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BioCryst Pharmaceuticals Reports Positive Results of Shionogi & Co. Sponsored Phase 3 Studies of i.v. Peramivir for Influenza
Date:7/17/2009

BIRMINGHAM, Ala., July 17 /PRNewswire-FirstCall/ -- BioCryst Pharmaceuticals (Nasdaq: BCRX) today announced positive results from two Phase 3 studies of intravenous (i.v.) peramivir in patients with seasonal influenza. The studies were sponsored by BioCryst's partner Shionogi & Co., Ltd. of Osaka, Japan and conducted during the 2008-2009 influenza season. Shionogi and Green Cross Corporation, the license holder of peramivir in Korea, co-conducted the portion of the studies in Korea.

In patients with uncomplicated seasonal influenza, Shionogi conducted a three-armed, multi-center, randomized, double-blind, multi-national Phase 3 study of i.v. peramivir that compared the efficacy and safety of a single dose of peramivir (either 300 mg or 600 mg) and treatment with oral oseltamivir phosphate 75 mg (Tamiflu((R))) twice a day for five days. A total of 1,099 patients were enrolled at 146 centers (Japan:100; Korea:25; Taiwan:21). Both the 300 mg and 600 mg single dose peramivir groups demonstrated non-inferiority for the primary endpoint, time to alleviation of symptoms (TTAS), compared to the oseltamivir group. The medians for TTAS for the peramivir 300 mg, peramivir 600 mg and oseltamivir groups were 78.0 hours, 81.0 hours and 81.8 hours, respectively.

Additionally, Shionogi conducted a double-blind, multi-center Phase 3 study of i.v. peramivir with dosing over multiple days. The study enrolled 42 influenza patients at high-risk of serious complications due to one or more qualifying conditions: diagnosis with poorly controlled diabetes mellitus, a chronic respiratory disease requiring pharmacotherapy, or current treatment with any immunosuppressive drug. Peramivir was administered at 300 mg or 600 mg per day, and the duration was adjusted (up to five days) on a case-by-case basis, depending on the pa
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