BioCryst's Partner Shionogi Files for Peramivir Regulatory Approval in Japan
Wed, 11/04/2009 - 3:38am
BioCrystPharmaceuticals, Inc. today announced that its partner,Shionogi & Co., Ltd. has filed a New Drug Application (NDA) in Japan to seekregulatory approval for intravenous (i.v.) peramivir to treat patients withinfluenza. As a consequence of this filing, BioCryst will receive aregulatory milestone payment of $7 million under its agreement with Shionogi."We congratulate Shionogi on this accomplishment and the great effort itsteam made to swiftly prepare the filing. This is the first application formarketing approval of peramivir in any country and it is a significantlandmark for BioCryst," said Jon P. Stonehouse, President and Chief ExecutiveOfficer of BioCryst. "BioCryst continues to work with U.S. agencies, othergovernments and our partners to provide i.v. peramivir as a treatment optionfor hospitalized patients with influenza during the ongoing pandemic, and tocomplete the development of peramivir through the traditional regulatorypathway."