4 January 2007

US Funds Clinical Development of Peramivir, a Parenteral Neuraminidase Inhibitor Influenza Antiviral Drug

On January 4 the US Department of Health and Human Services announced on their pandemic influenza website (www.pandemicflu.gov) that they had awarded a four-year contract for $102.6 million for further clinical development of the influenza antiviral drug “peramivir” by Biocryst Pharmaceuticals, Inc., based in Birmingham, Alabama.

The website of Biocryst (www.biocryst.com) notes that in 2002 results of a Phase III clinical trial using an oral (pill) formulation of the drug failed to show statistical significance for the primary endpoint. The company is now developing peramivir for parenteral administration (intravenously (IV) or intramuscularly (IM)) due to the apparent low bioavailability of the oral formulation.

HHS funding is reported to be used for Phase 2 and 3 clinical trials using parenteral (not oral) administration of the drug. The Food and Drug Administration (FDA) has given “Fast Track” designation to peramivir and thus regulatory review will be accelerated.

The HHS news release today also states that their funding for clinical development of parenteral peramivir will include study of both “seasonal and life-threatening influenza, including highly pathogenic H5N1 influenza”.

Addition of an influenza antiviral neuraminidase inhibitor drug such as peramivir would be a welcome addition for clinicians to have given that Tamiflu can only be given orally and Relenza only by an inhaler. Moreover, some patients cannot absorb drugs adequately, particularly when critically ill. Furthermore, some patients cannot take Relenza via an inhaler especially if they have a preexisting lung disease.

Daniel R. Lucey, MD, MPH

Director, Center for Biologic Counterterrorism and Emerging Diseases

EROne Institutes, Washington Hospital Center

Co-Director, Masters Program (M.S.) in Biohazardous Threat Agents and Emerging Infectious Diseases

Georgetown University Department of Microbiology and Immunology

Washington, DC

Email: Daniel.R.Lucey@Medstar.net

Website: www.BePast.org