HHS awards $77.2 million contract to BioCryst to complete Phase 3 development of peramivir

Sep 21 2009

BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that it has been awarded a $77.2 million contract modification by the U.S. Department of Health & Human Services (HHS) to complete Phase 3 development of its influenza neuraminidase inhibitor, intravenous (i.v.) peramivir, for the treatment of complicated influenza.

"We are very excited to continue working with the U.S. government to advance the development of peramivir," said Jon P. Stonehouse, President and Chief Executive Officer, BioCryst Pharmaceuticals. "Peramivir is being developed with HHS to treat seriously ill and hospitalized patients, with the goal of saving lives. This contract modification supports peramivir's Phase 3 clinical development with the aim of gaining U.S. regulatory approval."

"There are currently no anti-viral drugs approved to treat seriously ill patients with influenza who need hospital care," said Dr. William P. Sheridan, Chief Medical Officer at BioCryst. "BioCryst is committed to working with the U.S. government to advance the development of peramivir to address unmet medical needs for an intravenous treatment for influenza. We intend to initiate our Phase 3 studies as soon as possible."

This contract modification brings the total award from HHS for the development of peramivir to $179.9 million and extends the contract term by 12 months to five years. BioCryst was originally awarded a $102.6 million, four-year contract from the HHS to develop peramivir for the treatment of influenza in January 2007. Under the original contract, peramivir was advanced through Phase 2 and the initial steps of Phase 3 development.

Phase 3 Development of peramivir

BioCryst has finalized its plans for Phase 3 studies intended to support U.S. regulatory approval of peramivir for influenza. Expenses for the Phase 3 studies are covered under the modified HHS contract announced today. BioCryst is currently in the process of obtaining the appropriate Health Authority and IRB/Ethics Committee approvals and is recruiting investigators for these studies in the U.S. and abroad. BioCryst plans to initiate enrollment of these trials in the upcoming flu season.