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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
Date:7/28/2008

s peramivir are necessary."

Dr. Thomas J. Simon, BioCryst's Senior Medical Advisor, stated, "Peramivir has now been studied in over 550 patients, allowing us to develop an extensive library of clinical knowledge about this potential therapy. The Shionogi Phase II study findings contribute important new information about the safety and efficacy of peramivir in patients with acute uncomplicated influenza."

"We are encouraged by the positive results of this Phase II study testing a single dose of i.v. peramivir in the outpatient setting," stated Jon P. Stonehouse, President and Chief Executive Officer of BioCryst. "As recently announced, we have initiated a Phase II study of intramuscular peramivir in a similar setting as the Shionogi study, which will add further confirmation of this promising compound's role in addressing seasonal influenza."

In February 2007, BioCryst and Shionogi entered into an exclusive license agreement under which Shionogi obtained rights to develop and commercialize peramivir in Japan for the treatment of seasonal and potentially life-threatening human influenza. In exchange, BioCryst received a $14 million up-front payment and may also receive future clinical event milestone payments (up to $21 million) and commercial event milestone payments (up to $95 million) in addition to double-digit (between 10 percent and 20 percent range) royalty payments on product sales of peramivir. BioCryst retains all rights to commercialize peramivir in North America, Europe, and other countries outside of Japan and Korea.

Earlier this month, BioCryst commenced a Phase II study of intra-muscular (i.m.) peramivir in the outpatient setting comparing a single 600 mg dose to placebo in the treatment of seasonal influenza. The dose was selected based upon an analysis of a Phase I study of a new, more concentrated 150 mg/ml formulation of i.m. peramivir, as well as prior studies of peramivir in patients with influenza. The Phase II study w
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SOURCE BioCryst Pharmaceuticals, Inc.
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