To: yields (662 )
From: Street Walker
Friday, Dec 11 1998 11:55AM ET
Reply # of 685
AVIR - fda REJECTED
...requires more studies
not on all wires.
Support not until $15
market makers pushing it down.
going to tank when people realize this over the weekend.
S.W.
Thursday December 10, 4:05 pm Eastern Time
Company Press Release
SOURCE: Aviron
Aviron Meets With FDA Regarding
FluMist(TM) License Applications
Bridging Trial Based on Safety and Immunogenicity Initiated in Australia
MOUNTAIN VIEW, Calif., Dec. 10 /PRNewswire/ -- Aviron (Nasdaq: AVIR - news) 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
aviron.com.
SOURCE: Aviron |
