BioCryst Pharmaceuticals, Inc. announced that its partner, Green Cross Corporation has received marketing and manufacturing approval from KFDA (Korean Food & Drug Administration) for intravenous (i.v.) peramivir to treat patients with influenza A & B viruses, including pandemic H1N1 and avian influenza. Green Cross Corp. intends to launch peramivir under the commercial name PeramiFlu in South Korea.

"We congratulate Green Cross on this achievement," said Jon P Stonehouse, president and chief executive officer of BioCryst. "We are pleased that intravenous peramivir is now approved in Korea and represents the second country this year to make this important treatment option available for patients suffering from seasonal influenza. BioCryst continues to focus on completing the US development of i.v. peramivir as a potential treatment for hospitalized patients with seasonal influenza."

Green Cross Corp. received the indication of single dose administration of 300 mg i.v. peramivir for treatment of adults with influenza A & B infection. In November 2009 after review through the Central Pharmaceutical Affairs Council, peramivir received approval for limited use in Korea in emergency cases. Approximately 50 individuals were treated under emergency use in Korea.

In June 2006, BioCryst Pharmaceuticals and Green Cross Corporation entered into an agreement that granted Green Cross Corp. the right to develop and commercialize peramivir in South Korea. As part of the agreement, Green Cross Corp. paid to BioCryst a one-time license fee. BioCryst will receive a double-digit royalty on all commercial sales, with the royalty rate being higher for non-commercial sales made to the S. Korean Government.

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 1,800 patients with complicated and uncomplicated influenza. In January 2010, Shionogi & Co., Ltd. launched intravenous (i.v.) peramivir in Japan under the name Rapiacta to treat patients with influenza.

BioCryst Pharmaceuticals designs, optimizes and develops novel small-molecule pharmaceuticals that block key enzymes involved in infectious diseases, cancer and inflammatory diseases. BioCryst has progressed two novel compounds that are in late-stage pivotal clinical trials; peramivir, an anti-viral for influenza, and forodesine, a purine nucleoside phosphorylase (PNP) inhibitor for cutaneous T-cell lymphoma (CTCL).