HHS awards $102 million for new flu drug

Jan 5, 2007 (CIDRAP News) – In an effort to expand the pool of antiviral drugs for influenza, the US government yesterday awarded a $102.6 million contract to BioCryst Pharmaceuticals Inc. of Birmingham, Ala., to develop peramivir, a new neuraminidase inhibitor.

The Department of Health and Human Services (HHS), in a press release, said peramivir has been effective against several influenza strains in laboratory studies. HHS said the contract will cover production of the investigational drug, phase 2 and 3 clinical studies, and validation of manufacturing processes.

Research under the contract will include tests involving the deadly H5N1 avian flu virus and may include research on the possible preventive use of the drug, according to HHS. BioCryst officials said the drug has been shown to help animals survive H5N1 infection.

"Antivirals are an important element of our pandemic influenza preparedness efforts," said HHS secretary Mike Leavitt in the press release. "Our antiviral strategy includes not only stockpiling existing antiviral drugs but also seeking out new antiviral medications to further broaden our capabilities to treat and prevent all forms of influenza."

Licensed drugs in the neuraminidase inhibitor class are taken orally (oseltamivir) or by an inhaler (zanamivir). However, peramivir is under development as a parenterally administered drug, meaning it can be given through intramuscular and intravenous routes.

HHS said a parenteral neuraminidase inhibitor may be particularly useful in hospital emergency departments for treatment of patients who have life-threatening flu. Parenteral injection could permit rapid buildup of peramivir to high levels throughout the body and allow treatment of people too ill to take medications by mouth, the agency said.

In a news release, BioCryst said its laboratory tests have shown that peramivir, an inhibitor of influenza A and B neuraminidases, is more potent than currently available drugs in its class and is active against antiviral-resistant flu strains. The company said high doses of injectable formulations have been safely administered to healthy people, and the drug has been found to promote survival in animals infected with the H5N1 virus.

At a BioCryst teleconference that followed the HHS announcement, Charles Bugg, PhD, the company's chairman and chief executive officer, said the contract allows the company to move peramivir as quickly as possible through clinical development.

HHS said awarding the contract to BioCryst is part of a larger initiative to support the development of new treatments and vaccines that would allow the United States to respond quickly to a flu pandemic.

Bugg said both the intramuscular and intravenous formulations of peramivir will go through phase 2 and 3 clinical trials. The intramuscular formulation will be tested against a placebo in outpatients, and the intravenous trial will likely test peramivir against oseltamivir in hospitals.

Enrollment of patients for the phase 2 trials will begin this flu season in the United States, Canada, and Europe, Bugg said, adding that the company has identified sites in the southern hemisphere that could be used to fill this year's phase 2 study groups or facilitate an early start on phase 3 studies. He said BioCryst is also identifying sites in Southeast Asia, where flu outbreaks occur year-round, that might be added to the study.

Bugg said the HHS contract to develop peramivir is subject to an emergency use authorization that would allow the department to stockpile the drug before approval by the Food and Drug Administration (FDA) if clinical data show it to be beneficial.

Jonathan Nugent, vice president of corporate communications at BioCryst, told CIDRAP News that the company hasn't ruled out developing oral or inhalational formulations of peramivir in the future. He said the company couldn't speculate on how long it might take for the drug to win FDA approval. HHS said the FDA has given peramivir "fast track" status, which would expedite the agency's review of BioCryst's application.

See also:

Jan 4 HHS press release
http://www.hhs.gov/news/press/2007pres/01/20070104a.html

Jan 4 BioCryst press release
http://investor.shareholder.com/biocryst/releasedetail.cfm?ReleaseID=224367

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