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
February 22, 2010
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)
| Delaware | 76-0837053 | |
| (State Or Other Jurisdiction Of Incorporation Or Organization) |
(IRS Employer Identification No.) |
355 Alhambra Circle, Suite 1370
Coral Gables, Florida 33134
(Address Of Principal Executive Offices)
(305) 529-2522
(Registrant’s 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:
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
| Item 8.01 | Other Events |
Development Plans for CPP-115
On February 22, 2010, the Company issued a press release reporting its development plans for CPP-115, which is the Company’s compound for the treatment of epilepsy and addiction being developed under an exclusive worldwide license between the Company and Northwestern University.
CPP-115 has been shown to be at least 200 times more potent than CPP-109, Catalyst’s version of vigabatrin, in both in-vitro and animal model studies. The increased potency could enable the development of superior or alternative dosage forms and routes of administration compared with the marketed version of vigabatrin, Sabril® (which is marketed in the U.S. by Lundbeck Inc. for infantile spasms and refractory complex partial seizures). It may also have superior specificity to GABA aminotransferase and, possibly, a better side effects profile (e.g. less visual field defects) compared with Sabril®. The Company believes that CPP-115 and other compounds that may be developed under the Northwestern University license are, in addition to vigabatrin, the only drugs currently in development or on the market having GABA aminotransferase inhibition as their primary mode of action.
Over the next year, the Company plans to advance the development of CPP-115 by completing a series of non-clinical studies designed to demonstrate critical safety and efficacy characteristics of CPP-115, as follows:
| • | CPP-115 will be evaluated through the Anti-convulsant Screening Program at the U.S. National Institutes of Health using a variety of recognized and widely accepted animal models for the evaluation of the effectiveness of potential anti-epileptic drugs. |
| • | The visual safety of CPP-115 will be evaluated and compared to the only FDA approved GABA aminotransferase inhibitor drug, vigabatrin. The Company hopes to demonstrate that CPP-115’s enhanced mechanism of enzyme inactivation results in reduced or eliminated visual field defects compared to vigabatrin. |
| • | The Company will complete other safety evaluations including genotoxicity and cardiac safety. |
| • | The Company, through its CPP-109 collaborator, Stephen Dewey, Ph.D., of The North Shore LIJ Hospital, will conduct studies to demonstrate CPP-115’s effectiveness in extinguishing the reinstatement of addictive behavior. Dr. Dewey will also conduct a PET imaging study to establish the minimum effective dose of CPP-115 required to modulate cocaine-induced dopamine surges. These studies, including an already completed conditioned place preference study, are considered the most predictive studies of a drug’s potential utility as a treatment for stimulant addiction. Vigabatrin performed well when previously evaluated in these same studies. The results of the CPP-115 conditioned place preference study referred to above have already been submitted to a peer-reviewed journal for publication. |
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By the end of the third quarter of 2010, most of the safety studies described above, including results from assessments of the comparative retinotoxicity of CPP-115 versus vigabatrin, are expected to be completed. Furthermore, during that same period, the Company expects to complete the above-described animal model efficacy screening of CPP-115 as a potential treatment for both epilepsy and drug addiction. The Company further expects that all of the above-described non-clinical studies, including evaluations after 90 days of dosing of visual safety including retinal histopathology, clinical chemistry, hematology, urinalysis and any necessary organ histopathology, will be completed by the end of the first quarter of 2011. The Company expects to spend approximately $1.5 million to complete all the non-clinical studies described herein.
The Company issued a press release on February 22, 2010 reporting the Company’s development plans for CPP-115. A copy of that press release is attached hereto as Exhibit 99.1.
Upcoming study of CPP-109 to treat cocaine addiction
On February 22, 2009, the Company executed a non-binding letter of intent with the National Institute on Drug Abuse (“NIDA”) to conduct a U.S. Phase II(b) clinical trial evaluating CPP-109, the Company’s formulation of vigabatrin, for the treatment of cocaine addiction. It is anticipated that NIDA, under their agreement with the Veteran’s Administration Cooperative Studies Program, will provide substantial resources for the trial and that the Company will contribute approximately $2.5 million in resources as part of the estimated $10 million trial cost (including study medication, patient recruitment costs and certain trial expenses). The Company expects to execute a binding clinical trial agreement with NIDA regarding this trial in the near future.
It is anticipated that this double-blind, placebo-controlled clinical trial will enroll approximately 200 patients and will be conducted at eight leading addiction facilities across the United States. The trial will seek to confirm the safety and efficacy of CPP-109 for the treatment of cocaine addiction and is scheduled to commence in the early summer of 2010. The study is being designed to deal with issues related to poor medication compliance that the Company observed in its recently completed Phase II cocaine trial.
