Pre-clinical trials indicate that CPRX's 2nd drug CPP115 offers a far better safety profile and efficacy then Sabril, the drug Lundbeck acquired for $900mm (600mm + 300mm in milestone payments) in 2009. Sabril is now generating ~ $100mm in revenue despite a rather dire black box warning label. Although just entering clinical trial, CPP115 makes CPRX far more interesting to me from an investment perspective.
Catalyst Pharmaceutical Partners, Inc. Announces Commencement of Phase I(a) Safety Study for CPP-115
Dec. 13, 2011 (GLOBE NEWSWIRE) -- Catalyst Pharmaceutical Partners, Inc. (Nasdaq:CPRX) today announced that it has commenced its first in man Phase I(a) safety study for its investigational drug, CPP-115, a novel GABA aminotransferase inhibitor.
"We are extremely pleased to now have two drugs, CPP-115 and CPP-109, in the clinic," said Patrick J. McEnany, Catalyst's President and Chief Executive Officer. "Our preclinical experience to date with CPP-115 has demonstrated its potential for certain addiction and epilepsy indications. We hope to offer providers and their patients safe and effective therapies for addiction, as well as safer, more effective medications for infantile spasms and other central nervous system (CNS) diseases than those currently available. We expect to report the results of this study at the end of the first quarter or the beginning of the second quarter of 2012."
The Phase I(a) study is a randomized, double-blind, single ascending dose study in six cohorts of eight normal healthy volunteers, totaling 48 healthy subjects. The study is designed to evaluate the basic human safety characteristics of CPP-115, including CNS side effects, and respiratory and cardiovascular safety.
About CPP-115
CPP-115 is a novel GABA aminotransferase inhibitor and an analogue of vigabatrin that is more potent than vigabatrin (CPP-109) and has reduced side effects (e.g., visual field defects, or VFDs and sedation) from those associated with vigabatrin in preclinical studies. Catalyst is planning to develop CPP-115 for several indications, including epilepsy (initially infantile spasms), drug addiction and for other selected CNS disease indications. CPP-115 has been granted orphan-drug designation by the FDA for the treatment of infantile spasms.
CPP-115 is the lead compound being developed by Catalyst under its license agreement with Northwestern University. Dr. Richard B. Silverman, the John Evans Professor of Chemistry at Northwestern University, led the team of scientists that invented CPP-115. Dr. Silverman holds more than 40 patents and is the inventor of Pfizer's drug, pregabalin (Lyrica®).
About Catalyst Pharmaceutical Partners
Catalyst Pharmaceutical Partners, Inc. is a development-stage 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 addiction and epilepsy. Catalyst has two products in development, CPP-109 and CPP-115, and is currently evaluating its lead product and first-in-class GABA aminotransferase inhibitor candidate, CPP-109 (vigabatrin), for the treatment of cocaine addiction. CPP-109 has been granted "Fast Track" status by the U.S. Food & Drug Administration (FDA) for the treatment of cocaine addiction. Catalyst also expects to evaluate CPP-109 for the treatment of other addictions. Catalyst believes that it controls all current intellectual property for drugs that have a mechanism of action related to the inhibition of GABA aminotransferase. For more information about Catalyst, go to www.catalystpharma.com. |
