Clinical Trial Begins With Liquid FluMist(TM) Formulation
MOUNTAIN VIEW, Calif., March 7 /PRNewswire/ -- Aviron (Nasdaq: AVIR)
announced today that the company plans to submit its Biologics License
Application (BLA) for FluMist(TM), an investigational intranasal influenza
vaccine, to the U.S. Food and Drug Administration (FDA) during the fourth
quarter of 2000. The company believes it has made significant progress towards
completing its BLA and intends to seek FDA licensure for the prevention of
influenza in children and adults.
Last fall, the company announced that it would not submit a BLA for
FluMist(TM) in 1999 due to inconsistent test results observed during
validation exercises. At that time, the company initiated an investigation
into these results. Importantly, based on this investigation, the company
believes that the inconsistencies were only associated with certain assays, or
tests, and not associated with the product or the manufacturing process.
Aviron, in collaboration with Wyeth Lederle Vaccines, a business unit of
Wyeth-Ayerst Laboratories, the pharmaceutical division of
American Home Products Corporation (NYSE: AHP), and its co-development and
co-promotion partner for FluMist(TM), is addressing these issues to ensure
consistent assay performance at commercial scale.
Separately, last fall, Aviron's contract manufacturer, Celltech Medeva
(Medeva), the international marketing arm of Celltech Group plc, notified
Aviron of facilities compliance issues associated with inadequate validation
of certain utility systems at its facility near Liverpool, England. While
largely separate from the utility systems in Aviron's dedicated manufacturing
suite at Medeva, these utilities, such as water and clean steam, are used to
prepare supplies used in the manufacture of FluMist(TM).
Medeva is working with the FDA to address these issues. The company
believes Medeva is taking the necessary steps to bring its systems into
compliance. At the same time, Aviron is working closely with Medeva to
eliminate the need for these utilities in association with FluMist(TM)
manufacturing by using disposable supplies.
"As a result of hard work by the Aviron team and our partners, we believe
we have identified the issues, and have begun implementing solutions that
should allow us to file a BLA in the fourth quarter," said C. Boyd Clarke,
Aviron president and chief executive officer. "While there is yet work to do,
we at Aviron are committed to getting FluMist(TM) to the market in a timely
manner to help prevent the substantial suffering and costs associated with
influenza."
Aviron is entitled to receive a $15.5 million milestone payment upon FDA
acceptance of the FluMist(TM) BLA and a $20 million milestone payment upon FDA
approval. The company can also earn an additional $20 million in milestone
payments for expansions in labeling claims and advisory body recommendations.
Wyeth Initiates Phase 2 Clinical Trial With Liquid FluMist(TM)
Aviron also announced today that Wyeth Lederle has initiated a Phase 2
bridging study with a refrigerator-stable liquid formulation of FluMist(TM),
an investigational intranasal influenza vaccine, in the Southern Hemisphere.
Data from this liquid FluMist(TM) clinical trial, if successful, would allow
the company to also use data from frozen FluMist(TM) clinical trials to
support license applications in international markets.
This trial, being conducted in conjunction with Aviron, is intended to
demonstrate clinical equivalence between frozen and liquid FluMist(TM). To
date, more than 500 of an anticipated 1,300 children, aged one to three years,
have been enrolled. Participants in this randomized, single-blind study will
receive either frozen or liquid FluMist(TM).
Unlike the United States, where pharmaceutical products requiring frozen
shipping and storage conditions are in widespread use, most international
markets are not equipped with the appropriate cold-storage equipment to
facilitate broad distribution of frozen vaccines.
"Frozen FluMist(TM) is extremely important in the United States, and the
development of liquid FluMist(TM) is equally important for distribution
outside the U.S.," added Clarke. "Liquid FluMist(TM) should expand our
worldwide manufacturing capacity, and continued success will trigger
significant milestone payments to Aviron."
Under the terms of the agreement signed in 1999, Wyeth Lederle's
international division will have the exclusive right to market and sell
FluMist(TM) internationally for up to 11 years. Aviron and Wyeth Lederle both
will manufacture liquid FluMist(TM). In consideration for these rights, Aviron
is entitled to receive a $10 million payment for the submission of a license
application in Europe, a $27.5 million payment for the approval of a
refrigerator-stable liquid formulation of FluMist(TM), and up to $50 million
upon licensure in international regions. This collaboration excludes Korea,
Australia, New Zealand and certain South Pacific countries.
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 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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Company News On-Call:
http://www.prnewswire.com/comp/114000.html or fax,
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CONTACT:
media, Karen Gilbert, 650-919-6578, or
investors, John Bluth, 650-919-3716, or Fred Kurland,
650-919-6666, all of Aviron; or media, Claudette Hibbert of
Fleishman-Hillard, 212-453-2000; or Douglas Petkus of
Wyeth-Ayerst Laboratories, 610-971-4980
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