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BioCryst Updates Peramivir Clinical Development Plan
Date:1/23/2008

150mg and 300mg doses in the Phase II trial, the Company also believes it is prudent to evaluate whether doses higher than 300mg provide additional efficacy. The Company has been limited in evaluating doses higher than 300mg due to the concentration of the formulation used in the Phase II trial. Alternative formulations are being developed, and should be available, that permit evaluation of a single dose higher than 300mg. BioCryst is now planning to initiate a Phase II clinical trial that will evaluate the 300mg dose and a higher dose of peramivir later this year. As a result, BioCryst will not continue to pursue a pivotal Phase III program for i.m. peramivir in the current influenza season.

"All of these analyses have reinforced our belief that adequate and consistent systemic exposure to peramivir is critical to demonstrate the clinical benefits of peramivir," said Jon P. Stonehouse, President and CEO of BioCryst. "This strategy allows us to test a higher dose, utilize a new formulation and make the adjustments in needle-length, all in one study. This strategy gives us confidence that we can maximize the likelihood of achieving a successful result."

After discussions between BioCryst and HHS, the Company believes that peramivir remains an important potential therapy for both seasonal influenza and pandemic preparedness. The key elements of the HHS contract remain the same. The contract amount is $102.6M and the term is four years (concluding December 31, 2010). The development plan for peramivir has changed from that outlined in the original proposal to HHS. HHS has indicated that they will fund certain elements of the revised program, including the ongoing Phase II i.v. study in hospitalized subjects, planning and conduct of the planned Phase II i.m. study, manufacturing and toxicology. Each of these elements has specific HHS funding limits. Any costs in excess of these limits will be the responsibility of BioCryst. The Company anticipates that th
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SOURCE BioCryst Pharmaceuticals, Inc.
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