Green Cross receives KFDA approval to manufacture, market i.v. peramivir: BioCryst Pharmaceuticals

Aug 16 2010

BioCryst Pharmaceuticals, Inc. (NASDAQ: BCRX) 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”

"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 U.S. 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.