Bridging Trial Based on Safety and Immunogenicity Initiated in Australia
MOUNTAIN VIEW, Calif., Dec. 10 /PRNewswire/ -- Aviron (Nasdaq: AVIR) today
reported on discussions in a recent meeting with the U.S. Food and Drug
Administration Center for Biologics Evaluation and Research (CBER) regarding
plans for submission of Aviron's license applications for its FluMist
intranasal influenza vaccine.
On August 31, Aviron reported that it had received notice from the FDA
that its license applications were not accepted for filing due to lack of data
on manufacturing, validation and stability.
"We had a productive meeting with the FDA, and received valuable input
regarding our plans. We feel confident that we will be able to comply fully
with the requirements of the agency," said J. Leighton Read, M.D., Aviron's
chairman and chief executive officer. "Aviron is moving forward to implement
its action plan based on this meeting, with the goal of submitting our
applications by the summer or fall of 1999."
At the meeting, Aviron discussed its plans to complete requirements for
submission. Requirements include data on manufacturing, validation and
stability. In addition, Aviron will conduct a bridging study designed to
evaluate clinical equivalence of vaccine blended and filled at Aviron's new
Pennsylvania facility as compared to vaccine used in earlier clinical trials.
This 225-person trial has been initiated in Australia in collaboration with
CSL Limited, Aviron's Australian marketing partner for FluMist and a leading
supplier of vaccines in the Southern Hemisphere. The study will be conducted
by principal investigators Terry Nolan, MB, BS, Ph.D., FRACP, FAFPHM and Geoff
Hogg, MB, BS, FRACP, FRCPA at the Royal Children's Hospital, Melbourne.
Aviron will include safety and immunogenicity data from this clinical study in
its licensing applications for the vaccine.
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 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 those suggested here. Factors that could cause
actual results to differ include, but are not limited to, failure in a
clinical trial, failure to demonstrate stability or to validate equipment or
the manufacturing process. Risk factors also include the assessment by the
FDA 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, 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
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http://www.aviron.com
Company News On-Call:
http://www.prnewswire.com/comp/114000.html or fax,
800-758-5804, ext. 114000
CONTACT:
investors, Lyn Christenson, 650-919-3716, or
media, Karen Gilbert, 650-919-6578, both of Aviron; or John Bluth
of Fleishman-Hillard, 212-453-2000, for Aviron
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