BioMarin Pharmaceutical Inc 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 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."
Stephen Aselage, senior vice president and chief business officer of BioMarin added, "3,4-DAP is currently the treatment of choice for LEMS. 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. 3,4-DAP has been widely recommended for use in LEMS, and the introduction of amifampridine phosphate will enable regular access to a high quality, stable proprietary product."
Bryan Morton, president and chief executive officer of EUSA Pharma said, "We are pleased now to be working with BioMarin to develop and commercialize 3,4-DAP. BioMarin is well placed to launch this important treatment for LEMS, and to continue its future broader development."
Under the terms of the agreement, BioMarin paid Huxley stockholders US$ 15.0 million upfront and will pay an additional US$ 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 US$ 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.
BioMarin develops and commercializes innovative biopharmaceuticals for serious diseases and medical conditions.
Huxley Pharmaceuticals, Inc. is private life sciences company founded and managed by Aceras BioMedical, LLC.
EUSA Pharma is a transatlantic specialty pharmaceutical company focused on in-licensing, developing and marketing late-stage oncology, pain control and critical care products.
Assistance Publique - Hopitaux de Paris (AP-HP) is a public health federation that gathers together 37 hospitals for the Paris metropolitan area.