Catalyst Pharmaceutical Partners, Inc.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT PURSUANT TO SECTION 13 OR 15(d) OF
THE SECURITIES EXCHANGE ACT OF 1934
DATE OF REPORT (DATE OF EARLIEST EVENT REPORTED)
Commission File No. 001-33057
CATALYST PHARMACEUTICAL PARTNERS, INC.
(Exact Name Of Registrant As Specified In Its Charter)
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Delaware
(State Or Other Jurisdiction Of
Incorporation Or Organization)
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76-0837053
(IRS Employer
Identification No.) |
220 Miracle Mile, Suite 234
Coral Gables, Florida 33134
(Address Of Principal Executive Offices)
(305) 529-2522
(Registrants Telephone Number, Including Area Code)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the
filing obligation of the registrant under any of the following provisions:
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 1.01 Entry into a Material Definitive Agreement
Catalyst Pharmaceutical Partners, Inc. (the Company) has extended its consulting relationship
with Charles OKeeffe, a member of its Board of Directors and a senior advisor to the Company. In
that regard, the Company and Mr. OKeeffe have entered into
Amendment No. 1 (Amendment), dated effective January 3,
2007, to that
certain Consulting Agreement, dated January 3, 2005, between the Company and Mr. OKeeffe. Under
the Amendment, Mr. OKeeffe will continue to act as an advisor to the Company for a fee of $1,250
per month, payable in cash. A copy of the Amendment is Exhibit 10.1 to this Form 8-K, and is
incorporated herein by this reference.
Item 8.01 Other Events
On January 3, 2007, the Company issued a press release updating the market on its clinical
development plans for CPP-109, its product candidate based on vigabatrin for the potential
treatment of cocaine addiction and methamphetamine addiction. A copy of the Companys press release
is Exhibit 99.1 to this Form 8-K and is incorporated herein by this reference.
Item 9.01 Financial Statements and Exhibits.
(c) Exhibits
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10.1
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Amendment No. 1 to Consulting Agreement, effective as of January 3, 2007,
between the Company and Charles OKeeffe |
99.1
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Press release issued by the Company on January 3, 2007 |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has caused this
report to be signed on its behalf by the undersigned, thereunto duly authorized.
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Catalyst Pharmaceutical Partners, Inc.
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By: |
/s/ Patrick J. McEnany
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Patrick J. McEnany |
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Chairman, President and CEO |
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Dated: January 3, 2007
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EX-10.1 Amendment No 1 to Consulting Agreement
Exhibit 10.1
AMENDMENT NO. 1 TO
CONSULTING AGREEMENT
This AMENDMENT NO. 1 TO CONSULTING AGREEMENT (Amendment) is executed this 5th day
of December, 2006, effective as of the 3rd day of January, 2007, by and between CATALYST
PHARMACEUTICAL PARTNERS, INC., a Delaware corporation (Company) and Charles OKeeffe
(Consultant).
Preliminary Statements
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The parties have previously entered into that certain Consulting Agreement dated
January 3, 2005 (the Agreement). Unless otherwise defined, capitalized terms used herein
have the meanings given to them in the Agreement. |
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The parties wish to further amend the Agreement to reflect the terms set forth below. |
Agreement
NOW, THEREFORE, in consideration of the premises, 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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Sections 1(c) and 1(d) of the Agreement are hereby amended by deleting all of their
text and replacing it with the following text: |
(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 five (5) hours per month,
with additional hours that may be agreed upon by mutual agreement between Consultant
and the Company and compensated as set forth in (d) below.
(d) Consulting Fee. In consideration of the Consultants services
hereunder, during the Engagement Period, the Consultant shall receive a monthly
consulting fee of One Thousand Two Hundred and Fifty Dollars ($1,250.00). Such fee
shall be paid in cash. Additional hours of consulting services provided hereunder
shall be compensated at the compensated at a rate of Two Hundred and Fifty Dollars
($250.00) per hour, payable in cash.
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Consultant shall retain the shares of common stock previously granted to him under
Section 1(d) of the Agreement and the common stock purchase options previously granted to
him under Section 1(e) of the Agreement. The parties agree that no further
grants of stock or stock options are due under the Agreement and that no further stock or
stock options shall be payable under the Agreement. |
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Except as amended by the terms of this Amendment, the Agreement remains in full force
and effect. |
IN WITNESS WHEREOF, the parties have executed this Amendment as of the date and year first set
forth above.
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CATALYST PHARMACEUTICAL PARTNERS, INC.