The Company issued a press release on February 23, 2010 reporting that the Company has entered into a non-binding letter of intent with NIDA to conduct this clinical trial. A copy of that press release is attached hereto as Exhibit 99.2.
Update on the Company’s Capital Resources
The Company believes that its existing cash resources will allow it: (i) to fund the pre-clinical studies of CPP-115, which are estimated to be approximately $1.5 million, (ii) to fund its share of the costs of the clinical trial of CPP-109 that the Company intends to conduct with NIDA, which are estimated to be approximately $2.5 million over a two-year period, and (iii) to meet general corporate requirements through at least the first quarter of 2011.
| Item 9.01 | Financial Statements and Exhibits. |
| (c) | Exhibits |
| 99.1 | Press release issued by the Company on February 22, 2010 |
| 99.2 | Press release issued by the Company on February 23, 2010 |
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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.
| Catalyst Pharmaceutical Partners, Inc. | ||
| By: | /s/ Jack Weinstein | |
| Jack Weinstein | ||
| Vice President, Treasurer and CFO | ||
Dated: February 23, 2010
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Exhibit Index
| Exhibit No. |
Description | |
| 99.1 | Press release issued by the Company on February 22, 2010 | |
| 99.2 | Press release issued by the Company on February 23, 2010 | |
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Exhibit 99.1
| NEWS RELEASE | FOR IMMEDIATE RELEASE | |
| For Further Information Contact: | ||
| Patrick McEnany, Catalyst Pharmaceutical | Melody Carey, Rx Communications Group | |
| President & Chief Executive Officer | Co-President | |
| (305) 529-2522 | (917) 322-2571 | |
| pmcenany@catalystpharma.com | mcarey@rxir.com | |
CATALYST PHARMACEUTICAL PARTNERS TO DISCUSS DEVELOPMENT PLANS
FOR CPP-115 ON FEBRUARY 23, 2010 CONFERENCE CALL
CORAL GABLES, FL, February 22, 2010 — Catalyst Pharmaceutical Partners, Inc. (NasdaqCM: CPRX) will hold a conference call on Tuesday, February 23, 2010 to discuss its initial development plans for CPP-115. Patrick J. McEnany, Catalyst Pharmaceutical’s Chief Executive Officer, will host the call.
CPP-115 is a compound in a new class of GABA aminotransferase inhibitors in-licensed by Catalyst from Northwestern University. Catalyst is seeking to develop new prescription therapies for a broad range of central nervous system illnesses that could benefit from the inhibition of GABA aminotransferase. Catalyst will initially explore the use of CPP-115 as a treatment for epilepsy, including infantile spasms, and addiction.
CPP-115 has been shown to be at least 200 times more potent than CPP-109, Catalyst’s version of vigabatrin, in both in-vitro and animal model studies. The increased potency could enable the development of superior or alternative dosage forms and routes of administration compared with the marketed version of vigabatrin, Sabril® (which is marketed in the U.S. by Lundbeck Inc. for infantile spasms and refractory complex partial seizures). It may also have superior specificity to GABA aminotransferase and, possibly, a better side effects profile (e.g. less visual field defects) compared with Sabril®. The Company believes that CPP-115 and other compounds that may be developed under the Northwestern University license are, in addition to vigabatrin, the only drugs currently in development or on the market having GABA aminotransferase inhibition as their primary mode of action.
Over the next year, Catalyst plans to advance the development of CPP-115 by completing a series of non-clinical studies designed to demonstrate critical safety and efficacy characteristics of CPP-115, as follows:
| • | CPP-115 will be evaluated through the Anti-convulsant Screening Program at the U.S. National Institutes of Health using a variety of recognized and widely accepted animal models for the evaluation of the effectiveness of potential anti-epileptic drugs. |
| • | The visual safety of CPP-115 will be evaluated and compared to the only FDA approved GABA aminotransferase inhibitor drug, vigabatrin. Catalyst hopes to demonstrate that CPP-115’s enhanced mechanism of enzyme inactivation results in reduced or eliminated visual field defects compared to vigabatrin. |
| • | The Company will complete other safety evaluations including genotoxicity and cardiac safety. |
| • | Catalyst, through its CPP-109 collaborator, Stephen Dewey, Ph.D., of The North Shore LIJ Hospital, will conduct studies to demonstrate CPP-115’s effectiveness in extinguishing the reinstatement of addictive behavior. Dr. Dewey will also conduct a PET imaging study to establish the minimum effective dose of CPP-115 required to modulate cocaine-induced dopamine surges. These studies, including an already completed conditioned place preference study, are considered the most predictive studies of a drug’s potential utility as a treatment for stimulant addiction. Vigabatrin performed well when previously evaluated in these same studies. The results of the CPP-115 conditioned place preference study referred to above have already been submitted to a peer-reviewed journal for publication. |
By the end of the third quarter of 2010, most of the safety studies described above, including results from assessments of the comparative retinotoxicity of CPP-115 versus vigabatrin, are expected to be completed. Furthermore, during that same period, Catalyst expects to complete the above-described animal model efficacy screening of CPP-115 as a potential treatment for both epilepsy and drug addiction. Catalyst further expects that all of the above-described non-clinical studies, including evaluations after 90 days of dosing of visual safety including retinal histopathology, clinical chemistry, hematology, urinalysis and any necessary organ histopathology, will be completed by the end of the first quarter of 2011. Catalyst expects to spend approximately $1.5 million to complete all the non-clinical studies described herein.
