I think it must be the following that some people must have had access to earlier than the rest of us:
Headline: JAMA Publishes Study on the Results of Aviron's FluMist(TM) in Working
Adults
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MOUNTAIN VIEW, Calif., and ST. DAVIDS, Pa., July 13 /PRNewswire/
-- Results of a Phase 3 study in healthy working adults being published in the
July 14 issue of the Journal of the American Medical Association (JAMA) show
that those receiving FluMist(TM), an investigational intranasal influenza
vaccine, experienced reductions in illness-associated absenteeism, health care
provider visits, and use of prescription antibiotics and over-the-counter
medication. FluMist(TM) is being developed by Aviron (NASDAQ:AVIR) and Wyeth
Lederle Vaccines, a business unit of American Home Products Corporation
(NYSE:AHP).
Reduced Illness By Multiple Definitions
The double-blind, placebo-controlled study of 4,561 healthy working adults
was conducted at 13 clinical sites nationwide during the 1997-98 flu season.
The report was authored by a team lead by Kristin L. Nichol, M.D., M.P.H.,
chief of medicine, Minneapolis Veterans Affairs Medical Center, Minneapolis,
MN, head of the trial's analysis committee.
The participants, aged 18 to 65, each received one dose of vaccine.
FluMist(TM) recipients had reduced illness by multiple definitions including
days of febrile illness (22.9 percent less), days of severe febrile illness
(27.3 percent less) and days of febrile upper respiratory tract illness
(24.8 percent less).
Reductions in Absenteeism, Doctor Visits
Reductions in illness-associated absenteeism and health resource use were
seen across several illness definitions. For example, those receiving
FluMist(TM) missed 28.4 percent fewer work days due to febrile upper
respiratory illness and had a 40.9 percent reduction in health care provider
visits. In addition, FluMist(TM) recipients experienced a 45.2 percent
reduction in days of prescription antibiotic use and 28.0 percent fewer days
of OTC medication due to febrile upper respiratory illness.
"Preventing influenza illness in the workplace can have significant
economic benefit, both in terms of reduced work loss and reduced health care
utilization," says Dr. Nichol. "Earlier studies have demonstrated that
vaccination with the flu shot can contribute to these savings. This new study
shows that a live intranasal vaccine can also provide benefits in these areas,
as well as reduce medication use."
"This field study broadens and complements the available clinical data
package on FluMist(TM)," says Peter Paradiso, Ph.D., Vice President,
Scientific Affairs and Research Strategy at Wyeth Lederle. "This is the
largest FluMist(TM) study conducted in adults to date and provides more
evidence regarding this vaccine's potential in fighting flu."
"These results highlight how important it is for us to complete the
validation and other work required to file our Biological License Application
(BLA) with the U.S. Food and Drug Administration," says J. Leighton Read,
M.D., Aviron's chairman and chief executive officer. "If the current
manufacturing validation exercises are successful, we remain on track for
filing our BLA in the fall. As we move closer to our goal of transitioning
from an R&D organization to a commercial-stage company, I have initiated a
search for an experienced president to help lead Aviron's strong management
team."
Protection rates against illness in healthy adults are similar to prior
effectiveness studies with the inactivated vaccine which have appeared
elsewhere in the scientific literature, and such rates are lower than in
laboratory-documented efficacy studies because they measure disease impact
from a variety of causes, not just influenza. Efficacy of FluMist(TM) to
prevent laboratory-documented influenza was not measured in this trial.
FluMist(TM) is being developed as part of a Collaborative Research and
Development Agreement (CRADA) between Aviron and the National Institute of
Allergy and Infectious Disease (NIAID). A preliminary analysis of this study
was presented in December 1998 at the International Symposium on Influenza and
Other Respiratory Viruses.
Aviron and Wyeth Lederle Vaccines are collaborating on the development and
marketing of FluMist(TM) worldwide except for Australia, New Zealand, certain
other South Pacific region countries, and Korea. Aviron's marketing partner in
Australia and the South Pacific region is CSL Limited, a leading supplier of
vaccines in the Southern Hemisphere.
Aviron is a biopharmaceutical company based in Mountain View, CA focused
on prevention of disease. The company's goal is to develop products that 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.
Wyeth Lederle Vaccines is a business unit of Wyeth-Ayerst Laboratories,
the pharmaceutical division of American Home Products Corporation.
Wyeth-Ayerst is a major research-oriented pharmaceutical company with leading
products in the areas of women's health care, cardiovascular disease
therapies, central nervous system drugs, anti-inflammatory agents, vaccines,
and generic pharmaceuticals. American Home Products Corporation is one of the
world's largest research-based pharmaceutical and health care products
companies. It is a leader in the discovery, development, manufacturing, and
marketing of prescription drugs and over-the-counter medications. It is also a
leader in vaccines, biotechnology, agricultural products, and animal health
care.
The statements in this press release that are not historical facts are
forward-looking statements that involve risks and uncertainties including,
without limitation, risks associated with the inherent uncertainty of
pharmaceutical research, product development and commercialization, and the
impact of competitive products and patents. Factors relating to Aviron that
could cause actual results to differ materially include, but are not limited
to failure in a clinical trial, failure to demonstrate stability or failure to
validate the manufacturing process, failure to receive regulatory approval for
the marketing of FluMist(TM) or to receive payments under collaborative
agreements that are contingent upon future events that may or may not occur.
Sales of FluMist(TM) and future payments to Aviron are dependent upon the
successful development, manufacturing, supply, sale and distribution of the
product by Aviron, its third party suppliers and Wyeth Lederle. Risks and
uncertainties also include those detailed from time to time in AHP's and
Aviron's periodic reports filed with the Securities and Exchange Commission
including Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K and
Form 20-F. Actual results may differ from the forward-looking statements.
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 companies can be located at aviron.com for
Aviron, and at ahp.com for American Home Products Corporation
(Wyeth-Ayerst Laboratories).
SOURCE Aviron
-0- 07/13/99
/CONTACT: media, Karen Gilbert of Aviron, 650-919-6578; or John Bluth,
415-356-1000, or Louise Leavitt, 212-453-2000, both of Fleishman-Hillard, for
Aviron; or Douglas Petkus of Wyeth-Ayerst Laboratories, 610-971-4980; or
investors, Fred Kurland of Aviron, 650-919-6666; Thomas Cavanagh of American
Home Products Corporation, 973-660-5706/
/Company News On-Call: prnewswire.com or fax,
800-758-5804, ext. 114000/
/Web site: ahp.com
aviron.com
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