MOUNTAIN VIEW, Calif., Sept. 3 /PRNewswire/ -- Aviron (Nasdaq: AVIR) today
announced the receipt of a complete response letter on August 31, 2001 from
the U.S. Food and Drug Administration (FDA) relating to its Biologics License
Application (BLA) submitted on October 31, 2000 for licensure of FluMist(TM).
The Company is seeking marketing approval of FluMist(TM) for the prevention of
influenza in healthy children and healthy adults.
In the complete response letter, the FDA requested additional information
and clarification regarding clinical and manufacturing data from the Company
in support of licensure of the product.
The Company will communicate with the FDA to clarify the FDA's requests in
order to establish a timeline for the submission of a response. The Company
is optimistic that it will be able to respond to the FDA's requests without
conducting additional clinical trials. After receiving the Company's
response, the FDA will establish a time period for review.
"This formal response to our BLA outlines the areas in which we will need
to work with the FDA in order to secure licensure of FluMist(TM)," said C.
Boyd Clarke, Aviron chairman and chief executive officer. "We look forward to
working closely with the FDA in order to fully respond to their requests."
Aviron is a biopharmaceutical company based in Mountain View, California,
focused on the prevention of disease through innovative vaccine technology.
This press release contains forward-looking statements. These statements,
which reflect management's current beliefs and expectations, are subject to
risks and uncertainties that may cause actual results to differ materially
from those projected in the forward-looking statements. Factors that could
cause actual results to differ include, but are not limited to, the risk that
the FDA will determine that the Company needs to conduct additional clinical
trials and/or provide additional data in order to obtain licensure, determine
that the Company's manufacturing facilities are not adequate or otherwise
determine that the Company's license application for FluMist(TM) is incomplete
or inadequate to approve the product for marketing to one or more target
populations, and other business risks identified in the Company's Annual
Report on Form 10-K, as amended, for the fiscal year ended December 31, 2000
and other quarterly filings.
Additional information about the company, including recent press releases,
can be located at http://www.aviron.com .
SOURCE Aviron
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CONTACT:
media and investors, John Bluth,
+1-650-919-3716; or investors, Fred Kurland, +1-650-919-6666,
both of Aviron; or media, Ben Butkus of Fleishman-Hillard,
+1-212-453-2000, for Aviron
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