FDAnews
www.fdanews.com/articles/89319-u-s-firm-awarded-102-6-million-contract-for-influenza-drug

U.S. FIRM AWARDED $102.6 MILLION CONTRACT FOR INFLUENZA DRUG

January 5, 2007

BioCryst Pharmaceuticals announced it has been awarded a four-year, $102.6 million contract from the U.S. HHS to develop its influenza neuraminidase inhibitor, peramivir, for the treatment of seasonal and pandemic influenza, including avian flu.

The award is part of a larger HHS initiative to pursue the development of new therapies and vaccines that may expand the ability of the United States to respond quickly to a potential pandemic. The contract commits $102.6 million to support the full development of both intravenous and intramuscular formulations of peramivir. The contract also funds the validation of multiple U.S.-based manufacturing facilities.

Peramivir is a member of the class of antiviral agents that inhibit influenza viral neuraminidase, an enzyme that is essential for the spread of influenza virus within the host. In laboratory tests peramivir has been shown to be more potent than currently available neuraminidase inhibitors. Peramivir is an inhibitor of influenza A and B neuraminidases.

Additionally, injectable formulations of peramivir have been shown to be safely administered at high dose levels to healthy subjects. In preclinical studies, peramivir has been shown to promote survival in animals infected with highly pathogenic strains of the H5N1 virus.