaceutical Partners,
Inc.
We are a specialty pharmaceutical company focused on the
development and commercialization of prescription drugs for the
treatment of addiction. Our initial product candidate is
CPP-109, which is based on the chemical compound
gamma-vinyl-GABA, commonly referred to as vigabatrin. We
intend to begin in the first quarter of 2007 a
U.S. Phase II clinical trial evaluating
CPP-109 for the
treatment of cocaine addiction. We also intend to develop
CPP-109 to treat
methamphetamine addiction. We believe that our
CPP-109 platform has
the potential to produce therapies for other addictions,
including addictions to nicotine, prescription pain medications,
alcohol, and marijuana, as well as treatments for related
addictive disorders, such as obesity and compulsive gambling.
Drug abuse and addiction, including cocaine and methamphetamine
abuse, comprise a worldwide health problem that affects millions
of people and has wide-ranging negative social consequences.
According to the Office of National Drug Control Policy, costs
of drug abuse to society were an estimated $180 billion in
2002 in the United States. In 2004, an estimated 19 million
people in the United States suffered from dependence on illicit
drugs, according to the National Survey on Drug Use and Health,
published by the Substance Abuse and Mental Health Services
Administration, or SAMHSA. According to the same source,
approximately two million people used cocaine in the month
preceding the survey, approximately one million were new users
in 2004, and approximately 884,000 patients sought treatment for
cocaine abuse in 2004. Also according to the SAMHSA survey,
approximately 583,000 people used methamphetamine in the month
preceding the survey, approximately 318,000 were new users in
2004, and approximately 393,000 patients sought treatment for
methamphetamine abuse in 2004. According to the United Nations
Office for Drug Control and Crime Prevention, in 2004 there were
approximately 3.4 million users of cocaine and
2.7 million users of amphetamine-type stimulants across
Europe. Despite the significance of cocaine and methamphetamine
abuse as a worldwide public health problem, there are no
currently approved pharmaceutical therapies for cocaine and
methamphetamine abuse.
Many addictive drugs, including cocaine and methamphetamine,
produce feelings of euphoria by increasing the concentration of
the chemical neurotransmitter dopamine in specific areas of the
brain. Under normal conditions, dopamine levels are relatively
constant, increasing temporarily as a result of experiences such
as eating or sexual arousal. Over time, the feeling of pleasure
is decreased by a reduction in dopamine to its pre-arousal level
and through the action of gamma-aminobutyric acid, or
GABA, a chemical neurotransmitter that inhibits the effect of
dopamine. Substances such as cocaine and methamphetamine cause
enormous amounts of dopamine buildup, producing feelings of
euphoria. CPP-109
increases the amount of GABA present, which suppresses the
responses to the dramatic increase in dopamine levels produced
by cocaine and methamphetamine, thereby preventing the
perception of pleasure that is associated with their use.
We have been granted an exclusive worldwide license from
Brookhaven National Laboratory to nine U.S. patents and two
U.S. patent applications relating to the use of vigabatrin
for the treatment of a wide variety of substance addictions. The
nine issued patents expire between 2018 and 2020. Additionally,
we have received approval from the European Union with respect
to one of our principal patents, which will allow us to seek
approval for this patent in each of the EU member states.
In the first quarter of 2007, we intend to begin an
approximately 375 patient, double-blind, randomized,
placebo-controlled Phase II clinical trial in the United States
to evaluate CPP-109 for the treatment of cocaine
3
addiction, although the final design of this clinical trial and
the number of patients to be included has not yet been
finalized. This trial is designed to provide potentially pivotal
efficacy data, which may support the filing of a New Drug
Application, or NDA. However it is likely that additional
non-clinical or clinical trials including a
U.S. Phase III clinical trial, will be required before
we are permitted to file an NDA for CPP-109. In order to further
the available research on the use of vigabatrin to treat cocaine
addiction, we are also supporting a 100 patient double-blind,
placebo-controlled clinical trial in Mexico. This trial, which
we believe will be the equivalent of a Phase II study in
the United States, will start in the fourth quarter of 2006 and
evaluate vigabatrin for the treatment of cocaine addiction. See
Risk Factors and Our Business Our
Clinical Research and Clinical Studies
that we Support.
In December 2004, the Food and Drug Administration, or FDA,
accepted our Investigational New Drug application, or IND, for
CPP-109 for the
treatment of cocaine addiction. We have been granted Fast
Track status by the FDA for
CPP-109, a designation
intended to facilitate drug development and expedite the
regulatory review process. A treatment for cocaine addiction is
recognized as addressing an unmet medical need for which no
pharmacological products are currently approved for marketing.
Fast track status does not mean that the regulatory requirements
necessary to obtain an approval are any less stringent. Further,
Fast Track status may be withdrawn at any time. Notwithstanding,
we believe that our receipt of Fast Track status for
CPP-109 may accelerate
the regulatory approval process, although we cannot assure you
of this fact.
Our intention to advance CPP-109 as a potential treatment for
cocaine and methamphetamine addiction is based on the results of
two open-label pilot studies conducted in Mexico in 2003 and
2004 under the supervision of Jonathan Brodie, M.D., Ph.D., a
member of our Scientific Advisory Board and a member of the
faculty of New York University. While the results of these pilot
studies were positive, these were open-label studies involving
only a small number of participants, and neither study provides
sufficient data regarding safety and efficacy to support an NDA
for CPP-109. Further, because these studies were conducted in
Mexico and were not subject to FDA oversight in any respect,
including study design and protocol, there can be no assurance
that the results of subsequent clinical trials in the United
States will corroborate the results of these pilot studies. We
cannot assure you that future clinical trials will be successful
or that we will obtain approval of an NDA for CPP-109. For more
details about the pilot studies, see Our
Business Pilot Studies.
The first pilot study was completed in 2003. This study was
designed to evaluate the efficacy of vigabatrin in the treatment
of cocaine dependence. It was an outpatient, open-label study
with a fixed dose treatment protocol. The study lasted
approximately nine weeks and was completed in a setting with
psychotherapeutic support and intervention. All subjects
remained in their respective communities for the duration of the
trial, with complete access to drugs of abuse. A total of 20
subjects were enrolled in the study, who were primarily daily
cocaine abusers meeting clinical criteria for cocaine
dependence. Most of the subjects were polydrug abusers whose
cocaine use was often supplemented with methamphetamine,
marijuana, and/or alcohol. At the beginning of the study, the
average subject consumed 1.7 grams of cocaine daily for 12 years
and was 29 years old.
Each subject received escalating doses of vigabatrin, to a
maximum of four grams daily, which were administered under
observation in the clinic. All subjects were encouraged to
participate in group and individual therapy programs and were
required to provide urine samples twice a week and to complete a
daily questionnaire regarding that individuals drug use
and craving. Of the 20 subjects enrolled in the study:
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eight remained in the program and were drug-free for periods
ranging from 46 to 58 days at the end of the study. During
the study, only two of these eight subjects had a single
slip or relapse into cocaine use after craving
stopped. For this study, a slip restarted the count of
consecutive days clean or drug-free (a successful
therapeutic outcome was defined as 28 consecutive cocaine-free
days); and |
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Twelve subjects failed to complete the program, of whom eight
requested termination within 10 days, stating that they did
not wish to stop their cocaine use, and four stayed in the study
for periods of 25 to 43 days, but continued to use cocaine,
though in reduced amounts, according to self reports. Two out of |
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the four had an 80% reduction in cocaine use, one out of the
four had a 50% reduction, and the other did not reduce his
cocaine use at all, according to self-reports by the subjects,
despite their claim that the drug did not engender the usual
high. |
We believe there was a significant difference in the consecutive
days clean for the study completers, an average of
48.5 days, compared to an average of 1.9 days, for the
non-completers. The P-value, which is a measure of statistical
significance, of these distinctions, was less than 0.0001
(meaning the probability of these findings being due to chance
was less than one in 10,000).
The second pilot study was completed in 2004. This study was a
nine-week, fixed-dose, open-label outpatient study designed to
examine whether short-term usage of vigabatrin caused peripheral
visual field defects, known as VFDs, in substance abusers, as
well as to evaluate the efficacy of vigabatrin for the treatment
of cocaine and methamphetamine abuse. The study involved 30
outpatient subjects who used an average of about 0.8 grams
of cocaine and/or methamphetamine on a daily basis and who met
clinical criteria for dependence on either cocaine or
methamphetamine, or both. The average duration of drug
dependence for all subjects was 12.8 years. Each subject
received escalating doses of vigabatrin, to a maximum of three
grams daily. Those who completed the study received a cumulative
dose of vigabatrin of 137 grams, which is less than 10% of the
1,500 gram lifetime exposure that we believe is associated with
an increase in the incidence of visual field defects.
Daily vital signs of all subjects were monitored, and
twice-weekly urine samples were obtained under direct
observation and tested for cocaine, methamphetamine, marijuana,
heroin, and alcohol. All subjects were encouraged to participate
in weekly group therapy. Of the 30 subjects enrolled, 11
subjects dropped out before completing four weeks, one
subject completed eight weeks, and 18 subjects completed
all nine weeks. Of the 18 subjects who completed all nine weeks,
15 completers were methamphetamine and cocaine-free for four
consecutive weeks, with no slips, and two of the 18 completers
were never drug-free, although, according to self reports, their
drug use was reduced. For all 18 completers, the average
drug-free interval was 40.1 consecutive days, with an average
use of 0.03 grams of cocaine or methamphetamine over the last
three weeks of the study. Completers reported increased appetite
and showed a significant weight gain over non-completers,
gaining an average of 11 pounds, compared to an average of four
pounds for non-completers, with a P-value of 0.004.
As part of the 2004 pilot study, a variety of ophthalmologic
measurements were performed in an ophthalmological institute on
each subject before, during and after treatment, and again at
one to two months following the end of treatment. In addition,
these data was independently evaluated by a Board Certified
Ophthalmologist who had no knowledge of each subjects
identity. There were no VFDs, retinal changes or other changes
in visual acuity detected in any subject, regardless of whether
the subject completed the study.
We were incorporated in Delaware in July 2006. We are currently
a wholly-owned subsidiary of Catalyst Pharmaceutical Partners,
Inc., a Florida corporation, (CPP-Florida) which was
incorporated in the State of Florida in January 2002. We have
recently entered into a merger agreement with CPP-Florida under
which, at the effective time of the merger, CPP-Florida will be
merged with and into us, and we will succeed to all of the
assets, liabilities, rights and operations of CPP-Florida. The
merger will be completed on or about September 6, 2006,
prior to the effectiveness of our registration statement.
Our principal executive offices are located at 220 Miracle
Mile, Suite 234, Coral Gables, Florida 33134, our telephone
number is (305) 529-2522 and our website is
www.catalystpharma.com. The information contained on our website
is not part of this prospectus.
5
Our Business Strategy
To facilitate our business development and growth, we plan to:
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Focus on CPP-109 for cocaine addiction. We intend to
commence a Phase II clinical trial for the use of CPP-109 as a
treatment for cocaine addiction. Treatment for cocaine addiction
addresses a significant unmet medical need, and we believe that
our receipt of Fast Track status may facilitate the regulatory
approval process. |
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Develop additional indications for CPP-109. The mechanism
of action of CPP-109 makes it suitable as a potential treatment
for addiction states that share the common element of heightened
dopamine levels. We plan next to develop CPP-109 for the
treatment of methamphetamine addiction. Further, our research
indicates that CPP-109 is a platform technology with the
potential to treat other conditions involving heightened
dopamine levels such as addictions to nicotine, prescription
pain medications, alcohol, marijuana, and related addictive
disorders, including obesity and compulsive gambling. |
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Acquire or license additional addiction therapies. We
know of other product candidates that may have potential for the
treatment of addiction. We may seek to acquire or license one or
more of these product candidates to expand our development
programs. We have entered into no such agreements to date. |
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Develop second generation of CPP-109. We plan to develop
a new form of CPP-109. If we are successful, we intend to
initially seek approval for this new form in Europe, where we
may be able to obtain exclusive marketing rights. Subsequently,
we may seek approval for this new formulation in the United
States. |
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Leverage the services of thought leaders in addiction
treatment. We believe that members of our Scientific
Advisory Board are among the most respected researchers in the
field of addiction therapy. We intend to utilize their
knowledge, services and relationships to guide our development
process and commercialization strategy. |
Risks Affecting Our Business
Our business is subject to numerous risks, as more fully
described herein and in the section entitled Risk
Factors immediately following this Summary. A few of these
risks are described below:
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We have a limited operating history, currently have no products
approved for sale and have incurred operating losses of
approximately $3.7 million from inception through
June 30, 2006. We expect to incur operating losses for the
foreseeable future. |
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Our product candidate,
CPP-109 is at an early
stage of development and has not yet been approved for use in
the treatment of cocaine addiction, methamphetamine addiction or
any other type of addiction. Failure can occur at any stage of
development of a pharmaceutical product such as
CPP-109, and it may be
years (if ever) before our product development efforts produce
viable products that we can commercialize. |
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We may never generate any product revenues, achieve
profitability or achieve our business objectives. |
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6
The Offering
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Common stock offered: |
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shares |
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Common stock outstanding after this offering: |
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shares |
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Use of proceeds: |
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We plan to use the net proceeds from this offering: |
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to fund our planned U.S. Phase II
clinical trial of CPP-109 for use in treating cocaine addiction; |
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to conduct, if required, a U.S. Phase
III clinical trial of CPP-109 for use in treating cocaine
addiction, to submit and seek approval of an NDA for CPP-109 for
use in treating cocaine addiction and to pay for any other
required clinical and non-clinical testing of CPP-109; |
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to conduct clinical studies and trials
for the use of CPP-109 in treating methamphetamine addiction,
and to submit such regulatory filings as are required to seek
approval for CPP-109 for use in treating methamphetamine
addiction; |
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to organize clinical studies of CPP-109
for use in treating nicotine addiction and to initiate clinical
studies and trials needed to commercialize CPP-109 in Europe; and |
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for general corporate purposes,
including compensation to our executive officers and employees,
rent on our leased facility and professional fees. |
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In addition, we may use a portion of the net proceeds to license
or acquire one or more products that show promise in the
treatment of addiction. No agreements with respect to any
acquisition have been entered into to this date. |
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Proposed Nasdaq Global Market symbol: |
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CPRX |
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Risk factors: |
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You should read the Risk Factors section of this
prospectus for a discussion of factors to consider before
deciding whether to invest in our common stock. |
The number of shares of our common stock outstanding after this
offering is based on the 6,281,900 shares outstanding as of
the date of this prospectus, and excludes as of that date:
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1,500,000 shares of common stock reserved for future grants
under our 2006 Stock Incentive Plan; |
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1,603,000 shares of common stock reserved for issuance upon the
exercise of outstanding stock options having a weighted exercise
price of $1.67 per share. |
Unless otherwise stated, all information in this prospectus
assumes:
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no exercise of the underwriters over-allotment option; and |
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the automatic conversion of all of our outstanding preferred
stock into 1,464,400 shares of our common stock immediately upon
the completion of this offering. |
7
Summary Financial Data
The following table sets forth our summary financial data for
the three years ended December 31, 2005, which have been
derived from our audited financial statements included elsewhere
in this prospectus. In addition, the table includes summary
financial data for the six months ended June 30, 2006 and
2005, and as of June 30, 2006, which have been derived from
our unaudited financial statements included elsewhere in this
prospectus. Our unaudited financial statements have been
prepared on a basis substantially consistent with our audited
financial statements and, in the opinion of management, include
all adjustments (consisting of normally recurring adjustments)
necessary for a fair presentation of results under those
periods. It is important that you read this information together
with Managements Discussion and Analysis of
Financial Condition and Results of Operations, Risk
Factors and our financial statements and the related notes
and schedules to these financial statements beginning on Page
F-1 of this prospectus. Our interim financial results are not
necessarily indicative of our financial results for the full
year, and our historical results presented below are not
necessarily indicative of results to be expected in future
periods.
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Cumulative period | |
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from January 4, | |
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Six Months Ended June 30, | |
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Year Ended December 31, | |
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2002 (date of | |
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inception) through | |
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2006 | |
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2005 | |
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2005 | |
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2004 | |
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2003 | |
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June 30, 2006 | |
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(unaudited) | |
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(unaudited) | |
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Statement of Operations Data:
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Revenues
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$ |
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$ |
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$ |
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$ |
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$ |
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$ |
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Operating costs and expenses:
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Research and development
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432,764 |
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1,200,769 |
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1,462,889 |
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378,254 |
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268,829 |
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2,680,416 |
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General and administrative
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242,194 |
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126,811 |
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359,279 |
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164,704 |
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165,483 |
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1,049,925 |
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Total operating expenses
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674,958 |
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1,327,580 |
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1,822,168 |
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542,958 |
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434,312 |
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3,730,341 |
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Loss from operations
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(674,958 |
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(1,327,580 |
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(1,822,168 |
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(542,958 |
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(434,312 |
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(3,730,341 |
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Interest income
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8,133 |
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5,908 |
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16,788 |
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3,138 |
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5,697 |
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33,756 |
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Loss before income taxes
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(666,825 |
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(1,321,672 |
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(1,805,380 |
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(539,820 |
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(428,615 |
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(3,696,585 |
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Provision for income taxes
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|
|
|
|
|
|
Net loss
|
|
$ |
(666,825 |
) |
|
$ |
(1,321,672 |
) |
|
$ |
(1,805,380 |
) |
|
$ |
(539,820 |
) |
|
$ |
(428,615 |
) |
|
$ |
(3,696,585 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share
|
|
$ |
(0.14 |
) |
|
$ |
(0.35 |
) |
|
$ |
(0.42 |
) |
|
$ |
(0.27 |
) |
|
$ |
(0.21 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares outstanding basic and diluted
|
|
|
4,720,000 |
|
|
|
3,767,033 |
|
|
|
4,252,219 |
|
|
|
2,000,000 |
|
|
|
2,000,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pro forma basic and diluted net loss per
share(1)
|
|
$ |
(0.12 |
) |
|
|
|
|
|
$ |
(0.36 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pro forma weighted average shares outstanding basic
and
diluted(1)
|
|
|
5,420,000 |
|
|
|
|
|
|
|
4,952,219 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
Pro forma gives effect to the conversion of issued shares of our
Series A Preferred Stock into 700,000 shares of our common
stock as if such shares of Series A Preferred Stock had
been converted into common stock as of the earlier of
January 1, 2005 or the beginning of the reporting period.
Such shares of Series A Preferred Stock will automatically
convert into common stock at the closing of this offering. |
8
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2006 | |
|
|
| |
|
|
Actual | |
|
Pro forma(1) | |
|
Pro forma as adjusted(2) | |
|
|
| |
|
| |
|
| |
Balance Sheet Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$ |
324,154 |
|
|
$ |
3,549,294 |
|
|
$ |
|
|
Working capital (deficiency)
|
|
|
(107,516 |
) |
|
|
3,312,624 |
|
|
|
|
|
Total assets
|
|
|
365,113 |
|
|
|
3,590,253 |
|
|
|
|
|
Total liabilities
|
|
|
434,351 |
|
|
|
239,351 |
|
|
|
|
|
Stockholders equity (deficit)
|
|
|
(69,238 |
) |
|
|
3,350,902 |
|
|
|
|
|
|
|
|
(1) |
Pro forma gives effect to our completion of a private placement
on July 24, 2006 of 7,644 shares of our Series B Preferred Stock
from which we received net proceeds of $3,225,140, the automatic
conversion of these Series B preferred shares upon the
closing of this offering into 764,400 shares of our common
stock, the automatic conversion of our outstanding Series A
Preferred Stock into 700,000 shares of our common stock on the
closing of this offering, and the issuance of 97,500 shares of
our common stock in July 2006 relating to services performed for
us by certain of our consultants and scientific advisors during
2004, 2005 and the first six months of 2006. |
|
|
(2) |
Pro forma information as adjusted gives further effect to our
sale of shares of
common stock in this offering at an assumed initial public
offering price of
$ per
share and our receipt of an estimated
$ in
net proceeds therefrom, after deducting underwriting discounts
and commissions and estimated offering expenses to be paid by us. |
9
RISK FACTORS
Any investment in our securities involves a high degree of
risk. You should carefully consider the risks and uncertainties
described below, and all information contained in this
prospectus, before you decide whether to purchase our
securities. The occurrence of any of the following risks could
cause our business, results of operations, financial condition
and prospects to materially suffer and the market price of our
stock to decline, and you may lose part or all of your
investment.
Risks Related to Our Business
We are a development stage company whose limited operating
history makes it difficult to evaluate our future
performance.
We are a development stage company that began operations in
2002. As such, we have a limited operating history upon which
you can evaluate our current business and our prospects. The
likelihood of our future success must be viewed in light of the
problems, expenses, difficulties, delays and complications often
encountered in the operation of a new business, especially in
the pharmaceutical industry, where failures of new companies are
common. We are subject to the risks inherent in the ownership
and operation of a development stage company, including
regulatory setbacks and delays, fluctuations in expenses,
competition and government regulation. If we fail to address
these risks and uncertainties our business, results of
operations, financial condition and prospects would be adversely
affected.
We have had no revenues from operations to date, currently have
no products available for commercial sale, and have never had
products available for commercial sale. We expect to incur
losses at least until we can commercialize CPP-109. Our net loss
was $1,805,380 for the year ended December 31, 2005 and
$666,825 for the six months ended June 30, 2006, and as of
June 30, 2006 we had an accumulated deficit of $3,696,585.
We may not obtain approval of an NDA for CPP-109 and may never
achieve profitability.
There is currently little scientific evidence supporting the
use of vigabatrin to treat addiction.
There is currently little scientific evidence indicating that
CPP-109 will be a safe and effective treatment for any addiction
in humans. Our studies and clinical trials evaluating CPP-109
may fail, and we may never commercialize this product candidate.
We will also have to conduct non-clinical testing on CPP-109 in
order to be in a position to file an NDA, although the scope of
such required testing is uncertain, and we are currently unable
to determine the timing of such non-clinical testing. To date,
two open-label clinical
studies have been completed in Mexico relating to the use of
vigabatrin in the treatment of cocaine and methamphetamine
addiction. Only 26 persons in the aggregate completed these
trials. Additionally, some of the study results described in
this prospectus, such as evidence regarding beneficial weight
gain, employment or other behavioral changes, have little
scientific correlation to the safety or efficacy of CPP-109 as a
treatment for addiction, and therefore are not reliable as
evidence of safety or efficacy. Further, because these studies
were conducted in Mexico and were not subject to FDA oversight
in any respect, including study design and protocol, there can
be no assurance that the results of subsequent clinical trials
in the United States will corroborate the results of these pilot
studies. The results of these studies are not necessarily
predictive of results that will be obtained in later stages of
clinical testing in the United States or ensure success in later
stage clinical trials and neither study provided enough evidence
regarding safety or efficacy to support an NDA filing with the
FDA.
Our product development efforts may fail.
Development of our pharmaceutical product candidates is subject
to risks of failure. For example:
|
|
|
|
|
CPP-109 may be found to be ineffective or unsafe, or fail to
receive necessary regulatory approvals; |
|
|
|
CPP-109, even if found to be safe and effective, could prove
difficult or impossible to manufacture on a large scale or on a
cost-effective basis; |
10
|
|
|
|
|
CPP-109 may be uneconomical to market or take substantially
longer to obtain necessary regulatory approvals than
anticipated; or |
|
|
|
competitors may market equivalent or superior products. |
As a result, our product development activities may not result
in any safe, effective and commercially viable products, and we
may not be able to commercialize our products successfully. Our
failure to develop safe, effective, and commercially viable
products would have a material adverse effect on our business,
prospects, results of operations and financial condition.
Failure can occur at any stage of our product development
efforts.
We will only obtain regulatory approval to commercialize CPP-109
if we can demonstrate to the satisfaction of the FDA (or the
equivalent foreign regulatory authorities) in adequate and
well-controlled clinical studies that the drug is safe and
effective for its intended use and that it otherwise meets
approval requirements. A failure of one or more preclinical or
clinical studies can occur at any stage of product development.
We may experience numerous unforeseen events during, or as a
result of, testing that could delay or prevent us from obtaining
regulatory approval for or commercializing CPP-109, including
but not limited to:
|
|
|
|
|
regulators or institutional review boards, which are commonly
called IRBs, may not authorize us to commence a clinical trial
or conduct a clinical trial at a prospective trial site; |
|
|
|
conditions may be imposed upon us by the FDA regarding the scope
or design of our clinical trials, or we may be required to
resubmit our clinical trial protocols to IRBs for reinspection
due to changes in the regulatory environment; |
|
|
|
we may be unable to reach agreements on acceptable terms with
prospective clinical research organizations; |
|
|
|
the number of subjects required for our clinical trials may be
larger than we anticipate, patient enrollment may take longer
than we anticipate, or patients may drop out of our clinical
trials at a higher rate than we anticipate; |
|
|
|
we may have to suspend or terminate one or more of our clinical
trials if we, regulators, or IRBs determine that the
participants are being subjected to unreasonable health risks; |
|
|
|
our third-party contractors or clinical investigators may fail
to comply with regulatory requirements or fail to meet their
contractual obligations to us in a timely manner; |
|
|
|
our tests may produce negative or inconclusive results, and we
may decide, or regulators may require us, to conduct additional
testing; and |
|
|
|
the costs of our clinical trials may be greater than we
anticipate. |
We are dependent on a single chemical compound,
vigabatrin.
To date, we have invested, and will in the foreseeable future
continue to invest, most or all of our time and resources to
develop products using a single chemical compound, vigabatrin,
for the treatment of addictions. Because all of our potential
products are based on this chemical compound, if we cannot
successfully develop and market products using it, and if we are
not successful in commercializing such products, it would have
an adverse effect on our business, financial condition, results
of operations and prospects.
11
Vigabatrin, the single chemical compound on which we depend,
has known side effects that may hinder our ability to produce
safe and commercially viable products.
When used long-term as a treatment for epilepsy, a formulation
of vigabatrin marketed as Sabril has been found to cause the
development of peripheral visual field defects, known as VFDs,
that increase progressively with continuing drug treatment. We
intend to include a standardized evaluation of each
patients visual fields before, during and after completion
of our clinical studies and trials. We do not yet know whether
our ultimate formulation for and dosing of vigabatrin will cause
VFDs or how the potential for this known side effect will affect
our ability to obtain marketing approval for CPP-109.
In addition to VFDs, a wide variety of other adverse effects,
including depression and other psychiatric reactions, have been
noted in patients treated with Sabril. As patients with seizures
often require treatment with multiple drugs, the relationship of
such adverse effects to Sabril, including the VFDs described
above, has not always been clear; however, such side effects
tended to disappear when treatment with Sabril was stopped.
These known side effects, as well as other side effects that may
be discovered during our clinical trials and studies, may cause
the FDA or other governmental agencies to halt clinical studies
prior to their completion, prevent the initiation of further
clinical studies, or deny the approval of CPP-109 as a treatment
for addiction. These known side effects may also cause the FDA
to impose marketing restrictions on CPP-109. For example, the
FDA may require specialized training for, or otherwise limit the
ability of, physicians to prescribe CPP-109 and of pharmacists
to fill prescriptions for CPP-109, may restrict our ability to
advertise CPP-109, and may require us to keep a registry of
patients who are prescribed CPP-109 to prevent such patients
from using CPP-109 over an extended period of time.
We rely on third parties to conduct our clinical trials, and
if they do not perform their obligations to us, we may not be
able to obtain approval for CPP-109.
We do not have the ability to conduct our clinical trials
independently. We rely on academic institutions, corporate
partners such as Brookhaven, and other third parties to assist
us in designing, managing, monitoring and otherwise carrying out
our clinical trials. Accordingly, we do not have control over
the timing or other aspects of these clinical trials. If these
third parties do not successfully carry out their duties, both
our clinical trials and our business may be materially adversely
affected. While we believe that there are numerous third parties
that can assist us with our clinical trials, if the third
parties with which we contract do not perform, our product
development efforts would likely be delayed by any such change,
and our efforts would likely be more expensive.
Although we rely on third parties to manage the data from these
clinical trials, we are responsible for confirming that each
clinical trial is conducted in accordance with its general
investigational plan and protocol. Moreover, FDA and foreign
regulatory agencies require us to comply with regulations and
standards, commonly referred to as good clinical practice, for
conducting, recording and reporting the results of clinical
trials to assure that the data and the results are credible and
accurate and that the trial participants are adequately
protected. Our reliance on third parties does not relieve us of
these obligations and requirements, and we may fail to obtain
regulatory approval for CPP-109 if these requirements are not
met.
If we are unable to file for approval for additional
indications for CPP-109 through supplemental NDAs, or if we are
required to generate additional data related to safety and
efficacy in order to obtain such approval for additional
indications, we may suffer material harm to our future financial
performance.
Our current plans for development of CPP-109 include efforts to
minimize the data we will need to generate in order to obtain
marketing approval of CPP-109 for methamphetamine addiction and
other additional indications. If we are successful in obtaining
approval of an NDA for CPP-109 as a treatment for cocaine
addiction, of which there can be no assurance, in the future we
plan to submit supplemental NDAs for additional indications.
Depending on the data we rely upon, approval for additional
indications for CPP-109 may be
12
delayed. In addition, even if we receive supplemental NDA
approval, the FDA has broad discretion to require us to generate
additional data related to safety and efficacy to supplement the
data used in the supplemental NDA filing. We could be required,
before obtaining marketing approval for CPP-109 for additional
indications, to conduct substantial new research and development
activities, which could be more costly and time-consuming than
we currently anticipate. We may not be able to obtain shortened
review of our applications, and the FDA may not agree that we
can market CPP-109 for additional indications. If we are
required to generate substantial additional data to support
approval, our product development and commercialization efforts
will be delayed and we may suffer significant harm to our future
financial performance.
We will need to develop marketing, distribution and
production capabilities or relationships to be successful.
We do not currently have any marketing, distribution or
production capabilities. In order to generate sales of CPP-109
or any other products we may develop, we must either acquire or
develop an internal marketing force with technical expertise and
with supporting documentation capabilities, or make arrangements
with third parties to perform these services for us. The
acquisition and development of a marketing and distribution
infrastructure will require substantial resources and compete
for available resources with our product development efforts. To
the extent that we enter into marketing and distribution
arrangements with third parties, our revenues will depend on the
efforts of others. If we fail to enter into such agreements, or
if we fail to develop our own marketing and distribution
channels, we would experience delays in product sales and incur
increased costs.
Similarly, we have no manufacturing capacity for production of
our products. We have entered into an agreement with a contract
manufacturer for the manufacture of CPP-109 for use in our U.S.
Phase II trial and to manufacture CPP-109 for us if we are
successful in obtaining FDA approval to commercialize this
product. We also have a contract to acquire the active
pharmaceutical ingredient used in CPP-109. Any third party we
contract with may not meet our manufacturing requirements, and
may not pass FDA inspection. Moreover, if any third party fails
to perform on a timely basis we may not be able to find a
suitable replacement. If we cannot obtain sufficient amounts of
CPP-109 or any related final product, it would have a material
adverse effect on our ability to successfully market CPP-109.
Our business is subject to substantial competition.
The development and commercialization of new drugs is highly
competitive worldwide. Although there is no currently approved
prescription drug treatment for cocaine or methamphetamine
addiction, there are a significant number of other companies
that are pursuing the development of drugs that, if approved and
commercialized, would be competitive with CPP-109. Some of these
other drugs have already begun or even completed Phase II
clinical trials. In addition, some or all of these drugs may not
have the side effects currently associated with vigabatrin,
including VFDs. Therefore, these competitive drugs may be
approved by the FDA instead of, or more quickly than, CPP-109,
and if approved may be more acceptable to health care providers.
Further, we expect that the number of companies seeking to
develop prescription drugs to treat drug addiction will
increase. Other products may be developed that either render
CPP-109 obsolete or have advantages that significantly outweigh
those of CPP-109. See Our Business
Competition for information about products that are
currently under development that may be competitive with CPP-109.
Many of our competitors have substantially greater financial,
technical, and human resources than we do. In addition, many of
our competitors have significantly greater experience than we do
in conducting clinical studies and obtaining regulatory
approvals of prescription drugs. Accordingly, our competitors
may succeed in obtaining FDA approval for products more rapidly
than we can. Furthermore, if we are permitted to commence
commercial sales of CPP-109, we may also compete with respect to
manufacturing efficiency and marketing capabilities. For all of
these reasons, we may not be able to compete successfully.
13
We may encounter difficulties in managing our growth, which
would adversely affect our results of operations.
If we are successful in obtaining approval to commercialize
CPP-109, we will need to significantly expand our operations,
which could put significant strain on our management and our
operational and financial resources. We currently have only four
employees and conduct most of our operations through outsourcing
arrangements. To manage future growth, we will need to hire,
train, and manage additional employees. Concurrent with
expanding our operational and marketing capabilities, we will
also need to increase our product development activities. We may
not be able to support future growth, or hire, train, motivate,
and manage the required personnel. Our failure to manage growth
effectively could limit our ability to achieve our goals.
Our success in managing our growth will depend in part on the
ability of our executive officers to continue to implement and
improve our operational, management, information and financial
control systems and to expand, train and manage our employee
base, and particularly to expand, train and manage a
specially-trained sales force to market our products. We may not
be able to attract and retain personnel on acceptable terms
given the intense competition for such personnel among
biotechnology, pharmaceutical and healthcare companies,
universities and non-profit research institutions. Our inability
to manage growth effectively could cause our operating costs to
grow at a faster pace than we currently anticipate, and could
have a material adverse effect on our business, financial
condition and results of operations.
We face a risk of product liability claims and may not be
able to obtain adequate insurance.
Our business exposes us to potential liability risks that may
arise from the clinical testing, manufacture, and sale of
CPP-109. Patients have received substantial damage awards in
some jurisdictions against pharmaceutical companies based on
claims for injuries allegedly caused by the use of
pharmaceutical products. Liability claims may be expensive to
defend and result in large judgments against us. While we intend
to carry liability insurance during our clinical trials with an
aggregate annual coverage limit of $10,000,000, with a
deductible of $50,000 per occurrence and $500,000 in the
aggregate, we do not currently have such a policy. We may not be
able to obtain a policy for these amounts at a reasonable cost,
or at all. Even if we obtain sufficient liability coverage, our
insurance may not reimburse us, or this coverage may not be
sufficient to cover claims made against us. We cannot predict
all of the possible harms or side effects that may result from
the use of CPP-109 or any of our other future products and,
therefore, the amount of insurance coverage we may be able to
obtain may not be adequate to cover all liabilities we might
incur. If we are sued for any injury allegedly caused by our
products, our liability could exceed our ability to pay the
liability. Whether or not we are ultimately successful in any
adverse litigation, such litigation could consume substantial
amounts of our financial and managerial resources, all of which
could have a material adverse effect on our business, financial
condition, results of operations, prospects and stock price.
Our commercial success depends on reimbursement from
third-party and governmental insurers.
Sales of pharmaceutical products in the United States depend
largely on reimbursement of patients costs by private
insurers, government health care programs including Medicare and
Medicaid, and other organizations. These third-party payors
control healthcare costs by limiting both coverage and the level
of reimbursement for healthcare products. The rising costs of
pharmaceutical products, in particular, has recently been the
subject of considerable attention and debate. Third-party payors
are increasingly altering reimbursement levels and challenging
the price and cost-effectiveness of pharmaceutical products. The
reimbursement status of newly approved pharmaceutical products
in particular is generally uncertain. The levels at which
government authorities and private health insurers reimburse
physicians or patients for the price they pay for CPP-109 and
other products we may develop could affect the extent to which
we are able to commercialize our products successfully.
14
We have no experience as a public company, and the
obligations incident to being a public company will place
significant demands on our management.
Since our inception, we have operated as a private company, not
subject to the requirements applicable to public companies.
While we plan to expand our finance and accounting staff when we
become public by adding a Controller/Chief Accounting Officer,
we currently have only two persons in our accounting department,
one of whom is our Chief Financial Officer and the other of whom
is a clerk. We may encounter substantial difficulty attracting a
Controller/Chief Accounting Officer with requisite experience
due to the high level of competition for experienced financial
professionals.
Following completion of their audit of our financial statements
for 2005, 2004 and 2003, our independent auditors, Grant
Thornton, LLP, advised our Board of Directors and management
that during the course of their audit, they noted an internal
control deficiency constituting a significant deficiency and a
material weakness as defined in professional standards. The
deficiency noted related to our accounting for equity
instruments. Management intends to correct this weakness by
hiring a Controller/ Chief Accounting officer with significant
experience in preparing financial statements in accordance with
generally accepted accounting principles.
As a public reporting company, we will need to comply with the
Sarbanes-Oxley Act of 2002 and the related rules and regulations
of the SEC, including periodic reports, disclosures and more
complex accounting rules. As directed by Section 404 of
Sarbanes-Oxley, the SEC adopted rules requiring public companies
to include a report of management on a companys internal
control over financial reporting in their Annual Report on
Form 10-K. In addition, the independent registered public
accounting firm auditing our financial statements must attest to
and report on managements assessment of the effectiveness
of our internal control over financial reporting. If we close
this offering as planned during 2006, this requirement will
first apply to our Annual Report on Form 10-K for the
fiscal year ending December 31, 2007. If we are unable to
conclude that we have effective internal control over our
financial reporting at December 31, 2007, and future
year-ends as required by Section 404 of Sarbanes-Oxley,
investors could lose confidence in the reliability of our
financial statements, which could result in a decrease in the
value of our common stock.
Risks Related to Our Intellectual Property
We are dependent on our relationship and license agreement
with Brookhaven, and we rely upon the patents granted to us
pursuant to the license agreement.
All of our patent rights are derived from our license agreement
with Brookhaven Science Associates, as operator of Brookhaven
National Laboratory under contract with the United States
Department of Energy, or Brookhaven. Pursuant to this license
agreement, we have licensed rights under nine patents and two
patent applications in the United States, and 79 corresponding
patents and patent applications outside of the United States,
that were filed and obtained by Brookhaven relating to the use
of vigabatrin to treat addiction. The nine issued patents expire
between 2018 and 2020. We also have the right to future patents
obtained by Brookhaven relating to the use of vigabatrin in
treating addiction. See Our Business Patents
and Intellectual Property Rights for more information
about our license with Brookhaven and our licensed patents and
patent applications. These rights are subject to the right of
the U.S. government, under limited circumstances, to practice
the covered inventions for or on its own behalf. We may lose our
rights to these patents and patent applications if we breach our
obligations under the license agreement, including, without
limitation, our financial obligations to Brookhaven. If we
violate or fail to perform any term or covenant of the license
agreement, Brookhaven may terminate the license agreement upon
satisfaction of any applicable notice requirements and
expiration of any applicable cure periods. Additionally, any
termination of the license agreement, whether by us or by
Brookhaven, will not relieve us of our obligation to pay any
license fees owing at the time of such termination. If we fail
to retain our rights under the license agreement, we would not
be able to commercialize
15
CPP-109, and our business, results of operations, financial
condition and prospects would be materially adversely affected.
The license agreement also grants us rights to two pending U.S.
patent applications. These applications may not result in issued
patents. If patents are issued, any such patents might not
provide any commercial benefit to us.
If we obtain approval to market CPP-109, our commercial success
will depend in large part on our ability to use patents,
especially those licensed to us by Brookhaven, to exclude others
from competing with us. The patent position of emerging
pharmaceutical companies like us can be highly uncertain and
involve complex legal and technical issues. Until our licensed
patents are interpreted by a court, either because we have
sought to enforce them against a competitor or because a
competitor has preemptively challenged them, we will not know
the breadth of protection that they will afford us. Our patents
may not contain claims sufficiently broad to prevent others from
practicing our technologies or marketing competing products.
Third parties may intentionally design around our patents so as
to compete with us without infringing our patents. Moreover, the
issuance of a patent is not conclusive as to its validity or
enforceability, and so our patents may be invalidated or
rendered unenforceable if challenged by others.
As a result of the foregoing factors, we cannot be certain how
much protection from competition patent rights will provide us.
Our success will depend significantly on our ability to
operate without infringing the patents and other proprietary
rights of third parties.
There may be third-party patents whose claims we infringe. In
the event that our technologies infringe or violate the patent
or other proprietary rights of third parties, we may be
prevented from pursuing product development, manufacturing or
commercialization of our products that utilize such
technologies. There may be patents held by others of which we
are unaware that contain claims that our products or operations
infringe. In addition, given the complexities and uncertainties
of patent laws, there may be patents of which we are aware that
we may ultimately be held to infringe, particularly if the
claims of the patent are determined to be broader than we
believe them to be. Adding to this uncertainty, in the United
States, patent applications filed in recent years are
confidential for 18 months, while older applications are
not publicly available until the patent issues. As a result,
avoiding patent infringement may be difficult.
If a third party claims that we infringe its patents, any of the
following may occur:
|
|
|
|
|
we may be required to pay substantial financial damages if a
court decides that our technologies infringe a competitors
patent, which can be tripled if the infringement is deemed
willful, or be required to discontinue or significantly delay
development, marketing, selling and licensing of the affected
products and intellectual property rights; |
|
|
|
a court may prohibit us from selling or licensing our product
without a license from the patent holder, which may not be
available on commercially acceptable terms or at all, or which
may require us to pay substantial royalties or grant
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we may have to redesign our product so that it does not infringe
others patent rights, which may not be possible or could
require substantial funds or time. |
In addition, employees, consultants, contractors and others may
use the proprietary information of others in their work for us
or disclose our proprietary information to others. Either of
these events could lead to disputes over the ownership of
inventions derived from that information or expose us to
potential damages or other penalties.
The occurrence of any of these events could have a material
adverse effect on our business, financial condition, results of
operations or prospects.
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We may incur substantial costs as a result of litigation or
other proceedings relating to patent and other intellectual
property rights.
There is a history of substantial litigation and other
proceedings regarding patent and intellectual property rights in
the pharmaceutical industry. We may be forced to defend claims
of infringement brought by our competitors and others, and we
may institute litigation against others who we believe are
infringing our intellectual property rights. The outcome of
intellectual property litigation is subject to substantial
uncertainties and may, for example, turn on the interpretation
of claim language by the court, which may not be to our
advantage, or on the testimony of experts as to technical facts
upon which experts may reasonably disagree.
Under our license agreement with Brookhaven, we have the right
to bring legal action against any alleged infringers of the
patents we license. However, we are responsible for all costs
relating to such potential litigation. We have the right to any
proceeds received as a result of such litigation, but, even if
we are successful in such litigation, there is no assurance we
would be awarded any monetary damages.
Our involvement in intellectual property litigation could result
in significant expense to us. Some of our competitors have
considerable resources available to them and a strong economic
incentive to undertake substantial efforts to stop or delay us
from commercializing products. For example, in April 2006,
Ovation Pharmaceuticals, Inc., or Ovation, which holds rights in
North America to Sabril for the treatment of epilepsy, indicated
at an industry conference its intent to seek to develop Sabril
for the treatment of cocaine addiction. We believe that Ovation
would infringe our patent rights, and we would pursue
infringement claims against Ovation, if it seeks to
commercialize Sabril for this indication. However, we, unlike
Ovation and many of our other competitors, are a relatively
small company with comparatively few resources available to us
to engage in costly and protracted litigation. Moreover,
regardless of the outcome, intellectual property litigation
against or by us could significantly disrupt our development and
commercialization efforts, divert our managements
attention and quickly consume our financial resources.
In addition, if third parties file patent applications or issue
patents claiming technology that is also claimed by us in
pending applications, we may be required to participate in
interference proceedings with the U.S. Patent Office or in other
proceedings outside the U.S., including oppositions, to
determine priority of invention or patentability. Even if we are
successful in these proceedings, we may incur substantial costs,
and the time and attention of our management and scientific
personnel will be diverted from product development or other
more productive matters.
Risks Related to Government Regulation
We have not received regulatory approval in the United States
or any foreign jurisdiction for the commercial sale of any of
our product candidates. The regulatory approval process is
lengthy, and we may not be able to obtain all of the regulatory
approvals required to manufacture and commercialize our product
candidates.
We do not have any products that have been approved for
commercialization. We will not be able to commercialize our
products until we have obtained the requisite regulatory
approvals from federal, state and local government authorities.
To obtain regulatory approval of a product candidate, we must
demonstrate to the satisfaction of the applicable regulatory
agency that such product candidate is safe and effective for its
intended uses. The type and magnitude of the testing required
for regulatory approval varies depending on the product
candidate and the disease or condition for which it is being
developed. In addition, we must show that the facilities used to
produce the product candidate are in compliance with applicable
manufacturing regulations, which under FDA regulations are
called current Good Manufacturing Practices, or cGMP. In
general, these requirements mandate that manufacturers follow
elaborate design, testing, control, documentation and other
quality assurance procedures throughout the entire manufacturing
process. The process of obtaining regulatory approvals typically
takes several years and requires the expenditure of substantial
capital and other resources. Despite the time, expense and
resources invested by us in the approval process, we may not be
able to
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demonstrate that our product candidates are safe and effective,
in which event we would not receive the regulatory approvals
required to market them.
The FDA and other regulatory authorities generally approve
products for particular indications. While our current focus is
on the development of CPP-109 as a treatment of cocaine
addiction, we also intend to pursue CPP-109 as a treatment for
addictions to other substances involving heightened dopamine
levels, such as methamphetamine, nicotine, prescription pain
medications, alcohol and marijuana, and related addictive
disorders such as obesity and compulsive gambling. CPP-109 may
not be approved for any or all of the indications that we
request, which would limit the indications for which we can
promote it and adversely impact our ability to generate
revenues. If the approvals we obtain are limited, we may be
required to conduct costly, post-marketing follow-up studies.
Our receipt of Fast Track status does not mean that our
product development efforts will be accelerated.
The FDA has granted Fast Track designation for CPP-109 to treat
cocaine addiction. Fast Track designation means, among other
things, that the FDA may initiate review of sections of an NDA
before the application is complete in order to expedite
regulatory review of the application. However, Fast Track
designation does not accelerate clinical trials, nor does it
mean that the regulatory requirements necessary to obtain an
approval are less stringent. Our Fast Track designation does not
guarantee that we will qualify for, or be able to take advantage
of, priority review procedures following a submission of an NDA.
Additionally, our Fast Track designation may be withdrawn by the
FDA if the FDA believes that the designation is no longer
supported by data from our clinical development program, or if a
competitors product is approved for the indication we are
seeking.
If our non-clinical or clinical trials are unsuccessful or
significantly delayed, our ability to commercialize our products
will be impaired.
Before we can obtain regulatory approval for the sale of our
product candidates, we must conduct, at our own expense,
extensive non-clinical tests to demonstrate the safety of
CPP-109 in animals and
clinical trials to demonstrate the safety and efficacy of
CPP-109 in humans.
Non-clinical testing is expensive, difficult to design and
implement, can take several years to complete and is uncertain
as to outcome. Our non-clinical tests may produce negative or
inconclusive results, and on the basis of such results, we may
decide, or regulators may require us, to halt ongoing clinical
trials or conduct additional non-clinical testing.
In the United States, where vigabatrin is not currently approved
for use, we intend to commence during the fourth quarter of 2006
a Phase II clinical trial to assess the efficacy of using
CPP-109 as a treatment for cocaine addiction. We may also
develop and implement additional studies (including a U.S. Phase
III clinical trial, if required) in order to seek approval to
commercialize CPP-109 for the treatment of cocaine addiction.
However, even if the results of a clinical trial are promising,
a drug may subsequently fail to meet the safety and efficacy
standards required to obtain regulatory approvals. Future
clinical trials for CPP-109 may not be successfully completed or
may take longer than anticipated because of any number of
factors, including potential delays in the start of the trial,
an inability to recruit clinical trial participants at the
expected rate, failure to demonstrate safety and efficacy,
unforeseen safety issues, or unforeseen governmental or
regulatory delays.
Our U.S. Phase II clinical trial or any other study we might
develop and implement may not be completed in a timely manner or
at all. CPP-109 may not be found to be safe and effective, and
may not be approved by regulatory authorities for the proposed
indication, especially in light of known side effects associated
with the drug. Further, regulatory authorities and IRBs that
must approve and monitor the safety of each clinical study may
suspend a clinical study at any time if the patients
participating in such study are deemed to be exposed to any
unacceptable health risk. We may also choose to suspend clinical
trials and studies if we become aware of any such risks. We
might encounter problems in our U.S. Phase II clinical trial or
in other future
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studies we may conduct, including problems associated with VFDs
or other side effects that will cause us, regulatory authorities
or IRBs to delay or suspend such trial or study.
We have entered into an agreement with a contract manufacturer
to formulate and manufacture CPP-109 for use in our U.S. Phase
II clinical trial. In the event that sufficient quantities of
CPP-109 are not available by the time we begin the trial, we
intend to use Sabril in our clinical trials and subsequently
demonstrate the bioequivalence of CPP-109 to Sabril. If we are
unable to demonstrate that CPP-109 is bioequivalent to Sabril,
the FDA may require us to repeat or conduct additional Phase I
or Phase II clinical trials using CPP-109. This would result in
significant delays in our product development activities, which
would have a material adverse effect on our business.
We may encounter difficulties in our clinical trials due to the
nature of the addiction mechanism and our resulting target
patient population. We do not know how long it will take to
recruit patients for our Phase II clinical trial. Trial
participants will be required to meet specific clinical
standards for cocaine dependence, as specified in DSM-IV, a set
of diagnosis guidelines established for clinical professionals.
Further, participants must meet DSM-IV criteria only with
respect to cocaine dependence, and will not be eligible to
participate in our study if they meet the DSM-IV criteria for
dependence with respect to other addictive substances. Because
addicts are typically addicted to multiple substances, we may
not be able to recruit a sufficient number of eligible
participants within our anticipated timeframe or at all. In
addition, due to the neurological and physiological mechanisms
and implications of substance addiction, and as evidenced by our
pilot studies of vigabatrin, it is likely that many of our
clinical trial participants will not complete the trial. An
unusually low rate of completion will present challenges, such
as determining the statistical significance of trial results. In
addition, unrelated third parties, including Ovation, have
expressed interest in testing vigabatrin for the treatment of
drug abuse. If these third-party tests are unsuccessful, or if
they show significant health risk to the test subjects, our
development efforts may be adversely affected.
In other countries where CPP-109 or any other product we develop
may be marketed, we will also be subject to regulatory
requirements governing human clinical studies and marketing
approval for drugs. The requirements governing the conduct of
clinical studies, product licensing, pricing and reimbursement
varies widely from country to country.
We have not conducted any non-clinical testing for CPP-109
and we are not certain at this time which non-clinical tests the
FDA will require with respect to any NDA that we may file.
The FDA may require us to conduct extensive non-clinical testing
before approving our product. Some testing, such as
carcinogenicity studies, which seek to identify the potential of
a drug to cause tumors in animals and to assess the relevant
risk in humans, may require several years to conduct. We do not
know whether any non-clinical tests will begin as planned, will
need to be restructured or will be completed on schedule, if at
all. We do not know whether the non-clinical tests, if
conducted, will be acceptable to the FDA.
If the FDA does not accept an NDA from us based on the
results of our Phase II clinical trial, our development and
commercialization activities would be significantly delayed.
Generally, the process of seeking approval of an NDA requires
multiple pivotal trials, including a Phase II clinical
trial and a Phase III clinical trial. However, if the
results of our Phase II clinical trial in the United States are
compelling, we may elect to file an NDA on the basis of this
study and seek FDA review under its accelerated approval
process. Accelerated approval provides the opportunity for
regulatory approval based on achieving endpoints in our current
studies, which are designed to show the safety and efficacy of
CPP-109 to the FDAs satisfaction. However, we may not
succeed in reaching our endpoints or we may be forced to end our
trial if we find that trial participants are exposed to
significant health risks, or we otherwise may not successfully
complete our Phase II trial. Even if our Phase II trial is
successfully completed, the FDA will not likely accept an NDA on
the basis of a single study or review the NDA under the
accelerated approval process.
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Failure to obtain review on the basis of a single study or to
obtain accelerated approval could require us to complete
additional and more extensive clinical trials, which would be
costly and time-consuming and would delay potential FDA approval
of CPP-109 for several years. Even if we are able to obtain FDA
review under its accelerated approval process, we might not be
granted full approval for commercial sale.
If our third-party suppliers or contract manufacturers do not
maintain high standards of manufacturing in accordance with cGMP
and other manufacturing regulations, our development and
commercialization activities could suffer significant
interruptions or delays.
We rely, and intend to continue to rely, on third-party
suppliers and contract manufacturers to provide us with
materials for our clinical trials and commercial-scale
production of our products. These suppliers and manufacturers
must continuously adhere to cGMP as well as any applicable
corresponding manufacturing regulations outside of the U.S. In
complying with these regulations, we and our third-party
suppliers and contract manufacturers must expend significant
time, money and effort in the areas of design and development,
testing, production, record-keeping and quality control to
assure that our products meet applicable specifications and
other regulatory requirements. Failure to comply with these
requirements could result in an enforcement action against us,
including the seizure of products and shutting down of
production. Any of these third-party suppliers or contract
manufacturers will also be subject to audits by the FDA and
other regulatory agencies. If any of our third-party suppliers
or contract manufacturers fail to comply with cGMP or other
applicable manufacturing regulations, our ability to develop and
commercialize our products could suffer significant
interruptions and delays.
Reliance on third-party manufacturers entails risks to which we
would not be subject if we manufactured the product ourselves,
including:
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reliance on the third party for regulatory compliance and
quality assurance; |
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limitations on supply availability resulting from capacity and
scheduling constraints of the third parties; |
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impact on our reputation in the marketplace if manufacturers of
our products, once commercialized, fail to meet the demands of
our customers; |
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the possible breach of the manufacturing agreement by the third
party because of factors beyond our control; and |
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the possible termination or nonrenewal of the agreement by the
third party, based on its own business priorities, at a time
that is costly or inconvenient for us. |
If any of our contract manufacturers fail to achieve and
maintain high manufacturing standards, patients using our
product candidates could be injured or die, resulting in product
liability claims, product recalls, product seizures or
withdrawals, delays or failures in testing or delivery, cost
overruns or other problems that could seriously harm our
business or profitability.
Post-approval marketing of our products will be subject to
substantial government regulation. Failure to comply with these
regulations could result in fines and withdrawal of
approvals.
Even if our products receive regulatory approvals, we will be
subject to extensive ongoing government regulation. The FDA or
other regulatory authorities may impose additional limitations
on the indicated uses for which a product may be marketed,
subsequently withdraw approval or take other actions against us
or our products for many reasons, including subsequent
discoveries of previously unknown problems or safety issues with
the product. Also, based on subsequent events or other
circumstances that may come to our attention, we may voluntarily
take action to limit the marketing or use of one or more of our
products. We may also be required to conduct additional
post-approval clinical studies.
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In particular, we are subject to inspection and market
surveillance by regulatory authorities for compliance with
regulations that prohibit the promotion of a medical product for
a purpose or indication other than those for which approval has
been granted. While a medical product manufacturer may not
promote a product for such off-label use, doctors
are allowed, in the exercise of their professional judgment in
the practice of medicine, to use a product in ways not approved
by regulatory authorities. A pattern of widespread off-label use
could cause regulatory authorities to scrutinize our marketing
activities.
Regulatory authorities have broad enforcement power, and any
failure by us to comply with manufacturing or marketing
regulations could result in penalties, including warning
letters, fines, total or partial suspension of production,
product recalls or seizures, withdrawals of previously approved
marketing approvals or applications, and criminal prosecutions.
Substantial and changing healthcare regulations by state and
federal authorities could reduce or eliminate our commercial
opportunity in the addiction treatment industry.
Healthcare organizations, public and private, continue to change
the manner in which they operate and pay for services. These
organizations have had to adapt to extensive and complex
federal, state and local laws, regulations and judicial
decisions governing activities including drug manufacturing and
marketing. Additionally, the healthcare industry in recent years
has been subject to increasing levels of government regulation
of reimbursement rates and capital expenditures. We believe that
the industry will continue to be subject to increasing
regulation, as well as political and legal action, as future
proposals to reform the healthcare system are considered by
Congress and state legislatures. Any new legislative
initiatives, if enacted, may further increase government
regulation of or other involvement in healthcare, lower
reimbursement rates and otherwise change the operating
environment for healthcare companies. We cannot predict the
likelihood of all future changes in the healthcare industry in
general, or the addiction treatment industry in particular, or
what impact they may have on our earnings, financial condition
or business. Government regulations applicable to our proposed
products or the interpretation thereof might change and thereby
prevent us from marketing some or all of our products and
services for a period of time or indefinitely.
Risks Related to this Offering and Our Common Stock
We are highly dependent on our small number of key personnel
and advisors.
