Analysis Of Catalyst Pharmaceutical's Vigabatrin And Its Potential For Phase IIb Trial Success



Catalyst Pharmaceutical Partners (NASDAQ: CPRX) is a specialty biopharmaceutical company focused on the development and commercialization of prescription drugs targeting diseases and disorders of the central nervous system (CNS), with a focus on the treatment of addiction, infantile spasms, epilepsy and other CNS indications. Catalyst is developing vigabatrin (CPP-109) for the treatment of addiction to cocaine, methamphetamine and other addictive substances. Catalyst is also developing a more potent vigabatrin analogue (designated CPP-115 by Catalyst) for the treatment of cocaine addiction, infantile spasms and epilepsy, as well as other addiction and CNS indications.

CPP-109 (Vigabatrin)

Vigabantrin is an irreversible inhibitor of gamma-aminobutyric acid transaminase (GABA-T), the enzyme responsible for the metabolism of the inhibitory neurotransmitter GABA. This action results in increased levels of GABA in the central nervous system. This increase in amount of GABA typically has relaxing, anti-anxiety, and anti-convulsive effects. By giving this drug to a cocaine-addict or methamphetamine addict, it prevents them from having withdrawal symptoms and eventually allows them to become free from drug addiction.

Vigabatrin is currently being marketed as Sabril by Lundbeck Pharmaceutical in the US, Canada and EU. Sabril is indicated as adjunctive therapy for adult patients with refractory complex partial seizures (CPS) who have inadequately responded to several alternative treatments and for whom the potential benefits outweigh the risk of vision loss. Catalyst Pharmaceutical is trying to get an initial indication for treating cocaine addiction with expanded indication for methamphetamine later. The patent for CPP-109 is protected until 2018 via "method of use" patent. But, the Waxman Hatch provisions would likely extend protection for five years following its introduction, which might extend protection to 2019 or 2020

Market Potential

According to the National Institute on Drug Abuse, Illicit drug use in America has been increasing. In 2010, an estimated 22.6 million Americans aged 12 or older-or 8.9 percent of the population-had used an illicit drug or abused a psychotherapeutic medication. This is up from 8.3 percent in 2002. The increase mostly reflects a recent rise in the use of marijuana, psychotherapeutics and cocaine. The treatment for substance abuse in the United States is likely to increase by 2.5x in the aging population by the year 2020.

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