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BioCryst Provides Peramivir Update and Reports First Quarter 2009 Financial Results
Date:5/8/2009

se in 2009 will be between $30.0 and $38.0 million, dependent on the achievement of certain clinical milestones.

Recent Clinical Highlights

Peramivir Program

  • BioCryst's partner, Shionogi & Company, Ltd. (Shionogi), initiated a Phase 3 program with i.v. peramivir in the outpatient setting. The Phase 3 study is a 1,050 subject study. BioCryst anticipates that Shionogi will complete its study within this influenza season and expects to file for new drug approval in Japan by fiscal year end. Shionogi initiated its Phase 3 study based on positive clinical results from a Phase 2 study that investigated the efficacy and safety of a single administration of 300 mg and 600 mg. i.v. peramivir for the treatment of seasonal influenza in the outpatient setting. The Phase 2 study, which was also sponsored by Shionogi, met its primary endpoint of time to alleviation of symptoms for both the 300 mg dose (p=0.0046) and 600 mg dose (p=0.0046).

Forodesine Program

  • BioCryst has enrolled more than half of the target number of patients in the pivotal Phase 2 study of forodesine for the treatment of cutaneous T-cell lymphoma. The target enrollment for this study is approximately 130 patients. The Company expects to report preliminary data in the first half of 2010.

  • BioCryst's forodesine Phase 2 single-arm, open-label study evaluating 200 mg of forodesine twice-daily in patients with chronic lymphocytic leukemia is ongoing, and the Company expects to provide an update on this study by the end of 2009.

Conference Call and Web Cast

BioCryst's management team will host a conference call and Web cast on Friday, May 8, 2009, at 8:30 a.m. Eastern Time to discuss the financial results and recent corporat
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SOURCE BioCryst Pharmaceuticals, Inc.
Copyright©2009 PR Newswire.
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Related medicine technology :

1. BioCryst Pharmaceuticals to Announce Peramivir Update and First Quarter 2009 Financial Results on May 8, 2009
2. BioCryst Reports Positive Preliminary Results of a Shionogi & Co., Ltd. Sponsored Phase II Study of I.V. Peramivir for the Treatment of Influenza in the Outpatient Setting
3. BioCryst Announces Initiation of Phase II Study of Intramuscular Peramivir for the Treatment of Seasonal Influenza
4. BioCryst Updates Peramivir Clinical Development Plan
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