We are highly dependent on our officers, on our Board of
Directors and on our scientific advisors. The loss of the
services of any of these individuals could significantly impede
the achievement of our scientific and business objectives. Other
than employment agreements that will become effective upon
completion of this offering with Patrick J. McEnany, our
Chairman and Chief Executive Officer, and Jack Weinstein, our
Chief Financial Officer, with respect to their services, and the
consulting agreements we have with one of our board members and
one of our scientific advisors, we have no employment or
retention agreements with our officers, directors or scientific
advisors. If we lose the services of any of our existing
officers, directors or scientific advisors, or if we were unable
to recruit qualified replacements on a timely basis for persons
who leave our employ, our efforts to develop CPP-109 or other
products might be significantly delayed. We do not carry key-man
insurance on any of our personnel.
We have relationships with our scientific advisers and
collaborators at academic and other institutions. Such
individuals are employed by entities other than us and may have
commitments to, or consulting advisory contracts with, such
entities that may limit their availability to us. Although each
scientific advisor and collaborator has agreed not to perform
services for another person or entity that would create an
appearance of a conflict of interest, the Chairman of our
Scientific Advisory Board, Stephen L. Dewey, Ph.D., is a member
of the Brookhaven staff and is actively involved in
Brookhavens investigation of the neurological mechanisms
involved in the addiction process. His research might result in
pharmaceutical products that are competitive with,
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or superior to, vigabatrin. Similarly, other similar conflicts
may arise from the work in which other scientific advisers
and/or collaborators are involved.
We are effectively controlled by our Chairman and Chief
Executive Officer.
Prior to this offering, our Chairman and Chief Executive
Officer, Patrick J. McEnany, beneficially owns approximately
40.0% of our outstanding common stock. Following this offering,
we expect that Mr. McEnany will beneficially own
approximately % of our outstanding common stock. As
a result, it is likely that Mr. McEnany will continue to own
sufficient shares of our common stock to be in a position to
significantly influence or exert control over the outcome of
most stockholder actions, including the election of all
directors. As a result, Mr. McEnany could take actions that
might not be considered by other stockholders to be in their
best interest.
There has been no prior market for our common stock, and it
may trade at prices below the initial public offering price.
Prior to this offering, there has been no public market for our
common stock. We cannot predict the extent to which a trading
market for our common stock will develop or be sustained after
this offering. The initial public offering price will be
determined by negotiations between us and the representatives of
the underwriters based on factors that may not be indicative of
future performance, and may not bear any relationship to the
price at which our common stock will trade upon completion of
this offering. You may be unable to sell your shares of common
stock at or above the initial public offering price.
The trading price of the shares of our common stock could be
highly volatile.
The trading price of the shares could be highly volatile in
response to various factors, many of which are beyond our
control, including:
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developments concerning our clinical studies and trials; |
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announcements of product development failures and successes by
us or our competitors; |
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new products introduced or announced by us or our competitors; |
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changes in reimbursement levels; |
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changes in financial estimates by securities analysts; |
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actual or anticipated variations in operating results; |
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expiration or termination of licenses (particularly our license
from Brookhaven), research contracts or other collaboration
agreements; |
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conditions or trends in the regulatory climate and the
biotechnology and pharmaceutical industries; |
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intellectual property, product liability or other litigation
against us; |
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changes in the market valuations of similar companies; and |
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sales of shares of our common stock, particularly sales by our
officers, directors and significant stockholders, or the
perception that such sales may occur. |
In addition, equity markets in general, and the market for
emerging pharmaceutical and life sciences companies in
particular, have experienced substantial price and volume
fluctuations that have often been unrelated or disproportionate
to the operating performance of companies traded in those
markets. In addition, changes in economic conditions in the
United States, Europe or globally could impact our ability to
grow profitably. Adverse economic changes are outside our
control and may result in material adverse impacts on our
business or financial results. These broad market and industry
factors may materially affect the market price of
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our shares, regardless of our own development and operating
performance. In the past, following periods of volatility in the
market price of a companys securities, securities
class-action litigation has often been instituted against that
company. Such litigation, if instituted against us, could cause
us to incur substantial costs and divert managements
attention and resources, which could have a material adverse
effect on our business, financial condition and results of
operations.
You will experience immediate and substantial dilution as a
result of this offering.
If you purchase common stock in this offering, you will pay more
for your shares than the amounts paid by existing stockholders
for their shares in prior offerings. In addition, you will
experience immediate and substantial dilution insofar as the
initial public offering price will be substantially greater than
the tangible book value per share of our outstanding common
stock after giving effect to this offering. See
Dilution. Additionally, we may in the future require
additional financing, and we may seek such financing by means of
additional equity issuances. If this occurs, your interests in
our common stock may experience further dilution.
We have broad discretion in the use of the proceeds from this
offering. Our use of the offering proceeds may not yield a
favorable return on your investment.
We expect to use the net proceeds from this offering to develop
and fund clinical studies of our product candidates and for
general corporate purposes, including the potential acquisition
or in-license of products that may have potential applications
in treating addiction. Our management has broad discretion over
how these proceeds are used and could spend the proceeds in ways
with which you do not agree. Pending the use of the proceeds in
this offering, we plan to invest them. However, the proceeds may
not be invested effectively or in a manner that yields a
favorable or any return, and consequently, this could result in
financial losses that could have a material adverse effect on
our business, cause the price of our common stock to decline and
delay the development of our product candidates.
Our business may require additional capital.
Our business goals include developing CPP-109 for use in
treating various addictions, including cocaine and
methamphetamine addiction. While we expect that the proceeds of
this offering will allow us to complete all of the clinical and
non-clinical trials required to seek approval of an NDA for
CPP-109 to treat
cocaine and methamphetamine addiction, our expectation, which is
based on information available to us at the date of this
prospectus, may not be correct. Further, we intend to develop
clinical studies to seek commercialization of
CPP-109 for nicotine
addiction and to commercialize
CPP-109 for sale in
Europe. While we have allocated a portion of the proceeds of the
offering to develop and commence these studies, these studies
have not yet been developed and we do not know the ultimate
costs of these studies. If we need additional funds to complete
required studies on
CPP-109 to treat
cocaine addiction and methamphetamine addiction, or as we move
closer to organizing studies regarding nicotine addiction or
relating to our efforts to obtain approvals for
CPP-109 in Europe, we
will require additional funding to pay such costs. There can be
no assurance that required funds will be available, or even if
they are available, that such funds will be available on terms
acceptable to us. Further, to the extent that we raise such
funds through collaborative arrangements, it may be necessary to
relinquish some of the rights to our technologies or grant
sublicenses on terms that are not favorable to us. If we are not
able to raise required funds, it may have an adverse impact on
our business and prospects.
Delaware law and our certificate of incorporation and by-laws
contain provisions that could delay and discourage takeover
attempts that stockholders may consider favorable.
Certain provisions of our certificate of incorporation and
by-laws, and applicable provisions of Delaware corporate law,
may make it more difficult for or prevent a third party from
acquiring control of us or changing our board of directors and
management. These provisions include:
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the ability of our board of directors to issue preferred stock
with voting or other rights or preferences; |
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limitations on the ability of stockholders to amend our charter
documents, including stockholder supermajority voting
requirements; |
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the inability of stockholders to act by written consent or to
call special meetings; |
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requirements that special meetings of our stockholders may only
be called by the board of directors; and |
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advance notice procedures our stockholders must comply with in
order to nominate candidates for election to our board of
directors or to place stockholders proposals on the agenda
for consideration at meetings of stockholders. |
In addition, Section 203 of the Delaware General
Corporation Law generally prohibits us from engaging in a
business combination with any person who owns 15% or more of our
common stock for a period of three years from the date such
person acquired such common stock, unless board or stockholder
approval is obtained. These provisions could make it difficult
for a third party to acquire us, or for members of our board of
directors to be replaced, even if doing so would be beneficial
to our stockholders.
Any delay or prevention of a change of control transaction or
changes in our board of directors or management could deter
potential acquirors or prevent the completion of a transaction
in which our stockholders could receive a substantial premium
over the then current market price for their shares.
Future sales of our common stock may cause our stock price to
decline.
After this offering, we will
have shares
of our common stock outstanding, of
which shares
will be restricted securities. The holders of % of
our restricted shares have entered into lock-up agreements with
the underwriters under which they have agreed not to sell their
shares of common stock for 180 days from the date of this
prospectus without the prior written consent of the
underwriters. We also intend to register for future sale the
1,500,000 shares of common stock that we may issue under our
2006 Stock Incentive Plan and the 1,603,000 shares of common
stock underlying our outstanding stock options. Sales of
restricted shares or shares underlying stock options, or the
perception in the market that the holders of a large number of
shares intend to sell shares, could reduce the market price of
our common stock.
We do not intend to pay cash dividends on our common stock in
the foreseeable future.
We have never declared or paid any cash dividends on our common
stock or other securities, and we currently do not anticipate
paying any cash dividends in the foreseeable future.
Accordingly, investors should not invest in our common stock if
they require dividend income. Our stockholders will not realize
a return on their investment unless the trading price of our
common stock appreciates, which is uncertain and unpredictable.
Our common stock may not appreciate in value after the offering
or even maintain the price at which investors purchased shares.
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FORWARD-LOOKING STATEMENTS
Certain statements made in this prospectus are
forward-looking statements, including statements
regarding our expectations, beliefs, plans or objectives for
future operations and anticipated results of operations. For
this purpose, any statements contained herein that are not
statements of historical fact may be deemed to be
forward-looking statements. Without limiting the foregoing, the
words, believes, anticipates,
proposes, plans, expects,
intends, may and similar expressions are
intended to identify forward-looking statements. Such statements
involve known and unknown risks, uncertainties and other factors
that may cause our actual results, performance or achievements
to be materially different from any future results, performance
or achievements expressed or implied by such forward-looking
statements. The forward-looking statements made in this
prospectus are based on current expectations that involve
numerous risks and uncertainties, including but not limited to
the following:
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our ability to successfully complete clinical trials required to
file and obtain approval of an NDA for the commercialism of
CPP-109, and the timing of any such filing and approval; |
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our ability to protect our intellectual property rights; |
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market acceptance of any products as to which we may receive
approval for commercialization; |
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the ability of others to develop, obtain approval of, and
commercialize competitive products; and |
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the information contained in the Risk Factors
section. |
Our current plans and objectives are based on assumptions
involving the growth and expansion of our business. Although we
believe that our assumptions are reasonable, any of our
assumptions could prove inaccurate. In light of the significant
uncertainties inherent in the forward-looking statements made in
this prospectus, which reflect our views only as of the date of
this prospectus, you should not place undue reliance upon such
statements.
25
USE OF PROCEEDS
The net proceeds to us from the sale of the securities offered
hereby are estimated to be approximately
$ ,
assuming an initial public offering price of
$ ,
and after deducting underwriting discounts and commissions and
estimated offering expenses. Each $1.00 increase
(decrease) in the assumed initial public offering price of
$ per
share would increase (decrease) the net proceeds to us from
this offering by approximately
$ ,
assuming that the number of shares offered by us, as set forth
on the cover page of this prospectus, remains the same.
Depending on market conditions at the time of pricing of this
offering and other considerations, we may sell fewer or more
shares than the number set forth on the cover page of this
prospectus. If the underwriters exercise their over-allotment
option in full, we estimate that our net proceeds will be
approximately
$ .
We expect to use approximately $26.0 million of the net
proceeds of this offering to complete the clinical studies and
non-clinical studies that we believe, based on currently
available information will be required for us to file an NDA for
the use of CPP-109 to
treat cocaine addiction and methamphetamine addiction, as
follows:
|
|
|
|
|
|
approximately $7.0 million will be used to fund our U.S.
Phase II clinical trial to evaluate CPP-109 for the treatment of
cocaine addiction; |
|
|
|
|
|
approximately $7.5 million will be used to fund a U.S.
Phase III clinical trial to evaluate CPP-109 for the treatment
of cocaine addiction, if required; |
|
|
|
|
|
up to approximately $4.0 million will be used to fund other
costs relating to our filing of an NDA for CPP-109 to treat
cocaine addiction, including any other clinical and non-clinical
studies that may be required; and |
|
|
|
|
|
approximately $7.5 million will be used to fund required
clinical studies and trials to evaluate CPP-109 as a treatment
for methamphetamine addiction and to fund costs relating to our
regulatory filings to seek approval for the use of CPP-109 to
treat methamphetamine addiction. |
|
We also expect to use approximately $5.0 million of the net
proceeds of this offering to organize clinical studies and
trials to evaluate CPP-109 as a treatment for nicotine addiction
and to initiate the clinical studies and trials needed to seek
approvals to commercialize CPP-109 in Europe. We have not yet
developed any of the studies required for these purposes, do not
yet have estimates of their costs and expect that we will need
to raise additional funding to complete these studies.
Additional net proceeds will be used for general corporate
purposes, including rent payments for our office facility,
compensation payments to our executive officers and employees,
and professional fees.
The above amounts represent our estimate of the costs to fund
the above clinical programs. However, we cannot assure you that
we will be able to complete our trials with the amounts
specified, and the costs we incur may be well in excess of the
above amounts.
In addition, we may use a portion of the net proceeds from this
offering to acquire or license one or more products that show
promise in treating addiction. However, we currently have no
commitments, agreements, or understandings relating to any such
acquisition.
We believe that the net proceeds from this offering, together
with our existing cash, cash equivalents and short-term
investments, will be sufficient to meet our projected operating
requirements for the next 30 months.
The allocation of the net proceeds of this offering described
above represents our best current estimate of our projected
operating requirements. However, the exact amount and timing of
our expenditures will depend on several factors, including the
success of our commercialization activities and the progress of
our clinical trials
26
and other development efforts as well as the amount of cash used
in our operations. Accordingly, our management will have broad
discretion in the application of the net proceeds and investors
will be relying on the judgment of our management regarding the
application of the proceeds of this offering. We reserve the
right to change the use of these proceeds as a result of certain
contingencies such as the results of our commercialization
efforts, competitive developments, opportunities to acquire or
in-license products, and other factors.
Pending the uses described above, we plan to invest the net
proceeds of this offering in short and medium-term, interest
bearing obligations, investment-grade instruments, certificates
of deposit or direct or guaranteed obligations of the U.S.
government.
DIVIDEND POLICY
We have not in the past and do not intend in the foreseeable
future to pay cash dividends. We expect to retain future
earnings, if any, to fund the development and growth of our
business. The declaration of dividends is subject to the
discretion of our board of directors and will depend on various
factors, including our results of operations, financial
condition, future prospects and any other factors deemed
relevant by our board of directors. In addition, the terms of
any future debt or credit facility may preclude us from paying
dividends on our common stock.
27
CAPITALIZATION
The following table sets forth our capitalization as of
June 30, 2006:
|
|
|
|
|
|
on an actual basis; |
|
|
|
|
|
on a pro forma basis to give effect to our completion on
July 24, 2006 of a private placement of 7,644 shares
of our Series B Preferred Stock from which we received net
proceeds of $3,225,140, the automatic conversion of these
Series B preferred shares upon the closing of this offering
into 764,400 shares of our common stock, the automatic
conversion upon the closing of this offering of the outstanding
Series A Preferred Stock into 700,000 shares of our common
stock, and the issuance of 97,500 shares of our common stock in
July 2006 relating to services performed for us by certain of
our consultants and scientific advisors during 2004, 2005 and
the first six months of 2006; and |
|
|
|
|
on a pro forma as adjusted basis to give further effect to our
sale
of shares
of common stock in this offering at an assumed initial public
offering price of
$ per
share and our receipt of an estimated
$ in
net proceeds therefrom, after deducting underwriting discounts
and commissions and estimated offering expenses to be paid by us. |
This table should be read in conjunction with
Managements Discussion and Analysis of Financial
Condition and Results of Operations, and the financial
statements and the related notes and schedules thereto, included
elsewhere in this prospectus.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2006 | |
|
|
| |
|
|
|
|
Pro forma as | |
|
|
Actual | |
|
Pro forma | |
|
adjusted(1) | |
|
|
| |
|
| |
|
| |
Cash and cash equivalents
|
|
$ |
324,154 |
|
|
$ |
3,549,294 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders equity (deficit)
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred stock, $.01 par value, 5,000,000 shares authorized;
70,000 shares actual, no shares pro forma and pro forma as
adjusted
|
|
$ |
700 |
|
|
$ |
|
|
|
$ |
|
|
Common stock, $.01 par value, 100,000,000 shares authorized;
issued and outstanding: 4,720,000 shares actual, 6,281,900
shares pro forma;
and shares
pro forma as adjusted
|
|
|
47,200 |
|
|
|
62,819 |
|
|
|
|
|
Additional paid-in capital
|
|
|
3,579,447 |
|
|
|
6,984,668 |
|
|
|
|
|
Accumulated deficit
|
|
|
(3,696,585 |
) |
|
|
(3,696,585 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total stockholders equity (deficit)
|
|
|
(69,238 |
) |
|
|
3,350,902 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total capitalization
|
|
$ |
(69,238 |
) |
|
$ |
3,350,902 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
Each $1.00 increase (decrease) in the assumed initial
public offering price of
$ per
share would increase (decrease) each of cash and cash
equivalents, additional paid-in capital, total
shareholders equity and total capitalization by
approximately $ million, assuming that the
number of shares offered by us, as set forth on the cover page
of this prospectus, remains the same. Depending on market
conditions at the time of pricing of this offering and other
considerations, we may sell fewer or more shares than the number
set forth on the cover page of this prospectus. The pro forma as
adjusted information discussed above is illustrative only and
following the completion of this offering will be adjusted based
on the actual initial public offering price and other terms of
this offering determined at pricing. |
The above table excludes 1,603,000 shares of common stock
underlying options outstanding on the date of this prospectus at
a weighted average exercise price of $1.67 per share.
28
DILUTION
If you invest in our common stock, your interest will be diluted
immediately to the extent of the difference between the initial
public offering price per share you pay in this offering and the
pro forma as adjusted net tangible book value per share of our
common stock immediately after this offering. Our pro forma net
tangible book value as of June 30, 2006, was $3,350,902, or
$0.53 per share. Pro forma net tangible book value per share
represents our tangible assets less total liabilities divided by
the 6,281,900 shares of our common stock outstanding, after
giving pro forma effect to our sale in July 2006 of 7,644 shares
of Series B Preferred Stock for net proceeds of $3,225,140;
the issuance in July 2006 of 97,500 shares of our common stock
for services; and the automatic conversion, upon completion of
this offering, of all outstanding shares of our convertible
preferred stock into an aggregate of 1,464,400 shares of our
common stock.
After giving effect to the sale
of shares
of common stock in this offering, at an assumed initial public
offering price of
$ per
share, and after deducting the estimated offering expenses, our
pro forma as adjusted net tangible book value at June 30,
2006 would have been approximately
$ ,
or approximately
$ per
share of common stock. This represents an immediate increase in
net tangible book value of approximately
$ to
our existing stockholders and an immediate dilution of
$ per
share to new investors in this offering.
The following table illustrates this calculation.
|
|
|
|
|
|
|
|
|
|
Assumed initial public offering price per share
|
|
|
|
|
|
$ |
|
|
|
Pro forma net tangible book value per share as of June 30,
2006
|
|
$ |
0.53 |
|
|
|
|
|
|
Increase per share attributable to this offering
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net tangible book value per share after this offering
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dilution per share to new investors
|
|
|
|
|
|
$ |
|
|
|
|
|
|
|
|
|
Each $1.00 increase (decrease) in the assumed initial
offering price of
$ per
share would increase (decrease) our pro forma as adjusted
net tangible book value by approximately
$ ,
or approximately
$ per
share, and dilution to new investors by
$ per
share, assuming that the number of shares offered by us, as set
forth on the cover page of this prospectus, remains the same.
Depending on market conditions at the time of pricing of this
offering and other considerations, we may sell fewer or more
shares than the number set forth on the cover page of this
prospectus.
If the underwriters exercise their over-allotment option in
full, our pro forma as adjusted net tangible book value as of
June 30, 2006 will increase to approximately
$ per
share, representing an increase to existing stockholders of
approximately
$ per
share, and there will be an immediate dilution of approximately
$ per
share to new investors.
The following table summarizes, on a pro forma as adjusted basis
as of June 30, 2006, the total number of shares of our
common stock purchased from us and the total consideration and
average price per share paid by existing stockholders and by new
investors:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares Purchased | |
|
Total Consideration Paid | |
|
|
|
|
| |
|
| |
|
Average Price Per | |
|
|
Number | |
|
Percent | |
|
Amount | |
|
Percent | |
|
Share | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
Existing stockholders
|
|
|
6,281,900 |
|
|
|
% |
|
|
$ |
5,334,140 |
|
|
|
% |
|
|
$ |
0.85 |
|
New investors
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
|
|
|
|
100% |
|
|
$ |
|
|
|
|
100% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Each $1.00 increase (decrease) in the assumed initial
public offering price of
$ per
share would increase (decrease) total consideration paid by
new investors, total consideration paid by all stockholders and
the average price per share paid by all stockholders by
$ ,
$ and
$ ,
respectively,
29
assuming that the number of shares offered by us, as set forth
on the cover page of this prospectus, remains the same.
Depending on market conditions at the time of pricing of this
offering and other considerations, we may sell fewer or more
shares than the number set forth on the cover page of this
prospectus.
If the underwriters exercise their over-allotment option in
full, the percentage of shares held by existing stockholders
will decrease to
approximately %,
and the number of shares held by new investors will increase
to ,
or
approximately %.
30
SELECTED FINANCIAL DATA
The following table sets forth our selected financial data
for each of the three years ended December 31, 2005 and as
of December 31, 2005 and 2004, which have been derived from
our audited financial statements included elsewhere in this
prospectus. In addition, the table includes selected financial
data for the six months ended June 30, 2006 and 2005, and
as of June 30, 2006, which have been derived from our
unaudited interim financial statements included elsewhere in
this prospectus. The table also includes unaudited data for the
year ended December 31, 2002 and as of December 31,
2003 and 2002, which are not included in this prospectus. Our
predecessor company was incorporated in 2002. It is important
that you read this information together with
Managements Discussion and Analysis of Financial
Condition and Results of Operations, Risk
Factors and our financial statements and the related notes
and schedules to these financial statements beginning on Page
F-1 of this prospectus. The results presented below are not
necessarily indicative of results to be expected in any future
periods.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period from | |
|
Cumulative period | |
|
|
|
|
|
|
January 4, 2002 | |
|
from January 4, | |
|
|
Six Months Ended June 30, | |
|
Year Ended December 31, | |
|
(date of inception) | |
|
2002 (date of | |
|
|
| |
|
| |
|
through | |
|
inception) through | |
|
|
2006 | |
|
2005 | |
|
2005 | |
|
2004 | |
|
2003 | |
|
December 31, 2002 | |
|
June 30, 2006 | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
|
|
|
|
|
|
|
|
(unaudited) | |
|
(unaudited) | |
|
|
(unaudited) | |
|
|
|
|
|
|
|
|
|
|
Statement of Operations Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
Operating costs and expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
432,764 |
|
|
|
1,200,769 |
|
|
|
1,462,889 |
|
|
|
378,829 |
|
|
|
268,829 |
|
|
|
137,680 |
|
|
|
2,680,416 |
|
|
General and administrative
|
|
|
242,194 |
|
|
|
126,811 |
|
|
|
359,279 |
|
|
|
164,704 |
|
|
|
165,483 |
|
|
|
118,265 |
|
|
|
1,049,925 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
674,958 |
|
|
|
1,327,580 |
|
|
|
1,822,168 |
|
|
|
542,958 |
|
|
|
434,312 |
|
|
|
255,945 |
|
|
|
3,730,341 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
(674,958 |
) |
|
|
(1,327,580 |
) |
|
|
(1,822,168 |
) |
|
|
(542,958 |
) |
|
|
(434,312 |
) |
|
|
(255,945 |
) |
|
|
(3,730,341 |
) |
Interest income
|
|
|
8,133 |
|
|
|
5,908 |
|
|
|
16,788 |
|
|
|
3,138 |
|
|
|
5,697 |
|
|
|
|
|
|
|
33,756 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before income taxes
|
|
|
(666,825 |
) |
|
|
(1,321,672 |
) |
|
|
(1,805,380 |
) |
|
|
(539,820 |
) |
|
|
(428,615 |
) |
|
|
(255,945 |
) |
|
|
(3,696,585 |
) |
Provision for income taxes
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$ |
(666,825 |
) |
|
$ |
(1,321,672 |
) |
|
$ |
(1,805,380 |
) |
|
$ |
(539,820 |
) |
|
$ |
(428,615 |
) |
|
$ |
(255,945 |
) |
|
$ |
(3,696,585 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share
|
|
$ |
(0.14 |
) |
|
$ |
(0.35 |
) |
|
$ |
(0.42 |
) |
|
$ |
(0.27 |
) |
|
$ |
(0.21 |
) |
|
$ |
(0.16 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares outstanding basic and diluted
|
|
|
4,720,000 |
|
|
|
3,767,033 |
|
|
|
4,252,219 |
|
|
|
2,000,000 |
|
|
|
2,000,000 |
|
|
|
1,616,438 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pro forma basic and diluted net loss per
share(1)
|
|
$ |
(0.12 |
) |
|
|
|
|
|
$ |
(0.36 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pro forma weighted average shares outstanding basic
and
diluted(1)
|
|
|
5,420,000 |
|
|
|
|
|
|
|
4,952,219 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
Pro forma gives effect to the conversion of shares of our
Series A Preferred Stock into 700,000 shares of our common
stock as if such shares of Series A Preferred Stock had
been converted into common stock as of the earlier of
January 1, 2005 or the beginning of the reporting period.
Such shares of Series A Preferred Stock will automatically
convert into common stock on the closing of this offering. |
31
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, | |
|
|
Pro forma June 30, | |
|
June 30, | |
|
| |
|
|
2006(1) | |
|
2006 | |
|
2005 | |
|
2004 | |
|
2003 | |
|
2002 | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
(unaudited) | |
|
(unaudited) | |
|
|
|
|
|
|
|
(unaudited) | |
Balance Sheet Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$ |
3,549,294 |
|
|
$ |
324,154 |
|
|
$ |
771,127 |
|
|
$ |
183,911 |
|
|
$ |
416,262 |
|
|
$ |
107,089 |
|
Working capital (deficiency)
|
|
|
3,312,624 |
|
|
|
(107,516 |
) |
|
|
428,579 |
|
|
|
116,111 |
|
|
|
362,563 |
|
|
|
40,388 |
|
Total assets
|
|
|
3,590,253 |
|
|
|
365,113 |
|
|
|
789,450 |
|
|
|
185,376 |
|
|
|
416,262 |
|
|
|
111,589 |
|
Total liabilities
|
|
|
239,351 |
|
|
|
434,351 |
|
|
|
342,988 |
|
|
|
67,800 |
|
|
|
53,699 |
|
|
|
66,701 |
|
Stockholders equity (deficit)
|
|
|
3,350,902 |
|
|
|
(69,238 |
) |
|
|
446,462 |
|
|
|
117,576 |
|
|
|
362,563 |
|
|
|
44,888 |
|
|
|
(1) |
Pro forma gives effect to our completion of a private placement
on July 24, 2006 of 7,644 shares of our Series B
Preferred Stock from which we received net proceeds of
$3,225,140, the automatic conversion of these Series B
preferred shares upon the closing of this offering into 764,400
shares of our common stock, the automatic conversion of our
outstanding Series A Preferred Stock into 700,000 shares of
our common stock on the closing of this offering, and the
issuance of 97,500 shares of our common stock in July 2006
relating to services performed for us by certain of our
consultants and scientific advisors during 2004, 2005 and the
first six months of 2006. |
32
MANAGEMENTS DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion and analysis should be read in
conjunction with our financial statements and the related notes
and schedule thereto appearing elsewhere in this prospectus.
This discussion and analysis may contain forward-looking
statements based upon current expectations that involve risks
and uncertainties. Our actual results may differ materially as a
result of various factors, including those set forth in
Risk Factors or elsewhere in this prospectus.
Overview
We are a specialty pharmaceutical company focused on the
development and commercialization of prescription drugs for the
treatment of drug addiction. Our initial product candidate is
CPP-109, which is based on the chemical compound
gamma-vinyl-GABA, commonly referred to as vigabatrin.
We have a small management team and very few employees. This has
resulted in low general and administrative expenses and overhead
relative to other companies of a similar size at a similar stage
of development. We have brought together a group of consultants
and a scientific advisory board whose members we believe are
among the most respected researchers in the field of addiction
therapy. We have also benefited from the extensive early-stage
research by Brookhaven studying the use of vigabatrin to treat
addiction. This has allowed us to move our product development
efforts forward to the point we are at today without having to
build a large infrastructure or to expend significant financial
resources for basic research.
The successful development of CPP-109 or any other product we
may develop, acquire, or license is highly uncertain. We cannot
reasonably estimate or know the nature, timing, or estimated
expenses of the efforts necessary to complete the development
of, or the period in which material net cash inflows are
expected to commence due to the numerous risks and uncertainties
associated with developing, such products, including the
uncertainty of:
|
|
|
|
|
the scope, rate of progress and expense of our clinical trials
and our other product development activities; |
|
|
|
the results of future clinical trials, and the number of
clinical trials (and the scope of such trials) that will be
required to seek and obtain approval of an NDA for CPP-109; and |
|
|
|
the expense of filing, prosecuting, defending and enforcing any
patent claims and other intellectual property rights. |
Research and development expenses, in the aggregate, represented
approximately 64%, 81%, 70% and 62% of our total operating
expenses for the six months ended June 30, 2006 and the
years ended December 31, 2005, 2004 and 2003, respectively.
Research and development expenses consist primarily of costs
incurred for clinical trials and development costs related to
CPP-109, personnel and related costs related to our product
development activities, and outside professional fees related to
clinical development and regulatory matters.
We expect that our research and development expenses will
substantially increase as a percentage of our total expenses due
to the estimated expense of our planned U.S. Phase II clinical
trial, and our anticipated costs related to the clinical trial
to be conducted in Mexico, and the ongoing cocaine craving
study. We estimate that we will incur approximately
$18.5 million in expenses, in addition to costs previously
incurred, for our further clinical trials and development costs
for CPP-109 to treat cocaine addiction. These estimates assume
that a U.S. Phase III clinical trial will be required by the FDA
before we are able to obtain approval of an NDA for CPP-109. A
portion of the net proceeds of this offering will be used to
fund all such expenses. We do not expect that we will be able to
commercialize CPP-109 for at least two to three years following
this offering.
The above costs include assumptions about events that may be
outside of our control. For example, the FDA could require us to
alter or delay our clinical trials at any stage, which may
significantly increase the costs of that trial, as well as delay
our commercialization of CPP-109 and our future revenue.
33
Basis of Presentation
We are a development stage company and have had no revenues to
date. We will not have revenues until such time as we receive
approval of CPP-109 and successfully commercialize our product,
of which there can be no assurance.
|
|
|
Research and development expenses |
Our research and development expenses consist of costs incurred
for company-sponsored research and development activities. These
expenses consist primarily of direct and research-related
allocated overhead expenses such as facilities costs, material
supply costs, and medical costs for VFD testing. It also
includes both cash and non-cash compensation paid to our
scientific advisors and consultants related to our product
development efforts. To date, all of our research and
development resources have been devoted to the development of
CPP-109. We expect this to continue for the foreseeable future.
Costs incurred in connection with research and development
activities are expensed as incurred.
Clinical trial activities require significant expenditures up
front. We anticipate paying significant portions of a
trials cost before any clinical trial begins, and
incurring additional expenditures as the trial progresses and
reaches certain milestones.
|
|
|
Selling and marketing expenses |
We do not currently have any selling or marketing expenses, as
we have not yet received approval for the commercialization of
CPP-109. We expect we will begin to incur such costs upon our
filing of an NDA, so that we can have a sales force in place to
commence our selling efforts immediately upon receiving approval
of such NDA, of which there can be no assurance.
|
|
|
General and administrative expenses |
Our general and administrative expenses consist primarily of
salaries, consulting fees for members of our Scientific Advisory
Board, information technology, and corporate administration
functions. Other costs include administrative facility costs,
regulatory fees, and professional fees for legal and accounting
services.
We recognize costs related to the issuance of common stock to
employees and consultants by using the estimated fair value of
the stock at the date of grant, in accordance with Statement of
Financial Accounting Standards (SFAS) No. 123,
Accounting for Stock-Based Compensation
(SFAS 123). We further account for the issuance of employee
stock options using the intrinsic value method. Accordingly,
compensation cost for stock options issued is measured as the
excess, if any, of the fair value of our common stock at the
date of grant over the exercise price of the options.
We have incurred operating losses since inception. As of
December 31, 2005 and 2004, we had net operating loss
carryforwards of $588,326 and $385,928, respectively. The
related deferred tax asset has a 100% valuation allowance as of
December 31, 2005 and 2004, as we believe it is more likely
than not that the deferred tax asset will not be realized. There
are no other significant temporary differences. The net
operating loss carry-forwards will expire at various dates
beginning in 2022 through 2025. If an ownership change, as
defined under Internal Revenue Code Section 382, occurs,
the use of these carry-forwards may be subject to limitation.
34
Critical Accounting Policies and Estimates
Our discussion and analysis of our financial condition and
results of operations are based on our financial statements,
which have been prepared in accordance with accounting
principles generally accepted in the U.S. The preparation of
these financial statements requires us to make judgments,
estimates, and assumptions that affect the reported amounts of
assets and liabilities and the disclosure of contingent assets
and liabilities at the date of the financial statements as well
as the reported revenue and expenses during the reporting
periods. We continually evaluate our judgments, estimates and
assumptions. We base our estimates on the terms of underlying
agreements, our expected course of development, historical
experience and other factors we believe are reasonable based on
the circumstances, the results of which form our
managements basis for making judgments about the carrying
value of assets and liabilities that are not readily apparent
from other sources. Actual results may differ from these
estimates.
The list below is not intended to be a comprehensive list of all
of our accounting policies. In many cases, the accounting
treatment of a particular transaction is specifically dictated
by generally accepted accounting principles, or GAAP. There are
also areas in which our managements judgment in selecting
any available alternative would not produce a materially
different result. Our audited financial statements and the notes
thereto included elsewhere in this prospectus contain accounting
policies and other disclosures required by GAAP.
|
|
|
Non-clinical study and clinical trial expenses |
Research and development expenditures are charged to operations
as incurred. Our expenses related to clinical trials are
expected to be based on actual and estimated costs of the
services received and efforts expended pursuant to contracts
with multiple research institutions and clinical research
organizations that conduct and manage clinical trials on our
behalf. The financial terms of these agreements are subject to
negotiation and vary from contract to contract and may result in
uneven payment flows. Generally, these agreements set forth the
scope of the work to be performed at a fixed fee or unit price.
Payments under the contracts will depend on factors such as the
successful enrollment of patients or the completion of clinical
trial milestones. Expenses related to clinical trials generally
are expected to be accrued based on contracted amounts applied
to the level of patient enrollment and activity according to the
protocol. If timelines or contracts are modified based upon
changes in the clinical trial protocol or scope of work to be
performed, we would be required to modify our estimates
accordingly on a prospective basis.
In December 2004, the FASB issued Statement 123(R),
Accounting for Share-Based Payment, which addresses
the accounting for share-based payment transactions (for
example, stock options and awards of restricted stock) in which
an employer receives employee-services in exchange for equity
securities of the company or liabilities. Statement 123(R)
requires that compensation cost be measured based on the fair
value of the companys equity securities. This proposal
eliminates use of APB Opinion No. 25, Accounting for
Stock Issued to Employees, and requires such transactions
to be accounted for using a fair value-based method and
recording compensation expense rather than optional pro forma
disclosure. The new standard substantially amends SFAS 123.
Statement 123(R) requires us to recognize an expense for
the fair value of our unvested outstanding stock options
beginning with our financial statements for the year ended
December 31, 2006. The Company had no unvested stock
options to employees as of January 1, 2006.
Results of Operations
Revenues. We had no revenues for the six month periods
ended June 30, 2006 and 2005 or for the years ended
December 31, 2005, 2004, and 2003.
35
Research and Development Expenses. Research and
development expenses for the six months ended June 30, 2006
and 2005 were $432,764 and $1,200,769, respectively. Research
and development expenses for the years ended December 31,
2005, 2004, and 2003 were $1,462,889, $378,254, and $268,829,
respectively. Expenses to date include costs associated with the
filing of our IND, payments with respect to clinical studies
that we support, and payments to consultants and members of our
Scientific Advisory Board and other service providers who have
assisted us with respect to these matters.
We recorded non-cash compensation in each of the six-month
periods in 2006 and 2005, and in 2005, 2004 and 2003. Such
non-cash compensation, which was part of our research and
development expenses, related to shares of common stock issued
to several of our consultants and scientific advisors for
services rendered and the value of stock options granted to
non-employees. In 2005, 2004, 2003 and the period from
January 4, 2002 (date of inception) through
December 31, 2005, we recorded compensation expense of
$1,067,750, $294,833, $75,833 and $1,514,249, respectively,
related to the issuance of stock options to nonemployees. The
weighted average fair value of the stock options granted in
2005, 2004 and the period from January 4, 2002 (date of
inception) through December 31, 2005 was $1.66, $1.46 and
$1.44, respectively. There were no stock options granted in 2003.
We expect that research and development activities will increase
substantially as we receive the vigabatrin that will be used in
our upcoming clinical trials, as we pay the costs associated
with our ongoing clinical studies and trials, and as we expand
our product development activities generally. Our historical
research and development expenses have been very low. This is
due to the fact that much of the early stage development costs
associated with the development of vigabatrin to treat addiction
were incurred by Brookhaven in connection with their ongoing
animal studies into the use of vigabatrin to treat addiction. We
benefit from their research by reason of our license.
Selling and Marketing Expenses. We had no selling and
marketing expenses during the six months ended June 30,
2006 and 2005 or during the 2005, 2004 and 2003 fiscal years. We
anticipate that we will begin to incur sales and marketing
expenses when we file an NDA for CPP-109, in order to develop a
sales organization to market CPP-109 and other products we may
develop upon the receipt of required approvals.
General and Administrative Expenses. General and
administrative expenses were $242,194 and $126,811,
respectively, for the six months ended 2006 and 2005. General
and administrative expenses were $359,279, $164,704 and
$165,483, respectively, for the years ended December 31,
2005, 2004 and 2003. General and administrative expenses include
office expenses, legal and accounting fees and travel expenses
for our employees, consultants and members of our Scientific
Advisory Board. We expect general and administrative expenses to
increase in future periods as we incur general non-research
expenses relating to the monitoring and oversight of our
clinical trials, add staff, expand our infrastructure to support
the requirements of being a public company and otherwise expend
funds to continue to develop our business as set forth in this
prospectus.
Interest Income. We reported interest income in all
periods relating to our investment of funds received from our
private placements in 2003 and 2005. All such funds were
invested in short and medium-term interest bearing obligations,
certificates of deposit and direct or guaranteed obligations of
the United States government.
Income taxes. We have incurred net operating losses since
inception. Consequently, we have applied a 100% valuation
allowance against our deferred tax asset as we believe that it
is more likely than not that the deferred tax asset will not be
realized.
Liquidity and Capital Resources
Since our inception, we have financed our operations primarily
through the net proceeds of private placements of our equity
securities. As of June 30, 2006, we had received total net
proceeds of approximately $1.9 million from private
placements of our securities. Subsequent to June 30, 2006,
we completed a private placement of our securities in which we
raised net proceeds of $3,225,140.
36
At June 30, 2006, we had cash and cash equivalents of
$324,154 and had a working capital deficit of $107,516.
Subsequent to June 30, 2006, we closed a private placement
in which we received net proceeds of $3,100,140 (after paying
our Chief Executive Officer $125,000 of deferred compensation
then due to him), increasing our cash and cash equivalents to
$3,424,294. We intend to use these funds for the following
purposes:
|
|
|
|
|
approximately $100,000 to purchase the active pharmaceutical
ingredient required to manufacture batches of CPP-109 for use in
our U.S. Phase II clinical trial; |
|
|
|
approximately $600,000 to pay a contract manufacturer for
services in connection with the development and manufacture of
our formulation of vigabatrin and to pay for required
bioequivalency studies with respect to the chemical composition
of CPP-109; |
|
|
|
|
approximately $500,000 to support the clinical trial for cocaine
addiction in Mexico; |
|
|
|
|
approximately $500,000 to start our U.S. Phase II clinical trial; |
|
|
|
approximately $650,000 to pay costs associated with this
offering; and |
|
|
|
the balance for general corporate purposes. |
|
|
|
Operating Capital and Capital Expenditure Requirements |
We have to date incurred operating losses, and we expect these
losses to increase substantially in the future as we expand our
product development programs and prepare for the
commercialization of CPP-109. We anticipate using a significant
portion of the proceeds from this offering to finance these
activities. It may take several years to obtain the necessary
regulatory approvals to commercialize CPP-109 in the United
States.
We believe that the net proceeds from this offering, together
with our existing cash, cash equivalents and short-term
investments, will be sufficient to meet our projected operating
requirements for the next 30 months, including our requirements
relating to obtaining necessary regulatory approvals and to the
commercialization of CPP-109 for use in treating cocaine and
methamphetamine addiction.
Our future funding requirements will depend on many factors,
including:
|
|
|
|
|
the scope, rate of progress and cost of our clinical trials and
other product development activities; |
|
|
|
future clinical trial results; |
|
|
|
the terms and timing of any collaborative, licensing and other
arrangements that we may establish; |
|
|
|
the cost and timing of regulatory approvals; |
|
|
|
the cost and delays in product development as a result of any
changes in regulatory oversight applicable to our products; |
|
|
|
the cost and timing of establishing sales, marketing and
distribution capabilities; |
|
|
|
the effect of competition and market developments; |
|
|
|
the cost of filing, prosecuting, defending and enforcing any
patent claims and other intellectual property rights; and |
|
|
|
the extent to which we acquire or invest in other products. |
If we are unable to generate a sufficient amount of revenue to
finance our future operations, product development and
regulatory plans, we may seek to raise additional funds through
public or private equity offerings, debt financings, capital
lease transactions, corporate collaborations or other means. We
may seek to raise additional capital due to favorable market
conditions or strategic considerations even if we have sufficient
37
funds for planned operations. Any sale by us of additional
equity or convertible debt securities could result in dilution
to our stockholders.
To the extent that we raise additional funds through
collaborative arrangements, it may be necessary to relinquish
some rights to our technologies or grant sublicenses on terms
that are not favorable to us. We do not know whether additional
funding will be available on acceptable terms, or at all. If we
are not able to secure additional funding when needed, we may
have to delay, reduce the scope of or eliminate one or more
research and development programs or sales and marketing
initiatives.
Net cash used in operations was $434,527 and $244,111,
respectively, for the six months ended June 30, 2006 and
2005, respectively and $455,360, $230,520 and $365,784,
respectively for 2005, 2004 and 2003. Net cash used in each of
these periods primarily reflects that portion of the net loss
for these periods not attributed to non-cash compensation.
Net cash used in investing activities was $12,446 and 3,940 for
the six months ended June 30, 2006 and 2005, respectively,
and $3,940, $1,831 and $0, respectively, for 2005, 2004 and
2003. Such funds were used primarily to purchase computer
equipment.
Net cash provided by financing activities was $0 and $1,046,516
for the six months ended June 30, 2006 and 2005,
respectively, and $1,046,516, $0 and $674,957 in 2005, 2004 and
2003, respectively. Net cash from financing activities is
comprised of the net proceeds of the two private placements that
we completed in April 2003 and March 2005. Such funds were used
to fund our research and development costs and our general and
administrative costs in 2005, 2004, 2003 and during the first
half of 2006.
As of June 30, 2006, we had contractual obligations as
follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments Due by Period | |
|
|
| |
|
|
|
|
Less than | |
|
|
|
After 5 | |
|
|
Total | |
|
1 year | |
|
1-3 years | |
|
4-5 years | |
|
years | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
Debt
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
Capital leases
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating leases
|
|
|
33,285 |
|
|
|
17,736 |
|
|
|
15,549 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$ |
33,285 |
|
|
$ |
17,736 |
|
|
$ |
15,549 |
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
We are also obligated to make the following payments:
|
|
|
|
|
|
Payment to Brookhaven under our license agreement. We
have agreed to pay Brookhaven a fee of $100,000 in the year of
NDA approval for
CPP-109, $250,000 in
each of the second and third years following approval, and
$500,000 per year thereafter until the last patent expires. |
|
|
|
|
|
Payments to our contract manufacturer. We are obligated
to pay our contract manufacturer approximately $513,200, with
payments to be based on the achievement of milestones relating
to the schedule of work that it has agreed to perform for us. |
|
|
|
|
We intend to enter into employment agreements with two of our
executive officers, which will become effective on the closing
of this offering and will require aggregate base salary payments
of $515,000 per year following this offering. |
38
|
|
|
Off-Balance Sheet Arrangements |
We currently have no debt and no capital leases. We have an
operating lease for our office facility. We do not have any
off-balance sheet arrangements as such term is defined in rules
promulgated by the SEC.
Recent Accounting Pronouncements
In May 2005, the Financial Accounting Standards Board, or FASB,
issued Statement of Financial Accounting Standards No. 154,
Accounting Changes and Error Corrections a
replacement of APB Opinion No. 20 and FASB Statement
No. 3, or SFAS 154. SFAS 154 replaces APB
Opinion No. 20, Accounting Changes, and FASB
Statement No. 3, Reporting Accounting Changes in
Interim Financial Statements, and changes the requirements
relating to the accounting for and reporting of any changes in
accounting principles. SFAS 154 is effective for accounting
changes and corrections of errors made in fiscal years beginning
after December 15, 2005. SFAS 154 applies to all
voluntary changes in accounting principles. It also applies to
changes required by an accounting pronouncement in the unusual
instance that the pronouncement does not include specific
transition provisions. When a pronouncement includes specific
transition provisions, those provisions should be followed.
APB Opinion No. 20 previously required that most voluntary
changes in accounting principles be recognized by including, in
net income of the period of the change, the cumulative effect of
changing to the new accounting principle. SFAS 154 requires
retrospective application to prior periods financial
statements of changes in accounting principle, unless it is
impracticable to determine either the period-specific effects or
the cumulative effect of the change. When it is impracticable to
determine the period-specific effects of an accounting change in
one or more individual prior periods presented, SFAS 154
requires that the new accounting principle be applied to the
balances of assets and liabilities as of the beginning of the
earliest period for which retrospective application is
practicable, and that a corresponding adjustment be made to the
opening balance of retained earnings (or other appropriate
components of equity or net assets in the statement of financial
position) for that period, rather than being reported in an
income statement. When it is impracticable to determine the
cumulative effect of applying a change in accounting principle
to all prior periods, SFAS 154 requires that the new
accounting principle be applied as if it were adopted
prospectively from the earliest date practicable. We do not
believe that the adoption of SFAS 154 will have a
significant effect on our financial statements.
In March 2006, the FASB issued SFAS 156
Accounting for Servicing of Financial Assets
an amendment of FASB Statement No. 140, or
SFAS 156. SFAS 156 is effective for the first fiscal
year beginning after September 15, 2006. SFAS 156
changes the way entities account for servicing assets and
obligations associated with financial assets acquired or
disposed of. We have not yet completed our evaluation of the
impact of adopting SFAS 156 on our results of operations or
financial position, but do not expect that the adoption of
SFAS 156 will have a material impact.
Other accounting standards that have been issued or proposed by
the FASB or other standards-setting bodies that do not require
adoption until a future date are not expected to have a material
impact on our consolidated financial statements upon adoption.
Quantitative and Qualitative Disclosures About Market Risk
Market risk represents the risk of changes in the value of
market risk-sensitive instruments caused by fluctuations in
interest rates, foreign exchange rates and commodity prices.
Changes in these factors could cause fluctuations in our results
of operations and cash flows.
Our exposure to interest rate risk is currently confined to our
cash that is invested in highly liquid money market funds. The
primary objective of our investment activities is to preserve
our capital to fund operations. We also seek to maximize income
from our investments without assuming significant risk. We do
not use derivative financial instruments in our investment
portfolio. Our cash and investments policy emphasizes liquidity
and preservation of principal over other portfolio
considerations.
39
OUR BUSINESS
Overview
We are a specialty pharmaceutical company focused on the
development and commercialization of prescription drugs for the
treatment of addiction. Our initial product candidate is
CPP-109, which is based on the chemical compound
gamma-vinyl-GABA, commonly referred to as vigabatrin. We
intend to begin in the first quarter of 2007 a Phase II clinical
trial evaluating CPP-109 for the treatment of cocaine addiction.
We also intend to develop CPP-109 to treat methamphetamine
addiction. We believe that our CPP-109 platform has the
potential to produce therapies for other addictions, including
addictions to nicotine, prescription pain medications, alcohol,
and marijuana, as well as treatments for related addictive
disorders, such as obesity and compulsive gambling.
Many addictive drugs, including cocaine and methamphetamine,
produce feelings of euphoria by increasing the concentration of
the chemical neurotransmitter dopamine in specific areas of the
brain. Under normal conditions, dopamine levels are relatively
constant, increasing temporarily as a result of experiences such
as eating or sexual arousal. Over time, the feeling of pleasure
is decreased by a reduction in dopamine to its pre-arousal level
and through the action of gamma-aminobutyric acid, or
GABA, a chemical neurotransmitter that inhibits the effect of
dopamine. Substances such as cocaine and methamphetamine cause
enormous amounts of dopamine buildup, producing feelings of
euphoria. CPP-109 increases the amount of GABA present, which
suppresses the responses to the dramatic increase in dopamine
levels produced by cocaine and methamphetamine, thereby
preventing the perception of pleasure that is associated with
their use.
We have been granted an exclusive worldwide license from
Brookhaven National Laboratory, which we refer to as Brookhaven,
to nine U.S. patents and two U.S. patent applications relating
to the use of vigabatrin for the treatment of a wide variety of
substance addictions. The nine issued patents expire between
2018 and 2020. Additionally, we have received approval from the
European Union with respect to one of our principal patents,
which will allow us to seek approval for this patent in each of
the EU member states.
In the first quarter of 2007, we intend to commence an
approximately 375 patient, double-blind, randomized,
placebo-controlled Phase II clinical trial in the United States
to evaluate CPP-109 for the treatment of cocaine addiction,
although the final design of this clinical trial and the number
of patients to be included has not yet been finalized. This
trial is designed to provide potentially pivotal efficacy data,
which may support the filing of a New Drug Application, or NDA.
However, it is likely that additional clinical trials, including
a U.S. Phase III clinical trial, will be required before we
are permitted to file an NDA for CPP-109. We are also supporting
a 100 patient double-blind, placebo-controlled clinical trial in
Mexico evaluating vigabatrin for the treatment of cocaine
addiction.
In December 2004, the Food and Drug Administration, or FDA,
accepted our Investigational New Drug application, or IND, for
CPP-109 for the treatment of cocaine addiction. We have been
granted Fast Track status by the FDA for CPP-109, a designation
intended to facilitate the drug development and regulatory
review process. A treatment for cocaine addiction is recognized
as addressing an unmet medical need for which no pharmacological
products are currently approved for marketing. The receipt of
Fast Track status does not mean that the regulatory requirements
needed to obtain an approval are less stringent. Also, Fast
Track status may be withdrawn at any time. Notwithstanding, we
believe that the receipt of Fast Track status may accelerate the
regulatory approval process, although we cannot assure you that
our clinical trials will be successful or that we will obtain
approval of an NDA for CPP-109.
Our intention to advance CPP-109 as a potential treatment for
cocaine and methamphetamine addiction is based on the results of
two open-label pilot studies conducted in Mexico in 2003 and
2004 by a member of our Scientific Advisory Board. In one study,
of the 30 patients enrolled, 18 completed the study and 16
tested negative for methamphetamine and cocaine during the last
six weeks of the trial. In another study, of the 20 patients
enrolled, eight completed the study and remained drug-free for
periods ranging from
46-58 days. These
40
studies strongly supported our intention to advance CPP-109 as a
potential treatment for cocaine and methamphetamine addiction.
However, these studies only involve a small number of patients
and neither study provided enough evidence regarding safety and
efficacy to support an NDA filing with the FDA. In addition,
because these studies were conducted in Mexico and were not
subject to FDA oversight in any respect, including study design
and protocol, there can be no assurance that the results of
subsequent clinical trials will corroborate the results of these
pilot studies.
Our Business Strategy
To facilitate our business development and growth we plan to:
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Focus on CPP-109 for cocaine addiction. We intend to
commence a U.S. Phase II clinical trial evaluating the use of
CPP-109 as a treatment for cocaine addiction. Treatment for
cocaine addiction addresses a significant unmet medical need,
and we believe that our receipt of Fast Track status may
facilitate the regulatory approval process. |
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Develop additional indications for CPP-109. The mechanism
of action of CPP-109 makes it suitable as a potential treatment
for addiction states that share the common element of heightened
dopamine levels. We plan next to develop CPP-109 for the
treatment of methamphetamine addiction. Further, our research
indicates that CPP-109 is a platform technology with the
potential to treat other conditions involving heightened
dopamine levels such as addictions to nicotine, prescription
pain medications, alcohol, marijuana, and related addictive
disorders, including obesity and compulsive gambling. |
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Acquire or license additional addiction therapies. We
know of other product candidates that may have the potential for
the treatment of addiction. We may seek to acquire or license
one or more of these product candidates to expand our
development programs. We have entered into no such agreements to
date. |
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Develop second generation of CPP-109. We plan to develop
a new form of CPP-109. If we are successful, we intend to
initially seek approval for this new form in Europe, where we
may be able to obtain exclusive marketing rights. Subsequently,
we may seek approval for this new formulation in the United
States. |
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Leverage the services of thought leaders in addiction
treatment. We believe that members of our Scientific
Advisory Board are among the most respected researchers in the
field of addiction therapy. We intend to utilize their
knowledge, services and relationships to guide our development
process and commercialization strategy. |
Industry Background Substance Abuse and
Addiction
Addiction is a worldwide health problem that affects millions of
people and has wide-ranging negative social consequences. In
2004, an estimated 19 million people in the United States
suffered from dependence on illicit drugs, according to the
National Survey on Drug Use and Health, published by the
Substance Abuse and Mental Health Services Administration, or
SAMHSA, which we refer to as the SAMHSA survey. According to the
Office of National Drug Control Policy, costs of drug abuse to
society were an estimated $180 billion in 2002 in the
United States.
Addiction is not only a U.S. health problem. For example,
according to the United Nations Office on Drugs and Crime, in
2004 there were approximately 3.5 million users of cocaine
and 2.7 million users of amphetamine-type stimulants across
Europe. We believe that the direct and indirect costs of cocaine
and methamphetamine use are indicative of a significant global
public health problem, representing a significant unmet medical
need for which no adequate pharmaceutical therapies exist.
41
Cocaine Addiction. According to the SAMHSA survey, an
estimated two million people had used cocaine in the month
preceding the survey. Additionally, in 2004 one million people
had used cocaine for the first time within the preceding
12 months, an average of approximately 2,700 new users per
day. According to the same study, approximately 884,000 patients
received treatment for cocaine abuse in 2004. According to the
National Institute of Drug Abuse, or NIDA, there are no
pharmacologic treatments for cocaine addiction currently
approved for marketing by the FDA. We believe that other
therapies being developed for the treatment of cocaine
addiction, but not yet approved for marketing, suffer from
significant limitations which have not been exhibited to date by
CPP-109.
Methamphetamine Addiction. According to the SAMHSA
survey, an estimated 583,000 people had used methamphetamine in
the month preceding the survey. Additionally, an estimated
318,000 people had used methamphetamine for the first time
within the preceding 12 months, an average of 871 new users
per day. Additionally, according to the SAMHSA survey, 393,000
patients received treatment for methamphetamine and other
stimulant abuse in 2004. A study conducted by the Center for
Business Research at the University of Arkansas Sam W. Walton
College of Business and funded by the Wal-Mart Foundation in
2004 determined that each methamphetamine-using employee costs
his or her employer $47,500 per year due to lost productivity,
absenteeism, higher healthcare costs and higher workers
compensation costs. Similar to cocaine addiction, there are no
currently approved drugs for treatment of methamphetamine
addiction.
Nicotine Addiction. According to the SAMHSA survey, an
estimated 70.3 million people had used tobacco products in
the month preceding the survey. Further, the study reported that
in 2004 the number of people who started smoking within the
preceding 12 months was approximately 2.1 million.
According to NIDA, in 2000 over $75 billion in annual
direct healthcare costs and an estimated $82 billion in
indirect costs were attributable to smoking. According to the
National Institutes of Health, 70% of adult smokers in the
U.S. want to quit and 40% make a serious attempt to quit
each year. However, fewer than 5% succeed in any given year,
according to industry data. Global sales of smoking cessation
products were approximately $1.4 billion in 2004.
