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
December 7, 2007
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
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76-0837053 |
(State Or Other Jurisdiction Of
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(IRS Employer |
Incorporation Or Organization)
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Identification No.) |
335 Alhambra Plaza, Suite 1370
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:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 8.01 Other Events
On December 7, 2007, Catalyst Pharmaceutical Partners, Inc. (the Company) issued a press release
announcing top-line results of an investigator-initiated, randomized, double-blind,
placebo-controlled clinical trial that was recently conducted in Mexico that demonstrates that vigabatrin is
effective for the treatment of cocaine addiction. A copy of the Companys press release is Exhibit
99.1 to this Form 8-K and is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
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Exhibits |
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99.1 |
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Press release issued by the Company on December 7, 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: December 7, 2007
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EX-99.1 Press Release
Exhibit 99.1
FOR IMMEDIATE RELEASE
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Contacts at Catalyst Pharmaceutical Partners
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Contacts at Rx Communications Group |
Patrick J. McEnany
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Tina Posterli (For media) |
Chief Executive Officer
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tposterli@rxir.com |
pmcenany@catalystpharma.com
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917-322-2565 |
305-529-2522 |
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Jack Weinstein
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Melody Carey |
Chief Financial Officer
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mcarey@rxir.com |
jweinstein@catalystpharma.com
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917-322-2571 |
201-934-4201 |
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CATALYST PHARMACEUTICAL PARTNERS ANNOUNCES POSITIVE PHASE II TRIAL
RESULTS FOR VIGABATRIN IN THE TREATMENT OF COCAINE ADDICTION
- Study Demonstrates Statistically Significant Efficacy vs. Placebo -
- Trial Conducted Under Direction of New York University School of Medicine -
CORAL GABLES, FL December 7, 2007 Catalyst Pharmaceutical Partners, Inc. (Nasdaq: CPRX), a
biopharmaceutical company that acquires, in-licenses, develops and commercializes prescription
drugs for the treatment of drug addiction, today announced positive initial top-line results from
an investigator-initiated Phase II double-blind, placebo-controlled trial, which demonstrates that
vigabatrin is effective for the treatment of cocaine addiction. Catalysts lead compound, CPP-109,
is bioequivalent to vigabatrin.
This 103 subject trial is the first randomized, double-blind, placebo-controlled clinical trial
studying vigabatrins effectiveness in treating cocaine addiction. These data show that a
statistically significantly greater number of subjects treated with vigabatrin were able to abstain
from cocaine usage during the last three weeks of the dosing period compared to those receiving
placebo. Achievement of abstinence for an extended period during treatment is the critical first
step for cocaine addicted patients to potentially achieve abstinence for much longer time periods.
The data confirm the positive results seen in two previous open-label trials conducted in 2003 and
2004 by the same investigators.
Commenting on the trial results, Patrick J. McEnany, Catalysts Chairman and Chief Executive
Officer, stated, This trial represents a key development in the field of cocaine addiction
research. CPP-109, our product candidate based on vigabatrin, could have a significant impact on
how patients struggling with cocaine addiction will be treated in the future. We believe that
the success of the trial provides scientific proof of concept. We are highly encouraged by the
top-line results and look forward to publication of the results in a peer-reviewed journal.
Catalyst will also evaluate the methodology and results for their potential applicability to our
ongoing U.S. Phase II trial evaluating CPP-109 for the treatment of cocaine addiction and to our
planned U.S. Phase II trial evaluating CPP-109 for the treatment of methamphetamine addiction.
About The Trial
This trial is the third in a series of human trials conducted in Mexico, which successfully tested
the safety and efficacy of vigabatrin to treat cocaine and/or methamphetamine addiction. These
trials followed more than 15 years of animal studies conducted by Dr. Stephen Dewey at Brookhaven
National Laboratory. All three human trials were conducted under the direction of Dr. Jonathan
Brodie, the Marvin Stern Professor of Psychiatry at the New York University (NYU) School of
Medicine and Dr. Emilia Figueroa, Director of the Clinica Integral de Tratamiento Contra las
Adicciones, S.A. de C.V. The first two trials were small open-label studies. The trials protocol
was approved by NYUs Institutional Review Board in May 2006 and the Federal Commission for
Sanitary Risks Protection (Mexico) in September 2006 and is registered at
www.clinicaltrials.gov with the identifier NCT00527683. Catalyst provided financial
support through an unrestricted gift to NYU.
