Basilea To Receive Milestone Payment From Astellas - Quick Facts

(RTTNews) - Basilea Pharmaceutica Ltd. (BPMUF.PK) announced that the U.S. FDA has accepted for filing the New Drug Application for isavuconazole submitted by its license partner Astellas Pharma Inc. (ALPMY). Based on the FDA's acceptance of filing of the U.S. NDA, Basilea said it will receive a CHF 12 million milestone payment from Astellas.

Ronald Scott, Basilea's CEO, stated: "We are pleased with the FDA acceptance of the NDA filing shortly after our European MAA was accepted. Isavuconazole has the potential to be a valuable new therapeutic option for patients suffering from invasive fungal infections."

Basilea expects that the European regulatory review of its MAA could be completed by the fourth quarter of 2015.

The NDA seeks approval of isavuconazole for the treatment of invasive aspergillosis and invasive mucormycosis, also known as zygomycosis, in adults. In accordance with the FDA Prescription Drug User Fee Act, the FDA designated the date of March 8, 2015 for the completion of the review.