BioCryst's investigational H1N1 drug granted Emergency Use OK

After market hours on Friday, BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) announced that the U.S. Food and Drug Administration (FDA), in response to a request from the U.S. Centers for Disease Control and Prevention (CDC), has issued an emergency use authorization (EUA)

Specifically, i.v. peramivir is authorized only for hospitalized adult and pediatric patients for whom therapy with an i.v. drug is clinically appropriate, based on one or more of the following reasons:

1. the patient is not responding to either oral or inhaled anti-viral therapy, or
2. when drug delivery by a route other than an intravenous route -- e.g., enteral (absorbed by the intestines) or inhaled -- is not expected to be dependable or feasible;
3. for adults only, when the clinician judges i.v. therapy is appropriate due to other circumstances.

Additional information regarding the peramivir EUA is available on the Web at:

www.cdc.gov/h1n1/eua

In advance of any U.S. 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 i.v. peramivir 600 mg 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.

"The issuance of this EUA is important because it makes peramivir a treatment option for physicians in the U.S. during the ongoing influenza health emergency," said Jon P. Stonehouse, Chief Executive Officer at BioCryst. "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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