BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that it has delivered a written response to the request for proposal (RFP) announced on September 21, 2009 from the U.S. Department of Health & Human Services (HHS) for the supply of intravenous (i.v) peramivir for the treatment of critically ill influenza patients under Emergency Use Authorization (EUA). BioCryst management intends to provide an update once the RFP process has reached a conclusion.
In addition, BioCryst announced it is initiating two Phase 3 studies of i.v. peramivir for the treatment of hospitalized patients with serious influenza. These studies are intended to support U.S. regulatory approval of peramivir as a treatment for influenza. Expenses for these Phase 3 studies are covered under the recently modified $180 million HHS/Biomedical Advanced Research and Development Authority (BARDA) contract to develop peramivir for the treatment of influenza.
"The novel H1N1 2009 virus is already producing significant morbidity and mortality within North America, and I expect the burden on the healthcare system to increase in the coming weeks," said Michael Ison, M.D. MS, Assistant Professor at Northwestern University Feinberg School of Medicine and lead investigator for one of the studies. "This Phase 3 study will provide an important opportunity to evaluate peramivir in an area of unmet medical need for seriously ill patients in the hospital setting."
According to the U.S. Centers for Disease Control & Prevention (CDC), on average 5 to 20 percent of the population gets the flu in the U.S.; more than 200,000 people are hospitalized from flu complications and about 36,000 people die from flu-related causes.