Conference Call Access information
| Date: | Tuesday, February 23, 2010 | |
| Time: | 11:00 am ET | |
| Dial-in numbers: | (877) 303-9214 (U.S. only) | |
| (760) 666-3555 (international) | ||
| Live webcast: | www.catalystpharma.com, under “Events and Presentations” |
The teleconference replay will be available three hours after completion through midnight Friday, February 26, 2010 at (800) 642-1687 (U.S. only) or (706) 645-9291 (international). The replay pass code is 57722443. The archived webcast will be available for one year on the Company’s website, www.catalystpharma.com, under “Events and Presentations.”
About CPP-115
CPP-115 is Catalyst’s compound for the treatment of epilepsy and addiction being developed under an exclusive worldwide license between Northwestern University and Catalyst. CPP-115 is covered by two composition of matter patents related to a new class of GABA aminotransferase inhibitors. CPP-115 allows Catalyst to potentially explore a broad range of CNS applications starting with epilepsy that could benefit from the inhibition of GABA aminotransferase.
CPP-115 has been shown to be at least 200 times more potent than CPP-109, Catalyst’s version of vigabatrin, in both in-vitro and animal model studies. The increased potency could enable the development of superior or alternative dosage forms compared with the marketed version of vigabatrin, Sabril®. It may also have superior specificity to GABA aminotransferase and, possibly, a better side effects profile (e.g. less visual field defects) compared to Sabril®. The Company believes that CPP-115 and other compounds that may be developed under the Northwestern University license, in addition to vigabatrin, are the only drugs currently in development or on the market having GABA aminotransferase inhibition as their primary mode of action.
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“CPP-115 works through the same mechanism of action as Sabril®, a known effective anti-epileptic drug, which was recently approved by the FDA. Compared to other anti-epileptic drugs, CPP-115 could have a relatively benign neurological side effects profile,” said Steven Miller, Ph.D., Catalyst’s Chief Scientific Officer. “CPP-115 was designed specifically to enhance the inactivation of GABA aminotransferase compared to Sabril®. This enhanced action is expected to lead to significantly higher potency and may lead to reduced, or eliminated, visual field defects. Sabril’s® visual field defects are its most serious side effect and the main reason that the drug is only available through a very restrictive Risk Evaluation and Mitigation Strategy (REMS) program. We are hopeful that CPP-115 will be an effective anti-epileptic with a more favorable safety profile than Sabril®.”
Dr. Richard B. Silverman, the John Evans Professor of Chemistry at Northwestern University, led the team of scientists that invented these compounds. Dr. Silverman holds 41 patents and is the inventor of pregabalin (Lyrica® marketed by Pfizer). He is the recipient of numerous awards, most recently the 2009 Perkin Medal, has published more than 250 peer reviewed articles and has written four books during his 33 year career in academia. Complete details of Dr. Silverman’s achievements can be found at http://chemgroups.northwestern.edu/silverman/.
