Shionogi files New Drug Application in Japan

BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that its partner, Shionogi & Co., Ltd. has filed a New Drug Application (NDA) in Japan to seek regulatory approval for intravenous (i.v.) peramivir to treat patients with influenza. As a consequence of this filing, BioCryst will receive a regulatory milestone payment of $7 million under its agreement with Shionogi.

"We congratulate Shionogi on this accomplishment and the great effort its team made to swiftly prepare the filing. This is the first application for marketing approval of peramivir in any country and it is a significant landmark for BioCryst," said Jon P. Stonehouse, President and Chief Executive Officer of BioCryst. "BioCryst continues to work with U.S. agencies, other governments and our partners to provide i.v. peramivir as a treatment option for hospitalized patients with influenza during the ongoing pandemic, and to complete the development of peramivir through the traditional regulatory pathway."