BioMarin Takes Over Huxley

BioMarin Pharmaceutical has acquired Huxley Pharmaceuticals, 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).

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.

Under the terms of the agreement, BioMarin paid Huxley stockholders $15.0m upfront and will pay an additional $7.5m upon final European Commission approval of amifampridine in LEMS, which is expected in late 2009 or early 2010. Additionally, Huxley stockholders are eligible to receive up to approximately $36.0m in milestone payments if certain annual, cumulative sales and US development milestones are met.

Jean-Jacques Bienaime, chief executive officer of BioMarin, said: “LEMS is a rare, serious and debilitating autoimmune disease treated by neuromuscular specialists. 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 US and in other indications in the US 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.”