Catalyst Pharmaceutical Partners, Inc
) recently announced that Firdapse was given 'Breakthrough
Therapy' designation by the U.S. Food and Drug Administration
The FDA gave the above-mentioned designation for the
indication of Lambert-Eaton myasthenic syndrome (LEMS).
We note that Catalyst Pharma is evaluating Firdapse, a phase
III candidate, for the treatment of debilitating symptoms
associated with LEMS, including muscle weakness.
The designation from the FDA was based on encouraging data
from clinical trials of Firdapse in patients with LEMS.
We remind investors that Firdapse enjoys orphan drug status in
the U.S. Catalyst Pharma acquired marketing rights to Firdapse
) in Oct 2012. Firdapse is currently in a phase III study for
LEMS with top-line results from the double-blind portion of the
study expected in the second quarter of 2014.
BioMarin Pharma currently markets Firdapse in the EU for the
treatment of LEMS. Firdapse generated sales of $14.2 million in
2012, up 8.4% year over year.
Meanwhile, Catalyst Pharma also plans to evaluate Firdapse for
the treatment of myasthenia gravis and congenital myasthenic
syndrome, among others.
Apart from Firdapse, Catalyst Pharma is also looking to
evaluate CPP-115 to treat epilepsy and other selected central
nervous disease indications. We note that CPP-115 also enjoys
orphan drug status in the U.S. for the treatment of infantile
spasms and West's syndrome (a form of infantile spasms) in the
Catalyst Pharma is also looking to develop CPP-109 for the
treatment of Tourette syndrome.
Catalyst Pharma currently carries a Zacks Rank #3 (Hold).
) look attractive, each with a Zacks Rank #2 (Buy).
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