Catalyst Pharmaceutical Partners, Inc.’s (CPRX) fourth quarter 2013 adjusted loss of 5 cents per share was narrower than the Zacks Consensus Estimate of a loss of 7 cents per share. The narrower-than-expected loss impacted the shares positively. The company incurred a loss of 4 cents in the year-ago quarter.
Catalyst Pharma did not generate revenues in the final quarter of 2013 as was the case a year ago. Research and development (R&D) expenses jumped 177% to 2.1 million in the final quarter of 2013 due to the company’s efforts to develop its pipeline. The company expects R&D costs to increase as Catalyst Pharma is evaluating Firdapse in phase III studies for the treatment of a rare autoimmune disorder Lambert-Eaton Myasthenic Syndrome (LEMS) which is characterized by muscle weakness. Firdapse is marketed in the EU by BioMarin Pharmaceuticals (BMRN) for LEMS in the EU since 2010.
Following an agreement with BioMarin in 2012, Catalyst Pharma is responsible for the above mentioned phase III trial on Firdapse. In 2013, the U.S. Food and Drug Administration (FDA) granted ‘Breakthrough Therapy’ designation to Firdapse for the LEMS indication. The designation should help fasten the development and review process of the candidate. Catalyst Pharma is leaving no stone unturned to assure the successful completion of the 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 by Sep 30, 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 study. Apart from Firdapse, Catalyst Pharma is evaluating CPP-115 in 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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