MOUNTAIN VIEW, Calif. and MADISON, N.J., July 27 /PRNewswire/ -- The
U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological
Products Advisory Committee (VRBPAC) today recommended that there are adequate
data to support the efficacy of FluMist(TM) (Influenza Virus Vaccine,
Trivalent, Types A & B Live, Cold Adapted) for the prevention of influenza in
healthy children and healthy adults ages 1 - 64.
The committee also recommended that the data analysis completed to date is
not sufficient to support the safety of the vaccine at this time. In closing
this discussion, Dr. Robert S. Daum, Chairman of VRBPAC, indicated that the
committee would welcome the opportunity to evaluate the safety data when the
analyses are complete. Aviron (Nasdaq: AVIR) is continuing to work with the
FDA as they complete the analysis of the safety data supporting the license
application.
The Biologics License Application for FluMist(TM) is currently under
review by the FDA, which will ultimately decide whether to approve the license
application. If licensed by the FDA, FluMist(TM) would be the first influenza
vaccine delivered as a nasal mist to be commercially available in the
United States. FluMist(TM) would be marketed by Aviron and Wyeth Lederle
Vaccines, a business unit of American Home Products (NYSE: AHP).
Delivered as a nasal mist, FluMist(TM) could offer an important new
approach to help protect people from influenza. Each year in the U.S.,
influenza infects 35-50 million Americans, resulting in 20,000 deaths
(predominantly in the elderly) and as much as $12 billion in direct and
indirect costs, including 70 million lost work days and 38 million lost school
days. Influenza vaccination may be particularly significant for children, who
are between two and three times more likely than adults to contract influenza
and who remain infectious longer.
"Delivering a flu vaccine via a nasal mist makes good clinical sense since
influenza is an airborne virus that typically enters the body through the
nose," said Robert B. Belshe, MD, professor of Internal Medicine, Pediatrics,
Molecular Microbiology and Immunology at Saint Louis University.
"There is a tremendous public health need to increase influenza
vaccination rates. New influenza vaccines could help meet that need," said
C. Boyd Clarke, chairman and chief executive officer of Aviron. "Together
with Wyeth Lederle Vaccines, Aviron looks forward to working with the FDA as
it completes its review of FluMist(TM)."
"Wyeth has a strong heritage rooted in the development of innovative
vaccines, particularly those directed at protecting the health of children,"
said Kevin Reilly, president of Wyeth Lederle Vaccines. "There's excitement
at both companies to be on the cutting edge of technology in influenza
prevention."
About Aviron and Wyeth Lederle Vaccines
Aviron is a biopharmaceutical company headquartered in Mountain View,
California, focused on the prevention of disease through innovative vaccine
technologies.
Wyeth Lederle Vaccines is a business unit of Wyeth-Ayerst Pharmaceuticals,
the pharmaceutical division of American Home Products Corporation.
Wyeth-Ayerst is a major research-oriented pharmaceutical company with leading
products in the areas of women's health care, cardiovascular disease
therapies, central nervous system drugs, anti-inflammatory agents, vaccines,
and generic pharmaceuticals. American Home Products Corporation is one of the
world's largest research-based pharmaceutical and health care products
companies. It is a leader in the discovery, development, manufacturing, and
marketing of prescription drugs and over-the-counter medications. It is also
a leader in vaccines, biotechnology, and animal health care. Actual results
may differ materially from the forward-looking statements contained in this
release. Factors that could cause actual results to differ include, but are
not limited to, the assessment by regulatory agencies that Aviron's license
application for its nasal influenza vaccine is incomplete or inadequate to
approve the product for marketing to one or more target populations.
Additional information concerning factors that could cause such a difference
is contained in both companies' SEC filings, including their Annual Reports on
Form 10-K.
SOURCE Aviron
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CONTACT:
Media inquiries on Friday, July 27 should be
directed to +1-301-721-0162; or Media, John Bluth,
+1-650-919-3716, or Asha Jennings, +1-650-919-1429, both of
Aviron; or Natalie de Vane of Wyeth-Ayerst Laboratories,
+1-610-999-8756; or Lowell Weiner of American Home Products,
+1-973-660-5013; or Investors, Justin R. Victoria of American
Home Products, +1-973-660-5340; or John Bluth, +1-650-919-3716,
or Fred Kurland, +1-650-919-6666, both of Aviron
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