Catalyst Pharmaceutical Partners and BioMarin Pharmaceutical Enter Into Strategic Collaboration for Firdapse(TM) in North America
Catalyst Licenses North American Rights to Firdapse™, a Phase III Orphan Drug for the Treatment of Lambert-Eaton Myasthenic Syndrome (LEMS)
Catalyst Expects Top-Line CPP-109 Phase II(b) Data During First Half of November
Under the terms of the collaboration, Catalyst and
Convertible Promissory Note and Note Purchase Agreement under which
BioMarinhas invested $5 millionin Catalyst, which will convert on a mandatory basis into Catalyst common stock at a future date. The conversion price will be based on the dollar weighted average of Catalyst's common stock during the 15 business day period prior to the conversion date. Catalyst has covenanted to BioMarinthat the $5 millioninvestment will be used solely for the purpose of developing Firdapse™ in the United States.
License Agreement in which Catalyst receives the exclusive rights to Firdapse™ for all indications in
North America. Catalyst will be responsible for all future costs of developing and commercializing Firdapse™ in North America, and will share equally the cost of various post-marketing studies in the EU, the data from which is also anticipated to be included in the Firdapse™ registration package in the United States. Subject to certain criteria, Catalyst will also owe royalty payments to BioMarin, and milestone and royalty payments to the former shareholders of Huxley Pharmaceuticalsand to a third-party licensor of the rights being sublicensed to Catalyst.
Firdapse™, also known as amifampridine phosphate, 3,4-diaminopyridine or 3,4-DAP, is a potassium channel blocker. It delays repolarization of the pre-synaptic neuron, causing voltage gated Ca2+ channels to remain open longer. The increased Ca2+ influx causes more acetylcholine to be released, making it more likely that a muscle action potential will be initiated, thereby reducing muscle weakness.
About United States Orphan Drug Designation
Orphan drug designation is granted by the U.S. Food &
Lambert-Eaton Myasthenic Syndrome is a rare autoimmune disease with the primary symptoms of muscle weakness. The muscle weakness in LEMS is caused by autoantibodies to voltage gated calcium channels leading to a reduction in the amount of acetylcholine released from nerve terminals. The prevalence of LEMS is estimated at approximately 3,000 patients in
This press release contains forward-looking statements. Forward-looking statements involve known and unknown risks and uncertainties which may cause actual results in future periods to differ materially from the statements made herein. A number of factors, including whether Firdapse™ will be approved for commercialization in the U.S., whether Catalyst will have sufficient resources to complete the development of Firdapse™ in the U.S., whether Catalyst's current Phase II(b) trial evaluating its product candidate CPP-109 for the treatment of cocaine addiction will be successful, whether Catalyst's current product candidates, CPP-109 and CPP-115, will ever be approved for commercialization in the U.S., and those other factors described in Catalyst's and
Patrick J. McEnany Catalyst Pharmaceutical PartnersChief Executive Officer (305) 529-2522 firstname.lastname@example.org Eugenia Shen BioMarin Pharmaceutical Inc.(415) 506-6570 Melody Carey Rx Communications GroupCo-President (917) 322-2571 email@example.com
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