Senior Staff Writer

A company formed in January 2002, based on research conducted at the Brookhaven National Laboratory, filed for an initial public offering to raise $40.25 million - money to support clinical development of its only product, a GABA analog to treat cocaine addiction.

Catalyst Pharmaceutical Partners, of Coral Gables, Fla., did not list the number of shares to be offered or the offering price in its prospectus filed with the SEC. The IPO's underwriters are First Albany Capital and Stifel Nicolaus, both of New York.

The company's lead product, CPP-109, is based on the chemical compound gamma-vinyl-GABA, commonly referred to as vigabatrin. It eliminates the feeling of pleasure associated with the use of dopamine-enhancing drugs by inhibiting the enzyme GABA transaminase (GABA-T). GABA-T is responsible for the breakdown of GABA, the most abundant inhibitory neurotransmitter in the brain that inhibits overexcitation and helps induce relaxation and sleep.

Through a natural process, GABA moderates the effects of the neurotransmitter dopamine. In contrast, drugs like cocaine block the natural reuptake and breakdown of dopamine, resulting in elevated levels of the neurotransmitter and triggering feelings of euphoria.

Paris-based Sanofi-Aventis has marketed vigabatrin as Sabril in more than 30 countries outside of the U.S. over the past decade as a secondary treatment for adult epilepsy and as a primary treatment for the management of infantile spasms called West Syndrome. The composition of matter patents expired in 1993.

With the IPO proceeds, Catalyst intends to spend $7 million to fund a U.S. Phase II trial, expected to begin in the fourth quarter, of CPP-109 to treat cocaine addiction; $7.5 million for a Phase III trial of the drug in the same indication, if required by the FDA; $4 million for costs relating to the filing of a new drug application; $3.5 million to start clinical studies of CPP-109 to treat methamphetamine addiction; $2.5 million to start trials for nicotine addiction; $3 million to begin development of clinical studies required to commercialize the drug in Europe; and the balance for general corporate purposes.

The company expects that net proceeds, along with existing cash and cash equivalents of about $3.4 million, would be enough to continue operations for 30 months. That would take Catalyst forward until early 2009 - about the time CPP-109 could reach the market for cocaine addiction, an indication for which there currently is no FDA-approved pharmacologic treatment. The company, which has fast-track status for CPP-109, intends to build its own sales force to promote the product.

The double-blind, randomized, placebo-controlled Phase II trial in cocaine addiction will involve about 375 patients throughout the U.S. and Canada who will be divided into three groups: one receiving vigabatrin for 26 weeks; one receiving it for nine weeks, followed by placebo for 17 weeks; and one receiving placebo for 26 weeks. The primary endpoint is three weeks of abstinence from cocaine at nine weeks and again at 26 weeks.

According to the National Survey on Drug Use and Health, published by the Substance Abuse and Mental Health Services Administration, an estimated 19 million people in the U.S. are dependent on illicit drugs. In Europe, there are about 3.4 million cocaine users and 2.7 million users of amphetamine-type stimulants, according to the United Nations Office for Drug Control and Crime Prevention.

While the sales potential of CPP-109 for cocaine addiction is uncertain, if the drug was found to be an effective treatment for nicotine addiction, it would tap into a $1.4 billion global market (per 2004 figures) for smoking-cessation products. CPP-109 also may be able to treat other addictive disorders such as obesity and compulsive gambling, which have similar mechanisms of action to drug addiction.

Catalyst believes its product has several advantages to others in development and approved drugs for addiction treatment because it may be used to treat multiple addictions. Other drugs that treat addiction have the potential to be abused themselves, and often require increasing dosages - limitations that CPP-109 does not appear to have, the company said.

Other therapies under development for cocaine and methamphetamine addiction include cocaine-mimetics, such as Basel, Switzerland-based Novartis AG's methylphenidate (Ritalin); and cocaine antagonists, such as Novartis' baclofen, Frazer, Pa.-based Cephalon Inc.'s tiagabine (Gabitril) and New York-based Pfizer Inc.'s gabapentin (Neurontin), among others. Celtic Pharma Holdings LP, of New York, is developing the cocaine vaccine TA-CD, currently in Phase II trials, which is designed to block cocaine transport into the brain, but Catalyst said such vaccines do not address the cravings associated with cocaine addiction.

While vigabatrin generally has been well tolerated in treating epilepsy, with common side effects of drowsiness and fatigue, there is one adverse side effect that Catalyst intends to watch closely in its trials. About 33 percent of patients who have taken increasing dosages of vigabatrin approaching 1,500 g have experienced peripheral visual field defects that are irreversible.

Catalyst holds exclusive, worldwide rights from Brookhaven to nine patents and two patent applications relating to the use of vigabatrin to treat substance addictions. The patents expire between 2018 and 2020. If the company gains approval of CPP-109, it will pay Brookhaven $100,000 in the first year, $250,000 in each of the second and third years following approval, and $500,000 per year until the last patent expires.

The company has four employees, including its co-founder, chairman, president and CEO, Patrick McEnany, who currently owns 2.7 million shares of Catalyst, a 39.9 percent stake. Another co-founder is director Hubert Huckel, who owns about 1.3 million shares, or 19 percent of Catalyst.

Published  July 27, 2006