Other Addictions. According to the SAMHSA survey, in 2004
an estimated six million people took prescription drugs for
non-medical purposes, including approximately 4.4 million
who abused prescription pain relievers. Further, according to
the SAMHSA survey approximately 16.7 million people in the
United States were classified as heavy drinkers. Additionally,
according to the SAMHSA survey there are approximately
14.6 million persons who used marijuana in the month
preceding the survey and approximately one million persons
sought treatment in 2004. Finally, other addictive disorders
such as obesity and compulsive gambling have been shown to have
similar mechanisms of action to drug addiction and affect
millions of persons in the United States and around the world.
Limitations of Current Approaches to Addiction Treatment: Our
Market Opportunity
Recent scientific evidence has established that drug abuse can
interfere with the brains normal balance of
neurotransmitter release and reuptake, resulting in addiction.
If this balance is not restored, addicted individuals, even
after significant periods of abstinence, may be incapable of
suppressing cravings or quitting through willpower alone, even
with the assistance of professional counseling.
Historically, addicted individuals have been treated primarily
through behavioral modification, which has a high rate of
relapse. According to the SAMHSA survey, treatment completion
rates in 2000 for outpatient treatment were only 41% for alcohol
and 21% for cocaine. For the treatment of cocaine dependence,
there is a one-year relapse rate of 69% after 90 days or
less of outpatient treatment and 80% after 90 days or less
of long-term residential treatment. We believe that a
pharmacological treatment for cocaine addiction would complement
and significantly improve the effectiveness of counseling
programs.
Despite the significant public health implications, there are
very few therapies approved for the treatment of addiction,
either in the United States or in the rest of the world. We
believe that currently approved
42
drugs for addiction treatment, as well as compounds under
development (other than CPP-109), are subject to the following
limitations:
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no single compound has broad applicability for treatment of
multiple addictions; |
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many of these compounds are receptor active, which
means they have drug-like effects themselves and have the
potential for abuse or addiction; |
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increasing dosages over time may be required; and |
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they are often ineffective at eliminating drug cravings or
responding to increasing levels of drug use. |
For example, we believe that a product candidate known as TA-CD,
which is being developed as a cocaine vaccine, would be limited
to treating only cocaine addiction and can be overwhelmed by
increasing doses of cocaine. Similarly, we believe that
baclofen, which is a type of chemical known as a
GABAB
agonist and which has been evaluated to treat cocaine addiction
but is not approved for that indication, is receptor active and
requires increasing dosing over time. Such limitations may
result in the United States Drug Enforcement Agency designating
these therapies, if they are approved, as
scheduled,subjecting them to a high level of
regulatory control as to manufacturing, distribution,
prescription and use. Neither of these compounds is approved for
marketing as a treatment for addiction in the United States, and
we believe that these limitations will significantly limit the
potential of these drugs as addiction treatments.
We believe that CPP-109 does not suffer from these limitations,
and therefore has the potential to become a widely prescribed,
safe and effective treatment for cocaine, methamphetamine and
other addictions, if approved.
Pharmacodynamics of Addictive Drugs
Addictive drugs are used recreationally because of the
transient, pleasurable effect they have on the user. These
effects are the result of biochemical changes the drug causes in
the brain.
Normal brain activity occurs through electrical signals which
are transmitted across brain cells known as neurons. Signals are
transmitted from neuron to neuron across a small gap, known as
the synaptic cleft, by the release of chemical messengers known
as neurotransmitters. The releasing, or pre-synaptic, neuron
sends a neurotransmitter into the synaptic cleft to the
receiving, or post-synaptic, neuron, which has specialized
receptor molecules that pick up the neurotransmitter, triggering
the post-synaptic neuron to initiate its own release. The
repetition of this process from neuron to neuron, along what are
known as the mesolimbic pathways, is responsible for the
transport of signals in the brain. Once the neurotransmitter has
stimulated the receptor, it is either broken down or reabsorbed
into the pre-synaptic neuron.
Almost all drugs of abuse affect the pathway for the
neurotransmitter known as dopamine. Dopamine is associated with
the pleasure system of the brain, causing feelings of enjoyment
in order to motivate certain behaviors, such as eating or sexual
function. Dopamine is a naturally produced chemical that binds
to dopamine-specific receptors on the neuron. Under normal
conditions, only a portion of the brains dopamine
receptors are occupied at any one time. After dopamine is
released from the receptor, the pre-synaptic neuron reuptakes
dopamine using a protein that is a dopamine reuptake
transporter, and the dopamine is subsequently stored or broken
down by an enzyme called monamine oxidase, or MAO. Drugs that
block the natural reuptake or breakdown of dopamine result in
elevated levels of dopamine in the synaptic cleft, triggering
feelings of pleasure and euphoria.
Over time, the feeling of euphoria fades due to the natural
reduction in dopamine and through the action of GABA, or
Gamma-aminobutyric acid, which is an inhibitory neurotransmitter
found in the brain. GABA, in turn, is broken down by a chemical
called GABA transaminase, or GABA-T. Under normal conditions,
dopamine effects are moderated by GABA, which in turn is
moderated by GABA-T, maintaining the brain in a balanced,
pre-arousal state.
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Mechanism of Action of Cocaine. Cocaine binds to the
dopamine reuptake transporter protein of the pre-synaptic
neurons preventing the reuptake and eventual breakdown of
dopamine, resulting in enhanced and prolonged stimulation of
dopamine on post-synaptic receptors, causing a feeling of
prolonged euphoria for the user.
Addiction to cocaine is caused by a neurological process called
desensitization. Because the brain senses an unnaturally high
level of dopamine, it responds by reducing the amount of
dopamine released and the number of dopamine receptors created.
Consequently, when the cocaine wears off, the user has a
lower amount of dopamine and fewer functioning dopamine
receptors, which results in a depressed mood. This
desensitization process creates a lowering of mood each time the
user takes more of the drug, causing the user to seek additional
cocaine to restore normal feelings, and requiring the user to
take an increasing amount of cocaine to achieve the same feeling
of euphoria as before.
Mechanism of Action of Methamphetamine. Methamphetamine
is chemically similar to dopamine and another neurotransmitter
called norepinephrine. Due to its chemical structure,
methamphetamine is carried into the pre-synaptic neuron and
triggers the release of dopamine and norepinephrine into the
synaptic cleft. Methamphetamine also reverses the action of the
transporter molecules that normally cause dopamine or
norepinephrine reuptake from the synaptic cleft back into the
neuron, resulting in a flood of dopamine back into the synaptic
cleft. In addition, methamphetamine blocks the enzymes that
cause the breakdown of these neurotransmitters. The resulting
elevated levels of dopamine trigger feelings of euphoria and
pleasure, and excess norepinephrine may be responsible for the
alertness and anti-fatigue effects associated with the drug.
Similar to cocaines mechanism of addiction,
methamphetamine users undergo the desensitization process,
resulting in increasing usage to achieve the same effects.
Mechanism of Action of Nicotine. Nicotine has a similar
chemical structure to the neurotransmitter acetylcholine.
Acetylcholine and its receptors are involved in many activities,
including respiration, maintenance of heart rate, memory,
alertness, and muscle movement. Once nicotine enters the brain,
it activates receptors that normally respond to acetylcholine,
called cholinergic receptors. Regular use of nicotine causes a
decrease in the number of cholinergic receptors and a decrease
in the sensitivity of these receptors to nicotine and
acetylcholine. Recent research has also shown that nicotine
causes an increased release of dopamine resulting in the
pleasurable sensation triggered by its use. We believe that the
increase in dopamine levels is similar, although less intense,
than that observed in cocaine and methamphetamine users.
Our Platform Technology
Mechanism of Action of CPP-109. We believe that our
product candidate, CPP-109, will be an effective addiction
treatment because it eliminates the perception of pleasure and
reward associated with the use of dopamine-enhancing drugs.
Addictive drugs have been shown to block or overwhelm mechanisms
involved in the removal of dopamine from synaptic clefts in the
mesolimbic pathways of the brain, resulting in highly elevated
levels of dopamine available to stimulate receptors and a
dramatically heightened sense of pleasure or reward. However,
dopamine is associated with other actions beyond the mediation
of those responses. Simply blocking dopamine effects at the
receptor site is ineffective and associated with profound side
effects, such as the extensive impairment of motor functions
seen in patients with Parkinsons disease. Therefore, more
sophisticated approaches to regulating the specific actions of
dopamine are required.
GABA, the most abundant inhibitory neurotransmitter in the
brain, balances the brain by inhibiting over-excitation. When
GABA binds to a GABA receptor, it inhibits the post-synaptic
neuron from triggering the release of neurotransmitters,
preventing the subsequent firing of an electrical signal. GABA
helps induce relaxation and sleep, and contributes to functions
such as motor control and vision. An enzyme known as GABA-T is
responsible for the eventual breakdown of GABA once the feeling
of euphoria has faded.
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Vigabatrin is a GABA analog that inhibits GABA-T. The drug is
readily absorbed and promptly available to the central nervous
system, producing effects that last for many hours after a
single dose. Therefore, administration of vigabatrin results in
significantly elevated GABA levels. This prevents the perception
of pleasure and reward resulting from dramatic increases in
dopamine levels caused by cocaine and methamphetamine use.
Vigabatrin administration does not appear to affect the baseline
levels of dopamine, nor those variations in dopamine levels
caused by normal stimuli.
History and Side Effect Profile. Vigabatrin has been
marketed over the past decade in over 30 countries by
Sanofi-Aventis under the brand name Sabril as a secondary
treatment for adult epilepsy and as a primary treatment for the
management of infantile spasms, known as West Syndrome. The
composition of matter patents for Sabril expired in 1993.
Neither vigabatrin nor Sabril has been approved in the United
States for any indication.
In chronic use for the treatment of epilepsy, vigabatrin has
been generally well tolerated. The most common side effects
reported have been drowsiness and fatigue. However, one clearly
established adverse side effect is the development, with
increasing cumulative dosage levels of vigabatrin approaching
1,500 grams, of peripheral visual field defects, or VFDs, in
approximately 33% of users. These VFDs are manifest as a
constriction of the peripheral field of vision, or the loss of
visual acuity at the extreme left and right edges of the field
of vision. While the exact cause of these VFDs is unknown, they
are believed to be irreversible, with the resultant requirement
that recipients of vigabatrin for epilepsy must receive regular
six month visual tests while using the drug.
Prior research has indicated that VFDs occur at doses far higher
than the dosage amount we anticipate will be used for addiction
treatment. However, we have not completed the testing necessary
to determine whether this is the case.
Brookhavens Research. Our initial interest in
vigabatrin was based on Brookhavens research with it
regarding the pathology and treatment of cocaine and other
addictions. Brookhaven scientists have shown that the dopamine
pathway responds similarly to drugs of abuse. In 1997,
scientists at Brookhaven harnessed an emerging technology,
positron emission tomography scans, or PET scans, and became the
first to image the effects of addicting substances in living
human subjects. Through the use of PET scans, Brookhaven
scientists were able to show that as the number of engaged
dopamine receptors in the brain increased, so too did the
high, or euphoric feeling, of the user.
Platform Technology. We believe that vigabatrin is
potentially suitable for the treatment of many addictions due to
its ability to block the euphoria associated with heightened
levels of dopamine. These include our initial focus areas of
cocaine and methamphetamine addictions and addictions to other
substances including nicotine, prescription pain medications,
alcohol and marijuana, as well as related addictive disorders
such as obesity and compulsive gambling. Brookhaven has licensed
to us patents relating to the use of CPP-109 as a treatment for
all abused drugs. Consequently, if CPP-109 is determined to be a
safe and effective treatment for cocaine and methamphetamine
addiction, we may pursue additional clinical trials to determine
whether CPP-109 can be used to treat addiction to other
substances.
Our Clinical Research
In 2004 the FDA accepted our IND for CPP-109 for the treatment
of cocaine addiction. We have been granted Fast Track status for
CPP-109 from the FDA. Under the Federal Food, Drug and Cosmetic
Act, or FFDCA, the FDA is directed to facilitate the development
and expedite review of drugs and biologics intended to treat
serious or life-threatening conditions and that demonstrate the
potential to address unmet medical needs. Fast Track designation
emphasizes communication between us and the FDA and affords us
benefits that may help to expedite the approval process. For
example, Fast Track designation affords us the opportunity to
submit an NDA for CPP-109 on a rolling, or modular, basis,
allowing the FDA to review sections of the NDA in advance of
receiving our full submission. The designation also means that
we may have increased
45
communications with the FDA regarding the design of our clinical
studies, which we hope will expedite the development and review
of our application for the approval of CPP-109 and provide
greater certainty overall in the regulatory pathway.
We intend to commence a Phase II clinical trial in the first
quarter of 2007 to evaluate CPP-109 for the treatment of cocaine
addiction. Our protocol design specifies a double-blind,
randomized, placebo-controlled trial involving approximately 375
patients at multiple treatment sites in the United States and
Canada, although the final design of our clinical trial and the
number of patients to be included in the trial has not yet been
finalized. To be eligible to participate in the trial,
participants must meet specific clinical standards for cocaine
dependence, as specified in DSM-IV, a set of diagnosis
guidelines established for clinical professionals. Additionally,
trial participants cannot meet the DSM-IV criteria for
dependence on other addictive substances. The trial is expected
to be 26 weeks in duration, with subjects divided into three
equal groups. One group will receive vigabatrin for a 26-week
period. A second group will receive vigabatrin for a nine-week
period, followed by a placebo for 17 weeks. The third group will
receive a placebo for the full 26 weeks. The primary
endpoint of this study is three weeks of abstinence from cocaine
at nine weeks and again at 26 weeks. A secondary endpoint
measures abstinence for three-week periods at 18 weeks and
a reduction in cocaine use from baseline at 18 weeks.
Further, eye safety studies will be conducted on all trial
participants to determine the extent of any VFDs among such
participants.
If the data from this clinical trial is compelling, we may file
an NDA and seek regulatory approval in the United States to
commercialize CPP-109. However, it is likely that additional
clinical or non-clinical trials, including a U.S. Phase III
clinical trial, will be required before we are permitted to file
an NDA and seek regulatory approval to sell CPP-109 in the
United States. There can be no assurance as to if and when we
will obtain approval of an NDA to market CPP-109.
Clinical Studies That We Support
The primary focus of our product development efforts is on our
clinical studies; however, we have in the past supported and
will continue in the future to support clinical studies of the
use of vigabatrin for the treatment of addiction by
investigators, including members of our Scientific Advisory
Board and the academic institutions with which they are
affiliated. In most cases, these studies have been funded in the
past and will be funded in the future by third parties, such as
the particular academic institution or a governmental agency,
such as the National Institute on Drug Abuse. In some cases, we
provide unrestricted sponsorship funds for these types of
studies. In other cases, we provide other assistance to the
investigator. We expect to continue to support investigator
studies in the future to the extent that they meet the criteria
described below. The clinical trial in Mexico that we are
currently supporting is an example of such a study. Our support
for these studies is intended to further the available research
on the use of vigabatrin to treat addiction, to assist
investigators in designing their studies so that such studies
are most appropriately conducted and, to the extent possible, to
make sure that these investigator studies do not adversely
impact our activities.
We believe that the clinical trial that we are currently
supporting in Mexico will be considered a Phase II study,
because it is designed to evaluate the safety and efficacy of
vigabatrin as a treatment for cocaine addiction. We have
received approval from Mexican authorities to begin enrollment,
which we expect to begin in the fourth quarter of 2006. The
principal investigators of this trial are Jonathan Brodie,
Ph.D., M.D., a professor of Psychiatry at New York University
and a member of our Scientific Advisory Board, and Emilia
Figueroa, M.D., a physician addiction specialist who directs
several addiction treatment clinics in Mexico. Dr. Brodie
designed the protocol for this trial, which is a double-blind,
placebo-controlled study and involves 100 patients at a single
location in Mexico City. Subjects will be selected from a pool
of cocaine-dependent prison parolees who meet the specific
clinical standards for cocaine dependence, as specified in
DSM-IV. The trial is expected to continue for one year. The
primary endpoint of the trial is patient abstinence from cocaine
for a period of 21 days following treatment. In addition to
the primary endpoints, eye safety studies may be conducted to
determine the extent of any visual field defects among the trial
participants.
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Pilot Studies
Our intention to advance CPP-109 as a potential treatment for
cocaine and methamphetamine addiction is based on two open-label
human pilot studies conducted in 2003 and 2004 in Mexico by a
member of our Scientific Advisory Board. We believe these pilot
studies support the therapeutic potential of vigabatrin as a
treatment for cocaine and methamphetamine addiction. However,
both studies involved a small number of patients and neither
study provided enough evidence regarding safety and efficacy to
support an NDA filing with the FDA. In addition, because these
studies were conducted in Mexico and were not subject to FDA
oversight in any respect, including study design and protocol,
there can be no assurance that the results of subsequent
clinical trials in the United States will corroborate the
results of these pilot studies.
These pilot studies are described below:
Cocaine Pilot Study 2003 Mexico. The first
pilot study of vigabatrin for treating cocaine addiction was
conducted in Mexico in 2003 under Dr. Brodies
supervision. The results of this study were published in a
peer-reviewed journal, in an article authored by Jonathan D.
Brodie, Emilia Figueroa and Stephen L. Dewey. Drs. Brodie
and Dewey are members of our Scientific Advisory Board.
Study design. The protocol was designed as an
outpatient, open-label, fixed-dose, time-limited trial in a
setting with psychotherapeutic support and intervention. A total
of 20 subjects, consisting of 19 men and one woman were enrolled.
Enrollment criteria. Subjects were primarily daily
cocaine abusers meeting DSM-IV criteria for cocaine dependence
with a minimum of three years of continuous use. Most of the
subjects were polydrug abusers whose cocaine use was often
supplemented with methamphetamine, marijuana, and/or alcohol. As
a prerequisite for inclusion, all subjects indicated that they
were interested in breaking their drug dependence and gave
informed, signed consent. Exclusion criteria included
intravenous drug use and subjects treated within the past year
for substance abuse. At the beginning of the study, the average
age of the subjects was 29, with an average 12-year history of
cocaine abuse and an average daily consumption of 1.7 grams of
cocaine.
Dosing. Following an admission physical
examination and screening for medical exclusion criteria, all
subjects were given a screening urinalysis and a craving
questionnaire and were then placed on vigabatrin. Each subject
was given escalating doses of vigabatrin. Vigabatrin was
administered on day 1 at two grams, consisting of one gram twice
daily. After 3 days, the dosage was increased to 1.5 grams
twice daily and on day seven vigabatrin was administered at a
continuing dose of two grams twice daily. All dosing was done
under observation in the clinic. Subjects who had a negative
drug screen for four successive weeks, or 28 days in total,
were then tapered down by one gram of vigabatrin per day per
week.
Testing. All subjects were encouraged to
participate in group and individual counseling programs and were
required to twice weekly provide urine samples in addition to
filling out a daily questionnaire of drug use and craving. The
drug screen included cocaine, heroin, methamphetamine,
tetrahydrocannabinol, or THC, and phencyclidine, or PCP.
Results. Of the 20 subjects enrolled in the study:
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eight remained in the program and were drug-free for periods
ranging from 46 to 58 days at the end of the study. Only
two subjects had a single slip or relapse into
cocaine use once the craving stopped. A slip restarted the
consecutive days clean or drug-free value. |
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Of the 12 subjects who failed to complete the program, eight
requested termination within 10 days, stating that they did
not wish to stop their cocaine use. The other four subjects
stayed in the protocol for periods of 25 to 43 days but
continued to use cocaine, although in reduced amounts: two out
of the four had an 80% reduction, one out of the four had a 50%
reduction, and the other did not reduce at all, according to
self-reports by the subjects, despite their claim that the drug
did not engender the usual high. |
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Most trial completers reported that their craving was not
eliminated until an average of 17.9 days following
vigabatrin administration. Craving was never eliminated in the
four subjects who continued to use cocaine in addition to
vigabatrin for three weeks, nor in the eight early
non-completers.
The trial completers did not differ significantly from the
non-completers in age, duration of cocaine abuse, or average
daily use. The consecutive days clean for the
completers averaged 48.5 days, compared to an average of
1.9 days for non-completers, with a P-value, which is a
measure of statistical significance, of less than 0.0001. There
was also a clear distinction between the two groups on the basis
of weight gained during the trial: an average of 18.2 pounds for
the completers, compared to an average of 0.2 pounds for
non-completers, with a P-value of less than 0.0001. A
P-value of less than .05 indicates that the
different results between treatment groups was not random. No
subject who continued cocaine use during their participation in
the study reported increased appetite or experienced weight
gain. In order for the studys outcomes to be convincing in
light of concerns about vigabatrins safety and efficacy,
an outcome measure of 28 consecutive days clean, in which the
subject tested negative for cocaine, was utilized. We believe
this measure is particularly stringent for an outpatient setting
and in the field of addiction therapy where statistical
significance often exceeds therapeutic reality.
A comparison of statistical information regarding trial
completers and non-completers is set forth below:
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Completers | |
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Non-Completers | |
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(n = 8) | |
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(n = 12) | |
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Age
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28.8 ± |
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5.7 29.3 ± 6. |
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Abuse History (Years)
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9.5 ± |
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4.9 11.5 ± 6 |
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.7 P=0.74 (ns |
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Mean Cocaine Use(g/day)
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1.8 ± |
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1.5 1.6 ± |
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0.8 P=0.62 (ns |
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Consecutive Clean Days
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48.5 ± |
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5.7 1.9 ± 3 |
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.3 P < 0.0001 |
Weight Increase (lbs)
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18.2 ± 10 |
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.7 0.2 ± 0. |
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6 P < 0.0001 |
Subjects in this study were all cocaine users who consumed
cocaine five to seven days per week and had been doing so for
three to 15 years. Nevertheless, 40% of those who entered
the study completed it without relapse. Once cocaine use ceased,
six of the eight completers were entirely drug free for the
duration of the study, or seven weeks. The others had a single
slip and were again clean for greater than four
weeks. On the other hand, the mean time to relapse of all 12
non-completers was less than 2 days. Significantly, all of
the trial completers gained weight, while none of the
non-completers gained any. Weight gain precisely paralleled
cessation of cocaine use by self-report as well as by the twice
weekly drug screen and daily observation. We believe that this
is not surprising in view of the well-known appetite-suppressing
effects of cocaine.
We believe that trial completers manifested clear behavioral
changes. They showed gains in self-esteem, reestablished healthy
family relationships, and went to work or actively sought work.
There were no relapses over an extended period despite
completers remaining in the same neighborhood environment in
which cocaine was readily available and with all of the cues and
social pressures that had previously supported their addiction.
We believe that without psychosocial intervention it is likely
that the fraction of subjects who complete a program would be
lower than observed in this study. For example, in this study
most subjects who continued using cocaine reported an altered
and diminished response or reward but persisted in their use,
albeit at reduced amounts. If the outcome measure was a greater
than 80% reduction in cocaine consumption, then that criterion
was met by 10 of the 12 subjects who stayed on vigabatrin for
more than 10 days. In addition, all eight subjects who
completed the program noted a cessation of craving which
persisted during the exit, or vigabatrin taper, phase. We
believe this suggests that elimination of craving might be the
single most important factor in achieving successful therapeutic
remission.
Side Effects Observed. Overall, vigabatrin was
well tolerated. No subjects reported visual disturbances of any
kind throughout their exposure to vigabatrin or admitted to
vision changes of any kind upon questioning. The major side
effects were transient somnolence, or drowsiness, in the first
10 days, observed in 17 of the 20
48
subjects, and an intermittent low-grade headache, observed in 9
of the 20 subjects, that occasionally persisted for several
weeks, although never severe enough for the subject to request
termination on that basis.
Cocaine and Methamphetamine Pilot Study 2004
Mexico. The second pilot study was conducted in Mexico
between November 2003 and January 2004 under
Dr. Brodies supervision and with our financial
support. The results of this study were published in a
peer-reviewed journal, in an article authored by Jonathan D.
Brodie, Emilia Figueroa, Eugene M. Laska and Stephen L. Dewey.
Drs. Brodie, Laska and Dewey are members of our Scientific
Advisory Board. This was an open-label, nine-week study
involving 30 subjects dependent on methamphetamine and/or
cocaine. The study evaluated the efficacy of vigabatrin for
treatment of cocaine and methamphetamine abuse and examined
whether short-term usage of vigabatrin caused VFDs.
Study design. All subjects, consisting of 29 men
and one woman, met DSM-IV criteria for drug dependence. The
protocol for this study was reviewed and approved by the
Government of Mexico according to the standards of the Helsinki
Convention as currently modified.
Enrollment criteria. Subjects abused
methamphetamine, cocaine, or both on a daily basis, but were
otherwise in good health. The average duration of drug
dependence for all subjects was 12.8 years. All 30 subjects
enrolled met DSM-IV criteria for substance abuse, three met the
criteria for dependence on cocaine alone, 10 met the criteria
for methamphetamine dependence alone, and 17 met the criteria
for dependence on both cocaine and methamphetamine. A complete
preadmission history and physical examination for all test
subjects were obtained.
Ophthalmologic Measurement. The baseline
ophthalmologic examination consisted of funduscopy, in which a
doctor examines the back of the eye with an ophthalmoscope in
order to assess any damage to the blood vessels that supply the
retina. In addition, visual acuity was determined by
conventional ophthalmic techniques, and measurements of the
subjects visual field were performed utilizing a
measurement technique known as an automated Humphreys VF60-4
protocol. These tests were repeated in the middle and end of
treatment and again at one to two months following treatment
cessation. Ophthalmic measurements were performed at the Codet
Eye Institute, Tijuana, B.C. Mexico. In addition, these data
were independently evaluated by a Board Certified
Ophthalmologist at the University of Medicine and Dentistry,
Newark, New Jersey, who had no knowledge of each subjects
identity.
Dosing. Vigabatrin administration was initiated at
500 milligrams twice daily for three days, then 1.5 grams per
day for the next four days and two grams per day for the next
week. On day 15, subjects were placed on three grams per day,
maintained at that dose for the next 28 days, and then
tapered to zero over the next three weeks. Completers received a
cumulative dose of vigabatrin of 137 grams, which is less than
10% of the 1,500 gram lifetime exposure that we believe is
associated with an increase in the incidence of visual field
defects.
Testing. Twice-weekly urine samples were obtained
under direct observation and tested for cocaine,
methamphetamine, marijuana, heroin, and alcohol. Daily vital
signs were monitored, and all subjects were encouraged to
participate in weekly group therapy.
Results. Of the 30 volunteers enrolled:
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11 subjects dropped out before completing 4 weeks, |
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One subject completed 8 weeks; and |
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18 subjects completed all nine weeks, consisting of all three
cocaine-only users, 6 of the 10 methamphetamine-only users, and
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Completers did not differ significantly from non-completers in
either the pre-study daily usage or years of dependence.
49
Administration of vigabatrin did not have an effect on vital
signs, even with continued use of cocaine and methamphetamine.
Further, there were no VFDs or other changes in visual acuity
detected in any subject, regardless of whether the subject
completed the study or not.
Completers reported increased appetite and showed a significant
weight gain over non-completers, gaining an average of 11.4
pounds, compared to an average of 4.4 pounds for non-completers,
with a P-Value of 0.004.
Fifteen completers were methamphetamine-free and/or cocaine-free
for four consecutive weeks, with no slips, while two were never
drug-free although use was markedly reduced according to
self-reports by the users. The average drug-free interval was
40.1 consecutive days, with an average use of 0.03 grams of
cocaine or methamphetamine over the last three weeks of the
study.
Nicotine Animal Studies
A member of our Scientific Advisory Board working at Brookhaven
has conducted preclinical studies using primates to evaluate the
effects of vigabatrin on nicotine addiction. In these studies,
the administration of vigabatrin inhibited the ability of
nicotine to increase dopamine levels in varying degrees based on
dosage level and time elapsed since administration of
vigabatrin. When vigabatrin was administered 12 or 24 hours
prior to the introduction of nicotine, researchers observed no
increase in dopamine levels. Based upon these findings, we
intend to commence clinical studies evaluating CPP-109 as a
treatment for nicotine addiction in 2008.
Our Competitive Strengths
We believe that the key strengths that distinguish us from our
competitors include:
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CPP-109, if approved, will offer potentially significant
advantages over current treatments for drug addiction. As set
forth below, relapse rates for traditional counseling treatments
are very high, while clinical studies of vigabatrin to date have
shown low relapse rates among the 26 patients who completed
treatment. There can be no assurance, however, that the relapse
rates over wider studies or in general use will remain as low. |
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If approved, we believe that the use of CPP-109 in conjunction
with counseling will potentially offer a more efficacious and
cost-effective addiction treatment than is currently available. |
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Unlike other compounds, we believe that CPP-109 has no abuse
liability; that is, we believe that CPP-109 does not substitute
addiction to one drug for addiction to another drug. As a
result, we believe it will be easier for patients to cease using
CPP-109 after treatment without withdrawal effects. |
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CPP-109s mechanism of action potentially allows it to be
used to treat most types of substance addiction and abuse. |
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We have been granted Fast Track status for CPP-109 by the FDA,
which allows us an expedited review process with the FDA of any
NDA we may file for CPP-109. |
Competition
The biotechnology and pharmaceutical industries are highly
competitive. In particular, competition for the development and
marketing of therapies to treat addictive substances such as
cocaine, methamphetamine, and nicotine is intense and expected
to increase. Many of our competitors have substantially greater
financial and other resources, larger research and development
staffs and more experience developing products, obtaining FDA
and other regulatory approval of products and manufacturing and
marketing products. We compete against pharmaceutical companies
that are developing or currently marketing therapies for
addictive substances. In addition, we compete against
biotechnology companies, universities, government agencies, and
other research institutions in the development of substance
abuse treatments, technologies and processes that are, or in the
50
future may be, the basis for competitive commercial products.
While we believe that our product candidates will offer
advantages over many of the currently available competing
therapies, our business could be negatively impacted if our
competitors present or future offerings are more
effective, safer or less expensive than ours, or more readily
accepted by regulators, healthcare providers or third-party
payors.
While there are no currently approved therapies for cocaine or
methamphetamine addiction, we are aware of other therapies under
development. These can be broadly classified into three groups:
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Cocaine-mimetics. The mechanism of action of these drugs
is similar to cocaine. None of these approaches have, to our
knowledge, shown any efficacy. These compounds include: |
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methylphenidate, which is marketed as Ritalin by Novartis, and |
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GBR-12909, which is known as vanoxerine and is currently in
Phase II clinical trials sponsored by the National Institute of
Drug Abuse. |
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Cocaine-antagonists. These compounds are intended to
selectively target GABA, moderating dopamine levels in the
brain. We believe that many of these compounds are receptor
active and require increasing dosing over time. None of these
compounds are presently approved for marketing to treat
addiction. These compounds include: |
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baclofen, marketed as Lioresal by Novartis, |
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topiramate, marketed as Topamax by Ortho-McNeil Neurologics, |
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tiagabine, marketed as Gabitril by Cephalon, |
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gabapentin, marketed as Neurontin by Pfizer, and |
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progabide, marketed as Gabrene by Sanofi-Aventis. |
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Addiction Vaccines. These vaccines are designed to block
cocaine transport into the brain. They do not address issues
relating to craving or other behaviors associated with cocaine
addiction. We also believe that they can be overwhelmed by
increasing dosages of cocaine. These compounds include: |
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TA-CD is a cocaine vaccine currently in Phase II clinical trials
sponsored by Celtic Pharma Development U.K. Plc. |
In addition to these therapies, we are aware that InterveXion
Therapeutics LLC is developing two monoclonal antibody based
compounds for treatment of methamphetamine and phencyclidine, or
PCP, addictions.
Finally, Ovation Pharmaceuticals, Inc., which holds the North
American rights to Sabril as an adjunctive therapy for the
treatment of epilepsy and as a primary treatment for West
Syndrome, indicated its intent to undertake studies with respect
to the use of Sabril in treating cocaine addiction at an
industry conference held in April 2006. We believe that any
commercialization by Ovation of Sabril for this use would
violate our licensed patents, and we would assert any such
rights if Ovation sought to market Sabril for the treatment of
cocaine addiction. There can be no assurance we would be
successful in that regard.
Most therapies to treat nicotine addiction can be classified
into two groups, nicotine replacement therapies and
prescription-only neurotransmitter modulators. Numerous
over-the-counter, or OTC, therapies currently exist to treat
nicotine addiction such as transdermal nicotine patches,
inhalation sprays, nicotine gum, lozenges and oral dose drugs.
Although there are a wide variety of OTC products for nicotine
addiction, the only currently marketed prescription product
specific to smoking cessation is Zyban, marketed by
GlaxoSmithKline plc.
51
Patents and Intellectual Property Rights
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Brookhaven license agreement |
We have been granted an exclusive, worldwide license from
Brookhaven Science Associates, as operator of Brookhaven
National Laboratory under contract with the United States
Department of Energy (which we refer to as Brookhaven), to nine
patents and two patent applications relating to the use of
vigabatrin for the treatment of a wide variety of substance
addictions, with expiration dates for the issued patents
occurring between 2018 and 2020. Additionally, we recently
received approval from the European Union with respect to one of
our principal patents, which will allow us to seek approval for
this patent in each of the EU member states.
The license agreement, which is dated as of April 30, 2006
and which supercedes a previous license agreement that was
entered into in 2002, grants us an exclusive worldwide license,
including the right to sublicense, to make, have made, use,
and/or sell licensed products and practice the licensed process
with respect to the medical application in humans of vigabatrin
under certain patent rights. These rights are subject to the
United States governments rights to practice the licensed
process for its own use. The purpose of this agreement is to
permit us to commercialize products upon the receipt of
government regulatory approval for the use of vigabatrin for the
treatment of human drug addiction and addiction-related
behavior. In exchange for such rights, we paid Brookhaven an
initial fee of $50,000 and have agreed to pay a fee of $100,000
in the year of NDA approval for CPP-109, $250,000 in each of the
second and third years following approval, and $500,000 per year
thereafter until the last patent expires. In addition, we have
agreed to reimburse Brookhaven for all reasonable and customary
expenses it incurs from the beginning of our agreement in
connection with the filing, prosecution and maintenance of all
patents and patent applications included in the patent rights we
have licensed. We are obligated to reimburse Brookhaven $69,352,
as of September 30, 2005, for such expenses upon our filing
of an NDA.
We have also agreed to consult with Brookhaven not less
frequently than quarterly with respect to drug development steps
taken and progress made toward the objective of gaining
marketing approval from the FDA for any licensed product from
the beginning of our agreement through the date the FDA grants
us its approval to sell any licensed product. We have also
agreed to have in effect and maintain a liability insurance
policy in an amount of at least $1,000,000 to cover claims
arising out of the manufacture and use of licensed products and
such policy shall designate Brookhaven as an additional insured.
We have agreed to increase and maintain, throughout the life of
the agreement and for five years after its termination,
liability insurance coverage in the amount of at least
$5,000,000 upon acceptance by the FDA of our application to
commence Phase III clinical trials involving licensed products.
Our agreement with Brookhaven expires simultaneously with the
expiration of the last to expire patent it has licensed to us.
Protection of our intellectual property and proprietary
technology is a strategic priority for our business. We rely on
a combination of patent, trademark, copyright and trade secret
laws along with institutional know-how and continuing
technological advancement to develop and maintain our
competitive position. Our ability to protect and use our
intellectual property rights in the continued development and
commercialization of our technologies and products, operate
without infringing the proprietary rights of others, and prevent
others from infringing our proprietary rights, is crucial to our
continued success. We will be able to protect our products and
technologies from unauthorized use by third parties only to the
extent that they are covered by valid and enforceable patents,
trademarks or copyrights, or are effectively maintained as trade
secrets, know-how or other proprietary information.
52
Manufacturing, Marketing and Reimbursement
Since the composition of matter patent for vigabatrin has
expired, we are free to manufacture CPP-109, subject to the
receipt of necessary regulatory approvals. We have an agreement
with a qualified manufacturer of the active pharmaceutical
ingredient used in vigabatrin to supply our current
requirements. We also have an agreement with a contract
manufacturer to formulate and manufacture CPP-109 for use in our
upcoming clinical trials and thereafter, to manufacture
commercial quantities of CPP-109. In the event that sufficient
quantities of CPP-109 are not available for our upcoming trials,
we intend to use the branded version of vigabatrin and
subsequently demonstrate the bioequivalence of CPP-109 to the
branded version of vigabatrin. See Managements
Discussion of Financial Condition and Results of
Operations Liquidity and Capital Resources and
Note 6 of Notes to Financial Statements for a description
of the terms of our agreement with our contract manufacturer.
Since we intend to contract with a third party to manufacture
our products, our contract manufacturer will be obligated to
comply with all applicable laws and regulations relating to the
environment in connection with the manufacturing process. As a
result, we do not believe that we will have any significant
exposure to environmental issues.
We do not currently have any in-house marketing, distribution,
or production capabilities. In order to generate sales of
CPP-109 or any other product candidates we may develop, we must
either acquire or develop an internal marketing force with
technical expertise and with supporting documentation
capabilities, or make arrangements with third parties to perform
these services for us. The acquisition and development of a
marketing and distribution infrastructure will require
substantial resources, which may divert the attention of our
management and key personnel away from our product development
efforts. To the extent that we enter into marketing and
distribution arrangements with third parties, our revenues will
depend on the efforts of others. If we fail to enter into such
agreements, or if we fail to develop our own marketing and
distribution channels, we would experience delays in product
sales and incur increased costs.
Government Regulation
Governmental authorities in the United States and other
countries extensively regulate the testing, manufacturing,
labeling, storage, record-keeping, advertising, promotion,
export, marketing and distribution, among other things, of
pharmaceutical products. In the United States, the FDA, under
the FFDCA, and other federal statutes and regulations, subjects
pharmaceutical products to review. If we do not comply with
applicable requirements, we may be fined, the government may
refuse to approve our marketing applications or allow us to
manufacture or market our products, our products may be seized
and we may be criminally prosecuted.
FDA Approval Process. To obtain approval of a new product
from the FDA, we must, among other requirements, submit data
supporting safety and efficacy as well as detailed information
on the manufacture and composition of the product and proposed
labeling. The testing and collection of data and the preparation
of necessary applications are expensive and time-consuming. The
FDA may not act quickly or favorably in reviewing these
applications, and we may encounter significant difficulties or
costs in our efforts to obtain FDA approvals that could delay or
preclude us from marketing our products.
The process required by the FDA before a new drug may be
marketed in the United States generally involves the following:
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completion of non-clinical laboratory and animal testing in
compliance with FDA regulations; |
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submission of an investigational new drug application, or IND,
which must become effective before human clinical trials may
begin; |
53
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performance of adequate and well-controlled human clinical
trials to establish the safety and efficacy of the proposed drug
for its intended use; and |
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submission and approval of an NDA by the FDA. |
The sponsor typically conducts human clinical trials in three
sequential phases, but the phases may overlap. In Phase I
clinical trials, the product is tested in a small number of
patients or healthy volunteers, primarily for safety at one or
more dosages. In Phase II clinical trials, in addition to
safety, the sponsor evaluates the efficacy of the product on
targeted indications, and identifies possible adverse effects
and safety risks in a patient population. Phase III clinical
trials typically involve testing for safety and clinical
efficacy in an expanded population at geographically-dispersed
test sites. The FDA closely monitors the progress of each phase
of clinical testing and may, at its discretion, reevaluate,
alter, suspend or terminate testing based on the data
accumulated to that point and its assessment of the risk/benefit
ratio to the patient. Total time required for carrying out such
clinical testing varies between two and ten years. Additional
clinical testing is often required for special classes of
patients, e.g., such as the elderly, or those with kidney
impairment, and to test for infections with other drugs. Based
on the known side effects of VFDs associated with vigabatrin
when used in the treatment of epilepsy, our clinical studies
will also seek to determine if VFDs are associated with
vigabatrin when dispensed in the dosages and for the limited
periods proposed for the treatment of cocaine and
methamphetamine addiction.
Clinical trials must be conducted in accordance with the
FDAs good clinical practices requirements. The FDA may
order the partial, temporary or permanent discontinuation of a
clinical trial at any time or impose other sanctions if it
believes that the clinical trial is not being conducted in
accordance with FDA requirements or presents an unacceptable
risk to the clinical trial patients. The institutional review
board, or IRB of each clinical site, generally must approve the
clinical trial design and patient informed consent at that site
and may also require the clinical trial at that site to be
halted, either temporarily or permanently, for failure to comply
with the IRBs requirements, or may impose other conditions.
The applicant must submit to the FDA the results of the
non-clinical and clinical trials, together with, among other
things, detailed information on the manufacture and composition
of the product and proposed labeling, in the form of an NDA,
including payment of a user fee. The FDA reviews all NDAs
submitted before it accepts them for filing and may request
additional information rather than accepting an NDA for filing.
Once the submission is accepted for filing, the FDA begins an
in-depth review of the NDA. Under the policies agreed to by the
FDA under the Prescription Drug User Fee Act, or PDUFA, the FDA
has 10 months in which to complete its initial review of a
standard NDA and respond to the applicant, and six months
to complete its initial review of a priority NDA. The priority
review process and the PDUFA goal date may be extended by three
months if the FDA requests or the NDA sponsor otherwise provides
additional information or clarification regarding information
already provided in the submission within the last three months
of the PDUFA goal date. If the FDAs evaluations of the NDA
and the clinical and manufacturing procedures and facilities are
favorable, the FDA may issue either an approval letter or an
approvable letter, which contains the conditions that must be
met in order to secure final approval of the NDA. If and when
those conditions have been met to the FDAs satisfaction,
the FDA will issue an approval letter, authorizing commercial
marketing of the drug for certain indications. If the FDAs
evaluation of the NDA submission and the clinical and
manufacturing procedures and facilities is not favorable, the
FDA may refuse to approve the NDA and issue a not approvable
letter.
Section 505(b)(1) New Drug Applications. The
approval process described above is premised on the applicant
being the owner of, or having obtained a right of reference to,
all of the data required to prove the safety and effectiveness
of a drug product. This type of marketing application, sometimes
referred to as a full or stand-alone
NDA, is governed by Section 505(b)(1) of the FFDCA. A
Section 505(b)(1) NDA contains full reports of
investigations of safety and effectiveness, which includes the
results of preclinical studies and clinical trials, together
with detailed information on the manufacture and composition of
the product, in addition to other information. We may submit a
Section 505(b)(1) application for CPP-109.
54
Section 505(b)(2) New Drug Applications. As an
alternate path to FDA approval for new indications, improved
formulations of previously-approved products, or new chemical
entities, a company may submit a Section 505(b)(2) NDA,
instead of a stand-alone or full NDA
filing under Section 505(b)(1) as described above.
Section 505(b)(2) of the FFDCA was enacted as part of the
Drug Price Competition and Patent Term Restoration Act of 1984,
otherwise known as the Hatch-Waxman Amendments.
Section 505(b)(2) permits the submission of an NDA where at
least some of the information required for approval comes from
studies not conducted by or for the applicant and for which the
applicant has not obtained a right of reference. For example,
the Hatch-Waxman Amendments permit the applicant to rely upon
the FDAs findings of safety and effectiveness for an
approved product, or on published literature reports, or both.
The FDA may also require companies to perform additional studies
or measurements to support approval.
To the extent that a Section 505(b)(2) applicant is relying
on the FDAs findings for an already-approved product, the
applicant is required to certify to the FDA concerning any
patents listed for the approved product in the FDAs Orange
Book publication, which is the FDAs list of approved drug
products and the indications for which they are approved.
Specifically, the applicant must certify that: (1) the
required patent information has not been filed; (2) the
listed patent has expired; (3) the listed patent has not
expired, but will expire on a particular date and approval is
sought after patent expiration; or (4) the listed patent is
invalid or will not be infringed by the manufacture, use or sale
of the new product. A certification that the new product will
not infringe the already approved products Orange
Book-listed patents or that such patents are invalid is called a
paragraph IV certification. If the applicant does not
challenge the listed patents, the Section 505(b)(2)
application will not be approved until all the listed patents
claiming the referenced product have expired. The
Section 505(b)(2) application may also not be approved
until any non-patent exclusivity, such as exclusivity for
obtaining approval of a new chemical entity, listed in the
Orange Book for the referenced product has expired.
If the applicant has provided a paragraph IV certification
to the FDA, the applicant must also send a notice of the
paragraph IV certification to the NDA and the holder of the
underlying patent once the NDA has been accepted for filing by
the FDA. The NDA and patent holders may then initiate a legal
challenge to the paragraph IV certification. The filing of
a patent infringement lawsuit within 45 days of their
receipt of a paragraph IV certification automatically
prevents the FDA from approving the Section 505(b)(2) NDA
until the earliest of 30 months, expiration of the patent,
settlement of the lawsuit or a decision in the infringement case
that is favorable to the Section 505(b)(2) applicant. For
drugs with five-year exclusivity, if an action for patent
infringement is initiated after year four of that exclusivity
period, then the 30-month stay period is extended by such amount
of time so that 7.5 years has elapsed since the approval of
the NDA with five-year exclusivity. This period could be
extended by six months if the NDA sponsor obtains pediatric
exclusivity. Alternatively, if the listed patent holder does not
file a patent infringement lawsuit within the required 45-day
period, the applicants NDA will not be subject to the
30-month stay. Vigabatrin has not yet been approved by the FDA
for the treatment of addiction, Ovation has indicated its intent
to pursue development of Sabril, its branded version of
vigabatrin, for treatment of cocaine addiction. As such, at this
time we do not anticipate submitting a paragraph IV
certification. However, other applicants submitting 505(b)(2)
applications for vigabatrin that rely on CPP-109, if approved,
as well as an applicant that submits an abbreviated new drug
application, or ANDA, that cites CPP-109 as the reference listed
drug, would be required to submit patent certifications for any
patents listed in the Orange Book for CPP-109.
Notwithstanding the approval of many products by the FDA
pursuant to Section 505(b)(2), over the last few years,
certain brand-name pharmaceutical companies and others have
objected to the FDAs interpretation of
Section 505(b)(2). If these companies successfully
challenge the FDAs interpretation of
Section 505(b)(2), the FDA may be required to change its
interpretation of Section 505(b)(2). This could delay or
even prevent the FDA from approving any Section 505(b)(2)
NDA that we submit.
The Hatch-Waxman Act. Under the Hatch-Waxman Amendments,
newly-approved drugs and indications benefit from a statutory
period of non-patent marketing exclusivity. The Hatch-Waxman
Amendments provide five-year marketing exclusivity to the first
applicant to gain approval of an NDA for a chemical entity,
55
meaning that the FDA has not previously approved any other drug
containing the same active ingredients. The Hatch-Waxman
Amendments prohibit the submission of an ANDA, or a
Section 505(b)(2) NDA for another version of such drug
during the five-year exclusive period; however, as explained
above, submission of an ANDA or Section 505(b)(2) NDA
containing a paragraph IV certification is permitted after
four years, which may trigger a 30-month stay of approval of the
ANDA or Section 505(b)(2) NDA. Protection under
Hatch-Waxman will not prevent the submission or approval of
another full or stand-alone NDA;
however, the applicant would be required to conduct its own
non-clinical and adequate and well-controlled clinical trials to
demonstrate safety and effectiveness. The Hatch-Waxman
Amendments also provide three years of marketing exclusivity for
the approval of new and supplemental NDAs, including
Section 505(b)(2) NDAs, for, among other things, new
indications, dosages, or strengths of an existing drug, if new
clinical investigations that were conducted or sponsored by the
applicant are essential to the approval of the application.
If the FDA approves another companys version of vigabatrin
before it approves CPP-109, and awards that company five-year
marketing exclusivity, then we could not submit a 505(b)(2)
application for CPP-109 for at least four years. If, however, we
submit a full or stand-alone NDA for
CPP-109 under Section 505(b)(1) of the FDCA, then any
competitors five-year marketing exclusivity will not block
approval of CPP-109.
In addition to non-patent marketing exclusivity, the
Hatch-Waxman Amendments amended the FFDCA to require each NDA
sponsor to submit with its application information on any patent
that claims the drug for which the applicant submitted the NDA
or that claims a method of using such drug and with respect to
which a claim of patent infringement could reasonably be
asserted if a person not licensed by the owner engaged in the
manufacture, use, or sale of the drug. Generic applicants that
wish to rely on the approval of a drug listed in the Orange Book
must certify to each listed patent, as discussed above. We
intend to submit for Orange Book listing all relevant patents
for our product candidate.
Finally, the Hatch-Waxman Amendments amended the patent laws so
that certain patents related to products regulated by the FDA
are eligible for a patent term extension if patent life was lost
during a period when the product was undergoing regulatory
review, and if certain criteria are met. We intend to seek
patent term extensions, provided our patents and products, if
they are approved, meet applicable eligibility requirements.
Fast Track Designation. The FDAs Fast Track program
is intended to facilitate the development and to expedite the
review of drugs that are intended for the treatment of a serious
or life-threatening condition and that demonstrate the potential
to address unmet medical needs. Under the Fast Track program,
applicants may seek traditional approval for a product based on
data demonstrating an effect on a clinically meaningful
endpoint, or approval based on a well-established surrogate
endpoint. The sponsor of a new drug candidate may request the
FDA to designate the drug candidate for a specific indication as
a Fast Track drug at the time of original submission of its IND,
or at any time thereafter prior to receiving marketing approval
of a marketing application. The FDA has granted fast track
status to CPP-109.
Fast track designation permits the FDA to initiate review of
sections of an NDA before the application is complete. This
so-called rolling review is available if the
applicant provides and the FDA approves a schedule for the
submission of the remaining information and the applicant has
paid applicable user fees. The FDAs PDUFA review clock for
both a standard and priority NDA for a fast track product does
not begin until the complete application is submitted.
Additionally, fast track designation may be withdrawn by the FDA
if it believes that the designation is no longer supported by
emerging data, or if the designated drug development program is
no longer being pursued. A product approved under the FDAs
Fast Track program is subject to expedited withdrawal of
approval if required post-approval studies are not conducted
with due diligence, if the studies fail to verify the clinical
benefit of the product, or if the sponsor disseminates false or
misleading materials with respect to the product.
Other Regulatory Requirements. We may also be subject to
a number of post-approval regulatory requirements. If we seek to
make certain changes to an approved product, such as promoting
or labeling a
56
product for a new indication, making certain manufacturing
changes or product enhancements or adding labeling claims, we
will need FDA review and approval of an NDA supplement before
the change can be implemented. While physicians may use products
for indications that have not been approved by the FDA, we may
not label or promote the product for an indication that has not
been approved. Securing FDA approval for new indications or
product enhancements and, in some cases, for manufacturing and
labeling claims, is generally a time-consuming and expensive
process that may require us to conduct clinical trials under the
FDAs IND regulations. Even if such studies are conducted,
the FDA may not approve any change in a timely fashion, or at
all. In addition, adverse experiences associated with use of the
products must be reported to the FDA, and FDA rules govern how
we can label, advertise or otherwise commercialize our products.
There are current post-marketing safety surveillance
requirements that we will need to meet to continue to market an
approved product. The FDA also may, in its discretion, require
post-marketing testing and surveillance to monitor the effects
of approved products or place conditions on any approvals that
could restrict the commercial applications of these products.
In addition to FDA restrictions on marketing of pharmaceutical
products, several other types of state and federal laws have
been applied to restrict certain marketing practices in the
pharmaceutical industry in recent years. These laws include
anti-kickback statutes and false claims statutes. The federal
health care program anti-kickback statute prohibits, among other
things, knowingly and willfully offering, paying, soliciting or
receiving remuneration to induce or in return for purchasing,
leasing, ordering or arranging for the purchase, lease or order
of any health care item or service reimbursable under Medicare,
Medicaid or other federally financed health care programs. This
statute has been interpreted to apply to arrangements between
pharmaceutical manufacturers on the one hand and prescribers,
purchasers and formulary managers on the other. Violations of
the anti-kickback statute are punishable by imprisonment,
criminal fines, civil monetary penalties and exclusion from
participation in federal health care programs. Although there
are a number of statutory exemptions and regulatory safe harbors
protecting certain common activities from prosecution or other
regulatory sanctions, the exemptions and safe harbors are drawn
narrowly, and practices that involve remuneration intended to
induce prescribing, purchases or recommendations may be subject
to scrutiny if they do not qualify for an exemption or safe
harbor.
Federal false claims laws prohibit any person from knowingly
presenting, or causing to be presented, a false claim for
payment to the federal government, or knowingly making, or
causing to be made, a false statement to have a false claim
paid. Recently, several pharmaceutical and other health care
companies have been prosecuted under these laws for allegedly
inflating drug prices they report to pricing services, which in
turn are used by the government to set Medicare and Medicaid
reimbursement rates, and for allegedly providing free product to
customers with the expectation that the customers would bill
federal programs for the product. In addition, certain marketing
practices, including off-label promotion, may also violate false
claims laws. The majority of states also have statutes or
regulations similar to the federal anti-kickback law and false
claims laws, which apply to items and services reimbursed under
Medicaid and other state programs, or, in several states, apply
regardless of the payor.
In addition, we and the manufacturers on which we rely for the
manufacture of our products are subject to requirements that
drugs be manufactured, packaged and labeled in conformity with
current good manufacturing practice, or cGMP. To comply with
cGMP requirements, manufacturers must continue to spend time,
money and effort to meet requirements relating to personnel,
facilities, equipment, production and process, labeling and
packaging, quality control, record-keeping and other
requirements. The FDA periodically inspects drug manufacturing
facilities to evaluate compliance with cGMP requirements.
Also, as part of the sales and marketing process, pharmaceutical
companies frequently provide samples of approved drugs to
physicians. This practice is regulated by the FDA and other
governmental authorities, including, in particular, requirements
concerning record-keeping and control procedures.
57
Any marketing of CPP-109 outside of the United States will be
contingent on receiving approval from the various regulatory
authorities. Foreign regulatory systems, although they vary from
country to country, include risks similar to those associated
with FDA regulation in the United States. Under the European
Union regulatory system, applications for drug approval may be
submitted either in a centralized or decentralized manner. Under
the centralized procedure, a single application to the European
Medicines Agency leads to an approval granted by the European
Commission which permits marketing of the product throughout the
European Union. The decentralized procedure provides for mutual
recognition of nationally approved decisions and is used for
products that do not comply with requirements for the
centralized procedure. Under the decentralized procedure, the
holders of national marketing authorization in one of the
countries within the European Union may submit further
applications to other countries within the European Union, who
will be requested to recognize the original authorization based
on an assessment report provided by the country in which
marketing authorization is held.
As with FDA approval, we may not be able to secure regulatory
approvals in certain European countries in a timely manner, if
at all. Additionally, as in the U.S., post-approval regulatory
requirements would apply to any products that is approved in
Europe, and failure to comply with such obligations could have a
material adverse effect on our ability to successfully
commercialize any product.
Outside of the European Union, we are subject to widely varying
foreign obligations, which may be quite different from those of
the FDA, governing clinical studies, product registration and
approval and pharmaceutical sales. Whether or not FDA approval
has been received, we must obtain separate approval for products
by the comparable regulatory authorities of foreign countries
prior to the commencement of marketing CPP-109 in those
countries. The approval process varies from country to country,
and the time may be longer or shorter than that required for FDA
approval. In addition, under current U.S. law, there are
significant restrictions on the export of products not approved
by the FDA, depending on the country involved and the status of
the product in that country.
Our Employees
We currently employ four persons, including our Chief Financial
Officer, who is currently a consultant but will be an employee
upon completion of this offering. We also utilize the services
of consultants, including members of our board of directors and
Scientific Advisory Board. None of our employees are covered by
a collective bargaining agreement. We believe our relationship
with our employees and consultants is good.
Our Scientific Advisory Board
We rely on prominent scientists and physicians to advise us on
our pipeline of drug candidates and the clinical development of
CPP-109. All of our advisors are employed by organizations other
than us and may have commitments to or consulting or advisory
agreements with other entities that may limit their availability
to us. Our Scientific Advisory Board currently consists of the
following members:
Stephen L. Dewey, Ph.D. serves as Chairman of our
Scientific Advisory Board. Dr. Dewey is a Senior Chemist at
Brookhaven National Laboratory. Dr. Dewey is a recognized
authority in positron emission tomography, which uses certain
compounds to visualize and quantitate biochemical processes as
well as the distribution and movement of drugs in the living
human and animal body. Dr. Dewey has been with Brookhaven
since 1986, serving as Assistant Chemist, Associate Chemist,
Chemist, Tenured Scientist and Senior Chemist. Dr. Dewey is
also a Research Professor of Psychiatry at the New York
University School of Medicine and an Adjunct Professor of
Neurobiology and Behavior at SUNY at Stony Brook. Dr. Dewey
has been developing a novel approach to treating addiction
within Brookhavens PET program and is devoted to research
within this area. Dr. Dewey is a co-inventor of
Brookhavens patents for substance addiction, including
Brookhavens patents for vigabatrin to treat addiction.
