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February 11, 2013
08:08 EDTCPRXCatalyst Pharmaceutical provides update on RND pipeline
Catalyst Pharmaceutical Partners, provided an update on its research and development pipeline. In October 2012, Catalyst acquired the North American rights to Firdapse, a proprietary form of amifampridine phosphate from BioMarin Pharmaceutical. Firdapse was approved in December 2009 by the European Medicines Agency for the treatment of Lambert-Eaton Myasthenic Syndrome, or LEMS, a rare and sometimes fatal autoimmune disease characterized by muscle weakness. Firdapse has been granted orphan drug designation by the FDA for the treatment of LEMS, making the product eligible to obtain seven-year marketing exclusivity, if Catalyst is the first pharmaceutical company to obtain approval of an NDA for its formulation of amifampridine. Assuming positive results are obtained from the trial, Catalyst hopes to file an NDA for Firdapse in 1Q15, to obtain approval from the FDA of such NDA by the end of 2015, and to commercially launch this product sometime in the first half of 2016.Catalyst believes Firdapse can achieve peak annual revenues from sales in the U.S. of approximately $100M. On August 27, 2009, Catalyst entered into a license agreement with Northwestern University (Northwestern), under which it acquired worldwide rights to commercialize new GABA aminotransferase inhibitors and derivatives of vigabatrin which were discovered and patented by Northwestern. In October 2011, a pre-IND meeting was conducted with the FDA, during which preclinical and clinical requirements were defined that would allow Catalyst to complete a development program through Phase II of CPP-115 for the treatment of infantile spasms.
News For CPRX From The Last 14 Days
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April 27, 2015
09:05 EDTCPRXCatalyst Pharmaceutical should be bought on weakness, says SunTrust
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April 24, 2015
16:56 EDTCPRXCatalyst director Charles O'Keeffe buys 5,000 shares of common stock
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14:44 EDTCPRXCatalyst slips after competitor surprises with positive data, TheStreet says
Shares of Catalyst Pharmaceutical are falling after its privately held competitor, Jacobus Pharmaceuticals, surprised with the disclosure of positive clinical trial data showing "unequivocal evidence" that its experimental drug is an effective treatment for patients with Lambert-Eaton Myasthenic Syndrome, said TheStreet's Adam Feuerstein. Jacobus Pharma's drug, which can now reportedly be submitted to FDA for approval, has the same active ingredient as in Firdapse, the report added. Shares of Catalyst are down about 17% to $3.88 in afternoon trading. Reference Link
14:33 EDTCPRXCatalyst Pharmaceutical weakness a buying opportunity, says Piper Jaffray
Piper Jaffray expects Catalyst Pharmaceutical's Firdapse to gain approval first and secure Orphan designation for Lambert-Eaton myasthenic syndrome. The firm reiterates its Overweight rating and $7 price target and would be buyers on weakness.

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