Catalyst Pharmaceutical Partners Names Director
CORAL GABLES, Fla., March 5 /PRNewswire-FirstCall/ -- Catalyst Pharmaceutical Partners, Inc. today announced the appointment of Patrick Kenny as Director - Corporate Clinical Compliance. In this capacity, Mr. Kenny will be responsible for ensuring the effectiveness and GCP compliance of the CROs, clinical contractors and clinical trial sites involved in the clinical trials conducted under Catalyst's sponsorship.
Commenting on today's announcement, Douglas Winship, Catalyst's Vice President of Regulatory Operations, noted, "Mr. Kenney joins Catalyst at a key point of our corporate development, the initiation of our first series of U.S. clinical trials. He will play a critical role in auditing the performances of our contractors involved in our sponsored clinical trials to assure overall compliance with current Good Clinical Practices guidelines. Pat will also identify opportunities for implementation of improvement programs and training needs, as well as help determine additional resource needs required by the clinical trial sites to facilitate expeditious trial completion. I am confident that his strength in the areas of clinical development planning and coordination, FDA regulations and project leadership will allow him to play an important role at Catalyst as we push forward with the clinical development and ultimate commercialization of CPP-109 for the treatment of both cocaine addiction and methamphetamine addiction."
Mr. Kenny brings to Catalyst 18 years of experience in conducting clinical research programs leading to product approvals in the pharmaceutical industry. Prior to joining the Company, Mr. Kenny was employed by Kendle International, Inc., a leading contract research organization, as a Senior Clinical Research Associate. Prior to joining Kendle, Mr. Kenny served as a Clinical Research Associate for several pharmaceutical companies including Acorda Therapeutics, Elan Pharmaceutical Research Corporation and Sandoz Pharmaceutical.
"We are pleased to welcome Mr. Kenny to Catalyst at such an important juncture for the Company," said Patrick McEnany, Catalyst's Chief Executive Officer. "Our clinical programs are generating solid momentum, including the continued enrollment of subjects for our U.S. Phase II cocaine trial and the expected initiation in the second quarter of our U.S. Phase II methamphetamine trial. The cutting-edge research we are undertaking to stem the cycle of drug addiction through treatment with vigabatrin is continuing to garner interest in the market. We were especially pleased that the positive results obtained under the Catalyst-funded, investigator-sponsored, Phase II, double-blind, placebo-controlled clinical trial in Mexico, treating patients addicted to cocaine with vigabatrin, was included in Newsweek Magazine's cover article on addiction in the March 3, 2008 issue. In the article, one of the foremost experts in the field of addiction noted that the results of this trial provide the best efficacy signal of any trial conducted so far for cocaine treatment and that treatment with vigabatrin seems especially promising, even for patients that are hardest to treat -- long-term cocaine addicts. We believe strongly in the viability of our technology and the promise that treatment with CPP-109, our version of vigabatrin, may bring to patients, the healthcare system and society at large. We have many goals to achieve and look forward to the innumerable contributions that Mr. Kenny will bring to the Company as we pursue this important work."
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 and obsessive-compulsive disorders. Catalyst has also been granted rights to Brookhaven's vigabatrin-related foreign patents or patents pending in more than 30 countries.
The Company's initial product candidate is CPP-109, our version of vigabatrin. CPP-109 has been granted "Fast Track" status by the 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 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.
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 Company's 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 Company's 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 Company's ability to protect its intellectual property and those other factors described in the Company's Annual Report on Form 10-K for 2006 and the Company's 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 Company's 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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