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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

tient's temperature and clinical condition. In this study, the median time to alleviation of symptoms in all 37 evaluable patients treated 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 were generally safe and well-tolerated in these trials. Further analyses of the study data, including secondary efficacy endpoints and detailed safety is underway. Additional data will be submitted for presentation at an upcoming medical meeting.

"The clinical outcomes of these Phase 3 studies are important, especially during the declared influenza pandemic, as they indicate the promise of peramivir as a treatment for influenza," commented Dr. William P. Sheridan, Chief Medical Officer of BioCryst. "The need for additional anti-viral treatment options for influenza remains high. BioCryst is currently finalizing its plans for peramivir Phase 3 studies intended to support U.S. regulatory approval, while continuing to support the pre-emergency use authorization review of peramivir by the U.S. Food & Drug Administration."

"This data represents a significant milestone for BioCryst -- the first Phase 3 studies successfully conducted with a drug candidate discovered by BioCryst," said Jon P. Stonehouse, President and Chief Executive Officer of BioCryst. "We congratulate Shionogi on the success of these rapidly completed studies, which have the potential to lead to the first regulatory approval for peramivir."

Shionogi has stated that the Company is making its best effort to file its New Drug Application and to receive a manufacturing approval as soon as possible in Japan.

About Peramivir

Peramivir is an anti-viral agent that inhibits the interactions of influenza neuraminidase, an enzyme which is critical to the spread of influenza within a host. Peramivir has demons
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SOURCE BioCryst Pharmaceuticals
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