BioCryst is also currently conducting a Phase II clinical trial studying an intravenous formulation of peramivir in hospitalized patients. That trial is designed to compare the efficacy and safety of intravenous peramivir to orally administered oseltamivir in patients who require hospitalization due to acute influenza.
BioCryst is developing peramivir injection for the treatment of acute influenza, including infection caused by highly virulent, life-threatening strains of influenza. In January, 2006 BioCryst received FDA Fast Track designation for the development of peramivir injection for this indication.
BioCryst is advancing the clinical development of peramivir under terms of a contract from the U.S. Department of Health and Human Services (DHHS) which on January 3, 2007 awarded BioCryst a $102.6 million, four-year contract to develop peramivir for the treatment of seasonal and life-threatening influenza. Funding from the contract will support Phase II and Phase III product development activities including manufacturing of clinical lots, process validation, clinical studies and other product approval requirements needed for U.S. licensure. BioCryst has retained all of its development and commercialization rights to peramivir worldwide except for in Japan and Korea where BioCryst recently established strategic partnerships with Shionogi & Co. in Japan, and Green Cross in Korea.
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. Peramivir is an inhibitor of influenza
A and B neuraminidases and certain strains of influenza viruses that may be
resistant to available neuraminidase inhibitors but are susceptible to
peramivir in laboratory tests. Peramivir injection has recei
|SOURCE BioCryst Pharmaceuticals, Inc.|
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