BioMarin buys Huxley Pharma for $15 million plus up to conditional $43.5 million

BioMarin Pharmaceutical says that it has acquired fellow USA-based 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).

Under the terms of the agreement, BioMarin paid Huxley stockholders $15.0 million upfront and will pay an additional $7.5 million 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 $36.0 million in milestone payments if certain annual, cumulative sales and US development milestones are met. In addition, successful development of multiple sclerosis will result in milestone payments to EUSA Pharma, from which Huxley licensed the rights to 3,4-DAP, which was developing the product after acquiring the rights from the original developer, Assistance Publique Hopitaux de Paris, France.

Last week, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has adopted a positive opinion recommending approval of amifampridine phosphate for LEMS (The Pharma Letter October 26). If approved by the European Commission, amifampridine phosphate will be the first approved treatment for LEMS, thereby conferring orphan drug protection and providing 10 years of market exclusivity in Europe.

"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 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 USA and in other indications in the USA 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," he stated.

3,4-DAP is currently the treatment of choice for LEMS, the company noted. Although its use has been limited as an unapproved product due to regulatory restrictions and limited availability of drug product, 3,4-DAP has been studied in six randomized controlled trials and has been shown to improve muscle strength in LEMS patients as measured by a variety of means.