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Friday, January 05, 2007

U.S. Pursues Advanced Development of New Antiviral Drug Against Pandemic

U.S. Health and Human Services Secretary Mike Leavitt announced that the government has awarded a $102.6 million, four-year contract to BioCryst Pharmaceuticals, Inc. for advanced development of their influenza antiviral drug, peramivir.

In laboratory studies to date, peramivir has shown effectiveness against a number of influenza strains, according to the Department of Health and Human Services (HHS). Funding provided under the new contract will support further studies to determine if peramivir can be an effective treatment for seasonal and life-threatening influenza, including highly pathogenic H5N1 bird-flu influenza. Additional research may also examine the drug's potential use for prophylaxis to protect against influenza infection.

"Antivirals are an important element of our pandemic influenza preparedness efforts," Leavitt says. "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."

Peramivir is a member of the neuraminidase inhibitor class of influenza antiviral drugs. While the other antiviral drugs in this class are either taken orally (oseltamivir/Tamiflu) or by an inhaler (zanamivir/Relenza), peramivir is being studied as a drug that can be administered parenterally, that is through intravenous or intramuscular injection. The ability to administer the drug through parenteral injection may be especially useful in hospital settings where it can be given to persons with life-threatening influenza upon admission to emergency rooms.

Additional advantages to parenteral injection of peramivir include the potential for high levels of the drug to be achieved rapidly throughout the body and its ability to be administered to people too ill to take medications by mouth, the government says. Funding in this contract will support manufacturing of clinical investigational and consistency lots; Phase 2 and 3 clinical studies to support product approval in the U.S.; manufacturing process validation; and other product approval requirements. The advanced development of peramivir by parenteral injection has been given "Fast Track" designation by the Food and Drug Administration, which will expedite the agency's review of BioCryst's application for approval.

The avian influenza H5N1 virus is widespread in bird populations in Asia, Africa and Europe, and nearly all human cases have been caused by direct contact with infected poultry. Although there have been a few isolated cases of human-to-human transmission, the virus does not currently transmit easily from human to human. Experts are worried, however, that the H5N1 virus could mutate and become more easily transmitted human-to-human which would worsen a pandemic.
Based on a report in Proceedings of the National Academy of Sciences on the identification of a new H5N1 virus sublineage in poultry, this new virus sublineage, called Fujian virus, appears to have become the dominant strain of the H5N1 avian influenza circulating in parts of Asia.

The highly pathogenic H5N1 avian influenza virus has not been found in the United States in either birds or humans. The award made to BioCryst is part of a larger HHS initiative to pursue the development of new therapies and vaccines which may expand the ability of the United States to respond quickly to a potential pandemic, HHS says.

A group also released findings that indicate the United States is not ready for a flu pandemic, including 25 that states would run out of hospital beds within two weeks of a moderate pandemic flu outbreak and four states that do not test year-round for the flu, which is necessary to monitor for a pandemic outbreak.

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