Japan Approves BioCryst/Shionogi Intravenous Flu Vaccine for Use in Infants and Children
Decision follows peramivir sanctioning for adult use in both Japan and South Korea.!--h2>
BioCryst Pharmaceuticals confirmed that its partner Shionogi has received approval in Japan for pediatric use of the intravenous flu vaccine peramivir. The vaccine, trademarked Rapiacta™, was launched in Japan at the start of 2010 for treating adults with uncomplicated seasonal influenza, and those at high-risk of developing flu-related complications. Shionogi says it plans to secure a supply of Rapiacta sufficient to treat about a million people if necessary during the forthcoming flu season.
BioCryst partnered with Shionogi in 2007 for development of peramivir in Japan. The year before BioCryst and Green Cross inked a deal to develop and commercialize peramivir in South Korea. In August 2010 approval was granted in South Korea for peramivir in the treatment of patients with influenza A and B viruses, including pandemic H1N1 and avian influenza. BioCryst has retained all of its development and commercialization rights to peramivir worldwide except in Japan, Taiwan, and South Korea.
Discovered by BioCryst, peramivir is an intravenously administered influenza virus neuraminidase inhibitor that is designed to block replication of influenza A and B viruses, including strains that may be resistant to available neuraminidase inhibitors. The vaccine is in development both for use on an outpatient basis and for patients with hopsitalized flu. Peramivir is currently undergoing Phase III trials in the U.S., and is being developed under a $180 million contract from the Biomedical Advanced Research and Development Authority (BARDA) within the U.S. Department of Health and Human Services (HHS).
BioCryst says it has separately established agreements with partners who will exclusively represent BioCryst and peramivir if stockpiling is requested in territories outside the U.S. These partners include: Hikma Pharmaceuticals for the Middle East and North Africa region, excluding Israel; Merck Serono for Europe, Russia, Canada, and Singapore; moksha8 Pharmaceuticals for Brazil and Mexico; and Neopharm Group for Israel.