Firdapse Progress Report To Date:
In October 2012, Catalyst acquired the North American rights to Firdapse, a proprietary form of amifampridine phosphate (3-4 diaminopyridine or 3,4-DAP), from BioMarin Pharmaceutical Inc. ("BioMarin"). As part of that transaction, BioMarin made a $5 million strategic investment in Catalyst to help fund the development of Firdapse. Firdapse was approved in December 2009 by the European Medicines Agency for the treatment of Lambert-Eaton Myasthenic Syndrome (LEMS), a rare and sometimes fatal autoimmune disease characterized by muscle weakness. Firdapse has been granted orphan drug designation by the U.S. Food & Drug Administration, (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.