MOUNTAIN VIEW, Calif., June 23 /PRNewswire/ -- Aviron (Nasdaq: AVIR) today
announced that it has extended its cooperative research and development
agreement (CRADA) for the development of FluMist(TM) with the National
Institute of Allergy and Infectious Diseases (NIAID) of the National
Institutes of Health (NIH) through June 2003. FluMist(TM) is Aviron's
investigational intranasal influenza vaccine.
In March 1995, Aviron entered into a five year CRADA with the NIAID to
conduct clinical trials designed to further explore potential benefits of the
FluMist(TM) technology. Including both Aviron's independent studies and
studies conducted cooperatively under the CRADA, Phase 1, 2 and 3 clinical
trials have been completed for FluMist(TM), generating safety and efficacy
data in more than 13,000 children and adults.
"Aviron's strong relationship with the NIH is a wonderful example of how
the public and private sectors can pool talent and resources to address a
major public health threat such as influenza," said C. Boyd Clarke, Aviron
president and chief executive officer.
Aviron intends to submit a Biologics License Application for FluMist(TM)
to the U.S. Food and Drug Administration in the fourth quarter of 2000.
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, failure to validate the manufacturing
process, facilities or equipment for the company's nasal influenza vaccine,
and the assessment by regulatory agencies that the company's future 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 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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CONTACT:
media or investors, John Bluth, 650-919-3716,
or investors, Fred Kurland, 650-919-6666, both of Aviron; or
media, Claudette Hibbert of Fleishman-Hillard, 212-453-2000, for
Aviron
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