Steve,
Here's the explanation for the pop - they filed the PLA:
News Alert from PR Newswire via Quote.com
Topic: (NASDAQ:AVIR) Aviron,
Quote.com News Item #6957305
Headline: Aviron Announces Submission of a Product License Application For
FluMist(TM) - The First Intranasal Influenza Vaccine
======================================================================
Company Reaches Major Milestone With Its First FDA Submission
MOUNTAIN VIEW, Calif., July 1 /PRNewswire/ -- Aviron (NASDAQ:AVIR) today
announced the company has submitted its first Product License
Application/Establishment License Application (PLA/ELA) to the U.S. Food and
Drug Administration for FluMist(TM), the company's intranasal influenza
vaccine. The company is seeking U.S. licensure for FluMist(TM) to prevent
influenza and its complications in children and adults. In addition, the
company is seeking licensure for FluMist(TM), when co-administered with
inactivated vaccine (flu shots), in high risk adults such as the elderly.
Epidemic influenza affects approximately 10-20 percent of the United States
population each year, resulting in 35-50 million cases of the illness and
approximately 20,000 deaths.
Aviron has tested FluMist(TM) in approximately 5500 individuals as part of
a Collaborative Research and Development Agreement (CRADA) between Aviron and
the National Institute of Allergy and Infectious Disease (NIAID) of the
National Institutes of Health (NIH). A pivotal Phase 3 clinical trial
published in the May 14 New England Journal of Medicine (NEJM) demonstrated a
93 percent protection rate by FluMist(TM) against culture-confirmed influenza
and a 98 percent reduction of influenza-associated otitis media (ear
infections). Data from this double-blind, placebo-controlled trial showed
that 14 of 1070 children (1 percent) vaccinated with FluMist(TM) experienced
culture-confirmed influenza, while 95 of 532 children (18 percent) in the
placebo group developed influenza. In the few children in the FluMist(TM)
group who had influenza, the spectrum of illness was milder than that in the
control group.
One child out of the 1070 (0.1 percent) vaccinated with FluMist(TM)
contracted influenza-related otitis media, while 20 of 532 (4 percent) of the
placebo recipients developed the condition. The NEJM study results showed
that overall, the rate of febrile otitis media (ear infections with fever) was
30 percent lower among those who received the FluMist(TM) vaccine and
resulting antibiotic use was cut by 35 percent. Otitis media is responsible
for over one-third of all visits to pediatricians' offices each year.
Antibiotics are often used to treat otitis media and the widespread use of
antibiotics is a major medical concern among health professionals today.
"Aviron believes that FluMist(TM) offers both effective protection against
influenza and significant reduction of complications, such as febrile otitis
media," said C. Jo White, M.D., Aviron's senior vice president, medical
affairs.
In another study among healthy adults, subjects receiving FluMist(TM)
experienced an 85 percent protection rate against laboratory-documented
influenza. Those receiving injectable vaccine experienced a 71 percent
protection rate. Aviron has an additional large multi-center double-blind,
placebo-controlled study underway to evaluate the benefits of FluMist(TM) in
reducing work loss and health care utilization in adults. In studies with
FluMist(TM), no serious adverse events associated with the vaccine were
reported. A minority of recipients reported transient cold-like symptoms such
as runny nose or sore throat. In a separate study, elderly high risk adults
(those with conditions such as diabetes, chronic obstructive pulmonary disease
or congestive heart failure) received FluMist(TM) co-administered with an
inactivated vaccine (flu shot). The vaccine was well-tolerated, with the most
common symptoms being runny nose or sore throat.
After influenza strains are selected by the Federal government, Aviron
creates the respective master virus seeds for use in large scale production.
Bulk supplies of the vaccine will be manufactured in the United Kingdom for
Aviron under a commercial supply agreement with Evans Medical Ltd., a
subsidiary of Medeva PLC. An additional PLA/ELA covering bulk manufacturing
of FluMist(TM) is being submitted by Evans Medical. Secondary manufacturing
will be performed in Philadelphia, at Packaging Coordinators Inc. (PCI), a
subsidiary of Cardinal Health, Inc. PCI is covered under Aviron's PLA/ELA
submission.
"This submission for FluMist(TM) is the culmination of several years of
effort by the Aviron team, our manufacturing partners, and the NIAID and its
network of vaccine researchers throughout the country," said J. Leighton Read,
M.D., chairman and chief executive officer. "It is a significant achievement,
and an important step towards addressing a major worldwide health problem."
Aviron is a biopharmaceutical company based in Mountain View, CA whose
strategy is to focus on the prevention of disease. The company's goal is to
develop vaccines which offer cost-effective prevention of a wide range of
infections that affect the general population. The majority of the 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, 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. 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.
SOURCE Aviron
-0- 07/01/98
/CONTACT: investors, Fred Kurland, 650-919-6666, or Lyn Christenson,
650-919-3716, both of Aviron/
/Company News On-Call: prnewswire.com or fax, 800-758-5804,
ext. 114000/
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