BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) announced today that it has acquired Huxley Pharmaceuticals, Inc. (Huxley), which has rights to a proprietary form of 3,4-diaminopyridine (3,4-DAP), amifampridine phosphate, for the rare autoimmune disease Lambert Eaton Myasthenic Syndrome (LEMS). Last week, the Committee for Medicinal Products for Human Use of the European Medicines Evaluations Agency adopted a positive opinion recommending approval of amifampridine phosphate for LEMS. If approved by the European Commission, amifampridine phosphate will be the first approved treatment for LEMS, thereby conferring orphan drug protection and providing ten years of market exclusivity in Europe. Huxley licensed the rights to 3,4-DAP from EUSA Pharma, which was developing the product after acquiring the rights from the original developer, Assistance Publique Hopitaux de Paris (AP-HP).
"This acquisition represents a natural extension of BioMarin's core business operations and strategy. LEMS is a rare, serious and debilitating autoimmune disease treated by neuromuscular specialists," said Jean-Jacques Bienaime, Chief Executive Officer of BioMarin. "This deal leverages our existing European infrastructure and commercial capabilities and provides the opportunity for near-term revenue growth and operating income growth. We expect to launch the product in Europe in the first quarter of 2010, and are evaluating the best development strategy for amifampridine phosphate in LEMS in the U.S. and in other indications in the U.S. and Europe. We will also evaluate development of amifampridine phosphate in other indications including multiple sclerosis. We expect this deal to be dilutive in 2010 and accretive in 2011 and beyond."