MAP Pharma gets $20 million milestone as US FDA accepts Levadex NDA

California, USA-based MAP Pharmaceuticals (Nasdaq: MAPP) says that its New Drug Application for Levadex (which contains a novel formulation of dihydroergotamine), its orally inhaled drug for the potential acute treatment of migraine in adults, has been accepted for filing by the US Food and Drug Administration, with a Prescription Drug User Fee Act (PDUFA) goal date of March 26, 2012.

The product is being developed for the US market with drugmaker Allergan (NYSE: AGN) under a deal that could earn MAP as much as $157 million, $60 million of which was paid up front (The Pharma Letter February 2). The FDA's acceptance for filing of the NDA triggers a milestone payment to MAP of $20 million.

"We are very pleased with the FDA's acceptance of the filing of our Levadex NDA submission as it is a significant achievement in the development of Levadex," said Timothy Nelson, president and chief executive of MAP Pharmaceuticals noting: "This takes us another step forward in our effort to provide the underserved migraine patient population with a potential new treatment option."