HHS Orders Intravenous Antiviral Flu Medication to Help Patients Hospitalized with 2009 H1N1

WASHINGTON--(Business Wire)--
The U.S. Department of Health and Human Services (HHS) today announced contract
awards for up to 120,000 treatment courses of intravenous (IV) antiviral drugs
to help treat hospitalized 2009 H1N1 influenza patients.

Patients hospitalized with 2009 H1N1 influenza are evaluated to determine if
antiviral drugs will be useful; some patients are not able to take the drugs
that are currently available as pills or liquid and may benefit from intravenous
antiviral medications.

To help meet the potential need for IV medications to combat the H1N1 virus, HHS
ordered 10,000 treatment courses each from BioCryst, Roche and GlaxoSmithKline,
totaling $31.5 million. The contracts allow HHS to place additional orders of up
to 30,000 treatment courses with each manufacturer over two years. Roche
manufactures Tamiflu; GlaxoSmithKline, Relenza, and BioCryst manufactures
Peramivir.

Because there are no Food and Drug Administration (FDA)-approved antiviral
medications that can be administered intravenously to treat influenza, the FDA
issued an emergency use authorization on Oct. 23 to allow use of intravenous
Peramivir, an investigational antiviral drug in the class of drugs known as
neuraminidase inhibitors.

The HHS orders for intravenous oseltamivir (Tamiflu) and intravenous zanamivir
(Relenza), also neuraminidase inhibitors, are predicated on FDA emergency use
authorization for these medications.

FDA has not issued emergency use authorization authorizing the use of
intravenous Tamiflu or Relenza. Orders for Tamiflu and Relenza are based on
anticipated need of emergency use authorizations for additional IV drugs in the
future. Tamiflu and Relenza are FDA-approved in the form of pills or liquid, and
studies are ongoing into the use of these two drugs intravenously for
hospitalized H1N1 flu patients.

The emergency use authorization for IV Peramivir allowed doctors to prescribe
the drug to treat certain adults and children hospitalized with confirmed or
suspected 2009 H1N1 infections. Specifically, IV Peramivir is authorized only
for hospitalized adult and pediatric patients for whom therapy with an IV drug
is clinically appropriate.

To authorize emergency use of any product, the FDA commissioner must determine
that in an emergency, based on the totality of scientific evidence available, it
is reasonable to believe that the product may be effective in diagnosing,
treating, or preventing the serious or life threatening disease or condition;
that the known and potential benefits of the product outweigh the known and
potential risks of the product in the emergency situation, and that there is no
adequate, approved, and available alternative to the product for diagnosing,
preventing, or treating such serious or life threatening disease or condition.

The Biomedical Advanced Research and Development Authority (BARDA) within the
HHS Office of the Assistant Secretary for Preparedness and Response (ASPR) will
manage the contracts. BARDA supported the advanced development of IV Peramivir
beginning in 2007 as part of a larger HHS initiative to develop promising new
influenza medications and vaccines.

For more information on the emergency use of IV Peramivir authorized by FDA,
including information for health care providers on patient eligibility, see
http://www.cdc.gov/h1n1flu/eua/. Healthcare providers can also call
1-800-CDC-INFO (1-800-232-4636). Additional information about BARDA contracts is
available at https://www.medicalcountermeasures.gov/announcements.aspx.

Note: All HHS press releases, fact sheets and other press materials are
available at http://www.hhs.gov/news.

HHS Press Office
202-690-6343

Copyright Business Wire 2009