"We are pleased to have established these relationships with strong partners who have extensive experience, capabilities, and regulatory contacts within these important markets," said Jon P. Stonehouse, President and Chief Executive Officer of BioCryst Pharmaceuticals. "In today's pandemic environment, such partnerships are the most expedient and effective option for getting peramivir to patients in need. BioCryst will continue to evaluate and develop partnerships outside the U.S. We are currently exploring other opportunities to expand the geographic reach of peramivir."

Peramivir U.S. Program Status

The pre-emergency use authorization (EUA) review of intravenous (i.v.) peramivir announced in May has continued to progress. U.S. Government agencies are considering the future option of providing peramivir through an EUA in the event of a severe influenza outbreak with significant hospitalizations. BioCryst has finalized its plans for peramivir Phase 3 studies intended to support U.S. regulatory approval for influenza. Expenses for initial steps of the Phase 3 studies are covered under our original U.S. Department of Health and Human Services (HHS)/Biomedical Advanced Research and Development Authority (BARDA) contract awarded to BioCryst in 2007. BioCryst is currently in the process of obtaining the appropriate Health Authority and IRB/Ethics Committee approvals and is recruiting investigators in the U.S. and abroad. BioCryst plans to initiate enrollment of these trials once all approvals are granted and when we have secured sufficient funding to support their completion.Discussions between BioCryst and the U.S. Government are continuing regarding a number of issues including necessary funding from HHS/BARDA for these Phase 3 studies, a potential stockpiling order, and use of our excess peramivir active pharmaceutical ingredient (API).

Source: biocryst