Aviron Receives Non-Filable Notification From FDA on FluMist;

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Aviron Receives Non-Filable Notification From FDA on FluMist;
        Company To Resubmit Application with Additional Information on
                     Manufacturing and Process Validation

    MOUNTAIN VIEW, Calif., Aug. 31 /PRNewswire/ -- Aviron (Nasdaq: AVIR)
announced today that it has received notification from the U.S. Food and Drug
Administration that its regulatory submission for FluMist(TM), its live
attenuated intranasal influenza vaccine, was not accepted for filing.  Aviron
has requested a meeting with FDA to clarify the specific information that will
be required.
    The FDA stated that it requires additional information on the
manufacturing processes and the facilities where the vaccine will be
manufactured.  No information was requested pertaining to the safety or
efficacy data for FluMist(TM).  The company submitted its original Product
License Application/Establishment License Application (PLA/ELA) to the FDA on
June 30, 1998.
    Bulk vaccine for the company's clinical trials is currently manufactured
by Medeva Pharma Ltd. (formerly known as Evans Medical) at a facility near
Liverpool, England.  A related PLA/ELA covering bulk manufacturing submitted
by Medeva Pharma was also the subject of a refusal to file notification.  The
bulk formulation is then transferred to Packaging Coordinators, Inc. (PCI), in
Philadelphia for blending, filling, packaging and labeling and storage.
    "We intend to work closely with the FDA in order to enable the earliest
possible review of our submission," said J. Leighton Read, M.D., Aviron's
chairman and chief executive officer.  "Most of the additional information the
FDA has requested is on-track and was already planned for submission in
October."
    The company noted that one important issue that may delay re-filing beyond
October is a potential FDA requirement for another trial to bridge from the
manufacturing process used for the Phase 3 pivotal trial to the process
planned for commercial production.
    "Aviron intends to discuss the need for such a trial with the FDA as soon
as possible," Dr. Read added.  "However, if such a trial were conducted, it
would take at least six months to conduct the trial and report results.
Additional stability data could also be required.  This potential delay might
significantly reduce the chance that FluMist(TM) would be approved in time for
the 1999-2000 flu season."
    "Aviron is currently in late-stage discussions with several potential
marketing partners and is reviewing these recent developments with them," Dr.
Read added.  "When we have selected our partner, we will jointly decide
whether to adjust our plans for the product launch timing from 1999-2000 to
2000-2001.  This decision will be made in light of our pending discussions
with FDA."
     Aviron is a biopharmaceutical company based in Mountain View, CA focused
on prevention of disease.  The company's goal is to develop products which
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 respiratory infections
and their complications; influenza, parainfluenza (PIV-3), and respiratory
syncytial virus (RSV); as well as cytomegalovirus (CMV) and genital herpes
(HSV-2).  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 regarding the
performance of Aviron.  Actual results may differ materially from those
suggested here.  Additional information concerning factors that could cause
such a difference is contained in Aviron's Annual Report on Form 10-K for year
ending December 31, 1997.
    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
http://www.aviron.com
Company News On-Call:
http://www.prnewswire.com or
fax, 800-758-5804, ext. 114000
CONTACT:
Media: John Bluth of Fleishman-Hillard,
212-453-2000; or Karen Gilbert, 650-919-6578; or Investors: Lyn
Christenson both of Aviron, 650-919-3716