58
Jonathan Brodie, Ph.D., M.D. is the Marvin Stern
Professor of Psychiatry at New York University School of
Medicine. Dr. Brodie completed his B.S. in Chemistry as a
Ford Foundation Scholar and his Ph.D. in Physiological Chemistry
(Organic Chemistry minor) at the University of
Wisconsin-Madison. He was an NIH postdoctoral Fellow in
Biochemistry at Scripps Clinic and Research Foundation and a
tenured associate professor of Biochemistry at the School of
Medicine at SUNY at Buffalo. He then received his M.D. at New
York University School of Medicine and joined the faculty after
completing his residency in psychiatry at NYU/ Bellevue Medical
Center. He is a member of the Promotions and Tenure Committee of
the School of Medicine as well as a member of the Executive
Advisory Committee of the General Clinical Research Center and
the Protocol Review Committee of the Center for Advanced Brain
Imaging (CABI) of Nathan Kline Institute. For 15 years, he
was the NYU Director of the Brookhaven National Laboratory/
NYUSOM collaboration investigating the use of positron emitters
and PET in neuroscience and psychiatry. Additionally,
Dr. Brodie serves as a psychopharmacology instructor to
psychiatry residents. As a clinician, he treats patients in
general issues of adult psychiatry including anxiety and
depression. Dr. Brodie is a co-inventor of
Brookhavens patents for substance addiction, including
Brookhavens patents for vigabatrin to treat addiction.
Donald R. Jasinski, M.D. is Chief of the Center for
Chemical Dependence at Johns Hopkins Bayview Medical Center in
Baltimore, Maryland. Dr. Jasinski received his medical
degree from the University of Illinois School of Medicine. After
receiving his degree, Dr. Jasinski worked at the
U.S. Public Health Service at the Addiction Research Center
in Kentucky, which was the first national laboratory set up to
deal with narcotics and their effects. Dr. Jasinski has
pioneered the use of buprenorphine to treat opioid dependence.
Buprenorphine, which was developed as a pain reliever for cancer
patients, is now seen by many in the medical community as the
best drug on the market to treat patients who are addicted to
heroin. Dr. Jasinski has agreed to be our principal
investigator for our U.S. Phase II Study.
Robert D. Fechtner, M.D. is Professor of Ophthalmology
and Director, Glaucoma Division at the Institute of
Ophthalmology and Visual Science UMDNJ New Jersey
Medical School, Newark, New Jersey. Dr. Fechtner received
his B.S. in Biomedical Science and his medical degree from the
University of Michigan School of Medicine. He completed his
residency at Albert Einstein College of Medicine in New York.
This was followed by a fellowship in glaucoma at the University
of California, San Diego under a National Research Service Award
from the National Institutes of Health. After several years on
the faculty at University of Louisville, he and his family
returned home to New Jersey where he joined the faculty at New
Jersey Medical School. Dr. Fechtner has published over 70
articles and chapters and is on the editorial boards of American
Journal of Ophthalmology and Journal of Glaucoma.
Eugene Laska, Ph.D. is Professor of Psychiatry at the
Department of Psychiatry at New York University Medical Center.
Dr. Laska received a Ph.D. in Mathematics at New York
University, and then completed a PHS Postdoctoral Fellowship at
the Department of Statistics at Stanford University.
Dr. Laska is the Director of the Statistical Sciences and
Epidemiology Division of the Nathan Kline Institute for
Psychiatric Research. Dr. Laska is also the Director of the
WHO Collaborating Center for Research and Training in Mental
Health Program Management, and has served as a consultant to
large and small pharmaceutical companies in the areas of
biostatistics and clinical trial design.
Facilities
We currently operate our business in leased office space in
Coral Gables, Florida. We pay annual rent on our office space of
approximately $17,900. In anticipation of the expansion of our
operations, we plan to obtain additional leased space in the
near future.
Legal Proceedings
We are not a party to any legal proceedings.
59
OUR MANAGEMENT
Officers and Directors
The following table shows information about our officers and
directors as of the date of this prospectus:
|
|
|
|
|
Name |
|
Age |
|
Position(s) |
|
|
|
|
|
Patrick J. McEnany |
|
59 |
|
Co-Founder, Chairman, President and Chief Executive Officer |
Hubert E. Huckel,
M.D.(1)
|
|
75 |
|
Co-Founder and Director |
Charles B.
OKeeffe(2)(3)
|
|
66 |
|
Senior Advisor and Director |
Philip H.
Coelho(2)(3)
|
|
62 |
|
Director |
David S. Tierney,
M.D.(1)(3)
|
|
43 |
|
Director |
Milton J.
Wallace(1)(3)
|
|
70 |
|
Director |
Jack Weinstein
|
|
50 |
|
Vice President, Treasurer and Chief Financial Officer |
M. Douglas Winship
|
|
57 |
|
Vice President of Regulatory Operations |
Charles W. Gorodetzky, M.D., Ph.D.
|
|
69 |
|
Chief Medical Officer |
|
|
(1) |
Member of the Audit Committee. |
|
(2) |
Member of the Compensation Committee. |
|
(3) |
Member of the Nominating and Corporate Governance Committee. |
Patrick J. McEnany is our Co-Founder, Chairman, President
and Chief Executive Officer. Mr. McEnany has been Chief
Executive Officer and a director since our formation in January
2002. He became Chairman and President in April 2006. From 1999
to 2002, Mr. McEnany was a consultant in the pharmaceutical
industry. From 1991 to 1997, Mr. McEnany was Chairman and
Chief Executive Officer of Royce Laboratories, Inc., a generic
pharmaceutical manufacturer. From 1997 to 1998, after the merger
of Royce into Watson Pharmaceuticals, Inc., Mr. McEnany
served as president of the wholly-owned Royce Laboratories
subsidiary and vice president of corporate development for
Watson Pharmaceuticals, Inc. From 1993 to 1997, he also served
as vice chairman and a director of the National Association of
Pharmaceutical Manufacturers. He currently serves on the board
of directors for ThermoGenesis Corp., Renal CarePartners, Inc.
and the Jackson Memorial Hospital Foundation.
Hubert E. Huckel, M.D. is our Co-Founder and is a member
of our board of directors. Dr. Huckel was Chairman of the
Board until April 2006. Dr. Huckel spent 29 years with
The Hoechst Group (now part of Sanofi-Aventis), and was at the
time of his retirement in 1992, executive chairman of the board
of Hoechst-Roussel Pharmaceuticals, Inc. Dr. Huckel has
continued his involvement in the prescription drug industry and
currently serves on the boards of directors of Titan
Pharmaceuticals, Inc., ThermoGenesis Corp., Valera
Pharmaceuticals, Inc., and Concordia Pharmaceuticals, Inc.
Dr. Huckel received his M.D. degree from the University of
Vienna, Austria and is a member of the Rockefeller University
Council.
Charles B. OKeeffe became a consultant to us in
December 2004 and has served as our Senior Advisor since that
time. Mr. OKeeffe has also served as a member of our
board of directors since December 2004. Mr. OKeeffe
is a Professor in the Department of Epidemiology and Community
Health at Virginia Commonwealth University, and has served in
such capacity since January 1, 2004. Mr. OKeeffe
joined VCU after retiring as President and chief executive
officer of Reckitt Benckiser Pharmaceuticals, Inc., a position
Mr. OKeeffe held from 1991 until 2003. As President
of Drug Abuse Rehabilitation Services (from 1970 until 1971), he
developed the first child-resistant, abuse-resistant vehicle for
dispensing methadone. He served as president of Washington
Reference Laboratories from 1972 until 1975, which provided
toxicology services to the Department of Defense during the
Vietnam War. He has served in the White House (from 1970 until
1973 and from 1976 until 1980) for three presidents
as advisor, special assistant for international health and deputy
60
director for international affairs in the Office of Drug Abuse
Policy and has served on U.S. delegations to
the World Health Assembly and the U.N. Commission on Narcotic
Drugs. Mr. OKeeffe played a significant role in
helping Congress reach consensus on the Drug Addiction Treatment
Act of 2000.
Philip H. Coelho has been a member of our board of
directors since October 2002. Mr. Coelho has been employed
with ThermoGenesis Corp., a company focused on the blood
processing and hospital/woundcare markets, since October 1986.
Since November 1997, Mr. Coelho has served as chairman and
chief executive officer of ThermoGenesis; from December 1989 to
November 1997, Mr. Coelho was president and chief executive
officer of ThermoGenesis; and from October 1986 to September
1989, Mr. Coelho served as vice president and director of
research and development of ThermoGenesis. Prior to this, from
October 1983 to October 1986, Mr. Coelho was president of
Castleton, Inc., a company that developed and licensed the
ultra-rapid heat transfer technology to ThermoGenesis.
Mr. Coelho holds a Bachelor of Science degree in Mechanical
Engineering from the University of California, Davis.
David S. Tierney, M.D. has served as a member of our
board of directors since October 2002. Dr. Tierney has
served as the president and chief executive officer of Valera
Pharmaceuticals, Inc. a specialty pharmaceutical company, since
2000 and has served as a director since 2001. From January 2000
to August 2000, Dr. Tierney served as President of Biovail
Technologies, a division of Biovail Corporation, a Canadian drug
delivery company, where he was responsible for all of
Biovails research and development, regulatory and clinical
activities. From March 1997 to January 2000, Dr. Tierney
was Senior Vice President of Drug Development at Roberts
Pharmaceutical Corporation, where he was responsible for all
research and development activities, and for drug development,
medical affairs, worldwide regulatory affairs and chemical
process development, as well as being part of the executive
management team. From December 1989 to March 1997,
Dr. Tierney was employed by Élan Corporation, a
pharmaceutical company, in a variety of management positions.
Dr. Tierney received his medical degree from the Royal
College of Surgeons in Dublin, Ireland and was subsequently
trained in internal medicine.
Milton J. Wallace became a member of our board of
directors in October 2002. Mr. Wallace was a practicing
attorney in Miami, Florida for over 40 years until 2005,
when he retired. Mr. Wallace served as co-founder and
chairman of Renex Corporation, a provider of kidney dialysis
services, from July 1993 to February 2000, when that company was
acquired by National Nephrology Associates, Inc.
Mr. Wallace also was the co-founder and a director of Home
Intensive Care, Inc., a provider of home infusion and dialysis
services, from 1985 to July 1993, when that company was acquired
by W.R. Grace & Co. Mr. Wallace was chairman of the
board of directors of Med/Waste, Inc., an entity engaged in the
business of medical waste, from June 1993 until
February 13, 2002, when that company filed a voluntary
bankruptcy petition under federal bankruptcy laws.
Mr. Wallace currently serves as chairman of the board of
directors of Renal CarePartners, Inc. and as a member of the
board of directors of Imperial Industries, Inc.
Jack Weinstein has served as a consultant to us and as
our Chief Financial Officer since October 2004. For the last
20 years Mr. Weinstein has primarily been employed as
an investment banker with various firms. From 2002 to 2004,
Mr. Weinstein was with, and he currently is a licensed
agent of, The Avalon Group, Ltd., a broker-dealer. From 1999 to
2002, Mr. Weinstein was employed by Ladenburg Thalmann
& Co., Inc. From 1994 to 1999, Mr. Weinstein was
employed by Gruntal & Co., LLC. Mr. Weinstein earned a
Bachelors Degree from the University of Miami in 1979 and a
Masters in Business Administration from Harvard University
Graduate School of Business Administration in 1983.
M. Douglas Winship joined us in July 2006 as our Vice
President of Regulatory Operations. Mr. Winship has worked
in regulatory affairs in the healthcare industry for
30 years. From 2004 to 2005, Mr. Winship was vice
president quality assurance and regulatory affairs
for Argos Theraputics, Inc., a biotechnology company developing
immuno therapy treatments for cancer, in Durham, North Carolina.
Previously, Mr. Winship was employed by CEL-SCI Corp., a
biotechnology company developing immune system based treatments,
in Vienna, VA, from 1998 to 2002 as senior vice
president regulatory affairs and
61
quality assurance, and from 1994 through 1998 as vice
president regulatory affairs and quality assurance.
From 1998 to 1994, Mr. Winship was employed by Curative
Technologies, Inc., a health-care company involved in the
wound-healing market, first as director of regulatory affairs
and quality assurance and later as vice president of Regulatory
Affairs and Quality Assurance. Mr. Winship earned his
Bachelor of Science in chemistry from Upsala College in 1971.
Charles W. Gorodetzky, M.D., Ph.D., became our Chief
Medical Officer in September 2006. Dr. Gorodetzky has more
than 43 years of experience in pharmacology, drug
development, clinical trials and addiction medicine. From 1999
to 2005, Dr. Gorodetzky was employed by Quintiles, Inc. in
a variety of management positions, including serving as a Vice
President in the Medical and Scientific Services Department.
While at Quintiles, he had extensive experience with designing,
organizing and managing large multi-center clinical trials in a
variety of central-nervous system (CNS) indications, abuse
liability, substance abuse treatment and smoking cessation.
Prior to joining Quintiles, from 1994 to 1998
Dr. Gorodetzky was a Vice President of Hoechst Marion
Roussel, Inc. (formerly Marion Merrell Dow), serving as Global
Head of CNS Development, Head of Clinical Research North America
and North American Medical Advisor. Dr. Gorodetzky has been
directly involved in the clinical development of vigabatrin
since 1995, first as the primary responsible development person
at Hoechst Marion Rousell (HMR) (now Sanofi Aventis) and then as
the person at Quintiles working with HMR in the development of
vigabatrin. Prior to joining HMR, Dr. Gorodetzky was
employed by several pharmaceutical companies in management
positions, with an emphasis on developing smoking cessation
therapies and antieplileptic drugs. From 1963 to 1984,
Dr. Gorodetzky was on the staff at the National Institute
on Drug Abuse, Addiction Research Center, serving in his last
position as the final director of NIDAs Lexington facility.
Board Composition
Our board of directors consists of six directors, each serving a
one-year term expiring at the next annual meeting of
stockholders. The board will satisfy all criteria for
independence established by the Nasdaq Global Market, or Nasdaq,
and other governing laws and regulations. No director will be
deemed to be independent unless the board affirmatively
determines that the director has no material relationship with
us directly, or as an officer, stockholder or partner of an
organization that has a relationship with us.
Board Committees
Upon the completion of this offering, the standing committees of
our board of directors will consist of the Audit Committee,
Compensation Committee and Nominating and Corporate Governance
Committee. These committees are described below. Our board of
directors may also establish various other committees to assist
it in its responsibilities.
Audit Committee
The Audit Committee is primarily concerned with the accuracy and
effectiveness of the audits of our financial statements by our
independent auditors. Its duties include:
|
|
|
|
|
selecting independent auditors; |
|
|
|
reviewing the scope of the audit to be conducted by them and the
results of their audit; |
|
|
|
approving non-audit services provided to us by the independent
auditor; |
|
|
|
reviewing the integrity, adequacy and effectiveness of our
financial reporting process and internal controls; assessing our
financial reporting practices, including the disclosures in our
annual and quarterly reports and the accounting standards and
principles followed; and |
|
|
|
conducting other reviews relating to compliance by our employees
with our policies and applicable laws. |
62
Currently, the Audit Committee is comprised of
Messrs. Wallace, Huckel and Tierney, each of whom is
independent as defined under Nasdaq rules. Mr. Wallace
currently serves as Chairman of the committee. The board of
directors has determined that Mr. Wallace qualifies as
audit committee financial expert as that term is
defined under the rules of the Securities and Exchange
Commission, or SEC.
Compensation Committee
This Compensation Committees primary responsibility is to
discharge our board of directors responsibilities relating
to compensation of our senior executives. Its duties include:
|
|
|
|
|
developing guidelines and reviewing the compensation and
performance of our executive officers; |
|
|
|
setting the compensation of the chief executive officer and
evaluating his performance based on corporate goals and
objectives; |
|
|
|
making recommendations to the board of directors with respect to
incentive compensation plans, equity-based plans and deferred
compensation plans; and |
|
|
|
reviewing director compensation levels and practices, and
recommending, from time to time, changes in such compensation
levels and practices to the board of directors. |
Currently, the Compensation Committee is comprised of
Messrs. OKeeffe and Coelho, each of whom is
independent as defined under Nasdaq rules.
Nominating and Corporate Governance Committee
The Nominating and Corporate Governance Committees
responsibilities include the selection of potential candidates
for our board of directors and the development and annual review
of our governance principles. This committee also annually
reviews director compensation and benefits, and oversees the
annual self-evaluations of our board of directors and its
committees. It also makes recommendations to our board of
directors concerning the structure and membership of the other
board committees.
The Nominating and Corporate Governance Committee is comprised
of all of our outside directors, each of whom is independent as
defined under Nasdaq rules.
Compensation Committee Interlocks and Insider
Participation
None of the members of our Compensation Committee were at any
time an officer or employee of ours. In addition, none of our
executive officers serves as a member of the board of directors
or compensation committee of any entity that has one or more
executive officers serving as a member of our board of directors
or Compensation Committee, except that Mr. McEnany serves
on the compensation committee of ThermoGenesis, the Chief
Executive Officer of which is Mr. Coelho.
Compensation of Directors
Our directors currently do not receive, and have not received,
any cash compensation for serving on our board. Directors are
eligible to receive stock options and restricted share grants of
our common stock under our 2006 Stock Incentive Plan. No options
or restricted shares have been granted to our directors to date.
Executive Compensation
|
|
|
Current and historic compensation paid to executives and
consultants |
Prior to 2005, Mr. McEnany received no compensation for
serving as our Chief Executive Officer. In January 2005, we
entered into an employment agreement with Mr. McEnany under
which he was to receive an annual salary of $100,000 per annum.
We also agreed to pay for Mr. McEnanys health
insurance, which costs
63
us less than $10,000 per year. However, Mr. McEnany agreed
to defer 50% of his annual salary until such time as we procured
financing and raised gross proceeds of at least
$2.0 million; Mr. McEnany subsequently agreed to defer
100% of his compensation until such financing was obtained. In
fact, Mr. McEnany received no compensation in 2002, 2003,
2004 and 2005 for his services. However, in July 2006, after we
completed our private placement, Mr. McEnany was paid all
deferred compensation, aggregating $125,000. We intend to enter
into a new employment agreement with Mr. McEnany which
shall become effective upon the completion of this offering.
In October 2004, we entered into a consulting agreement with
Mr. Weinstein. Under the terms of the consulting agreement,
as amended, Mr. Weinstein receives a monthly consulting fee
of $7,500. In addition, Mr. Weinstein will receive a fee in
the amount of approximately $150,000 from the proceeds of this
offering. See Certain Relationships and Related
Transactions. We intend to enter into an employment
agreement with Mr. Weinstein which will become effective
upon the completion of this offering.
In January 2005, we entered into a consulting agreement with
Mr. OKeeffe under which we pay him a monthly
consulting fee of $5,000, payable $2,500 in cash and $2,500 in
shares of our common stock valued at $2.00 per share. We also
pay consulting fees to several members of our scientific
advisory board, as follows: Dr. Dewey ($1,500 per month),
Dr. Jasinski ($1,500 per month), and Dr. Brodie
($1,000 per month).
Mr. Winship is paid a base salary of $180,000 per annum for
serving as our Vice President of Regulatory Operations. He also
will have the opportunity to earn bonuses of up to 20% of his
base salary by meeting performance objectives approved by the
Compensation Committee of the Board.
Mr. Gorodetzkys contract provides that he will
contribute at least 10 hours per week to our business, a minimum
of 40 hours per month or 120 hours per quarter.
Mr. Gorodetzky is paid $250 per hour for his services.
Mr. Gorodetzky is paid $200 per hour for services above and
beyond 120 hours per quarter. In addition, Mr. Gorodetzky
has been granted stock options under our 2006 Stock Incentive
Plan to purchase 15,000 shares of our common stock, at an
exercise price equal to the public offering price in this
offering. These options will vest over a 3-year period.
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Post-offering compensation for Messrs. McEnany and
Weinstein |
We intend to enter into employment agreements with
Messrs. McEnany and Weinstein which shall become effective
upon completion of this offering. Under these agreements,
Messrs. McEnany and Weinstein will receive base salaries of
$315,000 and $200,000, respectively, and bonus compensation
based on performance. Each employment agreement will also
contain a change of control severance arrangement if
the employee is not retained in our employment after a change of
control.
Stock Options and Stock Incentive Plans
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Currently outstanding stock options |
In each of July 2002 and March 2005, we issued options to
purchase 250,000 shares of our common stock to each of
Mr. McEnany and Dr. Huckel (options to purchase
1,000,000 shares in the aggregate). These options are currently
vested, expire ten years after their grant dates, and have an
exercise price of $1.00 per share.
In 2004 and 2005, we issued options to purchase shares of our
common stock to Messrs. Weinstein and OKeeffe.
Mr. OKeeffe holds options to purchase 200,000 shares
of our common stock at an exercise price of $2.00 per share.
Mr. OKeeffes options expire in January 2010.
Mr. Weinstein holds options to purchase 300,000 shares of
our common stock, 200,000 of which are at an exercise price of
$2.00 per share (100,000 expire in October 2009 and 100,000
expire in March 2010) and 100,000 of which are at an exercise
price of $4.35 per share (50,000 expire in October 2009 and
50,000 expire in March 2010). All of the options held by Messrs.
Weinstein and OKeeffe are fully vested.
64
In July 2006, we issued five-year options to purchase 100,000
shares of our common stock to Mr. Winship. These options
will vest over a four-year period and have an exercise price of
$4.35 per share.
The following table sets forth the number and value of
securities underlying unexercised options held by our named
executive officers at December 31, 2005. Because there was
no public market for our common stock as of December 31,
2005, amounts described in the following table under the heading
Value of Unexercised In-the-Money Options at
December 31, 2005 are determined by multiplying the
number of shares issued or issuable upon exercise of the option
by the difference between the assumed initial public offering
price of
$ per
share, which is the midpoint of the range set forth on the cover
and the per share option exercise price. In 2005, none of our
named executive officers exercised any options.
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Number of | |
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Value of Unexercised | |
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Unexercised Options at | |
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In-the-money Options at | |
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December 31, 2005 | |
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December 31, 2005 ($)(1) | |
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Exercisable | |
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Unexercisable | |
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Exercisable | |
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Unexercisable | |
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Patrick J. McEnany
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500,000 |
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Jack Weinstein
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200,000 |
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100,000 |
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(1) |
Based upon an assumed initial public offering price of
$ per
share, which is the midpoint of the range set forth on the cover
of this prospectus. |
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The 2006 Stock Incentive Plan |
Overview. Our board of directors has recently approved
the 2006 Stock Incentive Plan (the 2006 plan), and
we anticipate that our stockholders will approve the 2006 plan
prior to this offering. We have reserved 1,500,000 shares for
issuance under the 2006 plan. Options to acquire 15,000 shares
have been granted to date under the 2006 plan. The purpose of
the 2006 plan is to continue to advance our interests by
allowing us to attract, retain, reward, and motivate individuals
eligible under the 2006 plan to strive for our continued success
by giving them additional opportunities to purchase further
equity stakes in our company.
Administration. The Compensation Committee of our board
of directors will administer the 2006 plan and will determine
which persons will receive grants of awards and the type of
award to be granted to such persons. The Compensation Committee
will also interpret the provisions of the 2006 plan and make all
other determinations that it deems necessary or advisable for
the administration of the 2006 plan.
Eligibility. All eligible individuals will be able to
participate in the 2006 plan. Eligible individuals include our
directors, officers, employees, independent contractors and
consultants, as well as individuals who have accepted an offer
of employment with us.
Transferability of awards. Awards are non-transferable
other than by will or by the laws of descent and distribution or
as otherwise expressly allowed by the Compensation Committee
pursuant to a gift to members of an eligible persons
immediate family. The gift may be directly or indirectly
transferred, by means of a trust, partnership, or otherwise.
Stock options and SARs may be exercised only by the optionee,
any such permitted transferee or a guardian, legal
representative or beneficiary.
Change of control. If there is a change in control of
Catalyst Pharmaceutical Partners, Inc., any award that is not
exercisable and vested may immediately become exercisable and
vested in the sole and absolute discretion of the Compensation
Committee. Vested awards will be deemed earned and payable in
full. The Compensation Committee may also terminate the awards,
entitling participants to a cash payment. If we are liquidated
or dissolved, awards may also be converted into the right to
receive liquidation proceeds. In the event that the Compensation
Committee does not terminate or convert an award upon a change
of control, then the award will be assumed, or substantially
equivalent awards will be substituted, by the acquiring or
succeeding corporation.
65
Amendments, modifications and termination. Our board of
directors may, at any time, amend, suspend or terminate the 2006
plan, but the board may not impair the rights of holders of
outstanding awards without the holders consent. No
amendment to the 2006 plan may be made without consent of our
stockholders. In the event that an award is granted to a person
residing outside of the United States, the board may, at its
discretion, modify the terms of the agreement to comply with the
laws of the country of which the eligible individual is a
resident. The 2006 plan will terminate 10 years after its
effective date.
66
OUR PRINCIPAL STOCKHOLDERS
The following table sets forth information regarding the
beneficial ownership of our common stock as of the date of this
prospectus by:
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each person or entity who we know beneficially owns more than 5%
of our outstanding common stock; |
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each of our directors and executive officers; and |
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all directors and executive officers as a group. |
Beneficial ownership is determined in accordance with the rules
of the U.S. Securities and Exchange Commission and includes
voting or investment power with respect to the shares. In
computing the number of shares beneficially owned by a person
and the percentage ownership of that person, shares of common
stock subject to options or warrants held by that person that
are currently exercisable or will become exercisable within
60 days of the date of this prospectus are deemed
outstanding and included in the number of shares beneficially
owned, while those shares are not deemed outstanding for
purposes of computing percentage ownership of any other person.
Except as otherwise indicated, the persons named in the table
have sole voting and investment power with respect to all shares
of common stock held by them.
Applicable percentage ownership in this table is based on
6,281,900 shares of common stock outstanding as of the date of
this prospectus
and shares
of common stock outstanding immediately after the completion of
this offering. The address for each shareholder listed in the
table is c/o Catalyst Pharmaceutical Partners, Inc., 220 Miracle
Mile, Suite 234, Coral Gables, Florida 33134.
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Percentage Owned | |
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Shares Owned | |
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Before Offering | |
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After Offering | |
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Patrick J.
McEnany(1)(2)
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2,706,750 |
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39.9% |
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Hubert Huckel,
M.D.(2)
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1,287,500 |
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19.0% |
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Jonathan Brodie
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315,000 |
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5.0% |
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Philip H. Coelho
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150,000 |
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2.4% |
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Charles B.
OKeeffe(3)
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222,500 |
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3.4% |
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David S. Tierney, M.D.
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125,000 |
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2.0% |
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Milton J.
Wallace(5)
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215,000 |
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3.4% |
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Jack
Weinstein(4)
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300,000 |
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4.6% |
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M. Douglas
Winship(6)
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Officers & directors as a group (8 persons)
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5,006,750 |
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64.3% |
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(1) |
Includes 100,000 shares owned by Mr. McEnanys wife. |
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(2) |
Includes options to purchase 500,000 shares of our common stock
at a price of $1.00 per share. |
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(3) |
Includes options to purchase 200,000 shares of our common stock
at a price of $2.00 per share. |
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(4) |
Includes options to purchase 300,000 shares of our common stock,
of which options to purchase 200,000 shares are exercisable at a
price of $2.00 per share and options to purchase 100,000 shares
are exercisable a price of $4.35 per share. |
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(5) |
Includes 20,000 shares owned by Biscayne National Corp.
Mr. Wallace is the president of Biscayne National Corp. |
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(6) |
Excludes options to purchase 100,000 shares of our common stock
exercisable at a price of $4.35 per share, none of which have
vested or will vest within 60 days of the date of this
prospectus. |
67
CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS
Effective May 2006, we amended our consulting agreement with
Jack Weinstein, our Chief Financial Officer. Pursuant to the
consulting agreement, as amended, Mr. Weinstein receives a
monthly consulting fee of $7,500. As part of
Mr. Weinsteins consulting arrangement with us, he
also received five-year options to purchase an aggregate of
300,000 shares of our common stock, all of which are currently
exercisable. Options to purchase 200,000 shares of our common
stock have an exercise price of $2.00 per share, and options to
purchase 100,000 shares of our common stock have an exercise
price of $4.35 per share.
In addition, Mr. Weinstein will receive a success fee of
approximately $150,000 upon the completion of this offering.
Pursuant to the agreement, $2,500 of the monthly consulting fees
payable to Mr. Weinstein after April 30, 2006 are
being applied towards this fee. The May 2006 consulting
agreement amended the previous agreement dated October 2004
pursuant to which Mr. Weinstein received a monthly
consulting fee of $5,000, in addition to the stock options
described above.
68
DESCRIPTION OF OUR CAPITAL STOCK
Our authorized capital currently consists of 100,000,000 shares
of common stock, par value $.001 per share, and 5,000,000 shares
of preferred stock, par value $.001 per share. As of the date of
this prospectus, we had 6,281,900 shares of common stock
outstanding, of which 4,817,500 are issued shares of our common
stock and 1,464,400 are shares of our common stock issuable upon
the automatic conversion at the closing of this offering of our
Series A and B Preferred Stock. At this date, 70,000 shares
of our Series A Preferred Stock and 7,544 shares of our
Series B Preferred Stock are outstanding. All share and per
share information contained in this prospectus assumes
conversion of the currently outstanding Series A Preferred
Stock and Series B Preferred Stock into common stock at the
closing of this offering.
We were incorporated in Delaware in July 2006. We are currently
a wholly-owned subsidiary of Catalyst Pharmaceutical Partners,
Inc., a Florida corporation (CPP-Florida), which was
incorporated in the State of Florida in January 2002. We have
recently entered into a merger agreement with CPP-Florida under
which, at the effective time of the merger, CPP-Florida will be
merged with and into us and we will succeed to all of the
assets, liabilities, rights and operations of CPP-Florida. The
merger will be completed on or about September 6, 2006,
prior to the effectiveness of our registration statement. All
information in this prospectus about us assumes completion of
the reincorporation.
The description below of our capital stock reflects information
about Catalyst Pharmaceutical Partners, Inc., a Delaware
corporation. Such information is a summary and is qualified in
its entirety by our Certificate of Incorporation and our
By-laws. Copies of our Certificate of Incorporation and By-laws
are filed as exhibits to our registration statement, of which
this prospectus forms a part.
Common Stock
Each holder of common stock is entitled to one vote for each
share held of record on all matters presented to our
stockholders, including the election of directors. In the event
of our liquidation, dissolution, or winding-up, the holders of
common stock are entitled to share ratably and equally in our
assets, if any, that remain after paying all debts and
liabilities and the liquidation preferences of any outstanding
preferred stock. The common stock has no preemptive or
cumulative rights and no redemption or conversion provisions.
Holders of our common stock are entitled to receive dividends
if, as, and when declared by our board of directors out of funds
legally available therefor, subject to the dividend and
liquidation rights of any preferred stock that may be issued and
outstanding, all subject to any dividend restrictions in any
credit facilities that we may enter into. No dividend or other
distribution (including redemptions and repurchases of shares of
capital stock) may be made, if after giving effect to such
distribution, we would not be able to pay our debts as they come
due in the usual course of business, or if our total assets
would be less than the sum of our total liabilities plus the
amount that would be needed at the time of a liquidation to
satisfy the preferential rights of any holders of preferred
stock.
Preferred Stock
Our board of directors is authorized, without further
stockholder action, to divide any or all shares of the
authorized preferred stock into series and fix and determine the
designations, preferences and relative rights and
qualifications, limitations, or restrictions thereon of any
series so established, including voting powers, dividend rights,
liquidation preferences, redemption rights and conversion
privileges.
Any further issuances of preferred stock with voting rights or
conversion rights may adversely affect the voting power of
common stock, including the loss of voting control to others.
The issuance of preferred stock may have the effect of delaying,
deferring, or preventing a change of control.
69
Provisions of the Certificate and the By-laws
A number of provisions of our certificate of incorporation and
by-laws concern matters of corporate governance and the rights
of stockholders. Certain of these provisions, as well as the
ability of our board of directors to issue shares of preferred
stock and to set the voting rights, preferences and other terms
thereof, may be deemed to have an anti-takeover effect and may
discourage takeover attempts not first approved by the board of
directors (including takeovers which certain stockholders may
deem to be in their best interests). To the extent takeover
attempts are discouraged, temporary fluctuations in the market
price of the common stock, which may result from actual or
rumored takeover attempts, may be inhibited. These provisions,
together with the classified board of directors (which we are
proposing to declassify) and the ability of the board to issue
preferred stock without further stockholder action, also could
delay or frustrate the removal of incumbent directors or the
assumption of control by stockholders, even if such removal or
assumption would be beneficial to our stockholders. These
provisions also could discourage or make more difficult a
merger, tender offer or proxy contests, even if they could be
favorable to the interests of stockholders, and could
potentially depress the market price of the common stock. The
board of directors believes that these provisions are
appropriate to protect the interest of us and all of our
stockholders.
Issuance of Rights. The certificate authorized the board
of directors to create and issue rights (the rights)
entitling the holders thereof to purchase from us shares of
capital stock or other securities. The times at which, and the
terms upon which, the rights are to be issued may be determined
by the board of directors and set forth in the contracts or
instruments that evidence the rights. The authority of the board
of directors with respect to the rights includes, but is not
limited to, the determination of (1) the initial purchase
price per share of the capital stock or other securities of
Catalyst Pharmaceutical Partners to be purchased upon exercise
of the rights, (2) provisions relating to the times at
which and the circumstances under which the rights may be
exercised or sold or otherwise transferred, either together with
or separately from, any other securities of Catalyst
Pharmaceutical Partners, (3) antidilutive provisions which
adjust the number or exercise price of the rights or amount or
nature of the securities or other property receivable upon
exercise of the rights, (4) provisions which deny the
holder of a specified percentage of the outstanding securities
of Catalyst Pharmaceutical Partners the right to exercise the
rights and/or cause the rights held by such holder to become
void, (5) provisions which permit Catalyst Pharmaceutical
Partners to redeem the rights and (6) the appointment of a
rights agent with respect to the rights.
Meetings of Stockholders. The by-laws provide that a
special meeting of stockholders may be called only by the board
of directors unless otherwise required by law. The by-laws
provide that only those matters set forth in the notice of the
special meeting may be considered or acted upon at that special
meeting, unless otherwise provided by law. In addition, the
by-laws set forth certain advance notice and informational
requirements and time limitations on any director nomination or
any new business which a stockholder wishes to propose for
consideration at an annual meeting of stockholders.
No Stockholder Action by Written Consent. The certificate
provides that any action required or permitted to be taken by
our stockholders at an annual or special meeting of stockholders
must be effected at a duly called meeting and may not be taken
or effected by a written consent of stockholders in lieu thereof.
Amendment of the Certificate. The certificate provides
that an amendment thereof must first be approved by a majority
of the board of directors and (with certain exceptions)
thereafter approved by the holders of a majority of the total
votes eligible to be cast by holders of voting stock with
respect to such amendment or repeal; provided, however, that the
affirmative vote of 80% of the total votes eligible to be cast
by holders of voting stock, voting together as a single class,
is required to amend provisions relating to the establishment of
the board of directors and amendments to the certificate.
Amendment of the By-laws. The certificate provides that
the board of directors or the stockholders may amend or repeal
the by-laws. Such action by the board of directors requires the
affirmative vote of a majority of the directors then in office.
Such action by the stockholders requires the affirmative vote of
the holders of at
70
least two-thirds of the total votes eligible to be cast by
holders of voting stock with respect to such amendment or repeal
at an annual meeting of stockholders or a special meeting called
for such purposes, unless the board of directors recommends that
the stockholders approve such amendment or repeal at such
meeting, in which case such amendment or repeal shall only
require the affirmative vote of a majority of the total votes
eligible to be cast by holders of voting stock with respect to
such amendment or repeal.
Provisions of Delaware Law
We will be subject to the provisions of Section 203 of the
Delaware General Corporation Law, or Delaware law, regulating
corporate takeovers. In general, these provisions prohibit a
Delaware corporation from engaging in any business combination
with any interested stockholders for a period of three years
following the date that the stockholder became an interested
stockholder, unless:
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either the business combination or the transaction that resulted
in the stockholder becoming an interested stockholder is
approved by our board of directors before the date the
interested stockholder attained that status; |
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upon consummation of the transaction that resulted in the
stockholder becoming an interested stockholder, the interested
stockholder owned at least 85% of the voting stock of the
corporation outstanding at the time the transaction commenced,
excluding for purposes of determining the voting stock
outstanding (but not the outstanding voting stock owned by the
interested stockholder) those shares owned (i) by persons
who are directors and also officers and (ii) employee stock
plans in which employee participates do not have the right to
determine confidentially whether shares held subject to the plan
will be tendered in a tender or exchange offer; or |
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on or after that date, the business combination is approved by
our board of directors and authorized at a meeting of
stockholders, and not by written consent, by at least two-thirds
of the outstanding voting stock that is not owned by the
interested stockholder. |
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Section 203 defines business combination to
include the following:
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any merger or consolidation involving the corporation and the
interested stockholder; |
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any sale, transfer, pledge or other disposition of 10% or more
of the assets of the corporation involving the interested
stockholder; |
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subject to certain exceptions, any transaction that results in
the issuance or transfer by the corporation of any stock of the
corporation to the interested stockholder; |
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any transaction involving the corporation that has the effect of
increasing the proportionate share of the stock of any class or
series of the corporation beneficially owned by the interested
stockholder; or |
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the receipt by the interested stockholder of the benefit of any
loans, advances, guarantees, pledges or other financial benefits
provided by or through the corporation. |
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In general, Section 203 defines an interested stockholder
as any entity or person beneficially owning 15% or more of the
outstanding voting stock of the corporation and any entity or
person affiliated with or controlling or controlled by any of
these entities or persons.
A Delaware corporation may opt out of this provision either with
an express provision in its original certificate of
incorporation or in an amendment to its certificate of
incorporation or by-laws approved by its stockholders. However,
we have not opted out of this provision. The statute could
prohibit or delay mergers or other takeover or change in control
attempts and, accordingly, may discourage attempts to acquire us.
71
Transfer Agent
The transfer agent for our common stock is Continental Stock
Transfer & Trust Company, 17 Battery Place, 8th Floor,
New York, New York 10004. Continental Stock Transfer &
Trust Company can be reached at (212) 509-4000.
72
SHARES ELIGIBLE FOR FUTURE SALE
General
Upon completion of this offering, there will
be shares
of our common stock outstanding. Of the shares which will be
outstanding after the offering:
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all shares
of common stock sold in the offering will be freely tradeable; |
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shares
will be restricted securities held by
non-affiliates; and |
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shares
will be held by our executive officers and directors. |
The restricted securities described above are eligible for sale
in the public market, subject to volume limitations, manner of
sale provisions and other requirements of Rule 144, from
time to time.
Rule 144
In general, under Rule 144 as currently in effect, a person
who has beneficially owned restricted securities for
at least one year, including an affiliate, is entitled to sell,
within any three-month period, a number of shares that does not
exceed the greater of:
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one percent of the then outstanding shares of our common stock
(approximately shares
immediately following the offering); or |
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the average weekly trading volume during the four calendar weeks
preceding filing of notice of such sale. |
A person (or persons whose shares are aggregated) who is not
deemed to have been an affiliate of ours at any time during the
90 days preceding a sale and who owns shares that were
acquired from us or an affiliate of ours for at least two years
prior to the proposed sale is entitled to sell such shares
pursuant to Rule 144(k) without regard to the volume
limitations, manner of sale provisions or other limitations of
Rule 144.
Shares held by our executive officers and directors may be sold
in the public market, subject to the volume, manner of sale and
other limitations of Rule 144, but may not be sold in
reliance upon Rule 144(k).
Lock-up Agreements
In addition to the limits placed on the sale of shares of our
common stock by operation of Rule 144 and other provisions
of the Securities Act of 1933, as amended, we, our directors and
executive officers and holders
of %
of our common stock (assuming the automatic conversion of all of
our shares of Series A Preferred Stock and Series B
Preferred Stock upon the closing of this offering), have entered
into lock-up agreements with the underwriters. Under these
agreements, subject to certain, limited exceptions, we may not
issue any new shares of common stock, and those holders of stock
may not, directly or indirectly, offer, sell, contract to sell,
pledge or otherwise dispose of or hedge any common stock or
securities convertible into or exchangeable for shares of common
stock, or publicly announce the intention to do any of the
foregoing, without the prior written consent of First Albany
Capital, Inc. for a period of 180 days from the date of
this prospectus. This consent may be given at any time without
public notice. If we issue an earnings release or material news
or a material event relating to us occurs during the 15 calendar
days plus 3 business days before the last day of the lock-up
period, or if prior to the expiration of the lock-up period, we
announce that we will release earnings results during the
16 days following the last day of the lock-up period, the
restrictions provided in the lock-up agreements will continue to
apply until 15 calendar days plus 3 business days after the
issuance of the earnings release or the occurrence of material
news or a material event. Also, during this 180-day period, we
have agreed not to file any registration statement for, any
shares of common stock or any securities convertible into or
exercisable or exchangeable for common stock without the prior
written consent of First Albany Capital, Inc.
73
MATERIAL U.S. FEDERAL INCOME AND ESTATE TAX
CONSEQUENCES
TO NON-U.S. HOLDERS
The following is a general discussion of the material
U.S. federal income and estate tax consequences of the
ownership and disposition of our common stock by a
non-U.S. holder that acquires our common stock pursuant to
this offering. The discussion is based on provisions of the
Internal Revenue Code of 1986, as amended (the
Code), applicable U.S. Treasury regulations
promulgated thereunder and administrative and judicial
interpretations, all as in effect on the date of this
prospectus, and all of which are subject to change, possibly on
a retroactive basis. The discussion is limited to
non-U.S. holders that hold our common stock as a
capital asset within the meaning of
Section 1221 of the Code (generally, property held for
investment). As used in this discussion, the term
non-U.S. holder means a beneficial owner of our
common stock that is not, for U.S. federal income tax
purposes:
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an individual who is a citizen or resident of the United States; |
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a corporation (including any entity treated as a corporation for
U.S. federal income tax purposes) created or organized in
or under the laws of the United States or any State of the
United States or the District of Columbia; |
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an estate the income of which is includible in gross income for
U.S. federal income tax purposes regardless of its source;
or |
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a trust (1) if a U.S. court is able to exercise
primary supervision over the administration of the trust and one
or more U.S. persons have authority to control all
substantial decisions of the trust, or (2) that has a valid
election in effect under applicable U.S. Treasury
regulations to be treated as a U.S. person. |
If a partnership or other pass-through entity holds common
stock, the tax treatment of a partner or member in the
partnership or other entity will generally depend on the status
of the partner or member and upon the activities of the
partnership or other entity. This discussion does not address
the U.S. federal income or estate tax consequences
applicable to any person who holds our common stock through a
partnership or other entity treated as a partnership, or any
other form of pass through-through entity, for U.S. federal
tax purposes or the tax consequences to such partnership or
other entity. Accordingly, we urge partnerships and other
pass-through entities which hold our common stock and partners
and members in these partnerships and other entities to consult
their tax advisors.
This discussion also does not consider:
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U.S. federal gift tax consequences, or any U.S. state
or local or non-U.S. tax consequences; |
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the tax consequences for the stockholders or beneficiaries of a
non-U.S. holder; |
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any U.S. federal tax considerations that may be relevant to
a non-U.S. holder in light of its particular circumstances
or to non-U.S. holders that may be subject to special
treatment under U.S. federal tax laws, such as financial
institutions, insurance companies, tax exempt organizations,
certain trusts, hybrid entities, certain former citizens or
residents of the United States, holders subject to the
U.S. federal alternative minimum tax, broker-dealers,
controlled foreign corporations, passive foreign investment
companies, and dealers and traders in securities; or |
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special tax rules that may apply to a non-U.S. holder that
holds our common stock as part of a straddle,
hedge, conversion transaction,
synthetic security, or other integrated investment. |
This discussion is for general purposes only. Prospective
investors are urged to consult their own tax advisors regarding
the application of the U.S. federal income and estate tax
laws to their particular situations and the consequences under
U.S. federal gift tax laws, as well as foreign, state, and
local laws and tax treaties.
74
Dividends
As previously discussed, we do not anticipate paying dividends
on our common stock. See Dividend Policy. If we pay
dividends on our common stock, those payments will constitute
dividends for U.S. federal income tax purposes to the
extent paid from our current or accumulated earnings and
profits, as determined under U.S. federal income tax
principles. To the extent those dividends exceed our current and
accumulated earnings and profits, for U.S. federal income tax
purposes, the dividends will constitute a return of capital and
first reduce the non-U.S. holders basis, but not
below zero, and then will be treated as gain from the sale of
stock.
We will be required to withhold U.S. federal income tax at
a rate of 30%, or a lower rate under an applicable income tax
treaty, from the gross amount of amounts constituting dividends
as determined under U.S. federal income tax principles (as
described above) paid to a non-U.S. holder, unless the
dividend is effectively connected with the conduct of a trade or
business of the non-U.S. holder within the United States
and, if an income tax treaty applies, attributable to a
permanent establishment of the non-U.S. holder within the
United States. Under applicable U.S. Treasury regulations,
a non-U.S. holder (including, in certain cases of
non-U.S. holders that are entities, the owner or owners of
such entities) will be required to satisfy certain certification
requirements in order to claim a reduced rate of withholding
pursuant to an applicable income tax treaty.
Non-U.S. holders should consult their tax advisors
regarding their entitlement to benefits under a relevant income
tax treaty.
Dividends that are effectively connected with a
non-U.S. holders conduct of a trade or business in
the United States and, if an income tax treaty applies,
attributable to a permanent establishment in the United States,
are taxed on a net income basis at the regular graduated
U.S. federal income tax rates in the same manner as if the
non-U.S. holder were a resident of the United States. In
such cases, we will not have to withhold U.S. federal
income tax if the non-U.S. holder complies with applicable
certification and disclosure requirements. In addition, a
branch profits tax may be imposed at a 30% rate, or
a lower rate under an applicable income tax treaty, on dividends
received by a foreign corporation that are effectively connected
with the foreign corporations conduct of a trade or
business in the United States.
In order to claim the benefit of an income tax treaty or to
claim exemption from withholding because the income is
effectively connected with the conduct of a trade or business in
the United States (or, if an income tax treaty applies, because
the income is effectively connected with the conduct of a trade
or business of the non-U.S. holder within the United States
through a permanent establishment situated in the United
States), the non-U.S. holder must provide a properly
executed IRS Form W-8BEN, for treaty benefits, or W-8ECI,
for effectively connected income, respectively (or such
successor forms as the IRS designates), prior to the payment of
dividends. These forms must be periodically updated.
A non-U.S. holder that is eligible for a reduced rate of
U.S. federal withholding tax under an income tax treaty may
obtain a refund of any excess amounts withheld by filing an
appropriate claim for a refund together with the required
information with the IRS.
Gain on Disposition of Common Stock
A non-U.S. holder generally will not be subject to
U.S. federal income or withholding tax with respect to gain
realized on a sale or other disposition of our common stock
unless one of the following applies
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the gain is effectively connected with the
non-U.S. holders conduct of a trade or business in
the United States and, if an income tax treaty applies, is
attributable to a permanent establishment maintained by the
non-U.S. holder in the United States; in these cases, the
non-U.S. holder generally will be taxed on its net gain
derived from the disposition at the regular graduated rates and
in the manner applicable to U.S. persons and, if the
non-U.S. holder is a foreign corporation, the branch
profits tax referred to above may also apply; |
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the non-U.S. holder is an individual who is present in the
United States for 183 days or more in the taxable year of
the disposition and certain other conditions are met; in this
case, unless an applicable income tax treaty provides otherwise,
the non-U.S. holder generally will be subject to a 30% U.S.
federal income tax on the gain derived from the disposition; or |
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our common stock constitutes a United States real property
interest by reason of our status as a United States real
property holding corporation, or a USRPHC, for
U.S. federal income tax purposes at any time during the
shorter of the 5 year period ending on the date of such
disposition or the period that the non-U.S. holder held our
common stock. While we believe that we are not currently, and
will not become, a USRPHC, the determination of whether we are a
USRPHC depends on the fair market value of our United States
real property interests relative to the fair market value of our
other business assets, and accordingly there can be no assurance
that we will not become a USRPHC in the future. However, as long
as our common stock is regularly traded on an established
securities market within the meaning of
Section 897(c)(3) of the Code, a non-U.S. holder would
be subject to U.S. federal income tax on any gain from the
sale, exchange or other disposition of our shares of common
stock, by reason of USRPHC status, only if such
non-U.S. holder, actually or constructively, owned more
than 5% of our common stock at some time during the shorter of
the periods described above. On the other hand, if we are or
were to become a USRPHC and were to fail to qualify as
regularly traded on an established securities
market, then a non-U.S. holder generally would be
subject to U.S. federal income tax on net gain derived from
the disposition of our common stock at regular graduated rates
and may be subject to U.S. federal income tax withholding on the
gross proceeds realized with respect to such disposition. A
non-U.S. holder may obtain a refund of any such amounts
withheld in excess of the non-U.S. holders federal
income tax liability. |
Federal Estate Tax
Shares of our common stock owned or treated as owned by an
individual who is a non-U.S. holder at the time of death
(including by reason of certain lifetime transfers of interests
therein) will be included in the individuals gross estate
for U.S. federal estate tax purposes and, unless an
applicable estate tax or other treaty provides otherwise, may be
subject to U.S. federal estate tax.
Information Reporting and Backup Withholding Tax
We must report annually to the IRS and to each
non-U.S. holder the amount of dividends paid to that holder
and the tax withheld from those dividends.
These reporting requirements apply regardless of whether
withholding was reduced or eliminated by an applicable income
tax treaty. Copies of the information returns reporting those
dividends and withholding may also be made available under the
provisions of an applicable income tax treaty or agreement to
the tax authorities in the country in which the
non-U.S. holder is a resident. Under some circumstances,
U.S. Treasury regulations require backup withholding and
additional information reporting on reportable payments on
common stock. The gross amount of dividends paid to a
non-U.S. holder that fails to certify its
non-U.S. holder status in accordance with applicable
U.S. Treasury regulations generally will be reduced by
backup withholding at the applicable rate (currently 28%).
In general, backup withholding and information reporting will
not apply to the payment of the proceeds of sale or other
disposition of common stock made to a non-U.S. holder if
the non-U.S. holder provides any required certifications.
Backup withholding is not an additional tax. Any amounts
withheld under the backup withholding rules from a payment to a
non-U.S. holder can be refunded or credited against the
non-U.S. holders U.S. federal income tax
liability, if any, provided that the required information is
furnished to the IRS in a timely manner.
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These backup withholding and information reporting rules are
complex and non-U.S. holders are urged to consult their own
tax advisors regarding the application of these rules to them.
The foregoing discussion of U.S. federal income and
estate tax considerations is not tax advice. Accordingly, each
prospective non-U.S. holder of our common stock should
consult that holders own tax advisor with respect to the
federal, state, local and non-U.S. tax consequences of the
ownership and disposition of our common stock.
77
UNDERWRITING
We are offering the shares of our common stock through the
underwriters named below. We have applied to have our common
stock included for quotation on the Nasdaq Global Market under
the symbol CPRX.
The Underwriters and the Underwriting Agreement
We and the underwriters named below have entered into an
underwriting agreement relating to this offering. First Albany
Capital Inc. and Stifel, Nicolaus & Company, Incorporated
are the representatives of the underwriters.
The underwriters have severally agreed, subject to the terms and
conditions of the underwriting agreement, to purchase from us
the number of shares indicated in the following table:
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First Albany Capital Inc.
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Stifel, Nicolaus & Company, Incorporated
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Total
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Except for the underwriters over-allotment option
described below, the underwriters must take and pay for all of
the shares, if they take any shares.
We have granted to the underwriters the option to purchase from
us up to an
additional shares
of our common stock to cover over-allotments, if any, made in
connection with this offering. First Albany Capital Inc., on
behalf of the underwriters, may exercise this option at any
time, from time to time, on or before the 30th day after the
date of this prospectus. If First Albany Capital Inc. exercises
this option, the underwriters will each severally purchase
shares in approximately the same proportion as set forth in the
table above. The underwriters are not obligated to purchase any
of these additional shares if they do not exercise their
over-allotment option.
We have agreed to indemnify the underwriters and their partners,
directors, officers and controlling persons against certain
liabilities, including liabilities under the Securities Act of
1933, as amended. If we are unable to provide this
indemnification, we have agreed to contribute to payments the
underwriters and these persons may be required to make in
respect of those liabilities.
Public Offering Price, Commissions and Discounts and Offering
Expenses
The underwriters will initially offer the shares to the public
at the public offering price set forth on the cover of this
prospectus. If all the shares are not sold at this public
offering price, the representatives may change the public
offering price or any other selling term.
Shares sold by the underwriters to securities dealers may be
sold at a discount of up to
$ per
share from the public offering price. Any of these securities
dealers may resell any shares purchased from the underwriters to
other brokers or dealers at a discount of up to
$ per
share from the public offering price.
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The table below shows the per share and total underwriting
discounts and commissions we will pay to the underwriters,
assuming both no exercise and full exercise of the
underwriters option to purchase up to an
additional shares:
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We estimate that the total expenses of this offering payable by
us, not including the underwriting discounts and commissions,
will be approximately $.
Lock-Up Agreements
We, each of our officers and directors, and stockholders owning
substantially all of our outstanding common stock have entered
into lock-up agreements with the underwriters. Subject to
certain exceptions, these lock-up agreements generally prohibit
us and each of these persons, without the prior written consent
of First Albany Capital Inc., from selling, offering to sell,
contracting to sell, hypothecating, pledging, granting an option
to purchase or otherwise disposing of any shares of our common
stock or securities convertible into or exchangeable or
exercisable for common stock or any warrants or other rights to
purchase common stock or such securities. These restrictions
will be in effect for 180 days after the date of this
prospectus. However, if we issue an earnings release or
significant news or a significant event relating to us occurs,
or if we announce during the 16-day period beginning on the last
day the restrictions would otherwise apply, then the
restrictions applicable to our officers, directors and
stockholders will continue to apply for 15 calendar days plus
three business days from the date we issue the earnings release
or the date the significant news or event occurs. At any time
and without public notice, First Albany Capital Inc. may in its
sole discretion release all or some of the securities from these
lock-up agreements.
Stabilization and Short Positions
In connection with this offering, the underwriters may engage in
activities that stabilize, maintain or otherwise affect the
price of our common stock. These activities include stabilizing
transactions, syndicate short covering and penalty bids. The
underwriters may carry out these activities on the Nasdaq Global
Market, in the over-the-counter market or otherwise. As a result
of these activities, the price of our common stock may be higher
than the price that may otherwise exist in the open market. If
these activities are commenced, they may be discontinued by the
underwriters at any time.
Stabilizing Transactions and Syndicate Short Covering.
Stabilizing transactions consist of placing a bid or effecting a
purchase for the purpose of pegging, fixing or maintaining the
price of a security. Stabilizing activities may include
purchases to cover short positions created by short sales. Short
sales are sales by the underwriters in excess of the number of
shares they are obligated to purchase from us in this offering.
Short sales create short positions that can be either
covered or naked. A covered short
position is a short position in an amount that does not exceed
the number of shares the underwriters may purchase from us by
exercising their over-allotment option described above. A naked
short position is a short position in excess of that amount.
The underwriters may close out a covered short position either
by exercising their over-allotment option, in whole or in part,
or by purchasing shares in the open market. In determining the
source of shares to close out a covered short position, the
underwriters will consider, among other things, the price of
shares available for purchase in the open market compared to the
price at which the underwriters may purchase shares by
exercising their over-allotment option. The underwriters must
close out a naked short position by purchasing shares in the
open market. A naked short position is more likely to be created
if the underwriters are concerned that there
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may be downward pressure on the price of the common stock in the
open market that could adversely affect investors who purchased
shares in this offering.
Penalty Bids. The underwriters may impose a penalty bid.
This occurs when a particular underwriter repays to the
underwriters a portion of the underwriting discount received by
it because the representatives have repurchased shares sold by
or for the account of that underwriter in stabilizing or short
covering transactions.
Determination of Offering Price
Prior to this offering, there was no public market for our
common stock. The initial public offering price will be
determined by negotiation between us and the representatives of
the underwriters. The principal factors to be considered in
determining the initial public offering price include:
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the information set forth in this prospectus and otherwise
available to representatives; |
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our history and prospects, and the history of and prospects for
the industry in which we compete; |
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our past and present financial performance and an assessment of
our management; |
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our prospects for future earnings and the present state of our
development; |
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the general condition of the securities markets at the time of
this offering; |
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the recent market prices of, and demand for, publicly traded
common stock of generally comparable companies; and |
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other factors deemed relevant by the underwriters and us. |
Affiliations
Certain of the underwriters and their respective affiliates have
from time to time performed and may in the future perform
various commercial banking, financial advisory and investment
banking services for us, for which they have received or will
receive customary fees.
