Recently, Catalyst Pharmaceutical Partners, Inc. (CPRX) announced that its pipeline candidate CPP-115, which is being developed for treating infantile spasms, has been granted orphan drug status by the US Food and Drug Administration (FDA).
The candidate is currently undergoing multiple preclinical studies to evaluate its safety and efficacy in various indications. The company intends to file an Investigational New Drug (IND) application for the candidate in the first half of 2011.
Infantile spasms, also known as West Syndrome, refer to a rare epileptic disorder in infants. The seizures usually affect infants aged between 4-8 months and continue until the child reaches the age of five. Moreover, the seizures, which often take place in groups of up to 100 at a time, start with a sudden jerk and muscle stiffening.
The orphan drug status is granted by the US regulatory agency to drugs developed for treating a rare disease which affects less than 200,000 people in the US. Moreover, the designation grants seven years of marketing exclusivity in the US to the company developing the drug, targeting the rare disease in addition to tax benefits on its development costs.
Consequently, the orphan drug status granted to CPP-115 will aid its development and provide a wider choice to patients suffering from the rare disease as currently limited options are available.
Apart from CPP-115, Catalyst Pharma is evaluating CPP-109. CPP-109 is in mid-stage development for treating cocaine addiction. The candidate is being developed for other indications as well.
Even though we have a Zacks #2 Rank (Buy) on the stock in the short-term, we prefer to remain on the sidelines with a Neutral view on the stock in the long-run. The lack of estimate revisions, highlighting the absence of directional pressure on the stock, further supports our long-term Neutral stance on Catalyst Pharmaceutical Partners.
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