One hundred and three community-based, non-hospitalized cocaine addicted individuals participated
in this investigator-initiated, randomized, double-blind, placebo-controlled trial conducted at a
single site in Mexico City. All subjects had ready access to cocaine and were self-motivated to
stop their use. The trial was designed to show whether vigabatrin treatment could significantly
increase abstinence compared to placebo. Subjects were randomly assigned to either a placebo or
vigabatrin and were treated for a period of nine weeks. Of the 103 participants in the trial, 50
were treated with vigabatrin and 53 received placebo. Twice-weekly urine screening tests were
obtained from each subject in order to objectively evaluate each subjects cocaine use. All
subjects were also offered one group counseling session per week.
The primary outcome measure of the trial was negative urine tests for cocaine for the last three
weeks of the nine-week trial.
A total of 18 subjects fulfilled the criteria for the primary outcome measure. Of these, 14 (28%)
were treated with vigabatrin versus four (7.6%) who were treated with placebo. A logistic
regression utilizing years of cocaine use and average amount per day at baseline yielded
statistically significant treatment differences. The p-value was 0.009.
There were no serious adverse events reported in this trial.
These positive results demonstrate that there is hope for the millions of individuals
who suffer from the life threatening consequences of this terrible illness, said Dr. Brodie. It
also demonstrates how a dedicated team of basic scientists and clinicians who persevere in a
mission can produce important medical advances by taking an idea from the bench to the community.
Investor Conference Call
Catalyst will hold a conference call today to discuss the trial results. Investors wishing to
participate may access the live call as follows:
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Date:
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December 7, 2007 |
Time:
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11:00 AM ET |
Dial-in numbers:
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888-802-2266 (U.S. only) or 913-312-1294 |
Live webcast:
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www.catalystpharma.com |
A recording of the conference call will be available two hours after completion until Wednesday,
December 12, 2007 at 11:59 PM ET at 888-203-1112 (U.S. only) or 719-457-0820. The replay passcode
is 8904535. The webcast will be archived for on-demand listening for one year on the Companys
investor website, www.catalystpharma.com.
About Catalyst Pharmaceutical Partners
Catalyst Pharmaceutical Partners, Inc. is a biopharmaceutical company focused on the development
and commercialization of prescription drugs for the treatment of addiction. The Company has
obtained from Brookhaven National Laboratory an exclusive worldwide license for nine patents and
four patents pending in the United States relating to the right to use vigabatrin to treat a wide
variety of substance addictions. Catalyst has also been granted rights to Brookhavens
vigabatrin-related foreign patents or patents pending in more than 30 countries.
The Companys initial product candidate based on vigabatrin is CPP-109. CPP-109 has been granted
Fast Track status by the U.S. Food & Drug Administration (FDA) for the treatment of cocaine
addiction. This indicates that the FDA has recognized that CPP-109 is intended for the treatment of
a serious or life-threatening condition for which there is no effective treatment and which
demonstrates the potential to address unmet medical needs. CPP-109 recently was selected as one of
the five most promising drugs entering Phase II trials in the July-September 2007 issue of The Ones
To Watch, published by Thomson Scientific, a Thomson Corporation publication. For more information
about the Company, go to www.catalystpharma.com.
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. A number of factors, including the Companys ability
to successfully complete the clinical trials required for it to file a new drug application for
CPP-109, its ability to complete such trials on a timely basis within the budgets established for
such trials, whether the Companys trials, which are being conducted in the U.S. under FDA good
clinical practice guidelines, will evidence that CPP-109 is safe and effective for the treatment of
cocaine addiction and methamphetamine addiction, the Companys ability to protect its intellectual
property and those other factors described in the Companys Annual Report on Form 10-K for 2006 and
the Companys Quarterly Report on Form 10-Q for the quarter ended September 30, 2007 that the
Company has previously filed with the U.S. Securities and Exchange Commission (SEC), could
adversely affect the Company. 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.
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