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NOTICE TO INVESTORS
European Economic Area
In relation to the Member States of the European Economic Area
(EEA), each of which, with the exception of Italy,
has implemented the Prospectus Directive, with effect from and
including the date on which the Prospectus Directive is
implemented in that Member State (the Relevant
Implementation Date), our common stock will not be offered
to the public in that Member State prior to the publication of a
prospectus in relation to our common stock that has been
approved by the competent authority in that Member State or,
where appropriate, approved in another Member State and notified
to the competent authority in that Member State, all in
accordance with the Prospectus Directive, except that, with
effect from and including the Relevant Implementation Date, our
common stock may be offered to the public in that Member State
at any time:
(a) to legal entities which are authorized or regulated to
operate in the financial markets or, if not so authorized or
regulated, whose corporate purpose is solely to invest in
securities;
(b) to any legal entity which has two or more of (1) an
average of at least 250 employees during the last financial
year; (2) a total balance sheet of more than
43,000,000 and
(3) an annual net turnover of more than
50,000,000, as
shown in its last annual or consolidated accounts; or
(c) in any other circumstances which do not require the
publication by us of a prospectus pursuant to Article 3 of
the Prospectus Directive.
As used above, the expression offered to the public
in relation to any of our common stock in any Member State means
the communication in any form and by any means of sufficient
information on the terms of the offer and our common stock to be
offered so as to enable an investor to decide to purchase or
subscribe for our common stock, as the same may be varied in
that Member State by any measure implementing the Prospectus
Directive in that Member State and the expression
Prospectus Directive means Directive 2003/71/EC and
includes any relevant implementing measure in each Member State.
The EEA consists of all of the member states of the
European Union, Norway, Iceland and Liechtenstein.
The EEA selling restriction is in addition to any other selling
restrictions set out below.
United Kingdom
Our common stock may not be offered or sold and will not be
offered or sold to any persons in the United Kingdom other than
to persons whose ordinary activities involve them in acquiring,
holding, managing or disposing of investments (as principal or
as agent) for the purposes of their businesses and in compliance
with all applicable provisions of the Financial Services and
Markets Act 2000 (FSMA) with respect to anything
done in relation to our common stock in, from or otherwise
involving the United Kingdom. In addition, each underwriter has
only communicated or caused to be communicated and will only
communicate or cause to be communicated any invitation or
inducement to engage in investment activity (within the meaning
of Section 21 of the FSMA) received by it in connection
with the issue or sale of our common stock in circumstances in
which Section 21(1) of the FSMA does not apply to us.
Without limitation to the other restrictions referred to herein,
this prospectus is directed only at (1) persons outside the
United Kingdom; (2) persons having professional experience
in matters relating to investments who fall within the
definition of investment professionals in
Article 19(5) of the Financial Services and Markets Act
2000 (Financial Promotion) Order 2005; or (3) high net
worth bodies corporate, unincorporated associations and
partnerships and trustees of high value trusts as described in
Article 49(2) of the Financial Services and Markets Act
2000 (Financial Promotion) Order 2005. Without limitation to the
other restrictions referred to herein, any investment or
investment activity to which this prospectus relates is
available only to, and will be engaged in only with, such
persons, and persons within the United Kingdom who received this
communication (other than persons who fall within (2) or (3)
above), should not rely or act upon this communication.
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France
No prospectus (including any amendment or replacement thereto)
has been prepared in connection with the offering of our common
stock that has been approved by the Autorité des
marchés financiers or by the competent authority of
another State that is a contracting party to the Agreement on
the European Economic Area and notified to the Autorité
des marchés financiers; no common stock has been
offered or sold and will be offered or sold, directly or
indirectly, to the public in France except to permitted
investors (Permitted Investors) consisting of
persons licensed to provide the investment service of portfolio
management for the account of third parties, qualified investors
(investisseurs qualifiés) acting for their own
account and/or corporate investors meeting one of the four
criteria provided in Article 1 of Decree N° 2004-1019
of September 28, 2004 and belonging to a limited circle of
investors (cercle restreint dinvestisseurs) acting
for their own account, with qualified investors and
limited circle of investors having the meaning
ascribed to them in Article L. 411-2 of the French Code
Monétaire et Financier and applicable regulations
thereunder; none of this prospectus or any other materials
related to the offer or information contained therein relating
to our common stock has been released, issued or distributed to
the public in France except to Permitted Investors; and the
direct or indirect resale to the public in France of any common
stock acquired by any Permitted Investors may be made only as
provided by articles L. 412-1 and L. 621-8 of the French
Code Monétaire et Financier and applicable
regulations thereunder.
Italy
The offering of shares of our common stock has not been cleared
by the Italian Securities Exchange Commission (Commissione
Nazionale per le Società e la Borsa, the
CONSOB) pursuant to Italian securities legislation
and, accordingly, shares of our common stock may not and will
not be offered, sold or delivered, nor may or will copies of
this prospectus or any other documents relating to shares of our
common stock or the offering be distributed in Italy other than
to professional investors (operatori qualificati), as defined in
Article 31, paragraph 2 of CONSOB
Regulation No. 11522 of July 1, 1998, as amended
(Regulation No. 11522).
Any offer, sale or delivery of shares of our common stock or
distribution of copies of this prospectus or any other document
relating to shares of our common stock or the offering in Italy
may and will be effected in accordance with all Italian
securities, tax, exchange control and other applicable laws and
regulations, and, in particular, will be: (i) made by an
investment firm, bank or financial intermediary permitted to
conduct such activities in Italy in accordance with the
Legislative Decree No. 385 of September 1, 1993, as
amended (the Italian Banking Law), Legislative
Decree No. 58 of February 24, 1998, as amended,
Regulation No. 11522, and any other applicable laws
and regulations; (ii) in compliance with Article 129
of the Italian Banking Law and the implementing guidelines of
the Bank of Italy; and (iii) in compliance with any other
applicable notification requirement or limitation which may be
imposed by CONSOB or the Bank of Italy.
Any investor purchasing shares of our common stock in the
offering is solely responsible for ensuring that any offer or
resale of shares of common stock it purchased in the offering
occurs in compliance with applicable laws and regulations.
This prospectus and the information contained herein are
intended only for the use of its recipient and are not to be
distributed to any third party resident or located in Italy for
any reason. No person resident or located in Italy other than
the original recipients of this document may rely on it or its
content.
In addition to the above (which shall continue to apply to the
extent not inconsistent with the implementing measures of the
Prospective Directive in Italy), after the implementation of the
Prospectus Directive in Italy, the restrictions, warranties and
representations set out under the heading European
Economic Area above shall apply to Italy.
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Spain
Neither the common stock nor this prospectus have been approved
or registered in the administrative registries of the Spanish
National Securities Exchange Commission (Comisión
Nacional del Mercado de Valores). Accordingly, our common
stock may not be offered in Spain except in circumstances which
do not constitute a public offer of securities in Spain within
the meaning of articles 30bis of the Spanish Securities
Markets Law of 28 July 1988 (Ley 24/1988, de 28 de
Julio, del Mercado de Valores), as amended and restated, and
supplemental rules enacted thereunder.
Sweden
This is not a prospectus under, and has not been prepared in
accordance with the prospectus requirements provided for in, the
Swedish Financial Instruments Trading Act (lagen
(1991:980) om handel med finasiella instrument) nor any
other Swedish enactment. Neither the Swedish Financial
Supervisory Authority nor any other Swedish public body has
examined, approved, or registered this document.
Switzerland
The common stock may not and will not be publicly offered,
distributed or re-distributed on a professional basis in or from
Switzerland and neither this prospectus nor any other
solicitation for investments in our common stock may be
communicated or distributed in Switzerland in any way that could
constitute a public offering within the meaning of
Articles 1156 or 652a of the Swiss Code of Obligations or
of Article 2 of the Federal Act on Investment Funds of
March 18, 1994. This prospectus may not be copied,
reproduced, distributed or passed on to others without the
underwriters prior written consent. This prospectus is not
a prospectus within the meaning of Articles 1156 and 652a
of the Swiss Code of Obligations or a listing prospectus
according to article 32 of the Listing Rules of the Swiss
Exchange and may not comply with the information standards
required thereunder. We will not apply for a listing of our
common stock on any Swiss stock exchange or other Swiss
regulated market and this prospectus may not comply with the
information required under the relevant listing rules. The
common stock offered hereby has not and will not be registered
with the Swiss Federal Banking Commission and has not and will
not be authorized under the Federal Act on Investment Funds of
March 18, 1994. The investor protection afforded to
acquirers of investment fund certificates by the Federal Act on
Investment Funds of March 18, 1994 does not extend to
acquirers of our common stock.
LEGAL MATTERS
Our counsel, Akerman Senterfitt, in Miami, Florida, will pass on
the validity of shares of common stock offered by this
prospectus. Philip B. Schwartz, a shareholder of Akerman
Senterfitt, is our corporate secretary and currently owns 90,000
shares of our outstanding common stock. Dewey Ballantine LLP,
New York, New York is counsel to the underwriters in connection
with this offering.
EXPERTS
Grant Thornton LLP, our independent registered public accounting
firm, has audited our financial statements as set forth in their
report, which is included herein. We have included our financial
statements in this prospectus in reliance on such report, given
on the authority of Grant Thornton LLP as experts in accounting
and auditing in giving said report.
83
WHERE YOU CAN FIND ADDITIONAL INFORMATION
We have filed with the SEC a registration statement on
Form S-1 under the Securities Act that registers the shares
of our common stock to be sold in this offering. This prospectus
does not contain all of the information set forth in the
registration statement with the exhibits and schedules filed as
part of the registration statement. For further information with
respect to us and our common stock, we refer you to the
registration statement and the exhibits and schedules filed as a
part of the registration statement. Statements contained in this
prospectus concerning the contents of any contract or any other
document are not necessary complete. If a contract or document
has been filed as an exhibit to the registration statement, we
refer you to the copy of the contract or document that has been
filed with the SEC. Each statement in this prospectus relating
to a contract or document filed as an exhibit is qualified in
all respects by the filed exhibit.
The reports and other information we file with the SEC can be
read and copied at the SECs Public Reference Room at 100
F. Street, N.E., Washington, D.C. 20549. Copies of these
materials can be obtained at prescribed rates from the
SECs Public Reference Room at such address. You may obtain
information regarding the operation of the public reference room
by calling 1-800-SEC-0330. The SEC also maintains a website
(http://www.sec.gov) that contains reports, proxy and
information statements and other information regarding issuers
that file electronically with the SEC. Upon completion of this
offering, we will become subject to the reporting and
information requirements of the Securities Exchange Act of 1934,
and, as a result, will file periodic reports, proxy statements,
and other information with the SEC. These periodic reports,
proxy statements and other information will be available for
inspecting and copying at the SECs public reference room
and the website of the SEC referred to above.
84
INDEX TO FINANCIAL STATEMENTS
|
|
|
|
|
Years ended December 31, 2005, 2004 and 2003
|
|
|
|
|
|
|
|
F-2 |
|
|
|
|
F-3 |
|
|
|
|
F-4 |
|
|
|
|
F-5 |
|
|
|
|
F-6 |
|
|
|
|
F-7 |
|
Six months ended June 30, 2006 and 2005
|
|
|
|
|
|
|
|
F-14 |
|
|
|
|
F-15 |
|
|
|
|
F-16 |
|
|
|
|
F-17 |
|
|
|
|
F-18 |
|
F-1
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
Board of Directors
Catalyst Pharmaceutical Partners
We have audited the accompanying balance sheets of Catalyst
Pharmaceutical Partners, Inc. (a Development Stage Company) (the
Company) as of December 31, 2005 and 2004, and
the related statements of operations, stockholders equity
and cash flows for each of the three years in the period ended
December 31, 2005 and the period from January 4, 2002
(date of inception) through December 31, 2005. These
financial statements are the responsibility of the
Companys management. Our responsibility is to express an
opinion on these financial statements based on our audits.
We conducted our audits in accordance with the standards of the
Public Company Accounting Oversight Board (United States). Those
standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are
free of material misstatement. An audit includes consideration
of internal control over financial reporting as a basis for
designing audit procedures that are appropriate in the
circumstances, but not for the purpose of expressing an opinion
on the effectiveness of the Companys internal control over
financial reporting. Accordingly, we express no such opinion. An
audit also includes examining, on a test basis, evidence
supporting the amounts and disclosures in the financial
statements, assessing the accounting principles used and
significant estimates made by management, as well as evaluating
the overall financial statement presentation. We believe that
our audits provide a reasonable basis for our opinion.
In our opinion, the financial statements referred to above
present fairly, in all material respects, the financial position
of Catalyst Pharmaceutical Partners, Inc. (a Development Stage
Company) as of December 31, 2005 and 2004, and the results
of its operations and its cash flows for each of the three years
in the period ended December 31, 2005 and the period from
January 4, 2002 (date of inception) through
December 31, 2005, in conformity with accounting principles
generally accepted in the United States of America.
/s/ Grant Thorton LLP
Miami, Florida
July 24, 2006
F-2
CATALYST PHARMACEUTICAL PARTNERS, INC.
(a development stage company)
BALANCE SHEETS
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, | |
|
|
| |
|
|
2005 | |
|
2004 | |
|
|
| |
|
| |
ASSETS |
Current Assets:
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$ |
771,127 |
|
|
$ |
183,911 |
|
|
Prepaid insurance
|
|
|
440 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
771,567 |
|
|
|
183,911 |
|
|
Property and equipment, net
|
|
|
4,031 |
|
|
|
1,465 |
|
|
Deposits
|
|
|
13,852 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$ |
789,450 |
|
|
$ |
185,376 |
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS EQUITY |
Current Liabilities:
|
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
$ |
67,753 |
|
|
$ |
30,734 |
|
|
Accrued expenses
|
|
|
275,235 |
|
|
|
37,066 |
|
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
342,988 |
|
|
|
67,800 |
|
|
|
|
|
|
|
|
Commitments and contingencies (See notes)
|
|
|
|
|
|
|
|
|
Stockholders equity
|
|
|
|
|
|
|
|
|
|
Preferred stock, $.01 par value, 5,000,000 shares authorized,
70,000 shares Series A Preferred Stock issued and
outstanding
|
|
|
700 |
|
|
|
700 |
|
|
Common stock, $.01 par value, 30,000,000 shares authorized,
4,720,000 shares issued and outstanding at December 31,
2005 and 2,000,000 shares issued and outstanding at
December 31, 2004
|
|
|
47,200 |
|
|
|
20,000 |
|
|
Additional paid-in capital
|
|
|
3,428,322 |
|
|
|
1,321,256 |
|
|
Deficit accumulated during the development stage
|
|
|
(3,029,760 |
) |
|
|
(1,224,380 |
) |
|
|
|
|
|
|
|
|
|
Total stockholders equity
|
|
|
446,462 |
|
|
|
117,576 |
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders equity
|
|
$ |
789,450 |
|
|
$ |
185,376 |
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these financial
statements.
F-3
CATALYST PHARMACEUTICAL PARTNERS, INC.
(a development stage company)
STATEMENTS OF OPERATIONS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cumulative Period | |
|
|
|
|
|
|
|
|
from January 4, | |
|
|
|
|
2002 (date of | |
|
|
Years Ended December 31, | |
|
inception) through | |
|
|
| |
|
December 31, | |
|
|
2005 | |
|
2004 | |
|
2003 | |
|
2005 | |
|
|
| |
|
| |
|
| |
|
| |
Revenues
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
Operating costs and expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
1,462,889 |
|
|
|
378,254 |
|
|
|
268,829 |
|
|
|
2,247,652 |
|
|
General and Administrative
|
|
|
359,279 |
|
|
|
164,704 |
|
|
|
165,483 |
|
|
|
807,731 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating costs and expenses
|
|
|
1,822,168 |
|
|
|
542,958 |
|
|
|
434,312 |
|
|
|
3,055,383 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
(1,822,168 |
) |
|
|
(542,958 |
) |
|
|
(434,312 |
) |
|
|
(3,055,383 |
) |
Interest income
|
|
|
16,788 |
|
|
|
3,138 |
|
|
|
5,697 |
|
|
|
25,623 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before income taxes
|
|
|
(1,805,380 |
) |
|
|
(539,820 |
) |
|
|
(428,615 |
) |
|
|
(3,029,760 |
) |
Provision for income taxes
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$ |
(1,805,380 |
) |
|
$ |
(539,820 |
) |
|
$ |
(428,615 |
) |
|
$ |
(3,029,760 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss per share-basic and diluted
|
|
$ |
(0.42 |
) |
|
$ |
(0.27 |
) |
|
$ |
(0.21 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Average Shares outstanding basic and diluted
|
|
|
4,252,219 |
|
|
|
2,000,000 |
|
|
|
2,000,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these financial
statements.
F-4
CATALYST PHARMACEUTICAL PARTNERS, INC.
(a development stage company)
STATEMENT OF STOCKHOLDERS EQUITY
for the period from January 4, 2002 (date of inception)
through December 31, 2005
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deficit | |
|
|
|
|
|
|
|
|
|
|
Accumulated | |
|
|
|
|
|
|
|
|
|
|
During the | |
|
|
|
|
|
|
|
|
|
|
Development | |
|
|
|
|
Preferred Stock | |
|
Common Stock | |
|
Paid-in Capital | |
|
Stage | |
|
Total | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
Balance at January 4, 2002 (date of inception)
|
|
$ |
|
|
|
$ |
15,000 |
|
|
$ |
85,000 |
|
|
$ |
|
|
|
$ |
100,000 |
|
|
Issuance of common stock
|
|
|
|
|
|
|
5,000 |
|
|
|
120,000 |
|
|
|
|
|
|
|
125,000 |
|
|
Issuance of stock options for services
|
|
|
|
|
|
|
|
|
|
|
75,833 |
|
|
|
|
|
|
|
75,833 |
|
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(255,945 |
) |
|
|
(255,945 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2002
|
|
|
|
|
|
|
20,000 |
|
|
|
280,833 |
|
|
|
(255,945 |
) |
|
|
44,888 |
|
|
Issuance of preferred stock
|
|
|
700 |
|
|
|
|
|
|
|
669,757 |
|
|
|
|
|
|
|
670,457 |
|
|
Issuance of stock options for services
|
|
|
|
|
|
|
|
|
|
|
75,833 |
|
|
|
|
|
|
|
75,833 |
|
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(428,615 |
) |
|
|
(428,615 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2003
|
|
|
700 |
|
|
|
20,000 |
|
|
|
1,026,423 |
|
|
|
(684,560 |
) |
|
|
362,563 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of stock options for services
|
|
|
|
|
|
|
|
|
|
|
294,833 |
|
|
|
|
|
|
|
294,833 |
|
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(539,820 |
) |
|
|
(539,820 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2004
|
|
|
700 |
|
|
|
20,000 |
|
|
|
1,321,256 |
|
|
|
(1,224,380 |
) |
|
|
117,576 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock
|
|
|
|
|
|
|
27,100 |
|
|
|
1,019,416 |
|
|
|
|
|
|
|
1,046,516 |
|
|
Issuance of common stock and stock options for services
|
|
|
|
|
|
|
100 |
|
|
|
1,087,650 |
|
|
|
|
|
|
|
1,087,750 |
|
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,805,380 |
) |
|
|
(1,805,380 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2005
|
|
$ |
700 |
|
|
$ |
47,200 |
|
|
$ |
3,428,322 |
|
|
$ |
(3,029,760 |
) |
|
$ |
446,462 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these financial
statements.
F-5
CATALYST PHARMACEUTICAL PARTNERS, INC.
(a development stage company)
STATEMENTS OF CASH FLOWS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cumulative period | |
|
|
|
|
from January 4, | |
|
|
For the Years Ended December 31, | |
|
2002 (date of | |
|
|
| |
|
inception) through | |
|
|
2005 | |
|
2004 | |
|
2003 | |
|
December 31, 2005 | |
|
|
| |
|
| |
|
| |
|
| |
Operating Activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$ |
(1,805,380 |
) |
|
$ |
(539,820 |
) |
|
$ |
(428,615 |
) |
|
$ |
(3,029,760 |
) |
Reconciliation of net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation
|
|
|
1,374 |
|
|
|
366 |
|
|
|
|
|
|
|
1,740 |
|
|
Stock-based compensation
|
|
|
1,172,750 |
|
|
|
294,833 |
|
|
|
95,733 |
|
|
|
1,659,249 |
|
|
(Increase) in other prepaid expenses and deposits
|
|
|
(14,292 |
) |
|
|
|
|
|
|
|
|
|
|
(14,292 |
) |
|
(Decrease) increase in Accounts Payable
|
|
|
37,019 |
|
|
|
14,436 |
|
|
|
(50,403 |
) |
|
|
67,752 |
|
|
Increase (decrease) in accrued expenses
|
|
|
153,169 |
|
|
|
(335 |
) |
|
|
17,501 |
|
|
|
170,236 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities
|
|
|
(455,360 |
) |
|
|
(230,520 |
) |
|
|
(365,784 |
) |
|
|
(1,145,075 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Investing Activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Capital Expenditures
|
|
|
(3,940 |
) |
|
|
(1,831 |
) |
|
|
|
|
|
|
(5,771 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in investing activities
|
|
|
(3,940 |
) |
|
|
(1,831 |
) |
|
|
|
|
|
|
(5,771 |
) |
Financing Activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from issuance of common stock
|
|
|
1,046,516 |
|
|
|
|
|
|
|
4,500 |
|
|
|
1,151,516 |
|
Proceeds from issuance of preferred stock
|
|
|
|
|
|
|
|
|
|
|
670,457 |
|
|
|
670,457 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities
|
|
|
1,046,516 |
|
|
|
|
|
|
|
674,957 |
|
|
|
1,821,973 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net increase in cash and cash equivalents
|
|
|
587,216 |
|
|
|
(232,351 |
) |
|
|
309,173 |
|
|
|
671,127 |
|
Cash and cash equivalents beginning of period
|
|
|
183,911 |
|
|
|
416,262 |
|
|
|
107,089 |
|
|
|
100,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents end of period
|
|
$ |
771,127 |
|
|
$ |
183,911 |
|
|
$ |
416,262 |
|
|
$ |
771,127 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosures of cash flow information:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash paid during the year for interest
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash paid during the year for income taxes
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-cash financing activities:
In 2005, 2004, 2003, and during the period from January 4,
2002 (date of inception) through December 31, 2005, the
Company recorded compensation expense of $1,067,750, $294,833,
$75,833 and $1,514,249, respectively, related to the issuance of
stock options to non-employees.
The accompanying notes are an integral part of these financial
statements.
F-6
CATALYST PHARMACEUTICAL PARTNERS, INC.
(a development stage company)
NOTES TO FINANCIAL STATEMENTS
|
|
1. |
Organization and Description of Business |
Catalyst Pharmaceutical Partners, Inc. (the
Company) is a development-stage specialty
pharmaceutical company focused on the acquisition, development
and commercialization of prescription drugs for the treatment of
drug addiction. The Company was incorporated in the State of
Florida on January 4, 2002.
The Company has incurred operating losses in each period from
inception through December 31, 2005. The Company has been
able to fund its cash needs to date through an initial funding
from its founders and four subsequent private placements. The
Companys management intends to raise additional equity
funds though an initial public offering of its equity securities.
|
|
2. |
Basis of Presentation and Significant Accounting Policies |
|
|
|
|
a. |
DEVELOPMENT STAGE COMPANY. Since inception, the Company
has devoted substantially all of its efforts to business
planning, research and development, recruiting management and
technical staff, acquiring operating assets and raising capital.
Accordingly, the Company is considered to be in the development
stage and the Companys financial statements are presented
in accordance with Statement of Financial Accounting Standards
No. 7, Accounting and Reporting by Development Stage
Enterprises. The Companys primary focus is on the
chemical compound gamma-vinyl-GABA, commonly referred to as
vigabatrin as a potential treatment for addictions. |
|
|
b. |
USE OF ESTIMATES. The preparation of financial statements
in conformity with U.S. generally accepted accounting principles
requires management to make estimates and assumptions that
affect the amounts reported in the financial statements and
accompanying notes. Actual results could differ from those
estimates. |
|
|
c. |
CASH AND CASH EQUIVALENTS. The Company considers all
highly liquid instruments purchased with an original maturity of
three months or less to be cash equivalents. The Company has
substantially all of its cash and cash equivalents deposited
with one financial institution. |
|
|
d. |
PROPERTY AND EQUIPMENT. Property and equipment are stated
at cost, less accumulated depreciation and amortization.
Depreciation is computed using the straight-line method over the
estimated useful lives of the respective assets, generally three
to seven years. |
|
|
e. |
RESEARCH AND DEVELOPMENT. Costs incurred in connection
with research and development activities are expensed as
incurred. These costs consist of direct and indirect costs
associated with specific projects as well as fees paid to
various entities that perform research for the Company. Total
research and development expenses were $1,462,889, $378,254, and
$268,829 in 2005, 2004, and 2003, respectively. |
|
|
f. |
LICENSES AND OTHER PURCHASED PRODUCT RIGHTS. The costs of
acquired licenses and other purchased product rights are
capitalized and amortized over their respective useful lives,
generally the actual life of the license agreement. The
Financial Accounting Standards Board (FASB) has
issued Statement of Financial Accounting Standards
(SFAS) No. 142, Goodwill and Other
Intangible Assets (SFAS 142). The
provisions of SFAS 142 provide that the carrying value of
intangible assets that have finite useful lives are to be
amortized over their respected useful lives. |
F-7
|
|
|
|
g. |
STOCK BASED COMPENSATION. The Company has recognized in
the income statement the costs related to employee/consultant
services in share-based payment transactions by using the
estimated fair value of the stock at the date of grant, in
accordance with Statement of Financial Accounting Standards
(SFAS) No. 123, Accounting for Stock-Based
Compensation (SFAS 123). |
|
|
|
The Company accounts for the issuance of employee stock options
using the intrinsic value method. Accordingly, compensation cost
for stock options issued is measured as the excess, if any, of
the fair value of the Companys common stock at the date of
grant over the exercise price of the options. In 2005, 2004,
2003 and during the period from January 4, 2002 (date of
inception) through December 31, 2005, the Company recorded
compensation expense of $1,067,750, $294,833, $75,833 and
$1,514,249, respectively, related to the issuance of stock
options to nonemployees. The weighted average fair value of the
stock options granted in 2005, 2004 and during the period from
January 4, 2002 (date of inception) through
December 31, 2005 was $1.66, $1.46 and $1.44, respectively.
There were no stock options granted in 2003. The fair values
were determined using the Black-Scholes option-pricing model
with an estimated annual volatility of 100% for all periods,
expected holding periods of five to ten years, and a risk-free
interest rate of 5% in all periods through 2004 and a risk free
rate of 5.5% in 2005. |
|
|
|
Had compensation cost for the stock-based compensation plans
been determined based on the fair value method at the grant
dates for awards of employee stock options consistent with the
method of SFAS No. 123, pro forma net loss and loss per
share would be as follows: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years ended December 31, | |
|
|
| |
|
|
2005 | |
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
| |
Net loss, as reported
|
|
$ |
(1,805,380 |
) |
|
$ |
(539,820 |
) |
|
$ |
(428,615 |
) |
Stock-based compensation expense determined under the fair
value-based method, net of tax
|
|
|
(507,917 |
) |
|
|
(75,833 |
) |
|
|
(75,833 |
) |
|
|
|
|
|
|
|
|
|
|
Net loss, pro forma
|
|
$ |
(2,313,297 |
) |
|
$ |
(615,653 |
) |
|
$ |
(504,448 |
) |
|
Loss per share basic and diluted, pro forma
|
|
$ |
(0.54 |
) |
|
$ |
(0.31 |
) |
|
$ |
(0.25 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
The above pro forma disclosures may not be representative of
the effects on reported net (loss) earnings for future years as
options vest over several years and the Company may continue to
grant options to employees. |
|
|
|
|
h. |
DEFERRED COMPENSATION. The Company has an agreement with
one of the executive officers to defer payment of a portion of
his compensation due to him until the Company has completed an
equity financing raising gross proceeds of at least
$2.0 million. This contingency was satisfied at the closing
of the recently completed private placement (See Note 10)
and the full amount due to this executive officer for services
has been recognized in the income statement for each period for
which compensation was accrued subject to the contingency (See
Note 7). |
|
|
i. |
CONCENTRATION OF CREDIT RISK. The financial instrument
that potentially subjects the Company to concentration of credit
risk is cash. The Company places its cash with high-credit
quality financial institutions. |
|
|
j. |
INCOME TAXES. The Company utilizes the asset and
liability method of accounting for income taxes. Under this
method, deferred tax assets and liabilities are determined based
on differences between financial reporting and tax bases of
assets and liabilities and are measured using enacted tax rates
and laws that will be in effect when the differences are
expected to reverse. A valuation allowance is provided when it
is more likely than not that some portion or all of a deferred
tax asset will not be realized. |
F-8
|
|
|
|
k. |
EARNINGS (LOSS) PER SHARE. Basic earnings (loss) per
share is computed by dividing net earnings (loss) for the period
by the weighted average number of common shares outstanding
during the period. Diluted earnings (loss) per share is computed
by dividing net earnings (loss) for the period by the weighted
average number of common shares outstanding during the period,
plus the dilutive effect of common stock equivalents, such as
convertible preferred stock and stock options. For all periods
presented, all common stock equivalents were excluded because
their inclusion would have been anti-dilutive. Potentially
dilutive common stock equivalents as of December 31, 2005
include 70,000 shares of Series A Preferred Stock
convertible into 700,000 shares of common stock as well as stock
options to purchase up to 1,500,000 shares of common stock at
exercise prices ranging from $1.00 to $4.35. In addition, on
July 24, 2006, the Company completed a private placement of
7,644 shares of Series B preferred stock convertible into
764,400 shares of common stock. |
|
|
|
|
l. |
NEW ACCOUNTING PRONOUNCEMENTS. In December 2004, the FASB
issued Statement 123(R) which addresses the accounting for
share-based payment transactions (for example, stock options and
awards of restricted stock) in which an employer receives
employee-services in exchange for equity securities of the
company or liabilities that are based on a fair value of the
companys equity securities. This proposal eliminates use
of APB Opinion No. 25, Accounting for Stock Issued to
Employees, and requires such transactions to be accounted for
using a fair value-based method and recording compensation
expense rather than optional pro forma disclosure. The new
standard substantially amends SFAS 123.
Statement 123(R) is effective on January 1, 2006 and
will require the Company to recognize an expense for the fair
value of its unvested outstanding stock options in future
financial statements. The Company had no unvested stock options
to employees as of January 1, 2006. |
|
|
|
In May 2005, the FASB issued SFAS No. 154,
Accounting Changes and Error Corrections, which
changes the requirements for the accounting and reporting of a
change in accounting principle. SFAS No. 154 applies to all
voluntary changes in accounting principle as well as to changes
required by an accounting pronouncement that does not include
specific transition provisions. SFAS No. 154 requires
that changes in accounting principle be retrospectively applied.
SFAS No. 154 is effective for accounting changes and
corrections of errors made in fiscal years beginning after
December 15, 2005. The Company does not expect the adoption of
this standard to have a material effect on the Companys
financial statements. |
|
|
A variety of proposed or otherwise potential accounting
standards are currently under study by standard-setting
organizations and various regulatory agencies. Because of the
tentative and preliminary nature of these proposed standards,
management has not determined whether implementation of such
proposed standards would be material to our condensed
consolidated financial statements. |
|
|
3. |
Property and Equipment |
Property and equipment, net consists of the following as of
December 31:
|
|
|
|
|
|
|
|
|
|
|
|
2005 | |
|
2004 | |
|
|
| |
|
| |
Computer equipment
|
|
$ |
3,303 |
|
|
$ |
1,831 |
|
Furniture and equipment
|
|
|
2,468 |
|
|
|
|
|
Accumulated depreciation
|
|
|
(1,740 |
) |
|
|
(366 |
) |
|
|
|
|
|
|
|
|
Total property and equipment
|
|
$ |
4,031 |
|
|
$ |
1,465 |
|
|
|
|
|
|
|
|
F-9
The Company has executed a noncancellable operating lease
agreement for its corporate office. As of December 31,
2005, future minimum lease payments under the noncancellable
operating lease agreement are as follows:
|
|
|
|
|
2006
|
|
$ |
17,736 |
|
2007
|
|
|
18,268 |
|
2008
|
|
|
6,149 |
|
|
|
|
|
|
|
$ |
42,153 |
|
|
|
|
|
Rent expense was $16,041, $10,914, and $0 as of
December 31, 2005, 2004 and 2003, respectively. Deferred
rent liability as of December 31, 2005 was immaterial.
Accrued expenses consist of the following as of December 31:
|
|
|
|
|
|
|
|
|
|
|
2005 | |
|
2004 | |
|
|
| |
|
| |
Common stock payable
|
|
$ |
105,000 |
|
|
$ |
20,000 |
|
Deferred payroll
|
|
|
83,327 |
|
|
|
|
|
Accrued license fee
|
|
|
69,352 |
|
|
|
|
|
Accrued professional fees
|
|
|
15,000 |
|
|
|
15,000 |
|
Other
|
|
|
2,556 |
|
|
|
2,066 |
|
|
|
|
|
|
|
|
|
|
$ |
275,235 |
|
|
$ |
37,066 |
|
|
|
|
|
|
|
|
|
|
|
|
a. |
LICENSE AGREEMENT WITH BROOKHAVEN. The Company has
entered into a license agreement with Brookhaven Science
Associates, LLC, as operator of Brookhaven National Laboratory
under contract with the United States Department of Energy
(Brookhaven), whereby the Company has obtained an
exclusive license for several patents and patent applications in
the U.S. and outside the U.S. relating to the use of vigabatrin
as a treatment for cocaine and other addictions. This license
agreement runs concurrently with the term of the last to expire
of the licensed patents, the last of which currently expires in
2020. The Company paid a fee to obtain the license in the amount
of $50,000. In addition the Company is required to reimburse
Brookhaven for the costs they have incurred relative to the
related patents. The amount of costs incurred prior to
September 30, 2005 is $69,352, which will become payable in
six monthly installments at the time the Company submits a new
drug application (NDA) to the U.S. Food and Drug
Administration (FDA). Costs incurred after
September 30, 2005 will also be due after the submission of
the NDA. The license agreement also calls for annual royalty
payments of $100,000 in the year of FDA approval of an NDA
relating to the licensed patents, $250,000 in the second and
third year after the approval and $500,000 for each subsequent
year until the expiration of the license agreement. The Company
also has the right to enter into sub-license agreements, and if
it does, a royalty of 20% of any sub-license fees will be
payable to Brookhaven. |
|
|
|
b. |
AGREEMENT WITH CONTRACT MANUFACTURER. The Company has
entered into an agreement with a contract manufacturer under
which such manufacturer will develop for the Company its version
of vigabatrin for use by the Company in its clinical trials. The
gross minimum costs related to this agreement are estimated at
$513,200. The contract manufacturer will progress bill under
this agreement pursuant to a schedule of payments to run
concurrent with the work they |
|
F-10
|
|
|
|
|
will be performing. The payments will be due 30 days from
the time of invoicing of the schedule procedure. |
In January 2005, the Company entered into an agreement with
Patrick McEnany, to act as the Companys Chief Executive
Officer. The agreement calls for an annual salary of $100,000
per year to commence as of March 1, 2005. The agreement
stipulates that half of Mr. McEnanys salary is to be
deferred until the Company raises equity in the amount of not
less than $2,000,000. Mr. McEnany has also deferred the
other half of his compensation until the equity minimum has been
met. As of December 31, 2005 and 2004, the amount payable
to Mr. McEnany for his deferred compensation was $83,327
and $0, respectively. All deferred compensation was earned and
paid to Mr. McEnany from the proceeds of the recently
completed private placement. (See Note 13.)
|
|
8. |
Related Party Transactions |
Since its inception in 2002, the Company has entered into
various Consulting Agreements with nonemployee officers and a
member of the Companys Scientific Advisory Board, a
portion of which were with related parties under common
ownership and control. During the years ended December 31,
2005 and 2004, the Company paid approximately $203,000 and
$15,000 in consulting fees to related parties. There were no
consulting fees paid to related parties for the year ended
December 31, 2003. In addition, as of December 31,
2005, the Company accrued $105,000 related to common stock
payable under certain consulting agreements. A fair value of $2
per share was used to determine the related expense in 2004 and
2005. This fair value was based on an internal valuation
performed by Company management based on the fair value of
similar entities and current market conditions. An aggregate of
52,500 shares of common stock were issued in July 2006 related
to this accrual. In addition, an additional 45,000 shares of
common stock were issued in July 2006 for services performed
from January 1, 2006 through June 30, 2006.
The Companys consulting agreement with its CFO requires a
bonus payment of approximately $150,000 upon the Companys
completion of a U.S. initial public offering of at least
$10 million.
Through July 2006, the Company did not have a formal stock
option plan.
On July 1, 2002, the Company entered into two
Non-Qualified Stock Option Agreements with the
Companys founders, Hubert Huckel and Patrick McEnany.
These agreements provided an option to purchase 250,000 shares
of the Companys common stock (500,000 shares in the
aggregate) at an exercise price of $1.00 per share. These
options expire ten years from their date of grant and previously
vested over three years.
On October 1, 2004, the Company entered into an agreement
with Jack Weinstein, a consultant to the Company. Pursuant to
this agreement, Mr. Weinstein received an option to purchase
150,000 shares of the Companys common stock. The exercise
price of 100,000 of these options is $2.00 per share. The
exercise price of the remaining 50,000 options is the offering
price of the next private placement to raise more than
$2 million ($4.35 based on the private placement that
closed on July 24, 2006). Of these 150,000 options, 50,000
vested immediately, 50,000 vested on October 1, 2005 and
50,000 vested upon completion of the July 2006 private
placement. These options expire five years from their date of
grant.
On January 3, 2005, the Company entered into a
Non-Qualified Stock Option Agreement with Charles
OKeeffe. This agreement included the right to purchase
200,000 shares of the Companys
F-11
common stock at an exercise price of $2.00 per share. These
options vested immediately and expire five years from their date
of grant.
On March 4, 2005, the Company entered into two
Non-Qualified Stock Option Agreements with Hubert
Huckel and Patrick McEnany. These agreements provided an option
to purchase 250,000 shares of the Companys common stock
(500,000 shares in the aggregate ) at an exercise price of $1.00
per share. These options vested immediately and expire ten years
from their date of grant.
On March 4, 2005, an additional Non-Qualified Stock
Option Agreement was entered into with Jack Weinstein, a
consultant to the Company. This agreement provided an option to
purchase 150,000 shares of the Companys common stock. The
exercise price of 100,000 of these options is $2.00 per share.
The exercise price of the remaining 50,000 options is the
offering price of the next private placement to raise more than
$2 million ($4.35 based on the private placement that
closed on July 24, 2006). 100,000 of these options vested
immediately and the remaining vested upon the completion of the
July 2006 private placement. These options expire five years
from their date of grant.
In July 2006, the Company granted five-year options to purchase
100,000 shares of the Companys common stock to
M. Douglas Winship, its Vice President of Regulatory
Operations. These options vest over four-years and are
exercisable at an exercise price of $4.35 per share. These
options expire five years from their date of grant.
A summary of the Companys stock option activity and
related information for the years ended December 31, 2005,
2004, and 2003:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 | |
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
| |
|
|
|
|
Weighted-Average | |
|
|
|
Weighted Average | |
|
|
|
Weighted Average | |
|
|
Number of Options | |
|
Exercise Price | |
|
Number of Options | |
|
Exercise Price | |
|
Number of Options | |
|
Exercise Price | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
Outstanding at beginning of year
|
|
|
650,000 |
|
|
$ |
1.41 |
|
|
|
500,000 |
|
|
$ |
1.00 |
|
|
|
500,000 |
|
|
$ |
1.00 |
|
Granted
|
|
|
850,000 |
|
|
|
1.55 |
|
|
|
150,000 |
|
|
|
2.78 |
|
|
|
|
|
|
|
|
|
Exercised
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Forfeited
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at end of year
|
|
|
1,500,000 |
|
|
$ |
1.49 |
|
|
|
650,000 |
|
|
$ |
1.41 |
|
|
|
500,000 |
|
|
$ |
1.00 |
|
Exercisable at end of year
|
|
|
1,400,000 |
|
|
$ |
1.29 |
|
|
|
433,333 |
|
|
$ |
1.23 |
|
|
|
166,667 |
|
|
$ |
1.00 |
|
The following information applies to options outstanding at
December 31, 2005:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options Outstanding | |
|
|
|
|
|
|
| |
|
|
|
Options Exercisable | |
|
|
|
|
Weighted-Average | |
|
|
|
| |
|
|
|
|
Remaining | |
|
Weighted Average | |
|
|
|
Weighted Average | |
Range of Exercise Prices |
|
Shares | |
|
Contractual Life | |
|
Exercise Price | |
|
Shares | |
|
Exercise Price | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
$1.00 $2.00
|
|
|
1,400,000 |
|
|
|
8.57 years |
|
|
$ |
1.29 |
|
|
|
1,400,000 |
|
|
$ |
1.29 |
|
$4.35
|
|
|
100,000 |
|
|
|
5 years |
|
|
$ |
4.35 |
|
|
|
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,500,000 |
|
|
|
|
|
|
|
|
|
|
|
1,400,000 |
|
|
|
|
|
In November 2002, the Company completed a private placement in
which it raised gross proceeds of $125,000 through the sale of
500,000 shares of its common stock.
In April 2003, the Company completed a private placement in
which it raised net proceeds of $670,457 through the sale of
70,000 shares of its Series A Preferred Stock.
In March 2005, the Company completed a private placement in
which it raised net proceeds of $1,046,516 through the sale of
2,710,000 shares of the Companys common stock.
F-12
|
|
|
|
a. |
COMMON STOCK. The Company has 30,000,000 shares of
authorized common stock with a par value of $0.01 per share. At
December 31, 2005 and 2004, 4,720,000 and 2,000,000 shares,
respectively, of common stock were issued and outstanding. Each
holder of common stock is entitled to one vote of each share of
common stock held of record on all matters on which stockholders
generally are entitled to vote. |
|
|
b. |
PREFERRED STOCK. The Company has 5,000,000 shares of
authorized preferred stock outstanding, $0.01 par value per
share. |
|
|
|
|
i. |
Series A Preferred Stock. At December 31, 2005,
the Company had 70,000 shares of Series A Preferred Stock
issued and outstanding. Each share of outstanding Series A
Preferred Stock has a liquidation preference of $1.00 per share
and votes with the Common Stock on the basis of ten votes for
each share of Series A Preferred Stock outstanding. Each
share of Series A Preferred Stock is convertible, at the
option of the holder, into ten shares of common stock; provided,
however, that all of the outstanding shares of Series A
Preferred Stock will automatically convert into shares of the
Companys Common Stock under certain circumstances,
including the completion of an initial public offering. |
As of December 31, 2005 and 2004 the Company had deferred
tax assets of approximately $1,151,000 and $465,000,
respectively, of which approximately $576,000 and $296,000
represent net operating loss carryforwards. The remaining
deferred tax assets represent nondeductible stock option
expense. The related deferred tax asset has a 100% valuation
allowance as of December 31, 2005 and 2004, as the Company
believes it is more likely than not that the deferred tax asset
will not be realized. The change in valuation allowance was
approximately $686,000, $205,000 and $163,000 in 2005, 2004, and
2003, respectively. There are no other significant temporary
differences. The net operating loss carry-forwards will expire
at various dates beginning in 2022 and expiring in 2025. If an
ownership change, as defined under Internal Revenue Code
Section 382, occurs, the use of these carry-forwards may be
subject to limitation.
The effective tax rate of 0% in all periods presented differs
from the statutory rate of 35% due to the valuation allowance.
|
|
|
|
a. |
PRIVATE PLACEMENT. On July 24, 2006, the Company
completed a private placement in which it raised net proceeds of
$3,225,140 through the sale of 7,644 shares of the
Companys Series B Preferred Stock. Each share of
outstanding Series B Preferred Stock has a liquidation
preference of $435 per share and votes with the Common Stock on
the basis of 100 votes for each share of Series B Preferred
Stock outstanding. Each share of Series B Preferred Stock
is convertible, at the option of the holder, into 100 shares of
common stock; provided, however, that all of the outstanding
shares of Series B Preferred Stock will automatically
convert into shares of common stock under certain circumstances,
including the completion of an initial public offering. |
|
|
b. |
2006 STOCK INCENTIVE PLAN. In July 2006 the Company
adopted the 2006 Stock Incentive Plan (the Plan).
The Plan provides for the Company to issue options, restricted
stock, stock appreciation rights and restricted stock units
(collectively, the Awards) to employees, directors
and consultants of the Company. Under the Plan, 1,500,000 shares
of the Companys Common Stock have been reserved for
issuance. No grants have been made to date under the Plan. |
F-13
CATALYST PHARMACEUTICAL PARTNERS, INC.
(a development stage company)
BALANCE SHEETS
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, | |
|
December 31, | |
|
|
2006 | |
|
2005 | |
|
|
| |
|
| |
|
|
(unaudited) | |
|
|
ASSETS |
Current Assets:
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$ |
324,154 |
|
|
$ |
771,127 |
|
|
Prepaid insurance
|
|
|
2,681 |
|
|
|
440 |
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
326,835 |
|
|
|
771,567 |
|
|
Property and equipment, net
|
|
|
14,426 |
|
|
|
4,031 |
|
|
Deposits
|
|
|
23,852 |
|
|
|
13,852 |
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$ |
365,113 |
|
|
$ |
789,450 |
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS EQUITY (DEFICIT) |
Current Liabilities:
|
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
$ |
24,946 |
|
|
$ |
67,753 |
|
|
Accrued expenses
|
|
|
409,405 |
|
|
|
275,235 |
|
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
434,351 |
|
|
|
342,988 |
|
|
|
|
|
|
|
|
Commitments and Contingencies (See notes)
|
|
|
|
|
|
|
|
|
Stockholders equity (deficit)
|
|
|
|
|
|
|
|
|
|
Preferred stock, $.01 par value, 5,000,000 shares authorized,
70,000 shares Series A Preferred Stock outstanding
|
|
|
700 |
|
|
|
700 |
|
|
Common stock, $.01 par value, 30,000,000 shares authorized,
4,720,000 shares issued and outstanding at June 30, 2006
and December 31, 2005
|
|
|
47,200 |
|
|
|
47,200 |
|
|
Additional paid-in capital
|
|
|
3,579,447 |
|
|
|
3,428,322 |
|
|
Accumulated deficit
|
|
|
(3,696,585 |
) |
|
|
(3,029,760 |
) |
|
|
|
|
|
|
|
|
|
Total stockholders equity (deficit)
|
|
|
(69,238 |
) |
|
|
446,462 |
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders equity (deficit)
|
|
$ |
365,113 |
|
|
$ |
789,450 |
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these interim
financial statements.
F-14
CATALYST PHARMACEUTICAL PARTNERS, INC.
(a development stage company)
STATEMENTS OF OPERATIONS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cumulative Period | |
|
|
For the Six Months Ended | |
|
from January 4, | |
|
|
June 30, | |
|
2002 (date of | |
|
|
| |
|
inception) to June | |
|
|
2006 | |
|
2005 | |
|
30, 2006 | |
|
|
| |
|
| |
|
| |
|
|
|
|
(unaudited) | |
|
|
(unaudited) | |
|
|
Revenues
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
Operating costs and expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
432,764 |
|
|
|
1,200,769 |
|
|
|
2,680,416 |
|
|
General and administrative
|
|
|
242,194 |
|
|
|
126,811 |
|
|
|
1,049,925 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating costs and expenses
|
|
|
674,958 |
|
|
|
1,327,580 |
|
|
|
3,730,341 |
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
(674,958 |
) |
|
|
(1,327,580 |
) |
|
|
(3,730,341 |
) |
Interest income
|
|
|
8,133 |
|
|
|
5,908 |
|
|
|
33,756 |
|
|
|
|
|
|
|
|
|
|
|
|
Loss before income taxes
|
|
|
(666,825 |
) |
|
|
(1,321,672 |
) |
|
|
(3,696,585 |
) |
Provision for income taxes
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$ |
(666,825 |
) |
|
$ |
(1,321,672 |
) |
|
$ |
(3,696,585 |
) |
|
|
|
|
|
|
|
|
|
|
Loss per share basic and diluted
|
|
$ |
(0.14 |
) |
|
$ |
(0.35 |
) |
|
|
|
|
Weighted average shares outstanding basic and diluted
|
|
|
4,720,000 |
|
|
|
3,767,033 |
|
|
|
|
|
The accompanying notes are an integral part of these interim
financial statements.
F-15
CATALYST PHARMACEUTICAL PARTNERS, INC.
(a development stage company)
STATEMENT OF STOCKHOLDERS EQUITY (DEFICIT)
(unaudited)
For the six months ended June 30, 2006
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deficit | |
|
|
|
|
|
|
|
|
|
|
Accumulated | |
|
|
|
|
|
|
|
|
|
|
During the | |
|
|
|
|
|
|
|
|
|
|
Development | |
|
|
|
|
Preferred Stock | |
|
Common Stock | |
|
Paid-in Capital | |
|
Stage | |
|
Total | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
Balance at December 31, 2005
|
|
$ |
700 |
|
|
$ |
47,200 |
|
|
$ |
3,428,322 |
|
|
$ |
(3,029,760 |
) |
|
$ |
446,462 |
|
|
Issuance of stock options for services
|
|
|
|
|
|
|
|
|
|
|
151,125 |
|
|
|
|
|
|
|
151,125 |
|
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(666,825 |
) |
|
|
(666,825 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at June 30, 2006
|
|
$ |
700 |
|
|
$ |
47,200 |
|
|
$ |
3,579,447 |
|
|
$ |
(3,696,585 |
) |
|
$ |
(69,238 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these interim
financial statements.
F-16
CATALYST PHARMACEUTICAL PARTNERS, INC.
(a development stage company)
STATEMENTS OF CASH FLOWS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cumulative period | |
|
|
|
|
from January 4, | |
|
|
For the Six Months Ended | |
|
2002 (date of | |
|
|
June 30, | |
|
inception) through | |
|
|
| |
|
June 30, | |
|
|
2006 | |
|
2005 | |
|
2006 | |
|
|
| |
|
| |
|
| |
|
|
(unaudited) | |
|
(unaudited) | |
Operating Activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$ |
(666,825 |
) |
|
$ |
(1,321,672 |
) |
|
$ |
(3,696,585 |
) |
Reconciliation of net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation
|
|
|
2,051 |
|
|
|
687 |
|
|
|
3,791 |
|
|
Stock-based compensation
|
|
|
241,125 |
|
|
|
1,013,374 |
|
|
|
1,900,374 |
|
|
(Increase) in other prepaid expenses and deposits
|
|
|
(12,241 |
) |
|
|
(16,100 |
) |
|
|
(26,533 |
) |
|
(Decrease) increase in accounts payable
|
|
|
(42,806 |
) |
|
|
90 |
|
|
|
24,946 |
|
|
Increase (decrease) in accrued expenses
|
|
|
44,169 |
|
|
|
79,510 |
|
|
|
214,406 |
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities
|
|
|
(434,527 |
) |
|
|
(244,111 |
) |
|
|
(1,579,601 |
) |
|
|
|
|
|
|
|
|
|
|
Investing Activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Capital expenditures
|
|
|
(12,446 |
) |
|
|
(3,940 |
) |
|
|
(18,218 |
) |
|
|
|
|
|
|
|
|
|
|
|
Net cash used in investing activities
|
|
|
(12,446 |
) |
|
|
(3,940 |
) |
|
|
(18,218 |
) |
Financing Activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from issuance of common stock
|
|
|
|
|
|
|
1,046,516 |
|
|
|
1,151,516 |
|
Proceeds from issuance of preferred stock
|
|
|
|
|
|
|
|
|
|
|
670,457 |
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities
|
|
|
|
|
|
|
1,046,516 |
|
|
|
1,821,973 |
|
|
|
|
|
|
|
|
|
|
|
Net increase in cash and cash equivalents
|
|
|
(446,973 |
) |
|
|
798,465 |
|
|
|
224,154 |
|
Cash and cash equivalents January 1
|
|
|
771,127 |
|
|
|
183,911 |
|
|
|
100,000 |
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents June 30
|
|
$ |
324,154 |
|
|
$ |
982,376 |
|
|
$ |
324,154 |
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosures of cash flow information:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash paid during the year for interest
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash paid during the year for income taxes
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-cash financing activities:
During the six months ended June 30, 2006 and 2005, the
Company recorded compensation expense of $151,125 and $998,375,
respectively, related to the issuance of stock options to
nonemployees.
The accompanying notes are an integral part of these interim
financial statements.
F-17
CATALYST PHARMACEUTICAL PARTNERS, INC.
(a development stage company)
NOTES TO INTERIM FINANCIAL STATEMENTS
|
|
1. |
Organization and Description of Business |
Catalyst Pharmaceutical Partners, Inc. (Company) is
a development-stage specialty pharmaceutical company focused on
the acquisition, development and commercialization of
prescription drugs for the treatment of drug addiction. The
Company was incorporated in the State of Florida on
January 4, 2002.
The Company has incurred operating losses in each period from
inception through June 30, 2006. The Company has been able
to fund its cash needs to date through an initial funding from
its founders and four subsequent private placements. The
Companys management intends to raise additional equity
funds though an initial public offering of its equity securities.
|
|
2. |
Basis of Presentation and Significant Accounting Policies |
|
|
|
|
a. |
DEVELOPMENT STAGE COMPANY. Since inception, the Company
has devoted substantially all of its efforts to business
planning, research and development, recruiting management and
technical staff, acquiring operating assets and raising capital.
Accordingly, the Company is considered to be in the development
stage and the Companys financial statements are presented
in accordance with Statement of Financial Accounting Standards
No. 7, Accounting and Reporting by Development Stage
Enterprises. |
|
|
b. |
INTERIM FINANCIAL STATEMENTS. The accompanying unaudited
interim condensed financial statements have been prepared
pursuant to the rules and regulations of the Securities and
Exchange Commission for reporting of interim financial
information. Pursuant to such rules and regulations, certain
information and footnote disclosures normally included in
financial statements prepared in accordance with accounting
principles generally accepted in the United States have been
condensed or omitted. The accompanying unaudited interim
condensed financial statements should be read in conjunction
with the Companys audited financial statements and the
notes thereto included elsewhere in this prospectus. |
|
|
|
In the opinion of management, the accompanying unaudited interim
condensed financial statements of the Company contain all
adjustments (consisting of only normal recurring adjustments)
necessary to present fairly the financial position of the
Company as of June 30, 2006, the results of its operations
for the six month periods ended June 30, 2006 and 2005 and
its cash flows for the six month periods ended June 30,
2006 and 2005. The results of operations and cash flows for the
six month period ended June 30, 2006 are not necessarily
indicative of the results of operations or cash flows which may
be reported for the year ending December 31, 2006. |
|
|
|
|
c. |
USE OF ESTIMATES. The preparation of financial statements
in conformity with U.S. generally accepted accounting principles
requires management to make estimates and assumptions that
affect the amounts reported in the financial statements and
accompanying notes. Actual results could differ from those
estimates. |
|
|
|
|
d. |
STOCK COMPENSATION PLANS. Through July 2006, the Company
did not have a formal stock option plan. As of June 30,
2006, there were outstanding stock options to purchase 1,500,000
shares of common stock of which stock options to purchase
1,400,000 shares of common stock were exercisable as of
June 30, 2006. There was no stock option activity during
the six-month period ended June 30, 2006. |
F-18
|
|
|
|
For the six month periods ended June 30, 2006 and 2005, the
Company recognized expense of $241,125 and $1,013,375,
respectively, in stock-based compensation costs, which is
reflected in research and development expenses. No tax benefits
were attributed to the stock-based compensation expense because
a valuation allowance was maintained for substantially all net
deferred tax assets. The Company elected to adopt the
alternative method of calculating the historical pool of
windfall tax benefits as permitted by FASB Staff Position (FSP)
No. SFAS 123R-c, Transition Election Related to
Accounting for the Tax Effects of Share-Based Payment
Awards. This is a simplified method to determine the pool
of windfall tax benefits that is used in determining the tax
effects of stock compensation in the results of operations and
cash flow reporting for awards that were outstanding as of the
adoption of SFAS No. 123R. As of June 30, 2006, the
Company has no unrecognized compensation costs related to
non-vested employee stock option awards. |
|
|
|
|
The following information applies to options outstanding and
exercisable at June 30, 2006: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options Outstanding | |
|
|
|
|
|
|
| |
|
|
|
Options Exercisable | |
|
|
|
|
Weighted-Average | |
|
|
|
| |
|
|
|
|
Remaining | |
|
Weighted Average | |
|
|
|
Weighted Average | |
Range of Exercise Prices |
|
Shares | |
|
Contractual Life | |
|
Exercise Price | |
|
Shares | |
|
Exercise Price | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
$1.00 $2.00
|
|
|
1,400,000 |
|
|
|
8.57 years |
|
|
$ |
1.29 |
|
|
|
1,400,000 |
|
|
$ |
1.29 |
|
$4.35
|
|
|
100,000 |
|
|
|
5 years |
|
|
$ |
4.35 |
|
|
|
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,500,000 |
|
|
|
|
|
|
|
|
|
|
|
1,400,000 |
|
|
|
|
|
|
|
|
The Company utilizes the Black-Scholes option-pricing model to
determine the fair value of stock options on the date of grant.
