BioMarin PharmaceuticalInc. has announced that the European Commission has grantedmarketing approval for 3,4-diaminopyridine (amifampridine phosphate), for therare autoimmune disease Lambert Eaton Myasthenic Syndrome (LEMS).Amifampridine phosphate, developed by the pharmaceutical unit (AGEPS) of theParis Public Hospital Authority (AP-HP) and licensed from EUSA Pharma SAS, isthe first approved treatment for LEMS, thereby conferring orphan drugprotection and providing ten years of market exclusivity in Europe. It hasalso received orphan drug designation in the U.S. “We are excited to bring the first approved therapeutic option to the EUto treat LEMS, a rare, serious and debilitating disease as we expand ourcommercial portfolio with our fourth approved product,” said Jean-JacquesBienaime, Chief Executive Officer of BioMarin. “We are on track to launchamifampridine in the EU in mid-March and look forward to meeting with the FDAin early 2010 to determine the necessary regulatory path for this product inthe U.S. We will also evaluate the amifampridine phosphate opportunity in anumber of countries outside the U.S. and Europe as well as the bestdevelopment strategy for amifampridine in other indications.”