|BioCryst's partner seeking approval for peramivir in Japan|
|By Staff and Wire Reports|
|Wednesday, 04 November 2009 17:14|
BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) announced that its partner, Shionogi & Co., Ltd. has filed a New Drug Application in Japan in order to seek approval for it's intravenous flu drug, peramivir.
As a consequence, BioCryst is set to receive a regulatory milestone payment of $7 million.
"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."
Recently, BioCryst announced that the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for i.v. peramivir in certain adult and pediatric patients with confirmed or suspected 2009 H1N1 influenza infection who are admitted to a hospital.
According to the CDC, on average in the U.S., approximately 200,000 people are hospitalized from flu complications and 36,000 people die from flu-related causes each year.