This model derives the fair value of stock options based on
certain assumptions related to expected stock price volatility,
expected option life, risk-free interest rate and dividend
yield. The Companys expected volatility is based on the
historical volatility of other publicly traded development stage
companies in the same industry. The estimated expected option
life is based upon estimated employee exercise patterns and
considers whether and the extent to which the options are
in-the-money. The risk-free interest rate assumption is based
upon the U.S. Treasury yield curve appropriate for the term of
the Companys stock options awards. As of June 30,
2006, the unrecognized compensation costs related to non-vested
stock option is immaterial. There were no stock options granted
during the six month period ended June 30, 2006. For the
six month period ended June 30, 2005, the weighted average
fair value of stock options granted was $1.66 per share. |
|
|
|
Had compensation cost for the stock-based compensation plans
been determined based on the fair value method at the grant
dates for awards of employee stock options consistent with the
method of SFAS No. 123, pro forma net loss and loss per
share would be as follows: |
F-19
|
|
|
|
|
|
|
For the Six Months | |
|
|
Ended | |
|
|
June 30, 2005 | |
|
|
| |
Net loss, as reported
|
|
$ |
(1,321,672 |
) |
Total stock-based employee compensation expense determined under
fair value-based method
|
|
|
(488,959 |
) |
|
|
|
|
Net loss, pro forma
|
|
$ |
(1,810,631 |
) |
|
|
|
|
Loss per share basic and diluted, pro forma
|
|
$ |
(0.48 |
) |
|
|
|
The above pro forma disclosures may not be representative of
the effects on reported net (loss) earnings for future years as
options vest over several years and the Company may continue to
grant options to employees. |
|
|
3. |
Property and Equipment |
Property and equipment, net consists of the following:
|
|
|
|
|
|
|
|
|
|
|
|
June 30, | |
|
December 31, | |
|
|
2006 | |
|
2005 | |
|
|
| |
|
| |
Computer equipment
|
|
$ |
11,715 |
|
|
$ |
3,303 |
|
Furniture and equipment
|
|
|
6,502 |
|
|
|
2,468 |
|
Accumulated depreciation
|
|
|
(3,791 |
) |
|
|
(1,740 |
) |
|
|
|
|
|
|
|
|
Total property and equipment
|
|
$ |
14,426 |
|
|
$ |
4,031 |
|
|
|
|
|
|
|
|
|
|
|
|
a. |
COMMON STOCK. The Company has 30,000,000 shares of
authorized common stock with a par value of $0.01 per share. At
June 30, 2006 and December 31, 2005, 4,720,000 shares,
respectively, of common stock were issued and outstanding. Each
holder of common stock is entitled to one vote of each share of
common stock held of record on all matters on which stockholders
generally are entitled to vote. |
|
|
b. |
PREFERRED STOCK. The Company has 5,000,000 shares of
authorized preferred stock outstanding, $0.01 par value per
share. |
|
|
|
|
i. |
Series A Preferred Stock. At December 31, 2005,
the Company had 70,000 shares of Series A Preferred Stock
outstanding. Each share of outstanding Series A Preferred
Stock has a liquidation preference of $1.00 per share and votes
with the Common Stock on the basis of ten votes for each share
of Series A Preferred Stock outstanding. Each share of
Series A Preferred Stock is convertible, at the option of
the holder, into ten shares of common stock; provided, however,
that all of the outstanding shares of Series A Preferred
Stock will automatically convert into shares of the
Companys Common Stock under certain circumstances,
including the completion of an initial public offering. |
|
|
5. |
Related Party Transactions. |
Since its inception in 2002, the Company has entered into
various Consulting Agreements with non-employee officers, and a
member of the Companys Scientific Advisory Board, a
portion of which were with related parties under common
ownership and control. During the six months ended June 30,
2006 and 2005, the Company paid approximately $65,000 and
$93,000 in consulting fees to related parties. In addition, as
of June 30, 2006, the Company accrued $195,000 related to
common stock payable under certain consulting arrangements. A
fair value of $4.35 per share was used to determine the related
F-20
expense for the six months ended June 30, 2006. This fair
value was based on an internal valuation performed by Company
management based on the fair value of similar entities and
current market conditions. An aggregate of 45,000 shares of
common stock were issued in July 2006 related to this accrual.
The Companys consulting agreement with its CFO requires a
bonus payment of approximately $150,000 upon the completion of a
U.S. initial public offering of at least $10 million.
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|
|
|
a. |
PRIVATE PLACEMENT. On July 24, 2006, the Company
completed a private placement in which it raised net proceeds of
$3,225,140 through the sale of 7,644 shares of the
Companys Series B Preferred Stock. Each share of
outstanding Series B Preferred Stock has a liquidation
preference of $435 per share and votes with the Common Stock on
the basis of 100 votes for each share of Series B Preferred
Stock outstanding. Each share of Series B Preferred Stock
is convertible, at the option of the holder, into 100 shares of
common stock; provided, however, that all of the outstanding
shares of Series B Preferred Stock will automatically
convert into shares of common stock under certain circumstances,
including the completion of an initial public offering. |
|
|
b. |
2006 STOCK INCENTIVE PLAN. In July 2006 the Company
adopted the 2006 Stock Incentive Plan (the Plan).
The Plan provides for the Company to issue options, restricted
stock, stock appreciation rights and restricted stock units
(collectively, the Awards) to employees, directors
and consultants of the Company. Under the Plan, 1,500,000 shares
of the Companys common stock have been reserved for
issuance. No options have been granted to date under the Plan. |
F-21
Common Stock
Shares
|
|
First Albany Capital |
Stifel Nicolaus |
The date of this prospectus
is ,
2006
Through and
including ,
2006 (the 25th day after the date of this prospectus), all
dealers that effect transactions in our common stock, whether or
not participating in this offering, may be required to deliver a
prospectus. This delivery requirement is in addition to the
dealers obligation to deliver a prospectus when acting as
underwriters and with respect to their unsold allotments or
provisions.
PART II
Information Not Required In Prospectus
Item 13. Other Expenses of
Issuance and Distribution
The following table sets forth the various costs and expenses to
be incurred in connection with the issuance and distribution of
the securities registered under this Registration Statement,
other than underwriting discounts and commissions. All such
expenses are estimates, except for the SEC registration fee, the
NASD filing fee, and the Nasdaq Global Market listing fee. The
following expenses will be borne solely by the Registrant.
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|
|
|
|
SEC Registration Fee
|
|
$ |
4,306.75 |
|
NASD Filing Fee
|
|
|
4,525.00 |
|
Nasdaq Global Market Listing Fee
|
|
|
* |
|
Printing and Engraving Expenses
|
|
|
* |
|
Legal Fees and Expenses
|
|
|
* |
|
Accounting Fees and Expenses
|
|
|
* |
|
Transfer Agent and Registrar Fees
|
|
|
* |
|
Miscellaneous Expenses
|
|
|
* |
|
|
|
|
|
Total
|
|
$ |
* |
|
* To be furnished by amendment.
Item 14. Indemnification of
Officers and Directors
Section 145 of the Delaware General Corporation Law
permits, in general, a Delaware corporation to indemnify any
person who was or is a party to any proceeding (other than an
action by, or in the right of, the corporation) by reason of the
fact that he or she is or was a director or officer of the
corporation, or served another business enterprise in any
capacity at the request of the corporation, against liability
incurred in connection with such proceeding, including the
estimated expenses of litigating the proceeding to conclusion
and the expenses actually and reasonably incurred in connection
with the defense or settlement of such proceeding, if such
person acted in good faith and in a manner he or she reasonably
believed to be in, or not opposed to, the best interests of the
corporation and, in criminal actions or proceedings,
additionally had no reasonable cause to believe that his or her
conduct was unlawful. A Delaware corporations power to
indemnify applies to actions brought by or in the right of the
corporation as well, but only to the extent of expenses
(including attorneys fees) actually and reasonably
incurred by the person in connection with the defense or
settlement of the action or suit, provided that no
indemnification shall be provided in such actions in the event
of any adjudication of negligence or misconduct in the
performance of such persons duties to the corporation,
unless a court believes that in light of all the circumstances
indemnification should apply. Section 145 of the Delaware
General Corporation Law also permits, in general, a Delaware
corporation to purchase and maintain insurance on behalf of any
person who is or was a director or officer of the corporation,
or served another entity in any capacity at the request of the
corporation, against liability incurred by such person in such
capacity, whether or not the corporation would have the power to
indemnify such person against such liability.
The Registrants By-Laws implement the indemnification
provisions permitted by Section 145 of the Delaware General
Corporation Law by providing that:
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The Registrant shall indemnify any person that was or is a party
to any proceeding by reason of the fact that he or she is or was
a director or an officer of the Registrant, to the fullest
extent permitted by the Delaware General Corporation Law. |
II-1
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The Registrant shall prepay expenses, including attorneys
fees, incurred by a director or an officer in connection with
defending a proceeding for which the Registrant is required to
provide indemnification, provided that the director or the
officer shall undertake to repay such advances if it is
ultimately determined that such person is not entitled to
indemnification for such expenses. |
|
|
|
The Registrant shall pay a claim for indemnification or
advancement of expenses within 30 days after it receives a
written claim from an indemnified director or officer. Such
director or officer may file suit to recover the unpaid claim
amount, and the corporation shall have the burden of proving
that the director or officer is not entitled to the requested
claim amount. |
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The grant of indemnification rights by the registrant shall not
be exclusive of any other rights that an indemnified director or
officer may have or hereafter acquire under any statute,
agreement, vote of stockholders or disinterested directors, or
provision of the Certificate of Incorporation or the by-laws of
the Registrant. |
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The Registrants obligation, if any, to indemnify or to
advance expenses to any indemnified person who was or is serving
another corporation, partnership, joint venture, trust,
enterprise or non-profit enterprise shall be reduced by any
amount such employee may collect as indemnification or
advancement of expenses from the other corporation, partnership,
joint venture, trust, enterprise or non-profit enterprise. |
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The Registrant may, in its discretion, indemnify and advance
expenses to employees and agents, to the extent and manner
permitted by law, under circumstances where indemnification is
not required by law. |
In addition, as permitted by Section 102 of the Delaware
General Corporation Law, the Registrants Certificate of
Incorporation includes a provision that eliminates the personal
liability of its directors for monetary damages for breach of
their fiduciary duty as directors to the fullest extent
permitted by the Delaware General Corporation Law.
These indemnification provisions may be sufficiently broad to
permit indemnification of the Registrants directors and
officers for liabilities (including reimbursement of expenses
incurred) arising under the Securities Act. Pursuant to the
Underwriting Agreement to be filed as Exhibit 1.1 to this
Registration Statement, the underwriters have agreed to
indemnify the Registrants directors, officers, and
controlling persons, and the Registrant has agreed to indemnify
the underwriters, against certain civil liabilities that may be
incurred in connection with the offering of securities pursuant
to this Registration Statement (including certain liabilities
under the Securities Act) as a result of any statement or
omission in this Registration Statement, in the related
prospectus, in any preliminary prospectus, or in any amendment
or supplement thereto, in each case to the extent that the
statement or omission was made in reliance upon and in
conformity with written information furnished by the
underwriters expressly for use therein.
Item 15. Recent Sales of
Unregistered Securities
The following is information furnished with regard to all
securities sold by the Registrant within the past three years
that were not registered under the Act.
On February 28, 2005, the Registrant completed a rights
offering of shares of its authorized but unissued common stock
to holders of its common stock and holders of its Series A
Preferred Stock. In the rights offering, the Registrant issued
2,710,000 shares of its common stock to its stockholders. No
commissions were paid in connection with the issuance of the
foregoing shares, all of which were issued pursuant to an
exemption from registration under Section 4(2) of the Act.
This offering resulted in proceeds of approximately $1,000,000
to the Registrant, net of expenses.
On July 24, 2006, the Registrant completed the sale of
7,644 shares of its Series B Preferred Stock, par value
$0.01 per share at a price of $435 per share. The foregoing
securities were issued to 51 accredited investors and were
issued pursuant to an exemption from registration under
Section 4(2) of the Act.
II-2
In July 2006, the Registrant issued an aggregate of 97,500
shares of its common stock to five of its advisors for services
performed during 2005 and through June 30, 2006. These
shares were issued pursuant to an exemption from registration
under Section 4(2) of the Act.
None of these transactions involved any underwriters,
underwriting discounts, or any public offering. The recipients
of securities in each transaction represented their intention to
acquire the securities for investment only and not with a view
to or for sale in connection with any distribution thereof, and
appropriate legends were affixed to the stock certificates and
instruments issued in such transactions. All recipients received
adequate information regarding the Registrant and the stock sold.
Item 16. Exhibits and
Financial Statement Schedules
(a) Exhibits
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Exhibit |
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Number |
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Description of Exhibit |
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1 |
.1 |
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Underwriting Agreement dated as
of ,
2006 between Catalyst Pharmaceutical Partners, Inc. and the
underwriters named therein(2) |
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3 |
.1 |
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Certificate of Incorporation(1) |
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3 |
.2 |
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Amendment to Certificate of Incorporation(1) |
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3 |
.3 |
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By-laws(1) |
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5 |
.1 |
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Opinion of Akerman Senterfitt(2) |
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10 |
.1 |
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Employment Agreement between the Company and Patrick J.
McEnany(2) |
|
10 |
.2 |
|
Employment Agreement between the Company and Jack Weinstein(2) |
|
10 |
.3 |
|
License Agreement, as amended, between the Company and
Brookhaven National Laboratories(1) |
|
10 |
.4 |
|
Stock Option Agreements between the Company and Patrick J.
McEnany(1) |
|
10 |
.5 |
|
Stock Option Agreements between the Company and Hubert Huckel(1) |
|
10 |
.6 |
|
Stock Option Agreements between the Company and Jack Weinstein(1) |
|
10 |
.7 |
|
Stock Option Agreement between the Company and Charles
OKeeffe(1) |
|
10 |
.8 |
|
2006 Stock Incentive Plan(1) |
|
10 |
.9 |
|
Agreement and Plan of Merger, dated August 14, 2006,
between the Company and Catalyst Pharmaceutical Partners, Inc.,
a Florida corporation* |
|
10 |
.10 |
|
Consulting Agreement, as amended, between the Company and Jack
Weinstein* |
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10 |
.11 |
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Consulting Agreement between the Company and Charles
OKeeffe* |
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10 |
.12 |
|
Consulting Agreement between the Company and Donald R. Jasinski* |
|
10 |
.13 |
|
Agreement between the Company and Charles Gorodetzky* |
|
10 |
.14 |
|
Agreement between the Company and Pharmaceutics International,
Inc.* |
|
23 |
.1 |
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Consent of Grant Thornton LLP* |
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23 |
.2 |
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Consent of Akerman Senterfitt (included as Exhibit 5.1) |
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24 |
.1 |
|
Power of Attorney (included on Page II-5) |
(1) Previously filed.
(2) To be filed by amendment.
* Filed herewith.
II-3
(b) Financial Statement Schedules
None.
Item 17. Undertakings
(1) The undersigned registrant hereby undertakes to provide
to the underwriters at the closing specified in the Underwriting
Agreement certificates in such denominations and registered in
such names as required by the underwriters to permit prompt
delivery to each purchaser
(2) Insofar as indemnification for liabilities arising
under the Securities Act of 1933 may be permitted to directors,
officers, and controlling persons of the registrant pursuant to
the foregoing provisions, or otherwise, the registrant has been
advised that in the opinion of the Securities and Exchange
Commission such indemnification is against public policy as
expressed in the Act and is, therefore, unenforceable. In the
event that a claim for indemnification against such liabilities
(other than the payment by the registrant of expenses incurred
or paid by a director, officer, or a controlling person of the
registrant in the successful defense of any action, suit, or
proceeding) is asserted by such director, officer or controlling
person in connection with the securities being registered, the
registrant will, unless in the opinion of its counsel the matter
has been settled by controlling precedent, submit to a court of
appropriate jurisdiction the question whether such
indemnification by it is against public policy as expressed in
the Act and will be governed by the final adjudication of such
issue.
(3) The undersigned registrant hereby undertakes that:
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(a) |
For purposes of determining any liability under the Securities
Act of 1933, the information omitted from the form of the
prospectus filed as a part of this registration statement in
reliance upon Rule 430A and contained in a form of
prospectus filed by the registrant pursuant to
Rule 424(b)(1) or (4) or 497(h) under the Securities
Act shall be deemed to be a part of this registration statement
at the time it was declared effective. |
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|
(b) |
For the purpose of determining any liability under the
Securities Act of 1933, each post-effective amendment that
contains a form of prospectus shall be deemed to be a new
registration statement relating to the securities offered
therein, and the offering of such securities at that time shall
be deemed to be the initial bona fide offering thereof. |
II-4
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, as
amended, the registrant has duly caused this Amendment
No. 1 to Registration Statement on
Form S-1 to be
signed on its behalf by the undersigned, thereunto duly
authorized, in City of Miami, State of Florida on
September 1, 2006.
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CATALYST PHARMACEUTICAL PARTNERS, INC. |
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By: |
/s/ Patrick J. McEnany |
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Patrick J. McEnany |
|
President and Chief Executive Officer |
Pursuant to the requirements of the Securities Act of 1933, this
Amendment No. 1 to Registration Statement on
Form S-1 has been
signed by the following persons, in the capacities and on the
dates indicated.
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Signature |
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Title |
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Date |
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/s/ Patrick J. McEnany
Patrick
J. McEnany |
|
Chairman of the Board of Directors, President and Chief
Executive Officer (Principal Executive Officer) |
|
September 1, 2006 |
|
/s/ Jack Weinstein
Jack
Weinstein |
|
Vice President, Treasurer and
Chief Financial Officer (Principal Financial and Accounting
Officer) |
|
September 1, 2006 |
|
/s/ Hubert E. Huckel, M.D.*
Hubert
E. Huckel, M.D. |
|
Director |
|
September 1, 2006 |
|
/s/ Charles B. OKeeffe*
Charles
B. OKeeffe |
|
Director |
|
September 1, 2006 |
|
/s/ Philip H. Coelho*
Philip
H. Coelho |
|
Director |
|
September 1, 2006 |
|
/s/ David S. Tierney, M.D.*
David
S. Tierney, M.D. |
|
Director |
|
September 1, 2006 |
|
/s/ Milton J. Wallace*
Milton
J. Wallace |
|
Director |
|
September 1, 2006 |
|
*/s/ Patrick J. McEnany
By: Patrick
J. McEnany, under power of attorney dated July 25, 2006. |
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II-5
EX-10.9 Agreement and Plan of Merger
EXHIBIT
10.9
AGREEMENT AND PLAN OF MERGER
This AGREEMENT AND PLAN OF MERGER (this Agreement) dated as of August 14, 2006, is made and
entered into by and between Catalyst Pharmaceutical Partners, Inc., a Florida corporation
(Parent) and Catalyst Pharmaceutical Partners, Inc., a Delaware corporation (Subsidiary).
RECITALS
|
1. |
|
Parent is a corporation organized and existing under the laws of the State of Florida. |
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|
2. |
|
Subsidiary is a corporation organized and existing under the laws of the State of
Delaware. |
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|
3. |
|
Parent and Subsidiary and their respective boards of directors deem it advisable and in
the best interest of both corporations and their respective stockholders to merge Parent
with and into Subsidiary pursuant to the provisions of the Florida Business Corporation Act
(the FBCA) and the Delaware General Corporation law (the DGCL), upon the terms and
conditions hereinafter set forth. |
NOW, THEREFORE, in consideration of the premises, the mutual covenants contained herein and
for other good and valuable consideration, the receipt and sufficiency of which are hereby
acknowledged, the parties hereunto agree that the Parent shall be merged with and into Subsidiary
(the Merger) upon the terms and conditions hereinafter set forth.
Article 1. PRINCIPAL TERMS OF THE MERGER
Section 1.1. Merger. At the Effective Time (as defined in Section 4.1 hereof), Parent
shall be merged with and into Subsidiary, the separate existence of Parent shall cease and
Subsidiary (following the Merger referred to as the Surviving Corporation) shall operate under
the name Catalyst Pharmaceutical Partners, Inc. by virtue of, and shall be governed by, the law
of the state of Delaware. The address of the registered office of the Surviving Corporation in the
State of Delaware shall be the registered office in Delaware of the Subsidiary.
Section 1.2. Certificate of Incorporation of the Surviving Corporation. The
Certificate of Incorporation of the Surviving Corporation shall be the Certificate of Incorporation
of the Subsidiary as in effect at the Effective Time hereof without change unless and until amended
in accordance with its terms and with applicable law.
Section 1.3. Bylaws of the Surviving Corporation. The Bylaws of the Surviving
Corporation shall be the Bylaws of the Subsidiary in effect at the Effective Time without change
unless and until amended or repealed in accordance with its terms and with applicable law.
Section 1.4. Directors and Officers. At the Effective Time of the Merger, the
directors and officers of the Subsidiary in office at the Effective Time of the Merger shall become
the directors and officers, respectively, of the Surviving Corporation, each of such directors and
officers to hold office, subject to the applicable provisions of the Certificate of Incorporation
and
1
Bylaws of the Surviving Corporation and the DGCL, until his or her successor is duly elected
or appointed and qualified.
Article 2. CONVERSION, CERTIFICATES AND PLANS
Section 2.1. Conversion of Shares. At the Effective Time of the Merger: (i) each
share of the Parents Common Stock, par value $0.01 per share, issued and outstanding immediately
prior to the Effective Time of the Merger shall, by virtue of the Merger, be converted into the
right to receive one validly issued, fully paid and nonassessable share of the Surviving
Corporations Common Stock, $0.001 per value per share, (ii) each share of the Parents Series A
Preferred Stock and Series B Preferred Stock issued and outstanding immediately prior to the
Effective Time of the Merger shall, by virtue of the Merger, be converted into the right to receive
one validly issued and fully paid and nonassessable shares of the Surviving Corporations Series A
Preferred Stock and Series B Preferred Stock, as the case may be, and (iii) each Common Stock
purchase option to purchase shares of the Parent common Stock issued and outstanding immediately
prior to the Effective Time of the Merger shall, by virtue of the Merger, be converted into the
right to receive a Common Stock purchase option to purchase shares of the Surviving Corporations
Common Stock. Additionally, each share of the Subsidiarys common stock issued and outstanding
immediately prior to the Effective Time of the Merger and held by the Parent shall be canceled
without any consideration being issued or paid therefor.
Section 2.2. Stock Certificates. At the Effective Time of the Merger, each
certificate theretofore representing issued and outstanding shares of the Parents Common Stock,
Series A Preferred Stock and Series B Preferred Stock will be exchanged for a certificate
representing the same number of shares of the Surviving Corporations Common Stock, Series A
Preferred Stock and Series B Preferred Stock.
Section 2.3. Employee Benefit and Compensation Plans. At the Effective Time of the
Merger, each employee benefit plan, incentive compensation plan and other similar plans to which
the Parent is then a party shall be assumed by, and continue to be the plan of, the Surviving
Corporation. To the extent any employee benefit plan, incentive compensation plan or any other
similar plan of the Parent provides for the issuance or purchase of, or otherwise relates to, the
Parents capital stock, after the Effective Time of the Merger such plan shall be deemed to provide
for the issuance or purchase of, or otherwise relate to, the same class and series of the Surviving
Corporations stock.
Section 2.4. Dissenting Shares. Notwithstanding anything in this Agreement to the
contrary, shares of Parents Common Stock, Series A Preferred Stock and Series B Preferred Stock
that are issued and outstanding immediately prior to the Effective Time held by holders of shares
who have properly demanded appraisal for such shares under Sections 607.1301 to 607.1333 of the
FBCA (the Dissenting Shares) shall not be converted under this Agreement; provided, however, that
if, after the Effective Time, any such shareholder shall fail to perfect or effectively waive,
withdraw, or lose such shareholders appraisal rights under the FBCA, such shareholders shares
shall no longer be deemed to be Dissenting Shares for purposes of this Agreement and shall
thereupon be converted at the Effective Time into shares of the Surviving
2
Corporations common stock, Series A Preferred Stock and Series B Preferred Stock, as the case
may be, in accordance with Section 2.1 of this Agreement.
Article 3. TRANSFER AND CONVEYANCE OF ASSETS AND ASSUMPTION OF LIABILITIES
Section 3.1. Effects of the Merger. At the Effective Time of the Merger, the Merger
shall have the effects specified in the FBCA, the DGCL and this Agreement. Without limiting the
generality of the foregoing, and subject thereto, at the Effective Time of the Merger, the
Surviving Corporation shall possess all the rights, privileges, powers, and franchises, of a public
as well as a private nature, and shall be subject to all of the restrictions, disabilities and
duties of each of the parties to this Agreement, the rights, powers, and privileges of the Parent
and the Subsidiary, and all property, real, personal, and mixed, and all debts due to each of them
on whatever account, shall be vested in the Surviving Corporation; and all property, rights,
privileges, powers, and franchises, and all and every interest shall thereafter be the property of
the Surviving Corporation as they were of the respective constituent entities, and the title to any
real estate whether by deed or otherwise vested in the Parent and the Subsidiary or either of them,
shall not revert to be in any way impaired by reason of the Merger, but all rights of creditors and
all liens upon any property of the parties hereto, shall be preserved unimpaired, and all debts,
liabilities and duties of the respective constituent entities shall thenceforth attach to the
Surviving Corporation, and may be enforced against it to the same extent as if such debts,
liabilities and duties had been incurred or contracted by it.
Section 3.2. If, at any time after the Effective Time of the Merger, the Surviving Corporation
shall consider or be advised that any further assignments or assurances in law or any other acts
are necessary or desirably (a) to vest, perfect, or conform, of record or otherwise, in the
Surviving Corporation, title and possession of any property right of the Parent acquired or to be
acquired by reason of, or as a result of, the Merger, or (b) otherwise carry out the purposes of
this Agreement, the Parent and its proper officers and directors shall be deemed to have granted to
the Surviving Corporation an irrevocable power of attorney to execute and deliver all such proper
deeds, assignments and assurances in law and to do all acts necessary or proper to vest, perfect,
or conform title to and possession of such property or rights in the Surviving Corporation and
otherwise carry out the purposes of this Agreement. The proper officers and directors of the
Surviving Corporation are fully authorized in the name of the Parent to otherwise take any and all
such action.
Article 4. APPROVAL BY SHAREHOLDERS OF PARENT; AMENDMENT; EFFECTIVE TIME
Section 4.1. Approval. The Merger contemplated hereby is subject to the approval by
the requisite vote of the shareholders of Parent in accordance with applicable Florida law.
Similarly, the Merger is subject to approval by Parent as the sole stockholder of Subsidiary. As
promptly as is practicable after approval of this Agreement by the shareholders of Parent and
Subsidiary in accordance with applicable law, duly authorized officers of the respective parties
shall make and execute Articles of Merger and a Certificate of Merger and shall cause such
documents to be filed with the Secretary of State of Florida and the Secretary of State of
3
Delaware, respectively, in accordance with the laws of the States of Florida and Delaware. The
effective time (Effective Time) of the Merger shall be the date and time on which the Merger
becomes effective under the laws of Florida or the date and time on which the Merger becomes
effective under the laws of Delaware, whichever occurs later.
Section 4.2. Amendments. The Board of Directors of Parent and Subsidiary may amend
this Agreement at any time prior to the Effective Time, provided that an amendment made subsequent
to the approval of this Merger by the shareholders of the Parent shall not (1) alter or change the
amount or kind of shares to be received in exchange for or on conversion of all or any of the
shares of the Parents Common Stock, Series A Preferred Stock or Series B Preferred Stock, (2)
alter or change any term of the Certificate of Incorporation of the Subsidiary, or (3) alter or
change any of the terms and conditions of this Agreement if such alteration or change would
adversely affect the holders of the Parents Common Stock, Series A Preferred Stock or Series B
Preferred Stock.
Article 5. MISCELLANEOUS
Section 5.1. Termination. This Agreement may be terminated and the Merger abandoned
at any time prior to the filing of this Agreement with the Secretary of State of Florida and the
Secretary of State of Delaware, whether before or after shareholder approval of this Agreement, by
the consent of the Board of Directors of the Parent and the Subsidiary.
Section 5.2. Counterparts. This Agreement may be executed in any number of
counterparts, each of which shall be considered to be an original instrument.
Section 5.3. Section Headings. The section headings are for the convenience of
reference only and shall not control or affect the meaning or construction of any provision of this
Agreement.
Section 5.4. Governing Law. This Agreement shall be construed in accordance with the
laws of the State of Delaware.
[Signatures on Following Page]
4
IN WITNESS WHEREOF, the undersigned officers of each of the parties to this Agreement,
pursuant to authority duly given by their respective boards of directors, have caused this
Agreement to be duly executed on the date first set forth above.
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CATALYST PHARMACEUTICAL PARTNERS, INC.,
a Florida corporation
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By: |
/s/ Patrick J. McEnany
|
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Name: |
Patrick J. McEnany |
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Title: |
President and Chief Executive Officer |
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CATALYST PHARMACEUTICAL PARTNERS, INC.,
a Delaware corporation
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By: |
/s/ Patrick J. McEnany
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Name: |
Patrick J. McEnany |
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Title: |
President and Chief Executive Officer |
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5
EX-10.10 Consulting Agreement as amended/Weinstein
Exhibit 10.10
CONSULTING AGREEMENT
THIS
CONSULTING AGREEMENT (this Agreement) is entered into
this 28th day of October, 2004,
effective October 1, 2004 (Effective Date), by and between CATALYST PHARMACEUTICAL PARTNERS,
INC., a Florida corporation with offices located in Coral Gables, Florida (the Company), and JACK
WEINSTEIN, an individual resident of the State of New Jersey (the Consultant).
In consideration of the mutual representations, warranties, covenants and agreements contained
in this Agreement, the parties hereto agree as follows:
1. Engagement.
(a) Retention. The Company agrees to engage the Consultant and the Consultant agrees
to accept such engagement to perform services for the Company as a consultant, subject to the terms
and conditions of this Agreement. The parties agree that the services to be rendered hereunder will
be deemed to be provided at the Companys offices in Coral Gables, Florida, even if Consultant
provides some of these services from his home in New Jersey.
(b) Engagement Period. The initial term during which the Consultant shall serve as a
consultant to the Company shall commence on the Effective Date hereof and, unless earlier
terminated pursuant to this Agreement, shall continue until April 30, 2005 (the Initial Term).
After the Initial Term, this Agreement shall automatically renew for successive six (6) month
periods unless at least thirty (30) days prior to the expiration of the Initial Term, or any
renewal term, either party hereto notifies the other party in writing of his or its intention to
terminate the Agreement (the Engagement Period). If such notice of termination is duly given,
the Agreement shall terminate at the end of the then current term.
(c) Duties and Responsibilities. During the Engagement Period, the Consultant shall
act on a full time basis as the Chief Financial Officer of the Company. Consultant shall also
assist the Company in its currently ongoing efforts to obtain equity financing. During the
Engagement Period, the Consultant shall be instructed with respect to the Companys requests for
services by the Companys Chief Executive Officer.
(d) Consulting Fee. In consideration of the Consultants services hereunder, during
the Engagement Period, the Consultant shall receive the following consideration:
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a monthly consulting fee of Five Thousand
Dollars ($5,000) (the Consulting Fee), payable on the first day of
each month; plus |
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(ii) |
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the stock options described in (e) below; plus |
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the success fees, if any, described in (f)
below. |
(e) Stock Options. Consultant shall be granted stock options to purchase shares of
the Companys authorized but unissued common stock, as follows:
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five-year options to purchase 50,000 shares of
the Companys common stock at an exercise price of $2.00 per share,
which options shall vest immediately; |
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five-year options to purchase 50,000 shares of
the Companys common stock at the exercise price described below, which
options shall vest upon the closing of an equity financing by the
Company during the term of the Agreement of at least
$2.0 million (excluding an offering placed with friends
and family); and |
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five-year options to purchase 50,000 shares of
the Companys common stock at the exercise price described below, which
options shall vest if the Consultant remains a consultant of the
Company on the date which is one year after the Effective Date. |
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the exercise price of the options described in
(ii) and (iii) above shall be the greater of $2.00 per share or the per
share purchase price paid by investors (other than investors who are
friends and family of the Companys officers and directors) who
invest at least $2.0 million of gross proceeds in an equity financing
of the Company. Such per share option exercise price shall be
determined in good faith based on a common share equivalent price to
the extent that the investor purchases preferred stock convertible into
common stock. |
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the options granted hereunder shall be
evidenced by a stock option agreement on the form generally used by the
Company for stock option grants and shall contain provisions allowing
for a cashless exercise of all such stock options. |
(f) Success Fees. Consultant shall receive a fee in the event that the Company
completes a successful equity financing during the term of the Agreement, equal to 5% of the first
$5.0 million of gross proceeds raised by the Company plus 3% of amounts raised in excess of $5.0
million. Notwithstanding the foregoing, if the source of the equity financing obtained by the
Company is a friend or family of the Companys officers and directors, or if such equity
financing is procured through Raymond James, Hyde Park Capital, or Batelle, the success fee due to
Consultant hereunder on any such equity capital raise will be 2% of the gross proceeds raised
rather than the amount set forth above. Additionally, with respect to any success fees due
hereunder:
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In all cases, the success fee payable to
Consultant hereunder will be reduced by all amounts of consulting fees
payable to Consultant
in accordance with Paragraph 1(d)(i) above and by all amounts of fees
payable to Avalon as described in Paragraph 2 below. |
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For a period of one year after the termination
of this Agreement, the Consultant shall receive the following success
fees: (A) the success fees due hereunder on any active lead for which a
face to face meeting has been held during the term of this Agreement;
or (B) in lieu of the fees payable above, a $25,000 success fee if the
party completing the equity financing has requested and received
information regarding the Company during the term of this Agreement
(but no meeting has been held with such investor during the term of
this Agreement). |
(g) Independent Contractor. The Consultant is an independent contractor of the
Company and is not entitled to any benefits, privileges or reimbursements (other than as set forth
below and as contained in Exhibit I, Indemnification) given or extended by the Company to its employees. The Consultant acknowledges that he
shall be responsible for the collection and payment of all withholdings, contributions and payroll
taxes relating to his services.
(h) Expenses. In addition to the Consulting Fee, during the Engagement Period, the
Consultant shall be reimbursed for documented out-of-pocket expenses properly and reasonably
incurred by him on behalf of or in connection with the business of the Company. Consultant shall
obtain prior consent from the Companys Chief Executive Officer for expenses exceeding $100.
(i) Termination. At any time during the Engagement Period, the Company shall have the
right to terminate the Engagement Period and to discharge the Consultant upon delivery of written
notice ninety (90) days prior to the effective date of such termination to the Consultant. Upon any
such termination by the Company, the Consultant shall be entitled to reimbursement of expenses
properly incurred by the Consultant prior to the date of termination and not previously reimbursed.
The Company shall have no further obligations hereunder from and after the date of such
termination.
2. Relationship with Avalon Group, Ltd. and Avalon Securities, Ltd. Consultant has
previously acted as a managing director of Avalon Group Ltd. and Avalon Securities, Ltd.
(collectively Avalon). On February 4, 2003, the Company and Avalon entered into a letter
agreement (the Advisory Agreement) pursuant to which Avalon agreed to act as a financial advisor
to the Company. As of the Effective Date, except as set forth below, the Advisory Agreement shall
be cancelled (and Avalons execution of this Agreement shall be evidence of their agreement to such
cancellation). Notwithstanding the foregoing, the Company shall remain
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liable to Avalon for fees due in accordance with the terms of the Advisory Agreement to the
extent that the Company obtains financing from one of the following sources: (i) Montreux, (ii)
Radius, (iii) Diaz & Alschul, and (iv) Ethypharm. In
addition, the indemnity and other provisions set forth
in Sections E, G and H of the Advisory Agreement shall remain
operative.
3. Representations. Consultant represents and warrants to the Company as follows:
(a) Consultant is not a party to any existing agreement which would conflict with this
Agreement or prevent Consultant from providing services to Company in accordance with the terms of
this Agreement.
(b) Consultant has received all releases, consents, waivers or other permission required or
necessitated by such agreements in order to permit the Consultant to enter into this Agreement.
4. Confidentiality. The Consultant agrees that at all times during the term of this
Agreement and after the termination of employment for as long as such information remains
non-public information, the Consultant shall (i) hold in confidence and refrain from disclosing to
any other party all information, whether written or oral, tangible or intangible, of a private,
secret, proprietary or confidential nature, of or concerning the Company or any of its subsidiaries
or affiliates and their business and operations, and all files, letters, memoranda, reports,
records, computer disks or other computer storage medium, data, models or any photographic or other
tangible materials containing such information (Confidential Information), including without
limitation, any sales, promotional or marketing plans, programs, techniques, practices or
strategies, any expansion plans (including existing and entry into new geographic and/or product
markets), and any customer lists, (ii) use the Confidential Information solely in connection with
his employment with the Company or any of its subsidiaries or affiliates and for no other purpose,
(iii) take all precautions necessary to ensure that the Confidential Information shall not be, or
be permitted to be, shown, copied or disclosed to third parties, without the prior written consent
of the Company or any of its subsidiaries or affiliates, and (iv) observe all security policies
implemented by the Company or any of its subsidiaries or affiliates from time to time with respect
to the Confidential Information. In the event that the Consultant is ordered to disclose any
Confidential Information, whether in a legal or regulatory proceeding or otherwise, the Consultant
shall provide the Company or any of its subsidiaries or affiliates with prompt notice of such
request or order so that the Company or any of its subsidiaries or affiliates may seek to prevent
disclosure. In addition to the foregoing the Consultant shall not at any time libel, defame,
ridicule or otherwise disparage the Company.
5. Notices. All notices, requests, demands, claims and other communications hereunder
shall be in writing and shall be deemed given if delivered by certified or registered mail (first
class postage pre-paid), guaranteed overnight delivery or facsimile transmission if such
transmission is confirmed by delivery by certified or registered mail (first class postage
pre-paid) or guaranteed overnight delivery to, the following addresses and telecopy numbers (or to
such other addresses or telecopy numbers which such party shall designate in writing to the other
parties): (a) if to the Company, at its principal executive offices, addressed to the Chief
Executive Officer, with a copy to Philip B. Schwartz, Esq., Akerman, Senterfitt & Eidson, P.A., One
Southeast Third Avenue, Miami, Florida 33131; and (b) if to the Consultant, at the address listed
on the signature page hereto.
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6. Amendment; Waiver. This Agreement may not be modified, amended, supplemented,
canceled or discharged, except by written instrument executed by all parties. No failure to
exercise, and no delay in exercising, any right, power or privilege under this Agreement shall
operate as a waiver, nor shall any single or partial exercise of any right, power or privilege
hereunder preclude the exercise of any other right, power or privilege. No waiver of any breach of
any provision shall be deemed to be a waiver of any preceding or succeeding breach of the same or
any other provision, nor shall any waiver be implied from any course of dealing between the
parties. No extension of time for performance of any obligations or other acts hereunder or under
any other agreement shall be deemed to be an extension of the time for performance of any other
obligations or any other acts. The rights and remedies of the parties under this Agreement are in
addition to all other rights and remedies, at law or equity, that they may have against each other.
7. Assignment; Third Party Beneficiary. This Agreement, and the Consultants rights
and obligations hereunder, may not be assigned or delegated by Consultant. The Company may assign
its rights, and delegate its obligations, hereunder to any affiliate of the Company or any
successor or assign. The rights and obligations of the Company under this Agreement shall inure to
the benefit of and be binding upon its respective successors and assigns.
8. Severability; Survival. In the event that any provision of this Agreement is found
to be void and unenforceable by a court of competent jurisdiction, then such unenforceable
provision shall be deemed modified so as to be enforceable (or if not subject to modification then
eliminated herefrom) for the purpose of those procedures to the extent necessary to permit the
remaining provisions to be enforced. The provisions of Section 4 will survive the termination for
any reason of the Consultants relationship with the Company.
9. Counterparts. This Agreement may be signed in any number of counterparts, each of
which shall be an original but all of which together shall constitute one and the same instrument.
10. Governing Law. This Agreement shall be construed in accordance with and governed
for all purposes by the laws of the State of Florida applicable to contracts executed and to be
wholly performed within such State.
11. Entire Agreement. This Agreement contains the entire understanding of the parties
in respect of its subject matter and supersedes all prior agreements and understandings (oral or
written) between or among the parties with respect to such subject matter.
[Signatures on Next Page]
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IN WITNESS WHEREOF, the parties have executed this Agreement as of the date first above
written.
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Company:
CATALYST PHARMACEUTICAL
PARTNERS, INC., a Florida corporation
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By: |
/s/
Patrick J. McEnany
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Patrick J. McEnany, President |
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Consultant:
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/s/
Jack Weinstein
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Jack Weinstein |
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Consultants Address for Notices:
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The provisions of Paragraph 2 are agreed to this
1st day of October, 2004.
Avalon Group, Ltd. and
Avalon Securities, Ltd.
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By: /s/ Lynda
Davey
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Name (print):
Lynda J.
Davey
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Title:
President
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EXHIBIT I
Indemnification
In connection with the engagement of Consultant to advise and assist with the matters set
forth in this Agreement, the Company hereby agrees to indemnify and hold harmless Consultant
(hereinafter called the Indemnified Person), to the full extent permitted by law, from and
against all losses, claims, damages, liabilities and expenses incurred by him as they are incurred
(including but not limited to reasonable fees and disbursements of counsel) which: (a) are
reasonably related to or arise out of actions taken or omitted to be taken (including statements
made or omitted to be made) by the Company or by the Indemnified Person (i) with the Companys
consent, or (ii) in conformity with the Companys actions or omissions in connection with
Consultants engagement; or (b) are otherwise reasonably related to or arise out of Consultants
activities on the Companys behalf under Consultants engagement pursuant to this Agreement. In no
event will Consultants liability exceed fees actually paid to Consultant under this Agreement.
The Company will not be responsible, however, for any loss, claim, damage, liability or
expense pursuant to clause (b) above to the extent it is finally judicially determined to have
resulted from the willful misconduct or gross negligence or material breach of the terms of this
Agreement by the Indemnified Person. The Company also agrees that Indemnified Person shall not have
any liability to the Company in connection with such engagement except for such liability for a
loss, claim, damage, liability or expense incurred by the Company to the extent it is finally
judicially determined to have resulted from Consultants willful misconduct or gross negligence or
material breach.
AMENDMENT NO. 1 TO
CONSULTING AGREEMENT
This AMENDMENT NO. 1 TO CONSULTING AGREEMENT (Amendment) is made and entered into this
6th day of June, 2006, effective as of the 1st day of May, 2006, by and
between CATALYST PHARMACEUTICAL PARTNERS, INC., a Florida corporation (the Company) and JACK
WEINSTEIN, an individual resident of the state of New Jersey (Consultant).
Preliminary Statements
A. The parties have previously entered into that certain Consulting Agreement dated October
28, 2004 (the Old Agreement). Unless otherwise defined, capitalized terms used herein
shall have the meanings given to them in the Old Agreement.
B. The parties have agreed to amend the Old Agreement in accordance with the terms set forth
in this Amendment (which with the Old Agreement is hereinafter sometimes collectively
referred to as the Agreement).
Agreement
NOW, THEREFORE, in consideration of the mutual covenants set forth herein and for other good
and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the
parties hereby agree as follows:
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Section 1(d)(i) of the Old Agreement is modified to change the monthly consulting fee
payable under the Agreement from $5,000 per month to $7,500 per month. Notwithstanding the
foregoing, the Company may defer the payment of the additional $2,500 per month to the
extent that it determines that it does not have sufficient cash available to make such
additional payments. Any such deferred payments will be paid to Consultant out of the
proceeds of any equity financing in which the Company raises more than $3,000,000. |
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Sections 1(e)(iii) and (iv) of the Old Agreement are hereby deleted in their entirety
and replaced with the following (to reflect an agreement reached between Consultant and
Company with respect to these matters in October 2005): |
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five-year options to purchase 50,000 shares of
the Companys common stock at an exercise price of $2.00 per share,
which options shall vest if the Consultant remains a consultant of the
Company on the date which is one year after the Effective Date. |
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the exercise price of the options described in
(ii) above shall be the greater of $2.00 per share or the per share
purchase price paid by investors (other than investors who are friends
and family of the Companys officers and directors) who invest at
least $2.0 million of gross proceeds in an equity financing of the
Company. Such per |
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share option exercise price shall be determined in good faith based
on a common share equivalent price to the extent that the investor
purchases preferred stock convertible into common stock. |
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Section 1(f) of the Old Agreement is hereby deleted in its entirety and replaced with
the following: |
(f) Success Fees. Company shall pay Consultant the following success
fees:
(i) a fee of $150,000 if the Company completes an equity financing of
at least $10,000,000 in a U.S. initial public offering (IPO) or an AIM
flotation that is completed on or before November 1, 2006;
(ii) a fee equal to five percent (5%) of amounts raised in a private
placement to individuals (other than existing shareholders of the Company or
persons who are friends and family of the Companys existing shareholders)
or institutional investors that is completed on or before November 1, 2006;
(iii) in no event shall the aggregate amount of all success fees
payable under Sections 1(f)(i) and (ii) exceed $250,000;
(iv) if the Company retains a placement agent in connection with a
private placement, then the success fees payable to Consultant hereunder
will be capped at the difference between 6% of the funds raised and amounts
payable to such placement agent for raising the funds in connection with the
private placement (for example, if a placement agent charges a fee of 4% of
the funds raised in connection with such placement, the success fee payable
to Consultants under Section 1(f)(ii) shall be capped at 2% of the funds
raised, subject (in all cases) to the cap under Section 1(f)(iii) on the
aggregate success fees payable to Consultant hereunder;
(v) if a private placement, IPO or AIM financing is in process at
November 1, 2006 and such financing is thereafter completed, any fee that
otherwise would have been payable hereunder had such financing been
completed on or before November 1, 2006 shall be earned as of the date of
the successful completion of such financing and paid from the proceeds of
such financing. For purposes of this Section 1(f)(v) of the Agreement, a
private placement, IPO or AIM financing shall only be considered in
process if: (A) in the case of an IPO or AIM financing, such financing has
previously been filed with regulatory authorities, has become effective (or
approved, as the case may be) and is awaiting final completion in accordance
with the terms of such documents; or (B) in the case of a private placement,
if such financing is on terms that are described in a private placement
memorandum (PPM) which is in
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circulation with investors at November 1, 2006, so long as such private
financing is completed by the outside date and on the terms set forth in
such PPM; and
(vi) $2,500 of the monthly consulting fee payable to Consultant under
Section 1(d)(i) of the Agreement for periods after April 30, 2006 shall be
applied against the first success fees earned by and payable to Consultant
under this Section 1(f).
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The Agreement shall terminate on November 1, 2006 unless otherwise agreed to in writing
by Company and Consultant. |
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Except as amended hereby, the Agreement remains in full force and effect. |
[Signatures on next page]
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IN WITNESS WHEREOF, the parties have executed this Amendment as of the date first above
written.
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Company:
CATALYST PHARMACEUTICAL PARTNERS, INC., a Florida corporation
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By: |
/s/ Patrick J. McEnany
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Patrick J. McEnany, President |
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Consultant:
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/s/ Jack Weinstein
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Jack Weinstein |
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4
EX-10.11 Consulting Agreement w/Charles O'keefe
Exhibit 10.11
CONSULTING AGREEMENT
THIS CONSULTING AGREEMENT (this Agreement) is entered into this 3rd day of January, 2005
(Effective Date) by and between CATALYST PHARMACEUTICAL PARTNERS, INC., a Florida corporation
with offices located in Coral Gables, Florida (the Company), and CHARLES OKEEFFE, an individual
resident of the State of Virginia (the Consultant).
In consideration of the mutual representations, warranties, covenants and agreements contained
in this Agreement, the parties hereto agree as follows:
1. Engagement.
(a) Retention. The Company agrees to engage the Consultant and the Consultant agrees
to accept such engagement to perform services for the Company as a consultant, subject to the terms
and conditions of this Agreement. The parties agree that the services to be rendered hereunder will
be deemed to be provided at the Companys offices in Coral Gables, Florida, even if Consultant
provides most of these services from his office in Richmond, Virginia.
(b) Engagement Period. The initial term during which the Consultant shall serve as a
consultant to the Company shall commence on the Effective Date hereof and, unless earlier
terminated pursuant to this Agreement, shall continue until June 30, 2005 (the Initial Term).
After the Initial Term, this Agreement shall automatically renew for successive six (6) month
periods unless at least thirty (30) days prior to the expiration of the Initial Term, or any
renewal term, either party hereto notifies the other party in writing of his or its intention to
terminate the Agreement (the Engagement Period). If such notice of termination is duly given,
the Agreement shall terminate at the end of the then current term.
(c) Duties and Responsibilities. During the Engagement Period, the Consultant shall
act on a part-time basis as a Senior Advisor to the Company. During the Engagement Period, the
Consultant shall be instructed with respect to the Companys requests for services by the Companys
Chief Executive Officer. Consultant shall assist the Company in its regulatory strategy, marketing
issues and other corporate issues. Consultant agrees to offer services of approximately 20 hours
per month.
(d) Consulting Fee. In consideration of the Consultants services hereunder, during
the Engagement Period, the Consultant shall receive the following consideration:
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a monthly consulting fee of Five Thousand
Dollars ($5,000) (the Consulting Fee), payable on the first day of
each month: Such fee will be paid with $2,500 per month in cash and
$2,500 of Company stock valued at $2.00 per share: |
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the stock options described in (e) below: |
(e) Stock Options. For joining the Companys Board of Directors and serving as a
consultant, consultant shall be granted stock options to purchase shares of the Companys
authorized but unissued common stock, as follows:
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five-year options to purchase 100,000 shares of
the Companys common stock at an exercise price of $2.00 per share,
which options shall vest immediately; |
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the options granted hereunder shall be
evidenced by a stock option agreement on the form generally used by the
Company for stock option grants. |
(f) Independent Contractor. The Consultant is an independent contractor of the
Company and is not entitled to any benefits or privileges given or extended by the Company to its
employees. The Consultant acknowledges that he shall be responsible for the collection and payment
of all withholdings, contributions and payroll taxes relating to his services.
(g) Expenses. In addition to the Consulting Fee, during the Engagement Period, the
Consultant shall be reimbursed for documented out-of-pocket expenses properly and reasonably
incurred by him on behalf of or in connection with the business of the Company. Consultant shall
obtain prior consent from the Companys Chief Executive Officer for expenses exceeding $1,000.00.
(h) Termination. At any time during the Engagement Period, the Company shall have the
right to terminate the Engagement Period and to discharge the Consultant upon delivery of written
notice ninety (90) days prior to the effective date of such termination to the Consultant. Upon any
such termination by the Company, the Consultant shall be entitled to reimbursement of expenses
properly incurred by the Consultant prior to the date of termination and not previously reimbursed.
The Company shall have no further obligations hereunder from and after the date of such
termination, with the exception of paragraphs 1f(ii) above and (2) below.
2. Representations. Consultant represents and warrants to the Company as follows:
(a) Consultant is not a party to any existing agreement which would conflict with this
Agreement or prevent Consultant from providing services to Company in accordance with the terms of
this Agreement.
(b) Consultant has received all releases, consents, waivers or other permission required or
necessitated by such agreements in order to permit the Consultant to enter into this Agreement.
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3. Confidentiality. The Consultant agrees that at all times during the term of this
Agreement and after the termination of employment for as long as such information remains
non-public information, the Consultant shall (i) hold in confidence and refrain from disclosing to
any other party all information, whether written or oral, tangible or intangible, of a private,
secret, proprietary or confidential nature, of or concerning the Company or any of its subsidiaries
or affiliates and their business and operations, and all files, letters, memoranda, reports,
records, computer disks or other computer storage medium, data, models or any photographic or other
tangible materials containing such information (Confidential Information), including without
limitation, any sales, promotional or marketing plans, programs, techniques, practices or
strategies, any expansion plans (including existing and entry into new geographic and/or product
markets), and any customer lists, (ii) use the Confidential Information solely in connection with
his employment with the Company or any of its subsidiaries or affiliates and for no other purpose,
(iii) take all precautions necessary to ensure that the Confidential Information shall not be, or
be permitted to be, shown, copied or disclosed to third parties, without the prior written consent
of the Company or any of its subsidiaries or affiliates, and (iv) observe all security policies
implemented by the Company or any of its subsidiaries or affiliates from time to time with respect
to the Confidential Information. In the event that the Consultant is ordered to disclose any
Confidential Information, whether in a legal or regulatory proceeding or otherwise, the Consultant
shall provide the Company or any of its subsidiaries or affiliates with prompt notice of such
request or order so that the Company or any of its subsidiaries or affiliates may seek to prevent
disclosure. In addition to the foregoing the Consultant shall not at any time libel, defame,
ridicule or otherwise disparage the Company.
4. Notices. All notices, requests, demands, claims and other communications hereunder
shall be in writing and shall be deemed given if delivered by certified or registered mail (first
class postage pre-paid), guaranteed overnight delivery or facsimile transmission if such
transmission is confirmed by delivery by certified or registered mail (first class postage
pre-paid) or guaranteed overnight delivery to, the following addresses and telecopy numbers (or to
such other addresses or telecopy numbers which such party shall designate in writing to the other
parties): (a) if to the Company, at its principal executive offices, addressed to the Chief
Executive Officer, with a copy to Philip B. Schwartz, Esq., Akerman, Senterfitt & Eidson, P.A., One
Southeast Third Avenue, Miami, Florida 33131; and (b) if to the Consultant, at the address listed
on the signature page hereto.
5. Amendment; Waiver. This Agreement may not be modified, amended, supplemented,
canceled or discharged, except by written instrument executed by all parties. No failure to
exercise, and no delay in exercising, any right, power or privilege under this Agreement shall
operate as a waiver, nor shall any single or partial exercise of any right, power or privilege
hereunder preclude the exercise of any other right, power or privilege. No waiver of any breach of
any provision shall be deemed to be a waiver of any preceding or succeeding breach of the same or
any other provision, nor shall any waiver be implied from any course of dealing between the
parties. No extension of time for performance of any obligations or other acts hereunder or under
any other agreement shall be deemed to be an extension of the time for performance of any other
obligations or any other acts. The rights and remedies of the parties under this Agreement are in
addition to all other rights and remedies, at law or equity, that they may have against each other.
-3-
6. Assignment; Third Party Beneficiary. This Agreement, and the Consultants rights
and obligations hereunder, may not be assigned or delegated by Consultant. The Company may assign
its rights, and delegate its obligations, hereunder to any affiliate of the Company or any
successor or assign. The rights and obligations of the Company under this Agreement shall inure to
the benefit of and be binding upon its respective successors and assigns.
7. Severability; Survival. In the event that any provision of this Agreement is found
to be void and unenforceable by a court of competent jurisdiction, then such unenforceable
provision shall be deemed modified so as to be enforceable (or if not subject to modification then
eliminated herefrom) for the purpose of those procedures to the extent necessary to permit the
remaining provisions to be enforced. The provisions of Section 4 will survive the termination for
any reason of the Consultants relationship with the Company.
8. Counterparts. This Agreement may be signed in any number of counterparts, each of
which shall be an original but all of which together shall constitute one and the same instrument.
9. Governing Law. This Agreement shall be construed in accordance with and governed
for all purposes by the laws of the State of Florida applicable to contracts executed and to be
wholly performed within such State.
10. Entire Agreement. This Agreement contains the entire understanding of the parties
in respect of its subject matter and supersedes all prior agreements and understandings (oral or
written) between or among the parties with respect to such subject matter.
[Signatures on Next Page]
-4-
IN WITNESS WHEREOF, the parties have executed this Agreement as of the date first above
written.
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Company:
CATALYST PHARMACEUTICAL
PARTNERS, INC., a Florida corporation
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By: |
/s/ Patrick J. McEnany
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Patrick J. McEnany, President |
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Consultant:
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/s/ Charles OKeeffe
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Charles OKeeffe |
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Consultants Address for Notices:
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EXHIBIT I
Indemnification
In connection with the engagement of Consultant to advise and assist with the matters set forth in
this Agreement, the Company hereby agrees to indemnify and hold harmless Consultant (hereinafter
called the Indemnified Person), to the full extent permitted by law, from and against all losses,
claims, damages, liabilities and expenses incurred by him as they are incurred (including but not
limited to reasonable fees and disbursements of counsel) which: (a) are reasonably related to or
arise out of actions taken or omitted to be taken (including statements made or omitted to be made)
by the Company or by the Indemnified Person (i) with the Companys consent, or (ii) in conformity
with the Companys actions or omissions in connection with Consultants engagement; or, (b) are
otherwise reasonably related to or arise out of Consultants activities on the Companys behalf
under Consultants engagement pursuant to this Agreement.
