BioCryst's anti-viral drug obtains FDA emergency use authorization

Mon. October 26, 2009; Posted: 12:28 PM

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Oct 26, 2009 (Datamonitor via COMTEX) -- BCRX | Quote | Chart | News | PowerRating -- BioCryst Pharmaceuticals, a biotechnology company, has reported that the FDA, in response to a request from the US Centers for Disease Control and Prevention, has issued an emergency use authorization or EUA for the investigational anti-viral drug intravenous peramivir in certain adult and pediatric patients with confirmed or suspected 2009 H1N1 influenza infection who are admitted to a hospital.

To prepare for peramivir orders that BioCryst may receive from the US or other governments during this pandemic emergency, BioCryst is completing production of approximately 130,000 courses of intravenous peramivir and is prepared to make more, if required.

In advance of any US government order that may come from the ongoing request for proposal (RFP) negotiations, BioCryst has donated and transferred to the Department of Health and Human Services (HHS) an initial supply sufficient for 1,200 courses of intravenous peramivir 600mg once-daily for five days. This transfer was made under the development contract with HHS to allow doctors and patients near-term access to the drug, and is separate from the RFP process.

BioCryst's partner, Shionogi & Co is currently preparing to file for regulatory approval in Japan in 2009.

Jon Stonehouse, CEO of BioCryst, said: "The issuance of this EUA is important because it makes peramivir a treatment option for physicians in the US. during the ongoing influenza health emergency. BioCryst has worked with HHS to enable the government to rapidly deploy an initial supply of peramivir, and we are prepared to deliver more."

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For full details on Biocryst Pharmaceuticals (BCRX) click here. Biocryst Pharmaceuticals (BCRX) has Short Term PowerRatings of 5. Details on Biocryst Pharmaceuticals (BCRX) Short Term PowerRatings is available at This Link.

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