8-K
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
March 3, 2009
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
Incorporation Or Organization)
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(IRS Employer
Identification No.) |
355 Alhambra Circle, 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 March 3, 2009, the Company issued a press release announcing its intention to halt enrollment of
new subjects into its ongoing U.S. Phase II trial evaluating CPP-109 for the treatment of
methamphetamine addiction and instead convert that trial into a smaller proof-of-concept study
treating the approximately 55 patients currently enrolled in the trial for the thirteen week active
phase as described in the protocol. 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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99.1 |
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Press release issued by the Company on March 3, 2009 |
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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: March 5, 2009
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EX-99.1
Exhibit 99.1
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Contact at Catalyst Pharmaceutical Partners
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Contacts at Rx Communications Group |
Patrick J. McEnany
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Melody Carey |
Chief Executive Officer
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mcarey@rxir.com |
pmcenany@catalystpharma.com
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917-322-2571 |
305-529-2522 |
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Catalyst To Focus Resources On Its Lead Indication For CPP-109; Cocaine Addiction
CORAL GABLES, Fla., March 3, 2009 Catalyst Pharmaceutical Partners, Inc. (Nasdaq: CPRX), a
biopharmaceutical company that acquires or in-licenses, develops and commercializes prescription
drugs for the treatment of drug addiction, today announced modifications to its previously
announced product development program. In order to extend its cash resources well into 2010,
Catalyst has decided to halt enrollment of new subjects into its ongoing U.S. Phase II trial
evaluating CPP-109 for the treatment of methamphetamine addiction and will instead convert that
trial to a smaller proof-of-concept study. Catalyst will continue to treat the approximately 55
subjects currently in the trial for the 13 week active phase as described in the trial protocol.
As previously announced, Catalysts Phase II cocaine trial is now fully enrolled, with 186
patients at 11 leading addiction research facilities around the United States, and top-line
results from the cocaine trial are expected to be available during the second quarter of 2009.
Patrick J. McEnany, Catalysts Chairman and Chief Executive Officer, stated, We believe that this
modification to our clinical development program is prudent in light of the capital markets and
economic environment that currently exists. Our immediate and primary focus continues to be on
concluding the Phase II trial evaluating our lead candidate CPP-109 for the treatment of cocaine
addiction. Furthermore, this modification does not change the previously announced timetable as it
relates to Catalysts intention to file a New Drug Application with the FDA to obtain the right to
market CPP-109 for the treatment of cocaine addiction. With the restructuring of our clinical
development programs, we will now have sufficient working capital for the next 18-24 months. The
extension of our cash resources also allows us more time to explore potential corporate
partnerships.
In addition, we intend to explore potential non-dilutive funding sources for a new large-scale
methamphetamine trial. It is our belief that such funding may become available under the economic
stimulus measures as part of the recently signed American Recovery and Reinvestment Act of 2009.
The Act includes a $10 billion increase in the National Institute of Healths (NIH) budget over the
next two years. We intend to actively pursue such funding opportunities with the appropriate
agencies that operate under the NIH umbrella, although there can be no assurance that any such
funding will be obtained. We will also continue to seek partnerships with leading clinical
investigators to evaluate CPP-109 for other indications including alcohol and nicotine abuse as
well as obsessive-compulsive disorders.
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 and
obsessive-compulsive disorders. The Company has obtained from Brookhaven National
Laboratory an exclusive worldwide license for Brookhavens patent portfolio in the United
States relating to the right to use vigabatrin to treat a wide variety of substance
addictions and obsessive-compulsive disorders. 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 is CPP-109, which is Catalysts version
of vigabatrin. 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. For more information about the Company, please visit
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
whether the results from the clinical trials and studies being conducted by the Company
will be positive, what future clinical and non clinical studies and trials will be required
to seek regulatory approval to commercialize CPP-109 for the treatment of cocaine addiction
and the timing of any New Drug Application filing with respect thereto, and those other
factors described in the Companys Annual Report on Form 10-K for 2007 and the Companys
Quarterly Report on Form 10-Q for the quarter ended September 31, 2008 that the Company has
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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