MOUNTAIN VIEW, Calif., Nov. 14 /PRNewswire/ -- Aviron (Nasdaq: AVIR),
today announced that the company will not file a Biologics License Application
(BLA) for FluMist(TM), its investigational influenza vaccine, with the U.S.
Food and Drug Administration (FDA) in 1999. The schedule change is due to
issues that arose in routine validation tests during the vaccine manufacturing
process.
Aviron has initiated investigations to evaluate certain tests (assays)
which have provided inconsistent readings. The investigations will determine
the need for any additional validation work on the assays or the manufacturing
process.
Separately, Medeva Pharma Limited, a subsidiary of Medeva PLC (NYSE: MDV),
which manufactures components of the vaccine, notified Aviron of facilities
compliance issues at its facility near Liverpool, England. Aviron is working
closely with Medeva to determine how this may impact FluMist(TM)
manufacturing, and the steps necessary to achieve compliance.
The timing of a BLA filing will depend on the information obtained from
these inquiries. Once they are completed, the company will announce a new
timeline for filing.
"Even though we have made tremendous progress towards manufacturing
consistently at commercial scale, we are not yet satisfied that all of the
pieces are in place to support a successful BLA application," said J. Leighton
Read M.D., Aviron Chairman and CEO.
"Aviron will be working closely with our partners to achieve the earliest
possible commercial launch of FluMist(TM). We are targeting the 2001-2002
influenza season," Read said.
Aviron is a biopharmaceutical company based in Mountain View, CA focused
on prevention of disease. The company's goal is to develop products that offer
cost-effective prevention of a wide range of infections that affect the
general population. The majority of Aviron's products under development are
live vaccines against viral infections. These include intranasal vaccines
under development for respiratory infections and their complications
-- influenza, parainfluenza (PIV-3), and respiratory syncytial virus (RSV),
and injectable vaccines to prevent cytomegalovirus (CMV) and genital herpes
(HSV-2). FluMist(TM) is being co-developed with Wyeth Lederle, the vaccine
unit of American Home Products Corporation (NYSE: AHP). Aviron is also
developing, in collaboration with SmithKline Beecham Biologicals, a subunit
vaccine against Epstein-Barr Virus (EBV) infection, a major cause of
infectious mononucleosis.
This press release contains forward-looking statements. 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 demonstrate stability or failure to validate the
manufacturing process 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 shelf S-3 Registration
Statement, Annual Report on Form 10-K for the year ended December 31, 1998,
and subsequent Forms 10-Q.
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, Louise Leavitt of Fleishman-Hillard,
212-453-2000, for Aviron; or media, Karen Gilbert, 650-919-6578,
or investors, John Bluth, 650-919-3716, or Fred Kurland,
650-919-6666, for Aviron
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