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Green Cross gets KFDA approvals for peramivir

Singapore, Aug 16, 2010: BioCryst Pharmaceuticals, Birmingham, UK, has announced that its South Korean partner, Green Cross Corporation has received marketing and manufacturing approval from KFDA (Korean Food & Drug Administration) for intravenous (iv) 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.

Mr Jon P Stonehouse, president and CEO of BioCryst said, "We are pleased that intravenous peramivir is now approved in South 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 iv peramivir as a potential treatment for hospitalized patients with seasonal influenza."

Green Cross Corp. received the indication of single dose administration of 300 mg iv 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 South Korea in emergency cases. Approximately 50 individuals were treated under emergency use in South 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 South Korean Government.

 

 

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