The independent Data Monitoring Committee (DMC) has
recommended the continuation of
Catalyst Pharmaceutical Partners, Inc.
) 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).
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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.
) 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
Catalyst Pharma carries a Zacks Rank #3 (Hold). Better-ranked
stocks in the medical sector include
). Both stocks hold a Zacks Rank #1 (Strong Buy).