The Company will not be responsible, however, for any loss, claim, damage, liability or
expense pursuant to clause (b) above to the extent it is finally judicially determined to have
resulted from the willful misconduct or gross negligence by the
Indemnified Party. The Company agrees that Indemnified Person shall
not have any liability to the Company in connection with such
engagement.
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EX-10.12 Agreement with Donald Jasinski
Exhibit 10.12
CONSULTING AGREEMENT
Catalyst Pharmaceutical Partners, Inc. (hereinafter
COMPANY) and Dr. Donald Jasinski (hereinafter
CONSULTANT) 3 Barranco Court, Towson, MD 21204
agree that CONSULTANT will advise COMPANY on matters relating to
the field of clinical studies with vigabatrin to treat
cocaine/methamphetamine addiction (hereinafter
Field) under the following terms and conditions
(this Agreement):
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1. |
Consulting Services. CONSULTANTs responsibilities
shall include, without limitation, the following activities
(hereinafter collectively referred to as Services): |
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Consult with Company with regard to clinical studies designed to
test vigabatrin for the treatment of cocaine/methamphetamine
abuse. Also, to serve on the Companys Scientific Advisory
Board. |
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The Services shall be performed via telephone and
correspondence, and may include meetings with personnel and
other consultants at times and locations to be mutually agreed
upon. In each instance, CONSULTANT shall perform the Services
only upon COMPANYs request and after the scope of the
Services has been approved by COMPANY. |
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The parties acknowledge that the Johns Hopkins University is not
a party to this Agreement, which is a private contract between
CONSULTANT and COMPANY. CONSULTANT and COMPANY also agree that
the Johns Hopkins University, its Schools and Divisions, and the
Johns Hopkins Hospital and Health System and its affiliated
hospitals (hereinafter individually and collectively
JHU) have no liability or responsibility to either
party under this Agreement. The CONSULTANTs office address
at JHU may be identified in this Agreement for the purpose of
convenient communication between COMPANY and CONSULTANT and does
not in any way alter the fact that this is a private agreement
between COMPANY and CONSULTANT. |
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CONSULTANT represents and warrants that at the time of execution
of this Agreement, the terms of this Agreement are not
inconsistent with any other contractual or legal obligation.
CONSULTANT may have or with the policies of any institution or
company with which CONSULTANT is associated. |
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COMPANY and CONSULTANT recognize that CONSULTANTs primary
duty as a full-time JHU faculty member is to JHU. COMPANY and
CONSULTANT also agree that JHU policies and CONSULTANTs
obligations to JHU shall govern and be afforded primacy in the
event a conflict arises between such policies and obligations
and this Agreement. CONSULTANT shall promptly notify COMPANY in
the event CONSULTANT becomes aware of a conflict between such
policies and obligations and this Agreement, to the extent that
such notification does not breach confidentiality provisions or
understandings regarding confidentiality between JHU and an
actual or potential research sponsor or collaborator or other
third party, or between CONSULTANT and any third party. COMPANY
and CONSULTANT will jointly determine whether or not to
terminate this Agreement as a result of aforementioned
notification. Nothing in this Agreement shall in any way inhibit
CONSULTANTs ability to conduct academic research and other
academic activities at, through, or on behalf of JHU, regardless
of the sponsor or field of such activities, during or at any
time after the term of this Agreement. |
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If CONSULTANT believes that consulting services she/he provides
for other parties under a private agreement or arrangement to
which JHU is not a party may be inconsistent with the terms of
this Agreement, CONSULTANT shall promptly notify COMPANY, to the
extent that such notification does not breach confidentiality
provisions or undertakings between CONSULTANT and any third
party. COMPANY and CONSULTANT will jointly determine whether or
not to terminate this Agreement as a result of aforementioned
notification. |
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CONSULTANT shall not use the facilities, equipment, materials,
funds, or resources owned or administered by JHU, or located on
any of the premises thereof; or engage or employ students,
trainees, post-doctoral fellows or other employees thereof, to
provide services under this Agreement. CONSULTANT may disclose
to COMPANY under this Agreement any information that she/he
would normally freely disclose to other members of the
scientific community at large, whether by publication, by
presentation at seminars, or in informal scientific discussions,
but CONSULTANT shall not disclose under this Agreement:
(a) information that is proprietary to JHU and not
generally available to the public other than through formal
institutional transactions; or (b) unpublished results of,
or data from, research or clinical activity conducted at, by, or
on behalf of JHU. COMPANY understands that in providing services
under this Agreement, CONSULTANT may inadvertently disclose
proprietary information of JHU to COMPANY. COMPANY agrees that
in the event CONSULTANT discloses proprietary information of JHU
under this Agreement, CONSULTANT has the right to so notify
COMPANY in writing within thirty (30) days of disclosure of
such information. COMPANY agrees not to disclose or use the
information in any way in the event of such notification.
Nothing in this Agreement in any way alters the terms of any
agreements to which JHU is a party, existing prior to the
effective date of this Agreement, or prepared and finalized
after the effective date of this Agreement. |
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2. |
Compensation. In consideration for CONSULTANTs
services hereunder, COMPANY shall pay CONSULTANT as follows:
[Complete only the applicable sections.] |
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a) |
$18,000.00 per year, paid monthly. |
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b) |
12,000 company stock options, with an exercise price of $2.00
per share and vesting as follows: 3,000 shares quarterly.
COMPANY will ask CONSULTANT to sign a separate stock option
agreement. |
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c) |
Reasonable out-of-pocket expenses (upon presentation of
appropriate receipts) incurred by CONSULTANT, including all
travel, food and lodging, in connection with the Services
provided hereunder. |
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Payment shall be made within forty five (45) days of
receipt of an invoice of itemized services and submission of
appropriate vouchers and receipts as may be reasonably necessary
to substantiate CONSULTANTs out-of-pocket expenses. |
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CONSULTANT shall not be paid vacation, holiday or sick time
during the term of Agreement. In the event of premature
termination of the Agreement COMPANY shall pay CONSULTANT for
the Services performed and expenses incurred through the date of
termination. In the event of any overpayment by COMPANY,
CONSULTANT shall, upon submission by COMPANY of documents
evidencing such overpayment, remit the same to COMPANY within
thirty (30) days after termination. CONSULTANT shall also
cooperate with COMPANY in producing documents as evidence of
overpayment of either party. |
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3. |
Term and Termination. This Agreement shall be effective
upon full execution of this Agreement and continue for a period
of (complete applicable box): |
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1 year |
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The Agreement may be extended by written agreement signed by the
parties. Either party may terminate this Agreement with or
without cause upon giving thirty (30) days prior written
notice to the other party. Termination or expiration of this
Agreement shall not affect any rights or obligations which have
accrued prior thereto or in connection therewith. Any written
agreements altering the term and/or conditions of this agreement
must be reviewed and approved in advance by the Johns Hopkins
University School of Medicines Office of Policy
Coordination. |
4. Confidential Information
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4a. |
With respect to any technical or business information of a
proprietary or confidential nature which CONSULTANT may obtain
from COMPANY under this Agreement or which is developed by
CONSULTANT as a result of CONSULTANTs Services hereunder
(all of such technical and business information being referred
to hereinafter as Company Information), it is
understood that unless disclosure or use provided by COMPANY; or
(b) is covered under a separate written agreement between
JHU and COMPANY, CONSULTANT will for a period of three
(3) years from the date of disclosure hereunder: |
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i) |
treat Company Information as confidential; |
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ii) |
not use any Company Information except as and to the extent
necessary for the aforesaid consulting tasks; and |
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iii) |
not disclose any Company Information to any third party without
prior written approval from COMPANY. |
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4b. |
Consultants objections set forth in this Section 4
shall not apply with respect to any portion of the Company
Information that: |
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i) |
was in the public domain at the time it was communicated to
CONSULTANT under this Agreement; |
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ii) |
entered the public domain through no breach of this Agreement by
CONSULTANT, subsequent to the time it was communicated to
CONSULTANT under this Agreement; |
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iii) |
was in CONSULTANTs possession to the best of
CONSULTANTs knowledge free of any obligation of confidence
at the time it was communicated to CONSULTANT under this
Agreement; |
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iv) |
was rightfully communicated to CONSULTANT free of any obligation
of confidence subsequent to the time it was communicated to
CONSULTANT under this Agreement; |
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v) |
was developed by CONSULTANT independently of and without
reference to any information communicated to CONSULTANT under
this Agreement; |
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vi) |
is required to be disclosed in response to a valid order by a
court or other governmental body, or as otherwise required by
law. |
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4c. |
Notwithstanding the above, prior to any subcontracting to third
parties, such third party must be bound to the same obligations
as under this Agreement regarding any Confidential Information
prior to disclosure. |
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Publications. CONSULTANT shall not publish, nor submit
for publication, any work resulting from the Services provided
hereunder without prior written approval from COMPANY. If
CONSULTANT publishes or submits for publication work resulting
from the Services provided hereunder, CONSULTANT shall include
the following statement in the publication: Dr. [Faculty
name] is a paid consultant to [Company name]. Nothing in
this agreement shall be construed as prohibiting or otherwise
limiting CONSULTANTs ability to publish, submit for
publication, or otherwise disclose the results of
CONSULTANTs activities as a faculty member of JHU, during
or at any time after the term of this Agreement. |
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Publicity. With the limited exception of citing
CONSULTANTS faculty title (subject to the conditions
outlined below), COMPANY and its affiliates will not use the
names, likenesses, or logos of the JHU in any of their
fund-raising or investment documents, publications, websites,
advertisements, press releases, or marketing and promotional
materials (hereinafter Materials). If COMPANY cites
Consultants title and/or affiliation with JHU in its
Materials, it agrees to include the following statement in such
Materials as a parenthetical comment next to the
consultants name, title, and/or affiliation:
Participation by Dr. Donald R. Jasinski does not
constitute or imply endorsement by the Johns Hopkins University
or the Johns Hopkins Hospital and Health System. |
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Compliance. In the performance of the Services hereunder,
CONSULTANT shall comply with all applicable federal, state and
local laws, regulations and guidelines. CONSULTANT shall also
comply with COMPANYs policies when on COMPANY premises. |
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8. |
Independent Contractor. CONSULTANTs status under
this Agreement is that of an independent contractor. CONSULTANT
shall not be deemed an employee, agent, partner or joint
venturer of COMPANY for any purpose whatsoever, and CONSULTANT
shall have no authority to bind or act on behalf of COMPANY.
This Agreement shall not entitle CONSULTANT to participate in
any benefit plan or program of COMPANY. CONSULTANT shall be
responsible for, and agrees to comply with, obligations under
federal and state tax laws for payment of income and, if
applicable, self-employment tax. |
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9. |
Assignment. CONSULTANT may not assign this Agreement or
any interest herein, or delegate any of its duties hereunder, to
any third party without COMPANYs prior written consent,
which consent is within COMPANYs sole discretion to grant
or withhold. Any attempted assignment or delegation without such
consent shall be null and void. |
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Debarment. CONSULTANT warrants and represents that
CONSULTANT has never been, if not currently, and, during the
term of this Agreement, will not become: |
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a) |
an individual who has been debarred by the U.S. Food and
Drug Administration (FDA) pursuant to
21 U.S.C. 335a (a) or (b) (Debarred
individual) from providing services in any capacity to a
person that has an approved or pending drug product application,
or an employer, employee or partner of a Debarred Individual or |
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a corporation, partnership or association that has been debarred
by the FDA pursuant to 21 U.S.C. 335a (a) or (b)
(Debarred Entity) from submitting or assisting in
the submission of any abbreviated drug application, or an
employee, partner, shareholder, member, subsidiary or affiliate
of a Debarred Entity. |
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CONSULTANT further warrants and represents that no Debarred
Individual or Debarred Entity has performed or rendered, or will
perform or render, any services of assistance relating to
activities taken pursuant to this Agreement. CONSULTANT further
warrants and represents that CONSULTANT has no knowledge of any
circumstances which may affect the accuracy of the foregoing
warranties and representations, including, but not limited to,
FDA investigation of, or debarment proceedings against
CONSULTANT or any person or entity performing services or
rendering assistance relating to activities taken pursuant to
this Agreement, and CONSULTANT will immediately notify COMPANY
if CONSULTANT becomes aware of any such circumstances during the
term of this Agreement. |
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11. |
Entire Agreement. This Agreement contains the entire
understanding of the parties with respect to the matters herein
contained and supersedes all previous agreements and
undertakings with respect thereto. This agreement may be
modified only by written agreement signed by the parties. |
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This Agreement shall be governed by and construed in accordance
with the laws of the State of Florida without regard to its
conflicts of laws rules. |
CATALYST PHARMACEUTICAL PARTNERS, INC.
220 Miracle Mile, Suite 234
Coral Gables, Florida 33134
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By: |
/s/ Patrick
J. McEnany |
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Donald R. Jasinski, M.D.
John Hopkins University Medical Center
Mason Lord Building
West Tower, 2nd Floor
4940 Eastern Avenue
Baltimore, Maryland 21224
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By: |
/s/ Donald
R. Jasinski |
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EX-10.13 Agreement with Charles Gorodetzky
Exhibit 10.13
AGREEMENT
This AGREEMENT (this Agreement) is made and entered into this 25th day of August, 2006,
effective the 1st day of September, 2006 (the Effective Date) by and between CATALYST
PHARMACEUTICAL PARTNERS, INC., a Delaware corporation, with offices located in Coral Gables,
Florida (the Company) and CHARLES W. GORODETZKY, M.D., Ph.D., an individual resident of the state
of Missouri (Gorodetzky).
In consideration of the mutual representations, warranties, covenants and agreements contained
in this Agreement, the parties hereto agree as follows:
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Services. Throughout the term of the Agreement, Gorodetzky shall act as the
Chief Medical Officer of the Company. |
Gorodetzky represents and warrants that, at the time of execution of this Agreement, the terms
of this Agreement are not inconsistent with any other contractual or legal obligation Gorodetzky
may have or the policies of any institution or company with which Gorodetzky is associated. If
Gorodetzky believes that consulting services he provides for other parties under a private
arrangement may be inconsistent with the terms of this Agreement, Gorodetzky shall properly notify
the Company, to the extent that such notification does not breach confidentiality provisions or
understandings between Gorodetzky and any third party. The Company and Gorodetzky will jointly
determine whether or not to terminate this Agreement as a result of the aforementioned
notification.
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Compensation. In consideration for Gorodetzkys services hereunder, the
Company shall pay Gorodetzky as follows: |
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an hourly rate of $250.00 per hour. Gorodetzky is guaranteed a minimum
of 120 hours per 12-week quarter (or 40 hours per four-week billing period). Hours
above 120 hours per 12-week quarter will be billed at a rate of $200.00 per hour. |
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15,000 options (the Options) to purchase shares of the Companys
common stock at an exercise price equal to the price at which the Company completes
its Initial Public Offering, which Options shall vest over a three-year period on
the following schedule: |
September 1, 2007: 5,000 options
September 1, 2008: 5,000 options (10,000 in the aggregate)
September 1, 2009: 5,000 options (15,000 in the aggregate)
The Options will be issued pursuant to the Companys 2006 Stock Incentive Plan;
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Any travel by Gorodetzky for Company purposes will be reimbursed,
provided that original receipts are submitted for all costs over $25.00. Domestic
air travel (U.S. and Canada) will be by coach only. International air travel will
be by |
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business class. Travel time, door-to-door, will be reimbursed at half Gorodetzkys
rate described in Section 2(a) above. If Gorodetzky chooses to use private
automobile travel for business travel purposes, the reimbursed cost and accrued time
will not exceed that what would be reasonably expected using airplane travel. Other
directly related business expenses over $10.00 will be billed with submission of
original receipts. |
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For purposes of this Agreement, Gorodetzky is termed an independent
contractor of the Company. Gorodetzky shall be responsible for, and agrees to
comply with, obligations under federal and state tax laws for payment of all income
taxes. All payments made to Gorodetzky will be reported using a IRS 1099 form or
similar form. All invoices must be paid within 30 days of receipt of such bill. |
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Gorodetzky will submit an invoice for work performed every four weeks
for 40 hours for that four-week billing period. Additional hours over the 120 hour
per quarter minimum will be billed at the end of each 12-week period. Any unused
hours in a four-week billing period will carry over into the next four-week billing
period (unless accrued in the last four-week period of the quarter). Such unused
hours will be deemed short-term carryover hours and, if not used in the 12-week
quarter in which they accrued, will expire and be cancelled at the end of that
12-week quarter. Any unused hours accrued because of unavailability of Gorodetzky
for more than one week will be termed long-term carryover hours and will carry
forward for the full contract period. |
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If not used by the end of the contract period, long-term carryover hours will expire
and be cancelled. If both short-term and long-term carryover hours exist in the same
12-week billing quarter, short-term carryover hours will be used first. Time will be
accounted for in quarter-hour increments. If the actual billable time in any 12-week
billing quarter exceeds the guaranteed 120 hours by more than 20%, the parties agree
to renegotiate the compensation plan described above. Gorodetzky must provide, in
writing, via e-mail to the Company any vacations for one week or longer a minimum of
six weeks prior to the starting date of the vacation. |
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Term and Termination. This Agreement shall be effective September 1, 2006 and
will be effective for a period of 48 weeks, ending on August 2, 2007, unless earlier
terminated by either party via ten business days prior notice. Upon the expiration of this
Agreement, it will continue for an additional period of 48 weeks unless terminated by
either party with 10 days notice prior to the expiration of any period. |
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4. |
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Confidentiality. Gorodetzky agrees that at all times during the term of this
Agreement and after the termination of employment for as long as such information remains
non-public information, Gorodetzky shall (i) hold in confidence and refrain from disclosing
to any other party all information, whether written or oral, tangible or intangible, of a
private, secret, proprietary or confidential nature, of or concerning the Company or any of
its affiliates and their business and operations, and all files, letters, |
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memoranda, reports, records, computer disks or other computer storage medium, data, models
or any photographic or other tangible materials containing such information (Confidential
Information), including without limitation, any sales, promotional or marketing plans,
clinical data or information about the Companys product development efforts, programs,
techniques, practices or strategies, or future development plans (including existing and
entry into new geographic and/or product markets), and any customer lists, (ii) use the
Confidential Information solely in connection with his employment with the Company or any of
its affiliates and for no other purpose, (iii) take all precautions necessary to ensure that
the Confidential Information shall not be, or be permitted to be, shown, copied or
disclosed to third parties, without the prior written consent of the Company or any of its
affiliates, and (iv) observe all security policies implemented by the Company or any of its
subsidiaries or affiliates from time to time with respect to the Confidential Information.
In the event that Gorodetzky is ordered to disclose any Confidential Information, whether in
a legal or regulatory proceeding or otherwise, Gorodetzky shall provide the Company or any
of its affiliates with prompt notice of such request or order so that the Company or any of
its subsidiaries or affiliates may seek to prevent disclosure. In addition to the foregoing
Gorodetzky shall not at any time libel, defame, ridicule or otherwise disparage the Company. |
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Gorodetzky agrees that all work done in the name of or on behalf of the Company is deemed the
property of the Company pursuant to this Agreement. |
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Notices. All notices, requests, demands, claims and other communications
hereunder shall be in writing and shall be deemed given if delivered by certified or
registered mail (first class postage pre-paid), guaranteed overnight delivery or facsimile
transmission if such transmission is confirmed by delivery by certified or registered mail
(first class postage pre-paid) or guaranteed overnight delivery to, the following addresses
and telecopy numbers (or to such other addresses or telecopy numbers which such party shall
designate in writing to the other parties): (a) if to the Company, at its principal
executive offices, addressed to the Chief Executive Officer, with a copy to Philip B.
Schwartz, Esq., Akerman, Senterfitt & Eidson, P.A., One Southeast Third Avenue, Miami,
Florida 33131; and (b) if to Gorodetzky, at the address listed on the signature page
hereto. |
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Amendment; Waiver. This Agreement may not be modified, amended, supplemented,
canceled or discharged, except by written instrument executed by all parties. No failure
to exercise, and no delay in exercising, any right, power or privilege under this Agreement
shall operate as a waiver, nor shall any single or partial exercise of any right, power or
privilege hereunder preclude the exercise of any other right, power or privilege. No
waiver of any breach of any provision shall be deemed to be a waiver of any preceding or
succeeding breach of the same or any other provision, nor shall any waiver be implied from
any course of dealing between the parties. No extension of time for performance of any
obligations or other acts hereunder or under any other agreement shall be deemed to be an
extension of the time for performance of any other obligations or any other acts. The
rights and remedies of the parties under this Agreement are in addition to all other rights
and remedies, at law or equity, that they may have against each other. |
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Assignment; Third Party Beneficiary. This Agreement, and Gorodetzkys rights
and obligations hereunder, may not be assigned or delegated by Gorodetzky. The Company may
assign its rights, and delegate its obligations, hereunder to any affiliate of the Company
or any successor or assign. The rights and obligations of the Company under this Agreement
shall inure to the benefit of and be binding upon its respective successors and assigns. |
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Severability; Survival. In the event that any provision of this Agreement is
found to be void and unenforceable by a court of competent jurisdiction, then such
unenforceable provision shall be deemed modified so as to be enforceable (or if not subject
to modification then eliminated herefrom) for the purpose of those procedures to the extent
necessary to permit the remaining provisions to be enforced. The provisions of Section 4
will survive the termination for any reason of Gorodetzkys relationship with the Company. |
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9. |
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Counterparts. This Agreement may be signed in any number of counterparts, each
of which shall be an original but all of which together shall constitute one and the same
instrument. |
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10. |
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Governing Law. This Agreement shall be construed in accordance with and
governed for all purposes by the laws of the State of Florida applicable to contracts
executed and to be wholly performed within such State. |
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11. |
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Entire Agreement. This Agreement contains the entire understanding of the
parties in respect of its subject matter and supersedes all prior agreements and
understandings (oral or written) between or among the parties with respect to such subject
matter. |
[ Signatures on Following Page]
4
IN
WITNESS WHEREOF, the parties hereto have caused this Agreement to be
made this 1st day of
September, 2006.
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/s/ Charles Gorodetzky
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Charles Gorodetzky |
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Address for Notices: |
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COMPANY
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/s/
Patrick J. McEnany
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Patrick J. McEnany |
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Chief Executive Officer |
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5
EX-10.14 Agreement with Pharmaceutics Int'l Inc
Development of Vigabatrin (Racemic Mixture) Film-Coated Tablets Leading
to the Manufacture of Clinical Trial Materials to Support a Phase II Study
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CPP Contact:
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Patrick J. McEnany, Chief Executive Officer |
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Catalyst Pharmaceutical Partners |
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220 Miracle Mile, Suite 234 |
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Coral Gables, FL 33134 |
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Phone:
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(305) 529-2522 |
Fax:
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(305) 529-0933 |
Email:
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mcenanv@bellsouth.net |
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PII Contacts:
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Tammy Bryan, Associate Director, Business Development |
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David Fidler, Director Project Management |
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Pharmaceutics International, Inc. |
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10819 Gilroy Road |
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Hunt Valley, MD 21031 |
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Corporate Phone:
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(410) 584-0001 ext. 239 (TB) |
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(410) 584-0001 ext. 156 (DF) |
Corporate Fax:
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(410) 584-0007 |
Email:
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tbryan@pharm-int.com / dfidler@pharm-int.com |
Project number: 12CAT01
The proposal is split into three sections:
(A) Project Definition and Scope
(B) Costs
(C) Legal and Signatures
(A) Project Definition and Scope
Catalyst Pharmaceutical Partners (CPP) requires PII (Pharmaceutics International, Inc.) to develop
the formulation, perform scale-up and manufacture Clinical Trial Materials (CTM) to support a Phase
II Study for Vigabatrin tablets. PII will manufacture 100,000 tablets of Vigabatrin tablets (250
mg, 300 mg, 500 mg or 750 mg strength), the ultimate strength and color to be determined by CPP.
CPP filed the IND for vigabatrin in the treatment of cocaine addiction on December 1, 2004 and has
been accepted by the FDA.
CPP plans to conduct an approximate 100 patient multi-center double-blind, placebo controlled
Phase II study using the CTM developed by PII under this agreement. This study may in fact be
the pivotal study for the NDA.
The product needs to be completely bioequivalent to Sabril (per FDAs minutes-ATTACHED) and
contain exact excipients per the Sabril Canadian monograph.
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12CAT01.04
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May 10, 2006
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Page 1 of 22 |
Product in Section C refers to Vigabatrin.
The documentation for PIIs activities will be complete, accurate and suitable for submission to or
review by regulatory authorities in the event CPP submits an application for marketing for a dosage
form developed by PII.
CPP has the right to audit PII at reasonable times and in a reasonable manner. PII will be required
to notify CPP of any inspection by FDA or other regulatory authorities, any observations or other
communications, and PIIs response. CPP will be notified of any inspection relating to the CPP
project immediately, and will have the right to participate in the inspection and review any
responses. Neither PII, nor any of its subcontractors use the services of any individual that has
been debarred.
Vigabatrin drug substance should be stored at controlled room temperature (15C -30C) protected from
moisture.
CPP will supply:
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API Vigabatrin with Certificate of Analysis (C of A) and Material Safety Data
Sheet (MSDS) |
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Reference standard and impurities |
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Technical data package, if any |
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Quantitative formulation |
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Product samples of the Sabril 500 mg tablet (10) and 500 mg sachet, C of A,
MSDS |
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Analytical methods for API and drug product with validation package, if available |
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Safety Information (for NCEs): Investigators Brochure or Summaries of Pre-
clinical safety/activity data, where available, including: |
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Safety Pharmacology Studies |
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Mutagenicity Studies (eg. AMES test) |
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Non-GLP and/or GLP acute and sub-chronic/chronic toxicity trials in any
species |
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Pharmacology Summary |
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Teratogenicity Studies |
PII will order and invoice to CPP at cost plus 10%:
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Excipients |
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Packaging components HPDE bottles |
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Analytical columns |
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12CAT01.04
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May 10,2006
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Page 2 of 22 |
PII Services:
1. |
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Materials: PII will order sufficient materials for all
activities in this proposal. PII will use stock excipients
where possible and will bill for materials and testing at the
completion of this contract. |
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1.1 |
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Vigabatrin PII will receive with C of A and perform ID testing. |
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1.1.1 |
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Description. |
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1.1.2 |
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Identification by IR (USP <197K>). |
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API usage table: |
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Cleaning method development and validation
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5gm |
Preformulation activities for dissolution, API
characterization and tablet compaction properties
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600 gm |
Formulation Development 2 prototypes x 10,000 batch sizes
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5.0 Kg |
Feasibility Batch Size of 100,000
tablets
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50.0 Kg |
CTM batch size of 100,000 tablets
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50.0 Kg |
Analytical method development and validation for dissolution,
assay and related substance
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5-10gm |
Subtotal
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105.61 Kg |
Overage-30%
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33.4 Kg |
Total
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109.01 Kg * |
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* |
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Based on 500 mg strength |
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1.2 |
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Excipients PII will receive and perform all appropriate testing, including ID testing. |
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Magnesium Stearate (Lubricant) |
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Ac-Di-Sol or Sodium Starch Glycolate (Disintegrant) |
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Colloidal Silicon Dioxide |
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Microcrystalline Cellulose (Avicel PHI01)
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Colorcon Opadry Film Coating Materials (to be confirmed) |
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Cab-O-Sil (Glidant) |
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NOTE: Excipients may be adjusted based on initial studies |
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12CAT01.04
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May 10,2006
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Page 3 of 22 |
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1.3 |
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Packaging components PII will receive on C of C and perform ID release
testing. |
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HDPE bottles |
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Child Resistant Closures |
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2.1 |
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PII will review CPP supplied information including purity profiles,
process related degradants, and related substances of API. |
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2.2 |
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PII will perform the following studies on the API: |
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Bulk / Tap Density |
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Flow |
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Screen Analysis |
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Appearance |
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Hygroscopicity at 25°C/60%RH (6 hours, 24 hours, 48 hours) |
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2.3 |
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Tablet compaction properties (neat API with lubricant) |
3. |
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Formulation Development Two (2) prototype batch sizes up to 10,000 film-
coated tablets (5.0 kg API) |
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3.1 |
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PII will review the technical data package supplied by CPP and prepare a
development protocol to be authorized by CPP prior to initiation of
formulation activities. CPP will provide quantitative formulation prior to
the start of the development activities. |
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3.2 |
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PII will develop (2) prototypes (batch sizes of up to 10,000 tablets). |
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3.3 |
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The first prototype batch will be a batch of core tablets at the smallest
reasonable scale (approximately 3,000 tablets) needed to determine the
compression characteristics and compression parameter ranges. (The core
tablet formula will be composed of Vigabatrin, Avicel PH101 (or
equivalent), Ac-Di-Sol (or equivalent), Cab-O-Sil (or equivalent), and
magnesium Stearate. |
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3.4 |
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The second prototype batch will be a batch to optimize process and
coating parameters. |
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3.5 |
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The prototypes will be packaged in HPDE bottles of 100 count. |
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3.6 |
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The prototypes will be tested for the following in-process tests: |
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12CAT01.04
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May 10, 2006
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Page 4 of 22 |
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3.6.1 |
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Tablet properties (hardness, thickness, weight and friability) |
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3.6.2 |
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Bulk and Tap Density / Flow |
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3.6.3 |
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Sieve Analysis |
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3.7 |
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The prototypes will be tested for the following finished product tests: |
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3.7.1 |
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Physical Appearance |
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3.7.2 |
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Assay and related substances |
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3.7.3 |
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Dissolution Profile |
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3.7.4 |
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Moisture -KF |
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3.7.5 |
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Hardness Profile |
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3.8 |
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Prototypes will be placed on accelerated stability at 40°C/75% RH and
will be tested at 1, 2 and 3 months for dissolution profile and assay and
related substances. |
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Condition |
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Initial |
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1 Month |
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2 Months |
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3 Months |
40°C/75%RH
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X
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X |
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X |
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X |
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25°C/60%RH
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0 |
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0 |
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0 |
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0-Optional
*Note: The formulation development for CPPs Vigabatrin equivalent to Sabril shall be owned
exclusively by CPP.
4. |
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Manufacture of Feasibility / Scale-up Batches One (1) active batch size up to 100,000 Vigabatrin
250 mg or 500 mg film-coated tablets (50.0 kg API) and one (1) placebo batch size up to 10,000
tablets |
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4.1 |
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Materials: See Section 1.1 & 1.2 |
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4.2 |
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PII will develop a matching placebo based upon the data obtained in
Section 3. Per CPP the placebo will be of the same physical dimension as
the active tablet. The run weight does not need to match the run weight of
the active tablet and is at PIIs discretion. The physical appearance and
size are the critical design parameters for the placebo tablets. |
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4.3 |
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PII will prepare Batch Records that will be used for the manufacture of the
Feasibility Batch. |
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4.4 |
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PII will use the following equipment train as needed: |
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4.4.1 |
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V-Blender |
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4.4.2 |
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Comil |
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4.4.3 |
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Roll Compactor / Mill (if required) |
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4.4.4 |
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Tablet Press |
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12CAT01.04
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May 10,2006
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Page 5 of 22 |
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4.5 |
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PII will manufacture (1) Feasibility Batch of Vigabatrin 500 mg tablets
and one (1) Matching Placebo. |
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4.6 |
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Operators will use appropriate personal protective equipment. |
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4.7 |
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A portion of the Feasibility Batch will be packaged in HDPE bottles of
100 count to satisfy stability requirements and placed on accelerated
stability at 40°C/75% RH and tested at 1, 2, and 3 and at 25°C/60% at 6
months. PII will comply with good documentation practices and that all
underlying data will be accurate, complete and suitable for submission to
or review by regulatory authorities. |
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4.8 |
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PII will perform the following in process testing for the blend and tablets: |
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4.8.1 |
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Tablet properties (weight, thickness, hardness and friability) |
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4.8.2 |
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Bulk and Tap Density / Flow |
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4.8.3 |
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Sieve Analysis |
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4.9 |
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PII will perform the following tests on the packaged Feasibility Batches: |
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4.9.1 |
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Physical Appearance |
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4.9.2 |
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Dissolution Profile (media and time points to be provided by CPP) |
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4.9.3 |
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Assay and Related Substances |
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4.9.4 |
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Content Uniformity (calculated based on average tablet weight) |
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4.9.5 |
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Moisture (USP<921>) |
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Condition |
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Initial* |
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1 Month |
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2 Months |
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3 Months |
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6 Months |
40°C/75%RH
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X
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X |
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X |
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X |
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0 |
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25°C/60%RH
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0 |
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0 |
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0 |
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X |
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* Release data will be used if initiated within one (1) month from manufacture
0-Optional
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4.10 |
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After completion of one (1) month accelerated stability, PII will prepare a
formulation development report. |
5 |
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Manufacture of Clinical Trial Materials (CTM) Batch One (1) active batch and one (1)
placebo batch of Vigabatrin 500 mg film-coated tablets batch sizes up to 100,000 tablets
each |
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5.1 |
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All materials used for the manufacture of the CTM Batches will be fully
released by PII unless otherwise specified by CPP. See Materials: Sections 1.1 & 1.2 |
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12CAT01.04
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May 10, 2006
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Page 6 of 22 |
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5.2 |
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PII will prepare Master Batch Records that will be approved by CPP at
least one (1) week prior to manufacture of the CTM Batches. |
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5.3 |
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The CTM batches will be manufactured under cGMP conditions as
directed in the Master Batch Records. |
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5.4 |
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PII will remove periodic samples per the agreed sampling protocols. |
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5.5 |
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PII will employ the following equipment train as needed: |
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5.5.1 |
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V-Blender |
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5.5.2 |
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Roll Compactor / Mill (if required) |
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5.5.3 |
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Tablet Press |
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5.5.4 |
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Coating Pan (2 pan loads may be required dependent on final tablet
weight) |
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5.6 |
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Operators will wear respirators and Tyvex suits if necessary. |
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5.7 |
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Based on the experience gained from manufacture of the Feasibility
Batches (See Section 4), PII will manufacture (1) Active CTM Batch (500
mg strength of Vigabatrin film-coated tablets, batch size up to 100,000
tablets). |
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5.8 |
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PII will manufacture (1) matching Placebo Batch (batch size of 100,000
tablets). |
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5.9 |
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PII will perform the following in-process testing on the Active Batch (to
be confirmed by CPP): |
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5.9.1 |
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Weight variation, Hardness, Thickness and Friability |
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5.9.2 |
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Bulk and Tap Density |
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5.9.3 |
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Sieve Analysis |
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5.10 |
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PII will perform the following finished product testing on the Active Batch
or as per mutually agreed upon by CPP and PII (should meet MasterSpecifications): |
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5.10.1 |
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Physical Appearance |
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5.10.2 |
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Dissolution Profile (media and time points to be provided by CPP) |
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5.10.3 |
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Assay and Related Substances |
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5.10.4 |
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Content Uniformity (calculated based on assay and weight) |
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5.10.5 |
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Moisture (USP<921>) |
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5.11 |
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PII will perform the following finished product testing on the Placebo
Batches or as per mutually agreed upon by CPP and PII (should meet
Master Specifications): |
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12CAT01.04
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May 10, 2006
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Page 7 of 22 |
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5.11.1 |
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Physical Appearance |
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5.11.2 |
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Absence of active |
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5.11.3 |
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Disintegration |
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5.12 |
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PII will store, monitor and test the stability of CTM Batches per the CPP
approved protocols. See Section (7). |
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5.13 |
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Once the Batches are released, PII will ship to CPP or CPP designated
facility (address to be provided by CPP). |
6. |
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Packaging and Labeling of CTM Batches to be confirmed with CPP |
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6.1 |
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Materials: See Section 1.3. |
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6.2 |
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Packaging and labeling protocols will be prepared by PII and approved by
CPP one (1) week prior to the manufacture of the batches. |
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6.3 |
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One (1) active batch and one (1) placebo batch will be packaged in HPDE
bottles of 100 count per CPP approved packaging protocols. |
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6.4 |
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If PII is not labeling, the packaged bottles will have the PII lot number ink
jetted on them and shipped to the contract packager for clinical labeling
and packaging. |
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6.5 |
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Any remaining tablets will be stored in bulk. |
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6.6 |
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PII will perform 200% count check on materials going into clinical trials. |
7. |
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Stability of Clinical Trial Material (CTM) Batches |
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7.1 |
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PII will monitor and test, using CPP approved stability protocol, the
stability of the Active and Placebo Batches of Vigabatrin tablets
manufactured by PII; the stability program is to be initiated as soon as the
Vigabatrin tablets are manufactured and packaged. |
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7.2 |
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Stability of the Packaged Product |
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7.2.1 |
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Two (2) batches (1 active and 1 placebo) of 500 mg Vigabatrin
tablets packaged in (configuration bottles of 100 count) will be
set down on stability. |
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7.2.2 |
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Stability protocols will be developed per ICH guidelines. The
stability protocols will include a 24 month long term stability at
25°C ±2°C /60% RH ±5% RH (25°C/60% RH) and a 6 month
accelerated stability at 40°C ±2°C /75% RH ±5% RH (40°C/75%
RH). CPP may elect to include a 12 month intermediate stability |
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12CAT01.04
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May 10, 2006
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Page 8 of 22 |
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at 30°C ±2°C /65% RH ±5% RH (30°C/65% RH) in the protocol. Sufficient
samples will be placed on stability to meet the stability protocol
requirements. |
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7.2.3 |
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The packaged product on stability will be tested at
Initial, 3 and 6 months at 40°C/75% RH and 3, 6, 9, 12, 18, and 24 months at
25°C/60% RH. Samples stored at 30°C/65% RH will be tested if significant
change occurs at the accelerated conditions or by CPPs request. |
Active Batch:
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Initial |
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1 |
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2 |
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3 |
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6 |
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9 |
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12 |
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18 |
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24 |
Condition |
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* |
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Month |
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Months |
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Months |
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Months |
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Months |
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Months |
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Months |
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Months |
25°C/60%RH
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X |
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X |
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X |
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X |
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X
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X |
40°C/75%RH
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X
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0 |
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0 |
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X |
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X |
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30°C/65%RH*
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0 |
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0 |
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0 |
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0 |
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Placebo Batch:
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Initial |
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1 |
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2 |
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3 |
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6 |
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9 |
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12 |
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18 |
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24 |
Condition |
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* |
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Month |
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Months |
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Months |
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Months |
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Months |
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Months |
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Months |
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Months |
25°C/60%RH
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X
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X
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X
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X
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X
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|
X |
40°C/75%RH
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X
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0 |
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0 |
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X
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X |
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0 = Optional, will be initiated subsequent to failure at 40°C/75% RH or at CPPs request
*Release data will be used at Time 0 (initial) if stability is initiated within one (1) month from
manufacture
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7.4.1 |
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The following tests will be performed on the Active Batches if not
specified in the approved protocol otherwise: |
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7.4.1.1 |
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Physical Appearance |
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7.4.1.2 |
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Assay and Related Substances |
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7.4.1.3 |
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Dissolution Single Time Point (to be determined by CPP) |
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7.4.1.4 |
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Moisture (USP<921>) |
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7.4.2 |
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The following tests will be performed on the Placebo Batches if
not specified in the approved protocol otherwise: |
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7.4.2.1 |
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Physical Appearance |
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7.5 |
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General Stability Support: |
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12CAT01.04
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May 10, 2006
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Page 9 of 22 |
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7.5.1 |
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PII will prepare stability protocols and CPP will review and
approve the stability protocols one (1) week prior to initiation of
stability study. |
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7.5.2 |
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PII will complete stability testing within thirty (30) calendar days
from the scheduled pull date. CPP will be notified in writing of
any testing that will not be completed in this time frame. |
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7.5.3 |
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PII will provide to CPP test results upon completion at each
stability time point and not later than forty-five (45) calendar days
from the scheduled pull date. |
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7.5.4 |
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CPP will be notified of any Out-of-Specification (OOS) Result
within three (3) days of completion of Phase I Investigation when
the OOS Result was confirmed. |
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7.5.5 |
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PII will provide to CPP an updated stability summary table after
each stability time point. |
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8.1 |
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PII will develop and validate the following drug product methods: |
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Cleaning |
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Dissolution |
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HPLC assay and related substances |
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NOTE: Method Validation will include the following activities: |
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System Precision |
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Accuracy/Recovery |
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Method Precision (Repeatability/Intermediate) |
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Linearity |
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Limit of Quantitation (LOQ) impurities only |
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|
Limit of Detection (LOD) impurities only |
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Range |
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Specificity (including degradation studies) |
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Robustness |
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|
Relative Response Factors (RRF) (impurities only) |
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|
Relative Retention Time (RRT) (impurities only) |
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Filter Interference |
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Solution Stability |
|
8.2 |
|
PII will develop and validate the following drug substance methods: |
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12CAT01.04
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May 10,2006
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Page l0 of 22 |
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Particle Size PII will subcontract |
|
8.3 |
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PII will transfer the following drug substance methods |
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Moisture |
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HPLC assay and related substances |
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|
Residual Solvents |
|
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|
|
IR Identification |
|
|
|
NOTE: Method Transfer includes the following activities: |
|
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|
Validation report/package from API supplier |
|
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|
|
Support from the API supplier that validated these methods |
|
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|
System Precision |
|
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|
|
Method Precision (reproducibility) |
|
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|
Linearity |
|
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|
|
Limit of Quantitation (LOQ) impurities only |
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|
|
Limit of Detection (LOD) impurities only |
|
9.1 |
|
PII will provide project management including project team meetings,
summary status reports, conference calls, project coordination and on site visits. |
|
10.1 |
|
PII will be responsible for report writing and issuance of the final report,
as well as approval of the final report. CPP will have the right to review
draft reports and all underlying data. |
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10.2 |
|
Method Validation or Transfer Protocols for the drug product will be
prepared by PII and approved by CPP, if required. |
|
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10.3 |
|
Waste from the manufacturing process will be incinerated. Any unused
excipients will be destroyed after expiry date, as it arises. |
|
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10.4 |
|
Dedicated excipients and packaging components will be destroyed six (6)
months after completion of the manufacturing campaign. If CPP elects for
PII to store the materials longer than six (6) months then there will be a
storage charge of $200 per month per pallet. |
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10.5 |
|
PII will prepare necessary documentation for NDA submission. However,
the NDA submission will be the responsibility of CPP. |
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12CAT01.04
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May 10, 2006
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Page 11 of 22 |
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11.1 |
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Master Specifications |
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11.2 |
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Master and Executed Batch Records |
|
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11.3 |
|
Packaging and Labeling Protocols |
|
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11.4 |
|
Invalidation Reports for Analytical Methods |
|
|
11.5 |
|
Master Labels |
|
|
11.6 |
|
Stability Test Reports |
Timing and Project Initiation:
The project will commence upon receipt of the signed contract, the drug substance, and the
initiation payment, thereafter payments are due thirty (30) days from the date of invoice. Unpaid
balances shall bear interest at a rate of 18% per annum unless determined not to be properly
payable.
Timing Timing will be finalized once the contract is signed but will be in line with CPP needs.
Microsoft Project timeline will be provided once contract is signed.
Month 1: Cleaning method will be completed four (4) to six (6) weeks from receipt of API
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12CAT01.04
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May 10, 2006
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Page 12 of 22 |
The Cost Table below lists the cost of each step of the program. If PII and CPP mutually agree in
writing that additional man-hours are required for completion of a step, PII shall invoice such
additional man-hours to CPP, provided however, such invoice describes in detail the additional
work conducted by PII.
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|
Activity |
|
Cost |
|
Section 1: Materials |
|
|
|
|
1.1
|
|
API- ID release at $1,500/lot.
|
|
$TBC
|
1.2
|
|
Excipients full release testing will be charged up to $3,000 / lot; PII
will use stock excipients where applicable and may opt to charge on a per Kg basis.
|
|
$TBC
|
1.3
|
|
Packaging Components release testing will be charged up to $2,500 /lot;
PII will use stock components where applicable and may opt to charge on a per
bottle basis.
|
|
$TBC
|
|
Section 2: Pre-formulation |
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|
|
|
2.2
|
|
API testing
|
|
$ |
13,000 |
|
|
Section 3: Formulation Development |
|
|
|
|
3.2
|
|
Prototype Development $20,000 per prototype
|
|
$ |
40,000 |
|
3.3
|
|
Accelerated stability testing: (3 pull points x two (2) batches x $2,500)
|
|
$ |
15,000 |
|
|
Section 4: Manufacture of Feasibility Batches |
|
|
|
|
4.4
|
|
Development of Matching Placebo
|
|
$ |
15,000 |
|
4.5
|
|
Manufacture of two (2) Feasibility Batches one of Vigabatrin Tablets
and one of Matching Placebo ($50,000 for active and $25,000 for placebo)
|
|
$ |
75,000 |
|
4.6
|
|
Packaging in bottles of 100 to satisfy stability requirements
|
|
$ |
10,000 |
|
4.7
|
|
Accelerated stability testing of (1) batch: (4 pull points x 1 batch x 1
packaging configuration x $3,500)
|
|
$ |
14,000 |
|
|
Section 5: Manufacture of CTM Batches / Placebo Batch |
|
|
|
|
Manufacture of (1) Active CTM Batch of Vigabatrin tablets (batch size of 100,000
tablets $50,000 per batch). |
|
$ |
50,000 |
|
Manufacture of (1) Placebo CTM Batch of tablets
(batch size of 100,000 tablets $25,000 per batch). |
|
$ |
25,000 |
|
|
Section 6: Packaging and Labeling of CTM Batches |
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|
Two (2) CTM Batches packaged in bottles of 100 count $15,000 per batch |
|
$ |
30,000 |
|
|
|
|
|
|
|
|
|
Section 7: Stability of CTM Batches |
|
|
|
|
Stability of Packaged Product |
|
$ |
29,600 |
|
8 time points x 1 active batch x $3,500 |
|
|
|
|
8 time points x 1 placebo batch x $200 |
|
|
|
|
|
Section 8: Analytical Support |
|
|
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|
|
|
Cleaning
|
|
$ |
20,000 |
|
|
|
Dissolution for drug product
|
|
$ |
27,200 |
|
|
|
HPLC assay and related substances for drug product
|
|
$ |
47,600 |
|
|
|
HPLC assay and related substances for drug substance
|
|
$ |
10,200 |
|
|
|
IR Identification
|
|
$ |
6,400 |
|
|
|
|
|
|
|
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12CAT01.04
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|
May 10, 2006
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|
Page 13 of 22 |
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|
|
Residual solvents for drug substance
|
|
$ |
10,200 |
|
|
|
Particle size for drug substance PII to subcontract
|
|
$TBC
|
|
|
|
|
|
|
|
|
Section 9: Project Management |
|
$ |
40,000 |
|
|
|
|
|
|
|
|
|
Section 10: General Support |
|
$ |
15,000 |
|
|
|
|
|
|
|
|
|
Section 11: NDA Documentation |
|
$ |
20,000 |
|
|
|
|
|
|
|
|
|
Total |
|
$ |
513,200 |
|
|
Non-Stability Payment Schedule
|
|
|
|
|
|
|
|
|
|
|
|
|
Invoice Issue |
|
Section |
|
Activity |
|
Amount Due |
|
Invoice Date and # |
Date |
|
Reference |
|
|
|
|
|
|
|
Mar/April 2006
|
|
8-10 |
|
Initiation Payment Cleaning,
Project Management & General Support |
|
$ |
75,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
April/May 2006 |
|
2 |
|
Completion of preformulation activities |
|
$ |
13,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
May 2006
|
|
3 |
|
Completion of first prototype |
|
$ |
20,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
May/June 2006
|
|
3 |
|
Completion of second prototype |
|
$ |
20,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 2006 |
|
3 |
|
Initiation of prototype stability
(non refundable up to 3 months) |
|
$ |
15000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TBC |
|
4 |
|
Completion of matching placebo
|
|
$ |
15,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TBC |
|
4 |
|
Initiation of Feasibility
Batches (1 active and 1 placebo) |
|
$ |
45,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TBC |
|
4 |
|
Completion of Feasibility Batches
Including Packaging (1 active and 1 placebo) |
|
$ |
40,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TBC |
|
4 |
|
Stability initiation of feasibility
batches |
|
$ |
14,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TBC |
|
5 |
|
Master Batch Records for Active
and Placebo Batches |
|
$ |
40,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TBC |
|
5 |
|
Executed Batch Records for Active and Placebo Batches |
|
$ |
35,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
12CAT01.04
|
|
May 10, 2006
|
|
Page 14 of22 |
|
|
|
|
|
|
|
|
|
|
|
|
|
TBC |
|
6 |
|
Executed Packaging and Labeling Protocals |
|
$ |
30,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TBC |
|
8 |
|
API reports for IR Identification, Assay and Resdidual Solvents |
|
$ |
26,800 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TBC |
|
8 |
|
Dissolution Method for the drug product |
|
$ |
17,200 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TBC |
|
8 |
|
Validation Report for dissolution method
for the drug product |
|
$ |
10,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TBC |
|
8 |
|
Validation protocal for assay method for
the drug product |
|
$ |
27,600 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TBC |
|
8 |
|
Validation report for dissolution method
for the drug product |
|
$ |
20,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TBC |
|
11 |
|
NDA documentation |
|
$ |
20,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TBC |
|
1 |
|
Materials & Testing |
|
$TBC
|
|
|
|
Total |
|
|
|
|
|
|
|
$ |
483,600 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stability Study Payment Schedule
|
|
|
|
|
|
|
|
|
Invoice Issue |
|
|
|
Amount Due |
|
Invoice Date |
Date |
|
|
|
|
|
and # |
|
TBC
|
|
Initiation Fee (non-refundable
up to three (3) months)
|
|
$ |
7,400 |
|
|
|
|
TBC
|
|
6th month pull points
|
|
$ |
7,400 |
|
|
|
|
TBC
|
|
9th month pull point
|
|
$ |
3,700 |
|
|
|
|
TBC
|
|
12th month pull point
|
|
$ |
3,700 |
|
|
|
|
TBC
|
|
18th month pull point
|
|
$ |
3,700 |
|
|
|
|
TBC
|
|
24th month pull point
|
|
$ |
3,700 |
|
|
|
|
Total
|
|
|
|
$ |
29,600 |
|
|
|
|
In addition to the above costs, CPP shall pay to PII upon receipt of PIIs invoice by CPP
for all non-capital materials (excipients, packaging components, HPLC columns, analytical
standards, microbial testing and tooling) used in the study at cost plus 10%. PII shall
obtain CPPs prior written approval for any expenditure greater than $5,000. For high priced
items more than $5,000, PII will charge cost plus 5% to CPP. PII shall
|
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|
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|
|
12CAT01.04
|
|
May 10, 2006
|
|
Page l5 of 22 |
invoice CPP for all reasonable and normal out-of pocket travel related expenses, including airfare,
room & board, car rental and the like, of PII during any technology transfer phase or project
update meetings requested in advance by CPP. Shipments outside of Service Contract work scope will
be invoiced as per the following:
a) |
|
Shipment requests with three (3) days notice will be charged at $500 plus shipping
costs and a 10% service charge on shipping. |
|
b) |
|
Shipment requests with two (2) days notice will be charged at $1,000 plus
shipping costs and a 10% service charge on shipping. |
|
c) |
|
Shipment requests with twenty-four (24) hours notice will be charged at $1,500
plus shipping costs and a 10% service charge on shipping. |
|
|
|
|
|
|
|
|
|
|
12CAT01.04
|
|
May 10, 2006
|
|
Page 16 of 22 |
1. CONFIDENTIALITY
The parties acknowledge that the Confidentiality Agreement between the parties dated
March 25, 2005 (the Confidentiality Agreement) shall continue to govern the parties respective
obligations to one another with regard to the confidential information each has disclosed to the
other and shall continue to disclose to the other in connection with this Agreement. The parties
respective obligations with regard to any such confidential information shall survive the
termination of this Agreement in accordance with the terms of the Confidentiality Agreement.
2. OWNERSHIP OF MATERIALS AND INFORMATION
All data, information, reports and any and all related documentation, which are developed,
generated or derived, directly or indirectly, by PII (or by any subcontractor or agent of PII) for
Catalyst Pharmaceutical Partners during the course of this Agreement (the Data), and all
inventions, discoveries, formulae, procedures, any other intellectual property, and any
improvements thereto, whether patentable or not, which result or evolve directly, during the
course of this Agreement or as a result of the services performed hereunder by PII (or by any
subcontractor or agent or PII) (together with any Data relating thereto, the Inventions), shall
be and remain the sole and exclusive property of Catalyst Pharmaceutical Partners if related to
the Product; provided, however, any Inventions made, developed or discovered solely by PII (or by
any subcontractor or agent of PII) that constitute an invention, improvement or other intellectual
property relating to drug delivery technology, formulation, analysis or manufacturing process of
pharmaceutical products (together with any Data relating thereto, PII Inventions), shall be and
remain the property of PII, and PII hereby grants to Catalyst Pharmaceutical Partners a
royalty-free, exclusive license to develop, use, manufacture and sell such PII Inventions in
connection with the development, use, manufacture and sale of the Product. Except as specifically
set forth herein, neither PII nor its employees or agents shall have or acquire any right, title
or interest in Inventions. If related to the Product, PII shall promptly disclose in writing to
Catalyst Pharmaceutical Partners any Inventions. If related to the Product and to the extent not
PII Inventions, PII shall assign any and all rights in any Inventions to Catalyst Pharmaceutical
Partners and shall assist Catalyst Pharmaceutical Partners, at no cost to PII, in perfecting its
rights in such Inventions.
3. TERMINATION
Catalyst Pharmaceutical Partners, but not PII, may terminate this Agreement at any time and for
any reason at the sole discretion of Catalyst Pharmaceutical Partners upon thirty (30) days
advance written notice to PII. Upon such termination, Catalyst Pharmaceutical Partners shall pay
all costs incurred by PII for work performed prior to the effective date of termination, provided
PII provides written evidence that such costs have been incurred and such work performed. PII may
terminate this Agreement if Catalyst Pharmaceutical Partners is in default of any of its material
obligations set forth herein, and such alleged breach is not cured
|
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|
|
|
|
|
|
|
12CAT01.04
|
|
May 10, 2006
|
|
Page 17 of 22 |
within thirty (30) days after written notice of such alleged breach is provided to Catalyst
Pharmaceutical Partners with reasonable detail of the alleged breach, which time period shall be
reduced to ten (10) days for any default of any monetary obligation.
4. NOTIFICATION OF SUB-CONTRACT LABS
Insofar as PII anticipates using contract laboratories for some of the activities described in
this Agreement, PII shall notify Catalyst Pharmaceutical Partners when use of such contract
laboratories becomes necessary. PII shall be responsible for assuring that any contract lab used
complies with Good Laboratory Practices. PII will be responsible for all laboratory work provided
by contract labs
5. WARRANTIES
PII warrants and covenants that it will perform all of its obligations under this Agreement in
accordance with all applicable laws and regulations. Without limiting the generality of the
foregoing, PII warrants and covenants that all CTM will meet the Specifications and will have been
produced in compliance with cGMPs. Except as specifically set forth in this Agreement, PII
DISCLAIMS ALL EXPRESS OR IMPLIED WARRANTIES AND COVENANTS, STATUTORY OR OTHERWISE, CONCERNING THE
DELIVERABLES. WITHOUT LIMITING THE FOREGOING, PII MAKES NO IMPLIED WARRANTY OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE REGARDING THE DELIVERABLES.
6. ACCEPTANCES OF SHIPMENTS; NON-CONFORMANCE
For each shipment hereunder, PII shall provide a Certificate of Analysis and within thirty (30)
days following delivery to Catalyst Pharmaceutical Partners, Catalyst Pharmaceutical Partners
shall have the right to give PII notice of rejection of any shipment that, in whole or part, fails
to meet Specifications or which otherwise breaches PIIs warranties set forth herein. Catalyst
Pharmaceutical Partners shall at all times supply PII with any evidence it has that relates to
whether any Product delivered to Catalyst Pharmaceutical Partners by PII is non-conforming as
contemplated hereunder. Failure by Catalyst Pharmaceutical Partners to give timely notice of
rejection shall constitute acceptance by it of the shipment to which the notice of rejection would
have otherwise applied. In the event of any disagreement between PII and Catalyst Pharmaceutical
Partners relating to Product conformance with Specifications or PIIs warranties set forth herein,
the parties will use best good faith efforts to reach an amicable resolution of such disagreement.
In the event that resolution cannot be reached, a mutually agreed upon, neutral, independent third
party laboratory shall be brought in to resolve the disagreement upon the request of either party.
