The independent Data Monitoring Committee (DMC) has recommended the continuation of Catalyst Pharmaceutical Partners, Inc.’s (CPRX) phase III study (n=36) on Firdapse. The randomized, double-blind, placebo-controlled, discontinuation study is evaluating Firdapse for the treatment of patients suffering from Lambert-Eaton myasthenic syndrome (LEMS).
The committee’s recommendation comes after reviewing the safety and clinical data from the study. Catalyst Pharma acquired the marketing rights to Firdapse from BioMarin Pharmaceutical Inc. (BMRN) in Oct 2012 in the U.S., as per which the former is responsible for the above-mentioned phase III study.
In 2013, the U.S. Food and Drug Administration (FDA) granted ‘Breakthrough Therapy’ designation to Firdapse for the LEMS indication. The designation should help to speed up the development and review process of the candidate. Catalyst Pharma is leaving no stone unturned to ensure the successful completion of this phase III study.
Catalyst Pharma expects to complete enrolling patients for the study shortly. Top-line data from the study’s double-blind portion is anticipated in the third quarter of 2014. The company expects to seek FDA approval for Firdapse in the LEMS indication next year. We expect investor focus to remain on updates relating to the Firdapse development program.
Catalyst Pharma mentioned in its press release that Firdapse is the first and only approved drug in the EU for symptomatic treatment in adults suffering from LEMS. The drug is available in the EU since 2010 and is marketed there by BioMarin. Apart from Firdapse, Catalyst Pharma also has CPP-115 in its pipeline, being developed for multiple indications including infantile spasms and epilepsy.
Catalyst Pharma carries a Zacks Rank #3 (Hold). Better-ranked stocks in the medical sector include Questcor Pharmaceuticals (QCOR) and Shire (SHPG). Both stocks hold a Zacks Rank #1 (Strong Buy).
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