BioCrystPharmaceuticals has announced positive results from two Phase3 studies of intravenous (i.v.) peramivir in patients with seasonal influenza.The studies were sponsored by BioCryst’s partner Shionogi & Co., Ltd. ofOsaka, Japan and conducted during the 2008-2009 influenza season. Shionogiand 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 athree-armed, multi-center, randomized, double-blind, multi-national Phase 3study of i.v. peramivir that compared the efficacy and safety of a single doseof peramivir (either 300 mg or 600 mg) and treatment with oral oseltamivirphosphate 75 mg (Tamiflu ) twice a day for five days. A total of 1,099patients were enrolled at 146 centers (Japan:100; Korea:25; Taiwan:21). Boththe 300 mg and 600 mg single dose peramivir groups demonstratednon-inferiority for the primary endpoint, time to alleviation of symptoms(TTAS), compared to the oseltamivir group. The medians for TTAS for theperamivir 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 3study of i.v. peramivir with dosing over multiple days. The study enrolled 42influenza patients at high-risk of serious complications due to one or morequalifying conditions: diagnosis with poorly controlled diabetes mellitus, achronic respiratory disease requiring pharmacotherapy, or current treatmentwith any immunosuppressive drug. Peramivir was administered at 300 mg or 600mg per day, and the duration was adjusted (up to five days) on a case-by-casebasis, depending on the patient’s temperature and clinical condition. In thisstudy, the median time to alleviation of symptoms in all 37 evaluable patientstreated with either 300 mg or 600 mg peramivir daily was 68.6 hours.i.v. peramivir 300 mg and 600 mg in both single and multiple doses weregenerally safe and well-tolerated in these trials. Further analyses of thestudy data, including secondary efficacy endpoints and detailed safety isunderway. Additional data will be submitted for presentation at an upcomingmedical meeting. “The clinical outcomes of these Phase 3 studies are important, especiallyduring the declared influenza pandemic, as they indicate the promise ofperamivir as a treatment for influenza,” commented Dr. William P. Sheridan,Chief Medical Officer of BioCryst. “The need for additional anti-viraltreatment options for influenza remains high. BioCryst is currentlyfinalizing its plans for peramivir Phase 3 studies intended to support U.S.regulatory approval, while continuing to support the pre-emergency useauthorization review of peramivir by the U.S. Food & Drug Administration.””This data represents a significant milestone for BioCryst — the firstPhase 3 studies successfully conducted with a drug candidate discovered byBioCryst,” said Jon P. Stonehouse, President and Chief Executive Officer ofBioCryst. “We congratulate Shionogi on the success of these rapidly completedstudies, which have the potential to lead to the first regulatory approval forperamivir.” Shionogi has stated that the Company is making its best effort to file itsNew Drug Application and to receive a manufacturing approval as soon aspossible in Japan.