MOUNTAIN VIEW, CA -- JULY 14, 1997
Statement
NIH Announcement of Pivotal Phase III Intranasal Influenza Vaccine Trial Success
--Initial analysis shows safety & high efficacy in children--
Background
The National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) announced that, based on an initial analysis of a pivotal Phase III trial, AvironÃs (pronounced Av-uh-ron; Nasdaq: AVIR) intranasal cold adapted influenza vaccine prevented culture-confirmed influenza in nearly all of the children who received it.
∑ The nasal spray demonstrated a 93 percent protection rate for children against culture-confirmed influenza. ∑ Only one percent of vaccinated children experienced culture-confirmed influenza compared to 18 percent of those receiving the placebo. ∑ This trial, conducted under a Collaborative Research and Development Agreement (CRADA), involved 1602 children between the ages of one and six years old and was conducted at 10 geographically dispersed sites (institutions and locations listed below).
Based on todayÃs results, Aviron plans to file a Product License Application (PLA) with the U.S. Food and Drug Administration (FDA) by mid-1998. A more comprehensive analysis of data from this trial is expected to be presented by study investigators at scientific meetings later this year.
Official Statement by J. Leighton Read, M.D., Chairman and CEO of Aviron
"Aviron is pleased to have been involved with the NIH in this extraordinary example of public-private collaboration. TodayÃs milestone is a major step toward providing a user-friendly vaccine for influenza, a condition resulting in tens of thousands of deaths and costing the American economy billions of dollars every year.
These results are particularly important since they indicate we can protect children from influenza. During an epidemic, children are at least two to three times as likely to get influenza as adults. In addition to the fever, cough, and sore throat they experience, their illness can result in work loss by parents, and evidence strongly suggests that children spread the flu in their family and in the community, endangering the lives of individuals at highest risk from complications, such as the elderly.
These results are consistent with previous NIH/Aviron studies, including a challenge efficacy study in 92 healthy adults which demonstrated 85 percent protection from disease after direct (intranasal) exposure to the flu virus. This coming influenza season, Aviron plans to conduct a Phase III trial in healthy working adults to assess the effectiveness of its vaccine in reducing work loss and medical costs due to influenza. We also look forward to seeing additional results from the follow-on trial in children, to gather information about how the vaccine will be used in consecutive influenza seasons.
Aviron is also planning trials to test the safety of its intranasal live vaccine in children with asthma. Other trials are planned to evaluate co-administration of the intranasal live vaccine with the inactivated influenza shot, with the hope of offering increased protection for individuals at high risk of complications from influenza.
We hope to have the cold adapted influenza vaccine available for widespread use in vaccination campaigns in 1999."
Official Statement from Lead Investigator, Robert Belshe, M.D., Professor of Infectious Diseases and Immunology, Director, Center for Vaccine Development, Saint Louis University, St. Louis, MO
"The high level of efficacy seen with this live attenuated intranasal influenza vaccine is likely due to its ability to stimulate a broad range of immune responses, including mucosal antibodies in the lining of the upper airways, circulating antibodies in the bloodstream, and cell-mediated immune responses.
Children and parents prefer the nasal spray to an injected vaccine. The ease of administration, safety and high efficacy make this vaccine suitable for public health campaigns."
Additional Information
The cold adapted influenza vaccine was first discovered by Dr. H.F. Maassab at the University of Michigan in 1967. Before Aviron entered into a license agreement with the University of Michigan and NIH in 1995, the vaccine had been tested in more than 7,000 individuals aged two months to 103 years.
The National Institute of Allergy and Infectious Disease, a division of the National Institutes of Health, conducts and supports research to prevent, diagnose, and treat infectious and immunologic diseases. NIAID has a major responsibility within the federal government for developing vaccines to control and prevent infectious and immunologic diseases. NIH is an agency of the U.S. Department of Health and Human Services.
The six NIAID-supported Vaccine Treatment and Evaluation Units (VTEUs) who participated in the pediatric efficacy study are: Center for Vaccine Development at Saint Louis University School of Medicine, St. Louis, MO; University of Maryland at Baltimore, Baltimore, MD; Vaccine Evaluation Unit at the School of Medicine and Dentistry at University of Rochester, Rochester, NY; Gamble Program for Clinical Research at ChildrenÃs Hospital Medical Center, Cincinnati, OH; Influenza Research Center, Baylor University College of Medicine, Houston, TX; and Harbor-UCLA Research and Education Institute, Torrance, CA.
The four Aviron-supported sites include: Vanderbilt University, Nashville, TN; University of Virginia Health Sciences Center, Charlottesville, VA; Kentucky Pediatric Research Institute, Inc., Bardstown, KY; and Pittsburgh Pediatric Research, Pittsburgh, PA.
Aviron recently announced a commercial supply agreement with its contract manufacturer, Evans Medical, a subsidiary of Medeva PLC in the UK, who also manufactured the vaccine used in this trial.
Aviron is an emerging biopharmaceutical company based in Mountain View, California whose strategy is to focus on the prevention of disease. The CompanyÃs goal is to develop vaccines to prevent a wide range of viral infections that affect the general population, providing a cost-effective means of addressing a number of major diseases.
The majority of the CompanyÃs products under development are live vaccines against viral infections, including influenza, parainfluenza (PIV-3), cytomegalovirus (CMV), genital herpes (HSV-2) and respiratory syncytial virus (RSV). 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. Additional information concerning factors that could cause such a difference is contained in AvironÃs Annual Report on form 10-K for the year ended December 31, 1996.
# # #
Note: B-roll about the intranasal influenza vaccine will be available via satellite feed on Monday, July 14 at the following times:
∑ 10:30 a.m. EDT -- Galaxy C-9, Transponder 22, Downlink frequency 4140H ∑ 1:00 and 2:00 p.m. EDT -- Galaxy C-9, Transponder 1, Downlink frequency 3720V
All transmissions are standard audio 6.2/6.8 and the feed will loop itself within 30-minute transmission windows.
For additional information, please contact:
* Media
John Bluth/Mary Curtin (NY)
Fleishman-Hillard
212-265-9150
Peter Garrett (DC) Fleishman-Hillard
202-828-8886
* Investors
J. Leighton Read, M.D.
Vera Kallmeyer, M.D.,Ph.D.
Aviron
415-919-6500
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