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By: |
/s/ Patrick J. McEnany
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Patrick J. McEnany |
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President and Chief Executive Officer |
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CONSULTANT
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/s/ Charles B. OKeeffe
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Charles B. OKeeffe |
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EX-99.1 Press Release issued January 3, 2007
Exhibit 99.1
FOR IMMEDIATE RELEASE
CATALYST PHARMACEUTICAL PARTNERS PROVIDES AN UPDATE ON
ITS CLINICAL DEVELOPMENT PLANS FOR CPP-109
Catalyst to conduct two simultaneous U.S. Phase II clinical trials evaluating the use of CPP-109
in treating cocaine addiction and methamphetamine addiction
CORAL GABLES, Florida January 3, 2007 Catalyst Pharmaceutical Partners, Inc. (Nasdaq: CPRX)
today provided an update on its clinical development plans for CPP-109, its product candidate based
on vigabatrin for the potential treatment of cocaine and methamphetamine addiction. The Company
reported that it has decided to reduce the number of patients in its contemplated U.S. Phase II
clinical trial evaluating the use of CPP-109 in treating cocaine addiction from 375 patients to
between 100 and 150 patients. The Company believes that by reducing the size of its contemplated
U.S. Phase II cocaine clinical trial, it will put the Company on a faster path towards the
pivotal U.S. Phase III clinical trial that the Company expects will be required to complete the
filing of an approvable new drug application (NDA) for CPP-109. The Company also reported that
its revised clinical development plan now includes a U.S. Phase II clinical trial to evaluate
CPP-109 for the treatment of methamphetamine addiction. The Company believes that its revised
clinical development plan will allow it to better take advantage of its receipt of Fast Track
status from the U.S. Food and Drug Administration (FDA) for CPP-109 than its previous clinical
development plan.
The Companys updated clinical research development plan for CPP-109
In the Companys Prospectus, dated November 7, 2006 (the Prospectus), the Company reported that
it intended to commence in the first quarter of 2007 a U.S. Phase II clinical trial for the
treatment of cocaine addiction. It also reported that while the final design of this trial and the
number of patients to be included had not yet been finalized, it anticipated at the time that the
trial would be a double-blind, randomized, placebo-controlled trial involving approximately 375
patients. Further, the Prospectus reported that the Company had sufficient funds to complete both
the Phase II and a Phase III clinical trial to evaluate CPP-109 for the treatment of cocaine
addiction.
Over the last few weeks, the Companys management, including its Chief Medical Officer, Charles
Gorodetzky, M.D., Ph.D., who joined the Company in September 2006, has been discussing possible
changes to the design of its U.S. Phase II clinical trial to evaluate CPP-109 in the treatment of
cocaine addiction. In addition, during the same period discussions with several potential clinical
investigators regarding the Companys proposed clinical trial have also occurred. Based on these
recent discussions, the Company has concluded that a smaller trial of between 100 and 150 patients
will provide relevant data in a typical U.S. cocaine addiction population more quickly than would
have been obtained in the larger U.S. Phase II clinical trial described in the Prospectus. The
Company also believes that the smaller trial will more quickly provide the clinical basis for
designing the pivotal U.S. Phase III clinical trial that the Company expects will be required to
support approval for an NDA for CPP-109. As such, the Company has decided to reduce the size of its
U.S. Phase II clinical trial to evaluate CPP-109 in the treatment of cocaine addiction from 375
patients to between 100 and 150 patients. The trial will continue to be a double-blind, randomized,
placebo-controlled clinical trial.
Additionally, based on the above-described discussions, the Company has concluded that its
shareholders will be better served if the Companys current clinical development plan for CPP-109
includes the conduct of a Phase II clinical trial evaluating the use of CPP-109 in the treatment of
methamphetamine addiction, rather than delaying such trial until the Company secures additional
funding at some time in the future. In that regard, the Company intends to conduct a U.S. Phase II
clinical trial evaluating the use of CPP-109 in the treatment of methamphetamine addiction. This
trial is expected to be a double-blind randomized, placebo controlled clinical trial with between
100 and 150 patients.
While the protocols for the Companys currently contemplated U.S. Phase II clinical trials are not
yet finalized, the Company expects, based on currently available information, that it will commence
its U.S. Phase II clinical trial evaluating CPP-109 for the treatment of cocaine addiction during
the second quarter of fiscal 2007 and its U.S. Phase II clinical trial evaluating CPP-109 for the
treatment of methamphetamine addiction during the second quarter or third quarter of fiscal 2007.
