BioMarin Receives Marketing Approval For Amifampridine Phosphate In EU

The European Commission has granted marketing approval for BioMarin’s 3,4-diaminopyridine (amifampridine phosphate), for the rare autoimmune disease Lambert Eaton Myasthenic Syndrome (LEMS).

Reportedly, Amifampridine phosphate, developed by the pharmaceutical unit (AGEPS) of the Paris Public Hospital Authority (AP-HP) and licensed from EUSA Pharma, is the first approved treatment for LEMS, thereby conferring orphan drug protection and providing ten years of market exclusivity in Europe. It has also received orphan drug designation in the US.

Jean-Jacques Bienaime, chief executive officer of BioMarin, said: “We are excited to bring the first approved therapeutic option to the EU to treat LEMS, a rare, serious and debilitating disease as we expand our commercial portfolio with our fourth approved product.

“We are on track to launch amifampridine in the EU in mid-March and look forward to meeting with the FDA in early 2010 to determine the necessary regulatory path for this product in the US We will also evaluate the amifampridine phosphate opportunity in a number of countries outside the US and Europe as well as the best development strategy for amifampridine in other indications.”