HHS and BioCryst advance development of new influenza drug

HHS Secretary Mike Leavitt announced that the Department 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. 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 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," Secretary Leavitt said. "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.

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. 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.