The results of the independent laboratory shall be binding on the parties and non-appealable, and
the cost of such independent laboratory shall be borne by the party hereunder determined by the
independent laboratory to be the non-prevailing party in such disagreement. For any Product
properly rejected pursuant to this Section, such Product shall be returned by Catalyst
Pharmaceutical Partners to PII at PIIs expense and shall be replaced by PII at no extra charge to
Catalyst Pharmaceutical Partners. In the event PII cannot replace such defective Product, it
shall
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|
12CATO1.04
|
|
May 10, 2006
|
|
Page 18 of 22 |
refund to Catalyst Pharmaceutical Partners the amount paid therefore.
7. INDEMNIFICATION
(a) Catalyst Pharmaceutical Partners agrees to indemnify, defend and hold harmless
PII, its stockholders, directors, officers, employees and agents from and against any and all
claims, losses, liabilities, lawsuits, proceedings, costs and expenses, including without
limitation, reasonable attorneys fees and the cost of recalls arising out of or in connection
with: (i) injuries and/or death to humans resulting from the use of any materials provided to
PII by Catalyst Pharmaceutical Partners (including all manufactured products or materials
resulting from the provision of PIIs services hereunder), including, without limitation,
claims based on negligence, warranty, strict liability or any other theory of product liability or a
violation of applicable laws or regulations, except to the extent that such injuries or
violations are the result of PIIs negligence or willful misconduct in performing the services
hereunder or breach of any covenant or agreement hereunder, (ii) negligence or willful
misconduct in advertising, labeling, or improper handling and storage by any person other
than PII, (iii) any specifications provided by Catalyst Pharmaceutical Partners that are
incorrect or do not meet FDA approved specifications, or other instructions given by Catalyst
Pharmaceutical Partners in connection with any materials provided to PII by Catalyst
Pharmaceutical Partners or PIIs services provided hereunder, (iv) any misrepresentation by
Catalyst Pharmaceutical Partners or breach by Catalyst Pharmaceutical Partners of any
covenant or agreement hereunder or (v) patent infringement relating to any materials
provided to PII by Catalyst Pharmaceutical Partners or PIIs services provided hereunder to
the extent that such infringement does not arise as a result of a breach of any representation
or warranty of PII hereunder.
(b) PII shall indemnify and hold harmless Catalyst Pharmaceutical Partners and
Catalyst Pharmaceutical Partners affiliates, and its and their stockholders, directors,
officers, employees and agents from and against any and all claims, losses, liabilities, lawsuits,
proceedings, costs and expenses, including without limitation, reasonable attorneys fees and
the cost of recalls arising out of or in connection with: (i) any negligence or willful
misconduct of PII in performing the services hereunder, (ii) any misrepresentation by PII or
breach by PII of any covenant or agreement hereunder, or (iii) any claim asserted by a third
party that PII in performing the services hereunder has infringed or misappropriated any
proprietary or confidential information or intellectual property rights of such third party,
except as relate to any materials, specifications or instructions provided to PII by Catalyst
Pharmaceutical Partners.
(c) In no event shall either party be liable to the other for indirect damages or
consequential damages, including without limitation, lost profits or revenues.
|
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|
|
12CAT01.04
|
|
May 10,2006
|
|
Page l9 of 22 |
Failure of any party to perform its obligations under this Agreement (except the obligation to make
payments) shall not subject such party to any liability or place it in breach of any term or
condition of this Agreement to the other party if such failure is caused by any cause beyond the
reasonable control of such non-performing party, including, without limitation, acts of God, fire,
explosion, flood, drought, war, riot, sabotage, embargo, interruption of or delay in
transportation, a national health emergency or compliance with any order or regulation of any
government entity acting with color of right.
This Agreement shall be governed by and construed in accordance with the laws of the State of
Maryland (exclusive of its conflicts of laws provisions).
10. DISPUTES; ARBITRATION
(a) Except as provided in clause (c) below or in Section 6 with respect to disputes
regarding non-conforming shipments, all disputes, controversies or claims arising out of or
relating to the operation or interpretation of this Agreement shall be resolved by arbitration
before one arbitrator in accordance with the Commercial Rules of the American Arbitration
Association. The arbitrator shall be jointly selected by the parties. Any award rendered by
the arbitrator shall be final and binding upon the parties and judgment upon any such award
may be entered in any court having jurisdiction thereof. Arbitration shall be conducted in
Baltimore, Maryland.
(b) The arbitrator shall award attorneys fees and other costs of the arbitration,
including the fees and expenses of the arbitrator, to the prevailing party, as determined by the
arbitrator.
(c) Notwithstanding anything to the contrary contained in this Section, in the event of
any breach or threatened breach of this Agreement by either party that the other party
believes will cause irreparable harm and damage to it, such party shall be entitled to an
injunction, restraining order restraining such breach or threatened breach by the other party
and all other remedies which shall be available to it at law or in equity and the parties
irrevocably submit to the jurisdiction of any state or federal court sitting in the State of
Maryland over any such suit, action or proceeding. Catalyst Pharmaceutical Partners
irrevocably waives, to the fullest extent permitted by law, any objection that it may now or
hereafter have to the laying of the venue of any such suit, action or proceeding brought in any
such court and any claim that any such suit, action or proceeding brought in any such court
has been brought in an inconvenient forum.
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12CAT01.04
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May 10, 2006
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Page 20 of 22 |
11. NON-SOLICITATION AND HIRING
During the term of this Agreement and for a period of two (2) years thereafter, regardless of the
reason for such termination, neither party will, directly or indirectly, without the prior written
consent of the other party, solicit or hire, as an employee or independent contractor, any person
who is, or was at any time, employed by or under contract with the other party, unless at the time
of the solicitation or hiring, at least one (1) year shall have elapsed since the person was last
employed by or under contract with the other party.
12. MISCELLANEOUS
(a) Waiver; Integration; Modification. The waiver of the breach of any term or
provision of this Agreement shall not operate as or be construed to be a waiver of any other
or subsequent breach of this Agreement. This Agreement sets forth the entire agreement
between the parties with respect to the subject matter of this Agreement and merges and
supersedes all prior discussions, agreements and understandings of every nature between
them. No modification or amendment to this Agreement or any other agreement with respect
to the subject matter of this Agreement shall be effective unless stated in writing and signed
by the parties.
(b) Construction. Whenever the context may require, the singular form of names
and pronouns shall include the plural and vice-versa. The section and subsection headings
are included solely for the convenience of the parties and shall not be used in the
interpretation of this Agreement. No rule of construction shall apply to this Agreement that
construes any language, whether ambiguous, unclear or otherwise, in favor of or against any
party based on the party that drafted such language.
(c) Counterparts. This Agreement may be executed in any number of
counterparts, and each such counterpart shall be deemed to be an original instrument, but all
such counterparts together shall constitute but one agreement.
(d) Survival. No termination or expiration of this Agreement shall relieve the
parties hereto of any obligation hereunder which by their terms are intended to or may
survive the termination or expiration of this Agreement.
(e) Relationship Between Parties. PIIs relationship to Catalyst Pharmaceutical
Partners shall be that of an independent contractor. No persons engaged by PII shall be
considered under the provisions of this Agreement or otherwise as an employee of Catalyst
Pharmaceutical Partners. Nothing contained in this Agreement shall create or imply the
creation of a partnership between Catalyst Pharmaceutical Partners and PII and neither party
shall have any authority (actual or apparent) to bind the other.
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12CAT01.04
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May 10, 2006
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Page 21 of 22 |
AGREED AND ACCEPTED
Pharmaceutics International, Inc.
/s/ Syed E. Abidi, Ph.D.
Syed E. Abidi, Ph.D.
President and CEO
Catalyst Pharmaceutical Partners
/s/
Patric J. McEnany
Authorized Agent or Representative
Title CEO
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Billing Contact: |
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E. DIAZ |
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Address: |
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220 MIRACLE MILE #234 |
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City, State, Zip: |
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CORAL GABLES, FL 33134 |
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Phone: |
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305.529.2522 |
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Fax: |
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305.529.0933 |
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Email Address: |
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mcenany@bellsouth.net |
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PO Number: |
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109 |
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12CAT01.04
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May 10,2006
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Page 22 of 22 |
EX-23.1 Consent of Grant Thornton LLP
Exhibit 23.1
CONSENT OF INDEPENDENT
REGISTERED PUBLIC ACCOUNTING FIRM
We have issued our report dated July 24, 2006, accompanying the financial statements of Catalyst
Pharmaceutical Partners, Inc. (a Development Stage Company) contained in the Registration Statement
and Prospectus. We consent to the use of the aforementioned report in the Registration Statement
and Prospectus, and to the use of our name as it appears under the caption Experts.
/s/ Grant
Thornton LLP
Miami, Florida
August 31, 2006
SEC Response Letter
September
1, 2006
VIA
FEDERAL EXPRESS AND EDGAR SUBMISSION
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E., Mail Stop 6010
Washington, DC 20549
Attn: Jeffrey Reidler, Assistant Director
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Re:
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Catalyst Pharmaceutical Partners, Inc.
Registration Statement on Form S-1
Commission File No. 333-136039 |
Dear Mr. Reidler:
We
are responding to the comments contained in your letter to Patrick J. McEnany, Chief Executive
Officer of Catalyst Pharmaceutical Partners, Inc., dated August 17, 2006. The comments should be
read in connection with the enclosed copy of Amendment No. 1. filed on the date hereof (the
Amendment), which has been marked to show changes to the Registrants Registration Statement on
Form S-1 filed on July 25, 2006. We refer to Catalyst
Pharmaceutical Partners, Inc. as the Registrant.
Comments Applicable to the Entire Prospectus
1. |
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Please provide us with proofs of all graphic, visual or photographic information you will
provide in the printed prospectus prior to its use, for example in a preliminary prospectus.
Please note that we may have comments regarding these materials. |
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Issuers Response |
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The Registrant does not currently intend to include pictures, graphics, or visuals in its
printed prospectus, but understands that if it decides to add pictures, graphics, or visuals
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Securities and Exchange Commission
September 1, 2006
Page 2
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to its printed prospectus, it will need to provide such pictures, graphics or visuals to the staff
for their review and comment before distributing such printed prospectus. |
2. |
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Please note that when you file a pre-effective amendment containing pricing-related
information, we may have additional comments. As you are likely aware you must file this
amendment prior to circulating the prospectus. |
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Issuers Response |
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The Registrant is aware of its obligation to file an amendment containing pricing-related
information before circulating a preliminary prospectus. |
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3. |
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Please note that when you file a pre-effective amendment that includes your price range, it
must be bona-fide. We interpret this to mean that your range may not exceed $2 if you price
below $20 and 10% if you price above $20. |
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Issuers Response |
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The Registrant understands that its price range must be bona fide. The Registrant also
understands the staffs views on this issue. |
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Please note that where we provide examples to illustrate what we mean by our comments, they
are examples and not complete lists. If our comments are applicable to portions of the filing
that we have not cited as examples, please make the appropriate changes in accordance with our
comments. |
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Issuers Response |
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The Registrant understands that comments to one section of the Registration Statement may have
applicability to other sections, and the Registrant has made all such changes as applicable. |
General
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Please provide a current signed and dated consent from your independent accountants in the
amendment for which effectiveness will be requested. |
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Issuers Response |
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The Registrant understands that a current signed and dated consent from its registered
independent public accounting firm will be required to be included in any amendment to the
Registration Statement for which effectiveness will be requested, and
the Registrant will comply with this
request. |
Securities and Exchange Commission
September 1, 2006
Page 3
______________________________
Prospectus Summary, page 1
6. |
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Throughout the document, including in your Business section, you reference several industry
sources and various statistics and other figures, including statements relating to the market
in which you expect your products to compete. Please provide us with copies of the sources in
which you obtained the statistical and other figures. Those copies should be marked to
indicate the information supporting your statements. |
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Issuers Response |
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On behalf of the Registrant, we have already provided the staff supplementally with copies
of the source materials referred to in the registration statement. As requested, we have
marked such materials with the information supporting all such statements. |
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7. |
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We note your disclosure of the results of your clinical trials throughout this section and in
your Business section. Please revise your discussions to include appropriate caveats
indicating that the results do not provide enough evidence regarding efficacy or safety to
support an application with the FDA, that additional tests will be conducted and that subsequent
results often do not corroborate earlier results. |
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Issuers Response |
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The Registrant has modified its disclosure throughout the Registration Statement regarding
the two pilot studies conducted in Mexico in 2003 and 2004 to reflect that such studies do
not provide enough evidence regarding safety and efficacy to support
an NDA filing for CPP-109 with the
FDA, and that the results of subsequent clinical trials may not corroborate earlier results. |
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8. |
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You indicate that you intend a merger with your predecessor, Catalyst Pharmaceutical
Partners, Inc., a Florida company incorporated in 2002, prior to the completion of the
offering where you will succeed to all of its assets, liabilities, rights and operations.
Please indicate specifically when this merger will occur in an appropriate section of your
document. Please also explain why you and not your predecessor proceeded with this IPO? You
should provide similar information in your Business section. |
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Issuers Response |
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The Registrant has stated in its prospectus that prior to completing its initial public
offering it intends to reincorporate in Delaware through a merger (the Merger) of Catalyst
Pharmaceutical Partners, a Florida corporation (Catalyst Florida) with and into the
Registrant, Catalyst Pharmaceutical Partners, Inc., a Delaware corporation. Upon
effectiveness of the Merger, the Registrant, which is currently a wholly-owned subsidiary
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Securities and Exchange Commission
September 1, 2006
Page 4
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of Catalyst Florida, will succeed to the assets, liabilities, rights and obligations of
Catalyst Florida. The Registrant elected to file its Registration
Statement prior to completion of the Merger based on its expectation that
the Merger would be completed before its Registration Statement
became effective. |
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The Registrant was organized on July 21, 2006 and Catalyst Florida was organized on January
4, 2002. As of August 14, 2006: (i) the Board of Directors and sole stockholder of the
Registrant had approved the Agreement and Plan of Merger (the Merger Agreement) between
Catalyst Florida and the Registrant under which Catalyst Florida will be merged with and
into the Registrant effective upon the filing of Articles of Merger and a Certificate of
Merger with the appropriate authorities in Florida and Delaware, respectively, and (ii) the
Board of Directors and the holders of more than the requisite number of outstanding
securities of Catalyst Florida (voting as a single voting group and acting by written
consent) required to approve the Merger had approved the Merger and the Merger Agreement.
Further, as of August 16, 2006, the Catalyst Florida shareholders who did not consent to the
Merger had been given notice of the Merger in accordance with applicable Florida law. Once
the applicable period for Catalyst Floridas shareholders to dissent from the Merger has
lapsed (close of business on September 5, 2006), the Registrant and Catalyst Florida will
file Articles of Merger and a Certificate of Merger with the appropriate authorities in
Florida and Delaware, respectively, and the Merger will become effective. The Merger is
expected to become effective on or about September 6, 2006. |
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Information setting forth the details of the Merger has been added, where appropriate, to
the text of the Registration Statement. |
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9. |
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You also indicate that you intend to reincorporate in Delaware in the near future. Please
indicate when you expect the reincorporation will occur in an appropriate section of your
document. |
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Issuers Response |
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See response to Question 8. |
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10. |
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You indicate in this section that you intend to commence a Phase II study during the fourth
quarter of 2006 for the treatment of cocaine addiction which may provide potential efficacy
data supporting the filing of an NDA. Please provide additional disclosure regarding the
possible necessity of you having to conduct at least one Phase III trial. If you do not
believe you will need to conduct a Phase III trial, please disclose your basis for that belief
and any process you will have to undergo conditions you would have to satisfy to avoid the
necessity of a Phase III trial. |
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Issuers Response |
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The Registrant has added language to the text of the Summary
on page 4 to discuss the likely need for
additional clinical studies, including a U.S. Phase III clinical trial, before the
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Securities and Exchange Commission
September 1, 2006
Page 5
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Registrant is able to file and obtain approval of an NDA for CPP-109. Similar language has
been added to Overview on page 40 of the Business section. |
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11. |
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We note the disclosure you make regarding your ongoing 100 patient study for cocaine
addiction and 10 patient study related to reduction of cocaine cravings. Please explain
briefly why these studies are being conducted and what phase these studies belong to, if any,
and what the studies are designed to show. You should also provide more detailed disclosure on
page 43. |
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Issuers Response |
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The Registrant has added language in the Business section of
its Registration Statement on page 46
describing its reasons for supporting investigator studies, including the 100 patient
Mexican study described in the Summary at page 5 and in the Business
section on page 46, and
describing the relevancy of such studies to the Registrants product development efforts. The Registrant
has also deleted references throughout the text of the prospectus to the proposed cocaine
craving study being undertaken by Dr. Haney of Columbia University, since Dr. Haney did not
receive the funding that she expected to receive from the National Institute on Drug Abuse
to fund the study, and therefore her proposed study is not expected to move forward. |
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12. |
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We also note disclosure you make regarding observed results of two open label pilot studies
you completed in Mexico during 2003 and 2004. You should relocate these results to page 44
where you can also put them in context by disclosing whether the results have been subject to
any type of statistical analysis and, if so, whether the results of trial were statistically
significant. In addition, the degree of statistical significance or the P value should be
disclosed. |
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Issuers Response |
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The Registrant has added language in the Summary
on pages 4 and 5 and in the Business section on pages 47 through
50 to better explain the details of the pilot studies and their significance. The Registrant
has also added cautionary language to the text describing the pilot
studies to make clear that the pilot studies are not sufficient
to support an NDA filing and that the results of the pilot studies may not be duplicated in
future studies. Notwithstanding, the Registrant believes the results of the pilot studies
were very supportive of the efficacy of using vigabatrin to treat cocaine and
methamphetamine addiction and were statistically significant. As a result, the Registrant
believes that the discussion on the pilot studies belongs in both the Summary and the
Business section. The Registrant has also expanded its discussion of the pilot studies in
both the Summary and the Business section to provide relevant published information about
the pilot studies. In that regard, copies of the articles that appeared in Synapse,
a peer-reviwed medical journal focused on the structure and study of synaptic function, that describes
the pilot studies have already been sent to the staff supplementally. |
Securities and Exchange Commission
September 1, 2006
Page 6
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Our Business Strategy, page 4
13. |
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We note your summary of the primary goals for your company for the future. Please balance the
discussion of your strategy in the summary with a discussion of obstacles implementing the
stated goals. |
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Issuers Response |
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The Registrant has added language to the section in the Summary entitled Risks Affecting
Our Business, on page 6 which immediately follows the discussion of our Business Strategy to cover
as appropriate in summary form the risks relating to the implementation of the Registrants stated
goals. |
Risks Affecting Our Business, page 5
14. |
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Please revise the embedded list of risks in bullet format. |
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Issuers Response |
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The list of risks has been placed in bullet form. |
The Offering, page 6
15. |
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We note the disclosure you have in the Use of Proceeds section. Please revise the embedded
list setting forth the net proceeds purposes in bullet point format. |
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Issuers Response |
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The Use of Proceeds discussion is now in bullet form. |
Summary Financial Data, page 6.
16. |
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Please present pro forma net loss per share for the year ended calculated as if all the
convertible preferred stock were converted into common stock as of the beginning of the year
ended December 31, 2005 or from their respective date of issuance, if issued after the
beginning of the year. Please make similar changes to you presentation of Selected Financial
Data on page 29. |
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Issuers Response |
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The Registrant has added to its statement of operations data the pro forma net loss per
share for the year end calculated as if all of the Registrants
Series A Preferred Stock had been
converted into common stock as of the beginning of the year ended December 31, 2005 and for
the six month period ended June 30, 2006. As discussed with
Mr. Sherman of your office on Thursday, August 31, 2006,
since the Registrants Series B Preferred Stock was
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Securities and Exchange Commission
September 1, 2006
Page 7
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not issued until July 2006, no pro forma adjustment is
being made to Statement of Operations with respect to the Series
B Preferred Stock. Similar changes have been made to the Registrants presentation of
Selected Financial Data. |
Risk Factors, page 9.
17. |
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Please delete the statement Additional risks and uncertainties not currently known to us or
that we currently do not deem material may also become important factors that may materially
and adversely affect our business. It is not appropriate to refer to other risks that are not
disclosed. |
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Issuers Response |
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The sentence has been deleted as requested. |
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18. |
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You indicate on page 35 of your Business section that if you are unable to generate a
sufficient amount of revenue to finance your future operations, product development and
regulatory plans, you may seek to raise additional funds through public or private equity
offerings, debt financings, capital lease transactions, corporate collaborations or other
means. You indicate that any sale of additional equity convertible debt securities could
result in dilution to your stockholders. Please consider discussing the dilution risks you may
face in a new separate risk factor. To the extent you do not believe a separate risk factor is
necessary, please provide us with a detailed explanation as to why no separate risk factor
discussion is warranted. |
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Issuers Response |
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Language has been added to the dilution risk factor on page
23 to address this issue. See also the Registrants response to
Comment No. 19. |
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19. |
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Additionally, please consider adding a risk factor discussing your need to raise additional
financing in the future beyond what you intend to raise in the public offering, and the
consequences to your operations if you are not able to raise the additional financing. If you
decide to include this risk factor, please place this risk factor discussion in close
proximity to the risk factor discussion regarding the dilution consequences of you raising
additional financing. If you do not believe a separate risk factor is necessary, please
provide us with a detailed explanation as why no separate risk factor discussion is warranted. |
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Issuers Response |
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A new risk factor has been added on page 23 to address the risk that the Registrant may need
to raise additional capital in the future. As requested, such risk
factor has been placed in close
proximity to the dilution risk factor. This new risk factor also addresses the question
raised by the staff in Comment No. 20. |
Securities and Exchange Commission
September 1, 2006
Page 8
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20. |
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You also indicate on page 35 of your Business section that to the extent you raise additional
funds through collaborative arrangements, it may be necessary to relinquish some rights to
your technologies or grant sublicenses not on terms favorable to you. Please consider
discussing these risks in a new separate risk factor. To the extent you do not believe a
separate risk factor is necessary, please provide us with a detailed explanation as to why no
separate risk factor discussion is warranted. |
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Issuers Response |
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See the Registrants response to Comment No. 19 above. The Registrant believes that the sentence added to the end
of the risk factor discussed in Comment No. 19 is sufficient to deal with this issue, and that a
separate risk factor is not required. |
We are a developmental stage company whose limited operating history..., page 9
21. |
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Please revise this risk factor heading to indicate that your company has no products
available nor have you ever had any products available for commercial sale. |
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Issuers Response |
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The requested language has been added to the risk factor on page 9. |
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22. |
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This risk factor appears to be focused on the difficulties with evaluating your future
performance based on your limited operating history. In that regard, please remove your
discussion relating to risks associated with your ability to manage future growth to the risk
factor entitled We may encounter difficulties in managing our growth, which would adversely
affect our results of operations on page 12. |
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Issuers Response |
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The Registrant has removed the language regarding the management of future growth from this
risk factor and added the information contained in this risk factor to the risk factor on
managing growth on page 14. |
We are subject to product development risks, page 9
We have not received regulatory approval in the United States ..., page 16
If our non-clinical or clinical trials are unsuccessful or significantly ..., page 17
If the FDA does not accept an NDA from us based on the results ..., page 18
23. |
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The above referenced risk factors all appear to contain overlapping disclosures and numerous
risks that warrant separate discussion. Please revise all of the above referenced risk factors
to eliminate all redundant disclosure. Additionally, please revise these risk factors so that
each risk factor contains a header and risk factor discussion that addresses only one risk and the consequences that could result from that
risk. |
Securities and Exchange Commission
September 1, 2006
Page 9
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Issuers Response |
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The risk factors set forth above have been revised as appropriate to eliminate overlapping
disclosures and to make sure, to the extent appropriate, that each risk factor contains only
one risk. |
We rely on third parties to conduct our trials and if they do not...,page 11
24. |
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Please indicate if you have alternative means available if your relationship with the
academic institutions, corporate partners or any of the other third parties terminate. If any
of these parties will be difficult to replace or will cause delays in receiving regulatory
approval, identify party and file any agreements with these parties as exhibits. |
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Issuers Response |
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Language has been added to the risk factor on page 12 to reflect the Registrants belief that suitable
replacements could be found to provide necessary contract services if its relationships with
third parties were terminated. |
We will need to develop marketing, distribution and production..., page 12
25. |
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Please identify the manufacturer that you have entered into the production of CPP-109 for use
in your U.S. Phase II trial as well as if you are successful in obtaining FDA approval to
commercialize this product. Please also describe the material terms of the agreement you have
in your Business section and file the agreement as an exhibit. If you did not believe the
agreement is material to you and therefore not required to be filed, please provide us with a
detailed explanation as to why the agreement is not material to you. |
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Issuers Response |
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The material terms of the Registrants agreement with its contract manufacturer are now
described on page 39 (in MD&A), and a cross reference has been added to the text on page 53 of the
Business section referring the reader to the description of the terms of this agreement. As requested, a copy of
the Registrants agreement with its contract manufacturer has been filed as an exhibit to the
registration statement. |
Securities and Exchange Commission
September 1, 2006
Page 10
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Our business is subject to substantial competition. page 12
26. |
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If you are aware of any specific competition, products in
development or new products that your competitors provide or will soon provide, disclose these competitive
threats and the potential impact of these products or product introductions on your
business. Also, you should consider naming your most relevant competitors whose business
activities could have a material adverse effect on your prospects or business going forward.
If there are too many competitors to name, please disclose the approximate number of
competitors in your target markets. |
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Issuers Response |
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A cross reference has been added to the
Competition risk factor on page 13 to refer
investors to the extensive discussion on potentially competitive products under development contained in the Business
section at pages 50 and 51. |
We have no experience as a public company, and the obligations ..., page 13
27. |
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You indicate that you have a very small accounting department. Please quantify how many
employees you have in this department. |
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Issuers Response |
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The risk factor has been modified to disclose the size of the Registrants accounting staff
and to disclose the Registrants plans to hire an experienced
Controller/Chief Accounting
Officer after completion of the offering. The Registrant has also added disclosure to this risk factor
regarding a material weakness that has been identified in the
Registrants internal controls. |
We are dependent on our relationship and license agreement with ...,page 14
28. |
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Please describe your patents for any key products and the expiration date of such patents. |
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Issuers Response |
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The expiration dates of the issued patents have been added to
the risk factor on page 15. Additionally,
a cross reference has been added to the text of the risk factor so
that readers can review the more
elaborate description of the Registrants licensed patents on
page 52. |
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29. |
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You discuss risks associated with your academic collaborators having certain rights to
publish data and information in which you have rights. In a separate new risk factor, please
discuss the risks and consequences associated with you possibly losing proprietary position a
result of your academic collaborators having certain publishing rights to the data obtained
from clinical studies. If you do not believe a
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Securities and Exchange Commission
September 1, 2006
Page 11
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separate risk factor discussion is warranted, please provide us with a detailed explanation
as to why no separate risk factor discussion is needed. |
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Issuers Response |
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The Registrant does not believe that it will lose any proprietary position as a result of
publication by academic collaborators of data obtained from clinical studies. Thus, the
Registrant has removed the language to that effect from the risk factor. |
We may incur substantial costs as a result of litigation or other ..., page 15
30. |
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Please disclose who has the obligations to take necessary actions to protect patents under
your license agreements with respect to your patents that you received from your license
agreement with Brookhaven. If you do not have the obligation to take action, do you have the
right to take necessary actions if the Brookhaven does not? |
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Issuers Response |
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Under the license agreement between the Registrant and Brookhaven, each party has an
obligation to the other to notify the other of any infringement of the licensed patents of
which they become aware. Neither party has an obligation to institute a suit against any
alleged infringer of the licensed patents. However, the Registrant has the right to bring
such suit, either in its own name or jointly in its own name and in Brookhavens name. In
such a case, the Registrant is responsible under the license agreement for all costs
associated with such suit; however, the Registrant may withhold during the term of any such
legal action any and all royalty payments due to Brookhaven in an equal amount to the costs
of such legal action. The Registrant is entitled to all proceeds that may result from such
suit, after repayment to Brookhaven of withheld royalties. If the Registrant elects to
abandon any such suit after commencing proceedings, it has an obligation to notify
Brookhaven, who may, if it so desires, continue prosecution of such suit. |
|
|
|
The Registrant has added an additional paragraph to its risk factor on IP litigation on page 17 to
discuss this issue. |
|
31. |
|
Please indicate when Ovation Pharmaceuticals announced its intention to seek to develop its
Sabril brand, a formulation of vigabatrin, for the treatment of cocaine addiction. |
|
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Issuers Response |
|
|
|
To the Registrants knowledge, Ovation announced its intention to develop Sabril for the
treatment of cocaine addiction at a UBS Global Specialty Pharmaceuticals Conference in April 2006.
This information has been added to the risk factor on page 17
and to the Competition discussion in the
Business section on page 51. |
Securities and Exchange Commission
September 1, 2006
Page 12
______________________________
If our non-clinical or clinical trials are unsuccessful or significantly...,page 17
32. |
|
You indicate that you may experience difficulties in enrolling patients in your clinical
trials. To the extent you have experienced difficulties in enrolling patients in the past,
please revise your disclosure to briefly explain the difficulties you experienced and the
impact it made on your studies or research project. |
|
|
|
Issuers Response |
|
|
|
Since the Registrant has not yet completed any of its own studies, it does not have specific
experiences of difficulties in enrolling patients in the past. However, the Registrant has
been advised by members of its Scientific Advisory Board that such difficulties are normal
in studies of pharmaceutical products being tested for use in treating addiction. |
We have not conducted any non-clinical testing for CPP-109 and we are... page 18
33. |
|
Please define what carcinogenicity studies mean. |
|
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Issuers Response |
|
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|
The definition of carcinogenicity studies has been added on page 19. |
If the FDA does not accept an NDA from us based on the results or our ... page 18
34. |
|
This risk factor appears to be discussing two risks; one is the risk of not being granted
accelerated approval and other is the risk of being granted accelerated approval and being
required to do post-marketing studies. Each risk factor discussion should only contain
discussion related to one risk and the consequences stemming from it. Please remove your
discussion regarding the potential risks related to your post-marketing studies to the risk
factor entitled post-approval marketing of our products will be subject to substantial
governmental regulation on page 19. |
|
|
|
Issuers Response |
|
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|
The requested changes have been made on pages 19 and 20. |
We are effectively controlled by our Chairman and Chief Executive Officer. page 20
35. |
|
Please indicate how many shares Mr. McEnany will own after the offering. |
Securities and Exchange Commission
September 1, 2006
Page 13
______________________________
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Issuers Response |
|
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|
Information about Mr. McEnanys ownership of shares following the offering has been added on
page 22. |
You will experience immediate and substantial dilution as a result of this ... page 21
36. |
|
Please revise this risk factor to explain that investors who purchase shares will: |
|
|
|
Pay a price per share that substantially exceeds the value of your assets after
subtracting its liabilities; and |
|
|
|
|
Contribute ___% of the total amount to fund the company but will own only ___% of the
outstanding share capital and ___% of the voting rights. |
|
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Issuers Response |
|
|
|
The Registrant has added a cross reference on page 23 to the Dilution section of the prospectus,
which contains all of the requested information regarding the impact of dilution on investors in this
offering. |
Future sales of our common stock may cause our stock price to....page 22
37. |
|
Please indicate how many shares of your common stock will be available immediately for sale
after the offering. |
|
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Issuers Response |
|
|
|
The requested information has been added to the risk factor
on page 24. |
|
38. |
|
Please indicate that some of your shares will be subject to lock-up agreements, which are
generally for a 180 day period. |
|
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|
Issuers Response |
|
|
|
The requested information has been added to the risk factor
on page 24. |
|
39. |
|
You indicate that you intend to register all common stock that you may issue under your 2006
stock option plan as well as stock options previously issued. |
|
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Issuers Response |
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|
The risk factor on page 24 has been revised to reflect that sales of restricted shares, or shares
underlying stock options, may impact the market price of the Registrants common stock. |
Securities and Exchange Commission
September 1, 2006
Page 14
______________________________
We do not intend to pay cash dividends on our common stock in . . . .. page 22
40. |
|
Please be advised that so far as the risk to investors is concerned, this risk states that
you will not pay dividends, which is not a risk by itself to investors. Clearly state that
readers should not rely on investment in your company if they require dividend income and an
income to them would only come from any rise in the market price of your stock, which is
uncertain and unpredictable. |
|
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Issuers Response |
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|
The risk factor on page 24 has been modified to make clear that rises in market price are uncertain and
unpredictable, and to make clear that investors seeking dividend income should not invest in
the Registrants common stock. |
Use of Proceeds, page 24
41. |
|
You disclose that you intend to use the proceeds to begin clinical studies of CPP-109 for
methamphetamine addiction, nicotine additional and European studies. Please state the
estimated total cost of the methamphetamine and nicotine studies and where you plan to obtain
the additional expected sources of funding to compete each of those studies. |
|
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Issuers Response |
|
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|
The discussion in Use of Proceeds on page 26 has been modified to reflect that while the Registrant
will use a portion of the net proceeds of the offering to commence studies relating to the
use of CPP-109 for the treatment of nicotine addiction and relating to its efforts to seek
approval for CPP-109 in Europe (and setting forth the amounts that it
will use for those purposes),
the Registrant does not currently know how much those studies will
ultimately
cost and the Registrant will need to obtain the funding
for these studies through a future financing. Statements to this
effect have been added to the text. |
|
42. |
|
We note the disclosure you provide in the first three bullet points in this section. Please
revise your disclosure to clarify, if true, that these amounts will complete the studies or
activities set forth in the bullets. |
|
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Issuers Response |
|
|
|
As requested, the Registrant has clarified in the text on
page 26 its belief, based on currently available information, that the amounts set forth
in the first four bullets of this section will complete each of these studies or activities. |
|
43. |
|
Please describe which general corporate purposes you plan to use the proceeds from this
offering for. State approximate dollar amount for each. |
Securities and Exchange Commission
September 1, 2006
Page 15
______________________________
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|
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Issuers Response |
|
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|
The Registrant has described the types of general corporate expenses that will be paid from
the proceeds of this offering. |
Capitalization, page 26
44. |
|
Please remove the effect of the automatic conversion of the Series A preferred stock from
your presentation of actual capitalization. It would appear that this effect would be more
appropriately included in the Pro forma basis of presentation. |
|
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Issuers Response |
|
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|
As requested, the Registrant has removed the effect of the automatic conversion of the
Series A Preferred Stock from its presentation of actual capital and added it to the Pro
Forma presentation. |
Dilution, page 27
45. |
|
Please revise to disclose historical net tangible book value and related per share amounts as
of the most recent historical balance sheet date. Please show a separate line into in your
dilution table for the effects of all conversions of preferred stock subsequent to the balance
sheet date. |
|
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Issuers Response |
|
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|
As discussed in my telephone conversation with Mr. Sherman on Thursday, August 31, 2006, the
Registrant believes that it is more meaningful to investors to compare the pro forma net
tangible book value as of June 30, 2006 to the initial offering price, since it accounts for
the effect of the funds raised in a recently completed private placement. The
Registrant also believes that it is not meaningful to provide investors with information
about tangible book value per share without accounting for the full conversion of the Series
A Preferred Stock and the Series B Preferred Stock, considering that the outstanding
preferred shares will automatically convert into shares of common stock on the closing of
the public offering. As a result, no change has been made to this section of the Registration
Statement. |
Managements Discussion and Analysis of Financial Conditions, page 30
Stock-based compensation, page 31
46. |
|
Please tell us and revise your disclosure to clarify apparent contradictory statements
regarding your accounting for employee share-based payments. It appears that you state that
you account for these transactions both under the estimated fair value method and the
intrinsic value method. |
Securities and Exchange Commission
September 1, 2006
Page 16
______________________________
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|
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Issuers Response |
|
|
|
The Registrant has revised its disclosure on page 34 to clarify the contradictory statements about its
accounting for employee share-based payments. |
Contractual Obligations, page 35
47. |
|
Please provide to us managements assessment as to why the payments associated with the
license agreement with Brookhaven and the agreement with Pharmaceuticals International, Inc.
were excluded from the table of contractual obligations. Please refer to Item 303(a)(5) of
Regulation S-K. Please include explanatory footnotes to this table necessary to provide
pertinent data for an understanding of the timing and amount of your specified contractual
obligations as well as those obligations that have been excluded from this table. Please refer
to Financial Reporting Release 72, section IV. |
|
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Issuers Response |
|
|
|
The Registrant has added below the table on page 38 information about each of these payment
obligations. Because these obligations are contingent on the achievement of certain
milestones which will occur in the future, it would be speculative at this time to place the
payments into any particular period. |
Our Business, page 37
48. |
|
To the extent applicable, please include information about compliance with environmental
laws, required by Item 101(c)(1)(xii) of Regulation S-K. Additionally, if you are subject to
any environmental laws, please consider adding a risk factor discussing the risks and
consequences of activities dealing with any environmentally hazardous materials. If you are
not subject to any environmental laws, please briefly explain to us why you are not subject to
such laws. |
|
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Issuers Response |
|
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|
Because the Registrant intends to manufacture its products using the services of a contract
manufacturer, it believes that the contract manufacturer will be responsible for compliance
with environmental laws in its manufacturing operations. Language has
been added on page 53 to this effect. |
Securities and Exchange Commission
September 1, 2006
Page 17
______________________________
Overview, page 37
49. |
|
You also indicate that you intend to conduct clinical trials for cocaine addiction in Mexico,
which you anticipate will begin the third quarter of 2006. Please clarify the extent to which
the FDA will allow you to rely on the results of these trials in support of a new drug application. If the FDA requires that you perform additional testing
or is likely to disregard any of these studies, please revise to disclose. |
|
|
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Issuers Response |
|
|
|
The Registrant has been advised by the FDA in writing that the FDA may consider the Mexican
study as clinical support for an NDA filing by the Registrant. |
|
50. |
|
We note your discussion of your Fast Track status by the FDA for your CPP-149 product. Please
revise your disclosure to clarify that the Fast Track status does not mean you may eliminate
any phases of clinical study. Please also state how the Fast Track status facilitates the drug
development and regulatory review process. We note you have provided the disclosure related to
how the Fast Track status facilitates the drug development and regulatory review process in
the regulatory section of your document. |
|
|
|
Issuers Response |
|
|
|
The discussion on fast track status in the Summary on
page 4 and in the Overview section of Our
Business on page 40 have been modified to make clear that Fast Track status does not mean that the
regulatory requirements necessary to obtain a product approval are less stringent and to
make clear that Fast Track status may be withdrawn at any time. |
Our Clinical Research, page 41
51. |
|
We note your disclosure in this section well as throughout your document regarding the safety
aspect related to the potential side effects of VFDs and the use of vigabatrin. Please
indicate whether any Phase I studies were conducted by you. If not, please revise your
disclosure to explain why no Phase I was required. |
|
|
|
Issuers Response |
|
|
|
While the Registrant will ultimately need to provide the FDA with evidence sufficient to
demonstrate that CPP-109 is safe, which is the primary purpose of a Phase I trial, because
Sabril has been on the market for many years outside the United States, has been well
tolerated in its use and, except for the issue of VFDs, which has been widely reported on by
the scientific community, has shown no significant adverse side effects, the Registrant
believes that a Phase I clinical trial may not ultimately be necessary. However, the Registrant has
included within the funds allocated for the clinical and non-clinical studies that it expects to fund with the
proceeds of this offering other studies that may be required,
including, if needed, a Phase I clinical
trial. |
Securities and Exchange Commission
September 1, 2006
Page 18
______________________________
Pilot Studies, page 43
52. |
|
We note your disclosure in this section where you provide the results of earlier or completed
studies as well as observed effects from these studies. Please disclose whether the results
have been subject to any type of statistical analysis and, if so, whether the results of the
trial were statistically significant. In addition, the degree of statistical significance or
the P value should be disclosed. |
|
|
|
Issuers Response |
|
|
|
See the Registrants response to Comment 12.
Additionally, information has been added to the discussion about the
pilot studies as to the statistical
significance of the studies. |
Brookhaven License Agreement, page 46
53. |
|
Please disclose the amounts you have made or incurred to date under agreement with
Brookhaven. |
|
|
|
Issuers Response |
|
|
|
The requested information has been added on page 52. |
Manufacturing, Marketing and Reimbursement, page 47
54. |
|
You indicate that since the composition of matter patent for vigabatrin has expired, you are
free to manufacture CPP-109 subject to the receipt of necessary regulatory approvals. Please
explain what regulatory approvals you will need to manufacture CPP-109 or what your
manufacturers will need to comply with in order to produce vigabatrin. |
|
|
|
Issuers Response |
|
|
|
In order to commercialize CPP-109, the Registrant will need to obtain approval of an NDA for CPP-109. Further, its contract
manufacturer will need to show compliance with cGMP in its manufacturing operation. All such
matters are disclosed in numerous places in the registration statement. |
Current and historic compensation paid to executives and consultants, page 57
55. |
|
Please provide in tabular format the executive compensation information required by Item
402(b) of Regulation S-K in addition to the narrative information you have provided regarding
executive compensation. |
|
|
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Issuers Response |
|
|
|
As discussed in my conversation with Song Brandon on August 30, 2006, because the
Registrants Chief Executive Officer received no compensation in 2002, 2003, 2004 or 2005,
and the Registrants Chief Financial Officer was a consultant receiving the
|
Securities and Exchange Commission
September 1, 2006
Page 19
______________________________
|
|
compensation described on page 64 of the prospectus, the Registrant does not believe that
the chart required by Item 402 of Regulation S-K provides meaningful information to investors, and has therefore elected to exclude
it. As discussed, the language on page 63
has been clarified to make clear that Mr. McEnany received no compensation during 2002,
2003, 2004 or 2005 (other than the payment of his health insurance benefits which
cost the Registrant less than $10,000 per annum). |
|
56. |
|
Please file each consulting agreement you have with your members of your scientific board.
Please also provide the material terms of each such agreement. If you do not believe these
agreements are material to you and therefore, not required are to be filed, please provide us
with a detailed explanation as to why they are not material. |
|
|
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Issuers Response |
|
|
|
The Registrant has already disclosed the material terms of
its arrangements with various members of its Scientific Advisory
Board and has filed all of its
agreement as exhibits to the Registration Statement. Not all members of the Scientific
Advisory Board have written agreements with the Registrant. |
Notice to Investors, page 73
57. |
|
Please identify each member state of the European Economic Area. |
|
|
|
Issuers Response |
|
|
|
The requested information has been included on page 81. |
Exhibits
58. |
|
Please file your remaining exhibits, including the legal opinion with your next amendment or
as soon as it becomes available as we will review it prior to granting effectiveness of the
registration statement. |
|
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Issuers Response |
|
|
|
Additional exhibits have been filed with this Amendment No. 1. The Registrant understands
that all exhibits, including our firms legal opinion, must be filed prior to granting
effectiveness of the Registration Statement. |
Signature Page
59. |
|
Your principal financial officer and either a controller or chief accounting officer must
sign the registration statement. Your next amendment and all subsequent amendments must
contain this signature. If a person acts in more than one of these
|
Securities and Exchange Commission
September 1, 2006
Page 20
______________________________
|
|
capacities, the signature page must indicate all of the capacities in which they are
signing. Please revise your signature page accordingly. |
|
|
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Issuers Response |
|
|
|
The signature pages have been modified to reflect that Jack Weinstein is executing the
Registration Statement in his capacity as both the Chief Financial Officer and Chief
Accounting Officer of the Registrant. |
Financial Statements
Statements of Operations, page F-4
60. |
|
Please revise your income statement presentation to classify non-cash compensation in the
same line or lines as cash compensation paid to the same employees. Refer to SAB Topic 14.F. |
|
|
|
Issuers Response |
|
|
|
The Income Statement has been modified to classify the non-cash compensation expense in the
same line as the cash compensation expense payable to the same employee. |
Notes to Financial Statements
2. Basis of Presentation and Significant Accounting Policies
g. Stock Based Compensation, page F-8
61. |
|
Please provide the disclosures required by paragraph 45c of SFAS 123, Accounting for
Stock-Based Compensation. |
|
|
|
Issuers Response |
|
|
|
The financial statement disclosures have been modified to include in tabular format the
disclosures required by paragraph 45c of SFAS 123. |
4. Lease Obligations, page F-9
62. |
|
It appears that your minimum lease payments escalate throughout the term of your lease. As
such, please disclose the amount of your deferred rent liability as of December 31, 2005. |
|
|
|
Issuers Response |
|
|
|
A sentence has been added to Note 4 on page F-10 stating that the Registrants deferred rent
liability as of December 31, 2005 was immaterial. |
Securities and Exchange Commission
September 1, 2006
Page 21
______________________________
5. Accrued Expenses, page F-10
63. |
|
Please describe to us the transactions that required the recognition of the common stock
payable as of December 31, 2005 and 2004 and why this accounting treatment and presentation is
deemed appropriate. Please cite the appropriate accounting literature management relied upon.
Please specifically tell us whether this transaction has resulted in any change to the amount
of common stock outstanding as of December 31, 2005 and 2004 and/or the calculation of net
loss per share. |
|
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Issuers Response |
|
|
|
In 2005 and 2004, the Registrant entered into consulting agreements with non-employees for
services that required it to pay consideration of cash and common stock in quarterly
installments. In accordance with EITF 96-18 Accounting for Equity Instruments That Are
Issued to Other Than Employees for Acquiring, or in Conjunction with Selling, Goods or
Services, as the common stock was not formally issued until July 2006, the Registrant
recognized a liability for these transactions as of December 31, 2005 and 2004, rather than
recording the transactions through equity. These transactions did not result in a change in
common stock during the respective reporting periods as the common stock was not issued
until July 2006. Net loss and the loss per share basic and diluted were reduced by
$105,000 and $0.02, respectively, in 2005 and $20,000 and $0.01,
respectively, in 2004, as a
result of these transactions. |
9. Stock Options Granted, page F-1 1
64. |
|
In order for us to fully understand the equity fair market valuations reflected in your
financial statements, please provide an itemized chronological schedule covering all equity
instruments issued since January 1, 2005 through the date of your response. Please provide the
following information separately for each equity issuance: |
|
a. |
|
The date of the transaction; |
|
|
b. |
|
The number of shares/options issued/granted; |
|
|
c. |
|
The exercise price or per share amount paid; |
|
|
d. |
|
Managements fair market value per share estimate and how the estimate was
made; |
|
|
e. |
|
An explanation of how the fair value of the convertible preferred stock and
common stock relate, given the one for one conversion ratio; |
|
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f. |
|
The identity of the recipient, indicating if the recipient was a related party; |
|
|
g. |
|
Nature and terms of concurrent transactions; and, |
Securities and Exchange Commission
September 1, 2006
Page 22
______________________________
|
h. |
|
The amount of any compensation or interest expense element. |
|
|
|
|
Progressively bridge managements fair market value determinations to the current estimated
IPO price range. Please reconcile and explain the differences between the mid-point of your
estimated offering price range and the fair values included in your analysis. |
|
|
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|
Issuers Response |
|
|
|
|
The following sets forth the securities that the Registrant has issued or agreed to issue
since January 1, 2005: |
|
|
|
In October 2004, the Registrant entered into a Consulting Agreement with Jack
Weinstein under which the Registrant agreed to grant Mr. Weinstein a stock option to
purchase 150,000 shares of the Registrants common stock, vesting 50,000 shares
immediately, 50,000 shares in October 2005 and 50,000 shares upon completion of a
financing of at least $3 million. The option exercise price of the first two tranches
of options was $2.00 per share and the option exercise price of the last tranche of
options was the price at which the financing is completed. At the time that the
Consulting Agreement was entered into, Mr. Weinstein was not a related party. |
|
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|
The $2.00 per share price was the amount that the Registrant believed at the time and
throughout 2005 and into the first quarter of 2006 to be the fair market value of its common and
common equivalent shares (shares of common stock issuable upon the
conversion of the outstanding Series A
Preferred Stock). This belief was based on the Registrants
belief as to its value based on its perception of the valuation of
companies in its business and based on its perception as to the
investment communitys then view of companies seeking pharmacologic treatments for substance abuse. |
|
|
|
|
In January 2005, the Registrant entered into a consulting agreement with Charles
OKeeffe under which it agreed to issue $2,500 per month in shares of the Registrants
common stock at a cost of $2.00 per share (aggregating 22,500 shares for services
through June 30, 2006). On the same date, Mr. OKeefe was granted a stock option to
purchase 200,000 shares of the Registrants common stock at an exercise price of $2.00
per share. On the date of the agreement with Mr. OKeeffe, the Registrant believed that
$2.00 per share was the fair market value of the shares. Further, on that
date, Mr. OKeeffe was not a related party. |
|
|
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|
In January 2005, the Registrant needed working capital.
At the time, the Registrant was
in discussions with several institutional funding sources with respect to a possible
institutional placement. In March 2005, the Registrant completed a rights offering to
its existing equity holders raising gross proceeds of $1,084,000 at a price of $0.40
per share. This offering doubled the number of common share and common share
equivalents outstanding. Since the rights offering was only made to existing holders |
Securities and Exchange Commission
September 1, 2006
Page 23
______________________________
|
|
of securities, and to avoid setting a valuation that might impact on its proposed
institutional placement, the Registrant elected to price the rights offering at a price having
no relation to the Registrants views as to the fair value of
its equity. As part of the rights offering,
the Company doubled the number of options granted to its co-founders, Patrick J. McEnany
and Hubert Huckel, M.D., in July 2002, and to Mr. Weinstein, on identical terms to the
options previously granted. |
|
|
|
Early in the third quarter of 2005, the Registrant agreed to issue shares of common
stock to several members of its Scientific Advisory Board, for services to be rendered
by each such person during the second half of 2005 and the first half of 2006, as
follows: |
|
|
|
|
|
|
|
Dr. Dewey
|
|
3,750 shares per quarter, or 15,000 shares in the aggregate |
|
|
Dr. Brodie
|
|
3,750 shares per quarter, or 15,000 shares in the aggregate |
|
|
Dr. Fechtner
|
|
5,000 shares per quarter, or 20,000 shares in the aggregate |
|
|
Dr. Laska
|
|
6,250 shares per quarter, or 25,000 shares in the aggregate |
|
|
When the Registrant committed to issue these shares it still believed that the fair
market value of its shares was $2.00 per share. Further, although each of these parties
is on the Registrants Scientific Advisory Board, such persons are independent of the
Registrant, as they are employed by other parties, could have required payments to be
made for their services in cash, and believed the shares to be valued at $2.00 per
share. While the shares were committed in the third quarter of 2005, they were not
issued until July 2006. |
|
|
|
In March 2006, the Registrant committed to issue options to purchase 3,000 shares of
its common stock at an exercise price of $2.00 per share to Donald
Jasinski, M.D., Ph.D., a member of
its Scientific Advisory Board. Dr. Jasinski was not a related party when the agreement
was reached. |
|
|
|
|
In the first quarter of 2006, the Registrant was granted Fast Track status by the
FDA with respect to CPP-109. It also determined that the its product development
strategy would require a significant Phase II study of CPP-109 and most likely a
significant Phase III study of CPP-109. In order to obtain the required funding, early
in the second quarter of 2006 the Registrant began discussions with several investment
banking firms interested in assisting the Registrant in obtaining the necessary
financing. |
|
|
|
|
In May 2005, the Registrant concluded that obtaining the
required financing needed
to complete the clinical studies to develop CPP-109 as a treatment for cocaine
and methampetamine addiction to the point where an NDA could be filed
for the product would likely take six to nine months, and the Registrant
|
Securities and Exchange Commission
September 1, 2006
Page 24
______________________________
|
|
wanted to be in a position to move forward with its product development efforts on a
more accelerated timetable. The Registrant was also concerned that it would be obligated
to spend significant funds on a potential financing, whether or not it was successful. As
a result, the Registrant decided to complete a small financing before
its larger financing to allow the Registrant
to continue its product development efforts while it sought a larger
funding and to pay the costs (legal, accounting, etc) of the larger financing. |
|
|
|
On June 9, 2006, the Registrant launched a private placement of its securities to
raise a minimum of $3 million and a maximum of $5 million for these purposes. This
private offering valued the Registrants equity (on a pre-money basis) at $30 million
(in this offering, the Registrant sold shares of its Series B Preferred Stock that were
sold at a common share equivalent price of $4.35 per share), which the Registrant believed to
be the fair market value of the common and common equivalent shares at that date. This
private placement was sold directly by the Registrant to its shareholders and to other
accredited investors introduced to the Registrant by several of its shareholders, and
no commissions or other remuneration was paid in connection this private placement. The
valuation of this offering was based on the Registrants discussions with several of
its potential investors and financial intermediaries, as well as on discussions between
the Registrant and several of its shareholders who were being asked to consider an
additional investment in the Registrant. The valuation also reflected the Registrants
need to complete this financing quickly. It further reflected the fact that investors
in the private placement were being asked to take on significant risk due to the fact
that the Registrant would need to complete another significantly larger financing
following the private placement in order to achieve its objectives. The placement
ultimately closed on July 24, 2006, although a substantial portion of the
private invested funds were
raised in June 2006, with the Registrant ultimately raising gross proceeds of $3.3 million from 48
accredited investors, about half of whom were existing holders of the Registrants
securities. |
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In the spring of 2006, the Registrant was engaged in a search for a Vice President
of Regulatory Operations. During that search, the Registrant was
introduced to Douglas
Winship, who was introduced to the Registrant by a search firm and was not affiliated
with the Registrant. In late June 2006, Mr. Winship agreed to join the Registrant. As
part of his compensation package, the Registrant agreed to grant Mr. Winship a
five-year stock option to purchase 100,000 shares of the Registrants common stock at
an exercise price of $4.35 per share (the price at which the then ongoing private
placement was being made). Mr. Winship joined the Registrant in early July 2006. |
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In the beginning of July 2006, the Registrant selected First Albany Capital, Inc.
and Stifel Nicolaus & Company, Incorporated as the managers of a proposed initial
public offering of the Registrants common stock. Based on recent discussions between the Registrant
and First Albany, which is acting as the managing underwriter, the Registrant believes |
Securities and Exchange Commission
September 1, 2006
Page 25
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that the underwriters are considering valuing the Registrant in the offering at a
pre-money valuation of between $110 million and $130 million. However, such pricing has
not yet been finalized. Notwithstanding, the Registrant is providing this information to
the staff so that the staff has an understanding of the valuation of this offering
compared to the Registrants prior offerings. |
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The Registrant believes that the substantial increase in the valuation of public
companies in the addiction marketplace has occurred in the last few months and has been
fueled by the following events: |
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During mid to late 2005, several events occurred in the
investment community that positively impacted the investment
communitys view
regarding companies developing products to treat addiction, and its views as to
the valuations of those entities. These events included the announcement of the
Alkermes, Inc. Cephalon, Inc. joint venture regarding Vivatrol in June 2005,
the follow-on offering in November 2005 by Hythiam, Inc. and the December 2005
initial public offering by Somaxon Pharmaceuticals, Inc.; |
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There has been substantial interest in scientific circles and
in the press about the development of pharmaceutical products to treat
addiction, and particularly in the use of vigabatrin to treat addiction.
Articles in the New York Times, the Wall Street Journal and in USA Today have
evidenced the widespread view that pharmacologic products to treat addiction
will be positively received and widely sought by the medical community. Copies
of these articles will be sent to the staff supplementally under separate
cover; and |
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Potential financing sources, including the investment bankers
who have preliminarily agreed to manage the Registrants initial public
offering viewed positively the current status of the Registrants product
development efforts, including the positive results shown in the 2003 and 2004
pilot studies and the fact that the FDA had granted
fast-track status to the Registrant with
respect to CPP-109. |
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The Registrant also believes that its proposed pre-money valuation range for its
proposed initial public offering is consistent with the valuations of other
biopharmaceutical companies at similar points of product development. |
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The Registrant has just retained Charles W. Gorodetzky, M.D.,
Ph.D. to act as the Registrants
Chief Medical Officer. As part of its arrangement with Dr. Gorodetzky, the Registrant
has agreed to issue to him five-year stock options to purchase 15,000 shares of the
Registrants common stock at an exercise price equal to the IPO price. |
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The Registrant has accounted for all the equity instruments,
other than the options issued to its Chief Executive Officer, using
variable accounting under EITF 96-18 and accordingly has reflected
these instruments at their fair value of $4.35 per share at
December 31, 2005. |
Securities and Exchange Commission
September 1, 2006
Page 26
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Interim Financial Statements
Notes to Financial Statements, page F-18
65. |
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Please provide the disclosures required by paragraphs 64, 84, and A240 of SFAS 123(R),
Share-Based Payment. |
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Issuers Response |
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The financial statement disclosures have been revised to include the disclosures required by
paragraphs 64, 84 and A240 of SFAS 123R Share Based Payment. |
* * * * * * * * * * * * * *
We look forward to hearing back from you regarding Amendment No. 1 to the Registration
Statement. If you have any questions, please feel free to give me a call.