MOUNTAIN VIEW, Calif., June 9 /PRNewswire/ -- Aviron (Nasdaq: AVIR) today
announced that a bridging study on FluMist(TM), the company's investigational
intranasal influenza vaccine, has been completed and the preliminary analysis
indicates that the results appear to meet all of the company's objectives.
The study was designed to compare one lot of FluMist(TM) blended and
filled at Aviron's facility at Packaging Coordinators, Inc. (PCI) in
Philadelphia, to one lot of vaccine manufactured with the process used in
earlier clinical trials, blended and filled by Medeva Pharma, Ltd. near
Liverpool, England. Medeva Pharma manufactured bulk supplies of FluMist(TM)
for both arms of the study.
The study's primary endpoint was to show that the lot of FluMist(TM)
blended and filled at Aviron's PCI facility had similar immunogenicity for all
three 1997-98 influenza strains to the lot of vaccine blended and filled at
Medeva. The secondary endpoint was to show that the two lots of vaccine had
similar safety and tolerability profiles.
The 225-person trial was conducted in Australia from December 1998 through
March 1999. Participants were children aged 12 to 42 months, randomized to
receive vaccine blended and filled at one of the two manufacturing sites.
Principal investigators at the Royal Children's Hospital, Melbourne, and The
University of Melbourne were Terry Nolan, MB, BS, Ph.D., FRACP, FAFPHM and
Geoff Hogg, MB, BS, FRACP, FRCPA.
The study was conducted in collaboration with CSL Limited, Aviron's
Australian marketing partner for FluMist(TM) and a leading supplier of
vaccines in the Southern Hemisphere. Aviron and Wyeth Lederle Vaccines, a
business unit of American Home Products, are collaborating on the development
and marketing of FluMist(TM) worldwide except for Australia, New Zealand,
Korea and certain other South Pacific region countries.
Aviron will include data from this clinical study in its licensing
application for the vaccine, which the company plans to file later in 1999.
"We are pleased that this study met the company objectives and look
forward to submitting the data for FDA evaluation," said J. Leighton Read,
M.D., Aviron's chairman and chief executive officer. "I want to thank the
entire study team for completing this study ahead of schedule."
On August 31, 1998, Aviron reported that it had received notice from the
FDA that its license applications for FluMist(TM) were not accepted for filing
due to lack of data on manufacturing, validation and stability. This bridging
study was undertaken to provide some of the data required for resubmission of
its regulatory package for FDA review.
Aviron is a biopharmaceutical company based in Mountain View, Calif.
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
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). 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 in a clinical trial, failure to demonstrate stability
or failure to validate the manufacturing process. Risk factors also include
the assessment by the regulatory agencies that the company's future license
applications for its intranasal 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 Annual Report on Form 10-K for the year ended
December 31, 1998.
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, John Bluth, 415-356-1000, or Louise
Leavitt, 212-453-2000, both of Fleishman-Hillard, for Aviron; or
Karen Gilbert, 650-919-6578, or investors, Fred Kurland,
650-919-6666, or Lyn Christenson, 650-919-3716, all of Aviron
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