Targeting Diseases of the Central Nervous System

Catalyst is a biopharmaceutical company focused on the de­vel­opment and commercialization of pre­scrip­tion drugs to fight addictions, manage pain, and treat diseases of the central nervous system such as epilepsy. Catalyst is de­vel­op­ing vigabatrin (vi•gá•ba•trin, des­ig­nated CPP-109 by Catalyst) for the treatment of addiction to cocaine, meth­am­phet­a­mine, and other addictive sub­stances. Catalyst is also de­vel­op­ing a more potent form of vigabatrin (des­ig­nated CPP-115 by Catalyst) to combat drug addiction — including opiate addiction in managing pain — and to treat central nervous system indications such as epilepsy. Catalyst believes that it controls all current in­tel­lec­tu­al property for drugs, like CPP-109 and CPP-115, whose primary mechanism of action relates to GABA aminotransferase (GABA–AT, also known as GABA transaminase or GABA–T). Such drugs may prove ef­fec­tive relative to a wide spec­trum of indications:

Broad Potential Applicability

The U.S. Food and Drug Administration has recognized that cocaine addiction is a "serious, life-threatening condition for which there is no cur­rent drug treatment," and the National Institute on Drug Abuse (NIDA) has stated that finding a pharmacological treatment for cocaine addiction is their number one research priority. Because of the high social and financial cost of ad­dic­tion, Catalyst's mission to develop a treat­ment for drug addiction could prove beneficial not only to addicts, but to investors and to society at large.

Previous studies in established animal models of addiction, involving both rats and primates, have shown that vigabatrin interrupts the neural mechanisms essential for addiction. In preclinical studies, vigabatrin prevented the characteristic drug-seeking behavior of addicted animals.

Three human trials of vigabatrin have been completed in Mexico with patients addicted to cocaine or meth­am­phet­a­mine, including a U.S. Phase II 103-patient, double-blind, placebo-controlled trial completed in 2007. Data from these three trials provide clinical evidence of vigabatrin's potential as a safe and ef­fec­tive treatment for patients with these addictions.

Most of the research on vigabatrin to treat addiction has emerged from work performed at Brookhaven National Laboratory (Brookhaven). Brookhaven holds various patents relating to its research findings.

Catalyst has obtained from Brookhaven an exclusive worldwide license for nine patents in the United States for all rights to use or sell vigabatrin for the treatment of addiction to cocaine, meth­am­phet­a­mine, prescription pain medications, heroin, nicotine, and other addictive drugs. Catalyst's license includes rights to Brookhaven's foreign patents or patents pending in more than 30 countries.

In addition, Catalyst has obtained rights to a novel class of GABA–AT inhibitors discovered by re­search­ers at North­west­ern Uni­ver­si­ty, which Catalyst is developing under the name CPP-115. In in vitro studies, CPP-115 has proven 200 times more potent than CPP-109; it may also have a better side effect profile. The com­po­si­tion of matter patents for CPP-115 will ensure exclusivity well beyond the expected ex­clu­siv­i­ty for CPP-109. CPP-115 not only extends Catalyst’s addiction franchise, but also allows the company to expand into areas like infantile spasms, epilepsy, and other CNS indications. For further information about CPP-115, see Catalyst's report of positive non-clinical safety and efficacy results for CPP-115 and CPP-115: Frequently Asked Questions.

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Catalyst highlights

• Founded: 2002
• Headquarters: Coral Gables, Florida
• NASDAQ Capital Market: CPRX
• Shares outstanding: 24.7 million
• Cash and investments: $7.4 million (Period ending 9/30/11 and 4Q2011 fund raising)
• Key investors: Federated Global and Investment Management (12.9%) & Fidelity Management and Research (7.6%)
• Read the 2010 Annual Report