BioCryst Pharmaceuticals, Inc. announced that it has signed agreements with two additional partners who will exclusively represent BioCryst and its anti-viral peramivir for influenza stockpiling opportunities for territories outside of the US. BioCryst's new partners are Merck Serono for Europe, Russia, Canada and Singapore and Hikma Pharmaceuticals PLC for the Middle East and North Africa (MENA) region, excluding Israel. BioCryst and its seven regional partners for peramivir cover all major and the majority of smaller pharmaceutical markets globally.
"Each of these companies has strong commercial infrastructures and established regulatory contacts in their respective territories, making them attractive partners for peramivir within these important markets," said Jon P. Stonehouse, president and chief executive officer of BioCryst Pharmaceuticals. "BioCryst has received peramivir emergency use inquiries from various countries in these regions, and we look forward to working with Merck Serono and Hikma to make peramivir available during the ongoing influenza pandemic."
Headquartered in Geneva, Switzerland, Merck Serono is the division for innovative prescription pharmaceuticals of Merck KGaA, Darmstadt, Germany, a global pharmaceutical and chemical company. Merck Serono reported 2008 revenues of approximately euro 5 billion.
Headquartered in London, Hikma Pharmaceuticals PLC is a fast growing multinational group focused on developing, manufacturing and marketing a broad range of both branded and non-branded generic and in-licensed products.
BioCryst is currently enrolling patients in two peramivir Phase 3 studies intended to support US regulatory approval for influenza. Approximately 300 study locations are targeted to participate in these studies globally.
Peramivir is a potent, intravenously administered anti-viral agent that rapidly delivers high plasma concentrations to the sites of infection. Discovered by BioCryst, peramivir inhibits the interactions of influenza neuraminidase, an enzyme which is critical to the spread of influenza within a host. In laboratory tests, peramivir has shown activity against multiple influenza strains, including pandemic H1N1 swine origin flu viral strains. Peramivir has been studied in over 1800 patients with complicated and uncomplicated influenza. Shionogi & Co., Ltd. has filed for regulatory approval in Japan. On October 23, 2009, BioCryst announced that the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for intravenous peramivir in certain adult and pediatric patients with confirmed or suspected 2009 H1N1 influenza A infection who are admitted to a hospital.
BioCryst Pharmaceuticals designs, optimizes and develops novel small-molecule pharmaceuticals that block key enzymes involved in infectious diseases, cancer and inflammatory diseases.