About Catalyst Pharmaceutical Partners
Catalyst Pharmaceutical Partners, Inc. is a biopharmaceutical company focused on the development and commercialization of prescription drugs targeting diseases of the central nervous system with a focus on the treatment of drug addiction and epilepsy. The Company has obtained from Brookhaven National Laboratory an exclusive license for nine patents in the United States relating to the right to use vigabatrin to treat a wide variety of substance addictions and obsessive-compulsive disorders. Catalyst also in-licensed worldwide rights to Brookhaven’s vigabatrin-related foreign patents or patents pending in more than 30 countries. The Company’s lead product candidate is CPP-109, which has been granted “Fast Track” status by the U.S. Food & Drug Administration (FDA) for the treatment of cocaine addiction. Catalyst has also in-licensed worldwide rights to CPP-115 from Northwestern University and intends to pursue its development for several indications, including epilepsy and drug addiction. 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 Company’s actual results in future periods to differ materially from forecasted results. A number of factors including whether CPP-115 is ultimately proven to be safe and effective to treat epilepsy and/or addiction, whether CPP-115 is determined not to have the visual field defects side effect profile of vigabatrin, the timing of the completion of the non-clinical studies described above and whether or not the non-clinical studies being undertaken will show positive results, and those factors described in the Company’s filings with the U.S. Securities and Exchange Commission (“SEC”), could adversely affect the Company. Copies of the Company’s filings with the SEC are available from the SEC, may be found on the Company’s website 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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Exhibit 99.2
| NEWS RELEASE | FOR IMMEDIATE RELEASE | |
| For Further Information Contact: | ||
| Patrick J. McEnany | Melody Carey | |
| Chief Executive Officer | Co-President | |
| Catalyst Pharmaceutical Partners | Rx Communications Group | |
| (305) 529-2522 | (917) 322-2571 | |
| pmcenany@catalystpharma.com | mcarey@rxir.com | |
CATALYST PHARMACEUTICAL PARTNERS AND THE NATIONAL INSTITUTE ON DRUG ABUSE PLAN TO INITIATE U.S. PHASE II(b) CLINICAL TRIAL FOR COCAINE ADDICTION
CORAL GABLES, FL, February 23, 2010 — Catalyst Pharmaceutical Partners, Inc. (NasdaqCM: CPRX) announced today that it has signed a non-binding Letter of Intent with the National Institute on Drug Abuse (NIDA) to conduct a U.S. Phase II(b) clinical trial evaluating CPP-109, Catalyst’s formulation of vigabatrin, for the treatment of cocaine addiction. It is anticipated that NIDA, under their agreement with Veteran’s Administration Cooperative Studies Program, will provide substantial resources for the trial and that Catalyst will contribute approximately $2.5 million in resources as part of the estimated $10 million trial cost.
“We believe that support from NIDA further validates our enthusiasm of the potential for CPP-109 to help solve the global problem of cocaine addiction,” said Patrick J. McEnany, Chief Executive Officer of Catalyst. “We are very pleased to be working with NIDA and look forward to their participation, financial support and guidance in this study as we advance the development of this important program.”
“Currently, there are no FDA-approved medications to battle cocaine addiction,” said Dr. David McCann, Associate Director, Division of Pharmacotherapies and Medical Consequences of Drug Abuse, NIDA. “We are involved because we are encouraged by findings from prior animal and human studies that suggest promise for this medication as a treatment for the nation’s estimated 2.1 million cocaine abusers.”
About The Phase II(b) Clinical Trial
It is anticipated that this double-blind, placebo-controlled trial will enroll approximately 200 patients and will be conducted at eight leading addiction facilities across the United States. The clinical trial is designed to confirm the safety and efficacy of CPP-109 for the treatment of cocaine addiction.
“We will build on the knowledge and experience gained from the five previous human trials that have been conducted with vigabatrin to treat cocaine and methamphetamine addiction,” said Douglas Winship, Catalyst’s Vice President of Regulatory Operations. “This collaboration will enable us to conduct a Phase II(b) registration-directed trial of CPP-109 as required by the FDA. We expect to commence enrollment of patients by early summer of 2010 and to complete enrollment within 12 months.”
About Catalyst Pharmaceutical Partners
Catalyst Pharmaceutical Partners, Inc. is a biopharmaceutical company focused on the development and commercialization of prescription drugs targeting diseases of the central nervous system with a focus on the treatment of drug addiction and epilepsy. The Company has obtained from Brookhaven National Laboratory an exclusive license for nine patents in the United States relating to the right to use vigabatrin to treat a wide variety of substance addictions and obsessive-compulsive disorders. Catalyst also in-licensed worldwide rights to Brookhaven’s vigabatrin-related foreign patents or patents pending in more than 30 countries. The Company’s lead product candidate is CPP-109, which has been granted “Fast Track” status by the U.S. Food & Drug Administration (FDA) for the treatment of cocaine addiction. Catalyst has also in-licensed worldwide rights to CPP-115 from Northwestern University and intends to its pursue development for several indications, including epilepsy and drug addiction. 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 Company’s actual results in future periods to differ materially from forecasted results. A number of factors, including the required execution of a definitive clinical trial agreement between NIDA and Catalyst with respect to the clinical trial described in this press release and those factors described in the Company’s filings with the U.S. Securities and Exchange Commission (“SEC”), could adversely affect the Company. Copies of the Company’s filings with the SEC are available from the SEC, may be found on the Company’s website 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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