- Triggers $15.5 Million Payment From American Home Products -
MOUNTAIN VIEW, Calif., Dec. 29 /PRNewswire/ -- Aviron (Nasdaq: AVIR) today
announced that the U.S. Food and Drug Administration (FDA) accepted for review
a Biologics License Application (BLA) for FluMist(TM), an investigational
intranasal influenza vaccine.
On October 31, 2000, Aviron submitted a BLA to the FDA seeking U.S.
licensure of FluMist(TM) to prevent influenza in healthy children and healthy
adults. Today's decision by the FDA to accept the submission for review was
the next step in the regulatory process. If approved, FluMist(TM) would be
the first flu vaccine delivered as a nasal mist to be commercially available
in the U.S.
The BLA acceptance triggers a $15.5 million payment to Aviron from
American Home Products Corporation (NYSE: AHP) as part of an ongoing global
collaboration agreement for the development and marketing of FluMist(TM). The
payment will appear as revenue in Aviron's fourth quarter 2000 financial
statements.
Annual influenza epidemics in the United States typically affect 10 to
20 percent of the general population and cause approximately 20,000 deaths.
FluMist(TM), which is delivered as a nasal mist, could be an important new way
to protect people from the flu. FluMist(TM) may be particularly significant
for children, who suffer high influenza attack rates and are thought to be
important in the spread of influenza.
Aviron is a biopharmaceutical company based in Mountain View, California,
focused on the prevention of disease through innovative vaccine technology.
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
the company's license applications for its nasal influenza vaccine are
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 Aviron's SEC filings, including its
S-3 Registration Statement and Annual Report on Form 10-K for the year ended
December 31, 1999.
To receive an index and copies of recent press releases, call Aviron's
News-On-Call toll-free fax service, 800-758-5804, extension 114000.
Additional information about the company can be located at
http://www.aviron.com.
SOURCE Aviron
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Related links:
http://www.aviron.com
Company News On-Call:
http://www.prnewswire.com/comp/114000.html or fax,
800-758-5804, ext. 114000
CONTACT:
media, John Bluth, 650-919-3716, or Asha
Jennings, 650-919- 1429, both of Aviron; or Camela Stuby of
Fleishman-Hillard, 212-453-2000, for Aviron; or investors, John
Bluth, 650-919-3716, Fred Kurland, 650-919-6666, or Asha
Jennings, 650-919-1429, all of Aviron
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