Aviron Announces Submission of a Product License Application ForFluMist(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
CO: Aviron
ST: California
IN: MTC
SU:
07/01/98 08:39 EDT prnewswire.com
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