In that regard, based on currently available information, the Company expects that the costs of
both of its contemplated U.S. Phase II clinical trials will be less than the projected cost of the
proposed U.S. Phase II trial described in the Prospectus, and that the funds available from the
Companys recently completed public offering will be sufficient to allow the Company to file an NDA
seeking approval for CPP-109.
The Company also reported that based on its current development plan, it expects, although there
can be no assurance, to have the results of the first of its Phase II clinical trials evaluating
the use of CPP-109 in the treatment of cocaine addiction in the second quarter of fiscal 2008 and
the results of its second U.S. Phase II clinical trial evaluating the use of CPP-109 in the
treatment of methamphetamine addiction sometime shortly thereafter.
There can be no assurance that any of the Companys clinical trials will be successful or that the
Company will obtain an approval of an NDA for CPP-109.
Finally, the Company reported that its U.S. Phase II trials will be undertaken with CPP-109
manufactured by the Companys contract manufacturer. It also reported that as stated in the
Prospectus, the Company intends to perform the studies required to demonstrate that CPP-109 is
bioequivalent to Sabril (registered trademark of Sanofi-Aventis), which could provide data
potentially linking CPP-109 to the extensive body of published clinical literature on vigabatrin.
In that regard, the Company will conduct these bioequivalency studies on CPP-109 prior to
initiating the U.S. Phase II clinical trials described above. The Company does not anticipate that
such study will delay the start of its U.S. Phase II clinical trials based on its review of the
testing data that it has received to date (which data has been obtained from the ongoing testing of
the prototype CPP-109 tablets that are currently being manufactured). However, if these
bioequivalency studies are not successful, it could delay the start of the Companys U.S. Phase II
clinical trials.
Status of clinical trial in Mexico that the Company is supporting
In the Prospectus, the Company reported that in order to further the available research on the use
of vigabatrin to treat cocaine addiction, it intended to support an investigator-sponsored clinical
trial to take place in Mexico that is being undertaken by one of the members of the Companys
Scientific Advisory Board, Jonathan Brodie, Ph.D., M.D., a Professor of Psychiatry at New York
University School of Medicine, and by Emilia Figueroa, M.D., an addiction physician specialist who
directs several addiction clinics in Mexico. The Prospectus stated that the clinical trial would be
a
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double-blind, randomized, placebo-controlled trial involving approximately 100 patients selected from a
pool of cocaine-dependent prison parolees who meet specific clinical diagnostic standards for
cocaine dependence. The Company further reported in the Prospectus that the trial had received
approval from Mexican authorities to begin enrollment.
In December 2006, a new government took office in Mexico. As a result, new persons have been placed
in charge of the governmental agencies responsible for overseeing this trial. Such persons have
sought additional information from the principal investigators regarding the protocol and the drug
to be used for this trial. These requests have delayed the initiation of the trial and are likely
to delay the trial further.
The Company intends to financially support this trial through an unrestricted grant to the
principal investigators. While there can be no assurance, the Company believes that this clinical
trial will still provide useful data supporting the potential efficacy of vigabatrin as a treatment
for cocaine dependency.
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Catalyst Pharmaceutical Partners, Inc. is a specialty pharmaceutical company focused on the
development and commercialization of prescription drugs for the treatment of addiction. The
Companys initial product candidate is CPP-109, which is based on the compound gamma-vinyl-GABA,
commonly referred to as vigabatrin. CPP-109 has been granted Fast Track status by the FDA, which
means that the FDA has recognized cocaine addiction as an unmet medical need for which no
pharmacological products are currently approved for marketing.
This press release contains forward-looking statements. Forward-looking statements involve known
and unknown risks and uncertainties which may cause the Companys actual results in future periods
to differ materially from forecasted results. Forward looking statements included in this press
release include the anticipated timing and costs of the Companys proposed U.S. Phase II clinical
trials evaluating CPP-109 for the treatment of cocaine and methamphetamine addiction and the
benefits that the Company believes will be obtained from revising its clinical development plan as
described above. Many factors could adversely impact the accuracy of the forward looking statements
contained in this press release, including those risk factors and other factors described in the
Companys Prospectus and in the Companys Quarterly Report on Form 10-Q for the third quarter of
fiscal 2006. Both of these documents have been filed by the Company with the U.S. Securities and
Exchange Commission (SEC). Copies of the Companys filings with the SEC are available from the
SEC or may be obtained upon request from the Company. The Company does not undertake any obligation
to update the information contained herein, which speaks only as of this date.
CONTACT:
Patrick J. McEnany, CEO
Jack Weinstein, CFO
Catalyst Pharmaceutical Partners, Inc.
220 Miracle Mile, Suite 234
Coral Gables, Florida 33134
(305) 529-2522
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