FDA Advisory Committee Recommends Approval For Medimmune’s FlumistTM To Prevent Influenza
GAITHERSBURG, MD, and RADNOR, PA, December 17, 2002 -- MedImmune, Inc. (Nasdaq: MEDI) and Wyeth Pharmaceuticals, a division of Wyeth (NYSE:WYE), today announced that the U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) has recommended that the FDA approve FluMist(TM) (Influenza Virus Vaccine Live, Intranasal) to prevent influenza in healthy children, adolescents and adults ages 5 through 49.
If approved by the FDA, FluMist would be the first and only intranasal influenza vaccine in the United States.
The VRBPAC panel voted in favor of the product's safety in the 50-to-64-year age group, but indicated that they believed the data set on efficacy in the 50-to-64-year age group was inadequate at this time.
Advisory committees provide the FDA with independent opinions and recommendations from outside experts on applications to market new drugs and on FDA policies. Advisory committees consist of individuals who are recognized as experts in their field from many different sectors including medical professionals, scientists and researchers, industry leaders, and consumer representatives and patient representatives. While advisory committee recommendations are valuable, all final decisions related to a regulated product are made by the FDA. There can be no assurance that the FDA will follow the advisory committee's recommendation.
Dr. Edward M. Connor, MedImmune's senior vice president, clinical development, said, "We are very pleased with the outcome of today's VRBPAC meeting and believe that the results move us closer to our goal of bringing FluMist to market by the 2003-2004 flu season. We look forward to continuing to work with the FDA to answer any additional questions that remain in the agency's review of our application."
A total of 20,228 children, adolescents and adults received 28,979 doses of FluMist in 20 clinical trials structured to evaluate the safety and efficacy of the vaccine to prevent influenza in healthy people. In the trials, the most common adverse event attributable to FluMist was runny nose/nasal congestion.
"FluMist is cutting-edge technology in influenza vaccine delivery in the U.S. aimed at protecting the health of children and adults," says Bernard Poussot, president, Wyeth Pharmaceuticals. "FluMist, with its intranasal administration, may help reduce disease burden on the health care system by increasing influenza vaccination rates."
Influenza is the most common cause of medically attended acute respiratory illness in the U.S. often involving fever, chills, muscle weakness, cough, sore throat, nasal congestion, headache and general malaise. According to the Centers for Disease Control and Prevention and the American Lung Association, 20 to 50 million people are infected annually in the U.S., causing 70 million lost work days , 38 million lost school days , and 20,000 to 50,000 deaths per year (primarily in the elderly) . The annual burden of the disease to society has been estimated at $15 billion.
If and when FluMist is approved for marketing by the FDA, it would be marketed by MedImmune and Wyeth Pharmaceuticals, a division of Wyeth, as part of an ongoing global collaboration agreement.
MedImmune is a leading biotechnology company focused on researching, developing and commercializing products to prevent or treat infectious disease, autoimmune disease and cancer. MedImmune actively markets three products, Synagis® (palivizumab), Ethyol® (amifostine) and CytoGam® (cytomegalovirus immune globulin intravenous (human)), and has 10 products in clinical testing. MedImmune employs approximately 1,600 people, is headquartered in Gaithersburg, Maryland, and has additional operations in Frederick, Maryland, as well as Pennsylvania, California, the United Kingdom and the Netherlands. For more information on MedImmune and full prescribing information for the company's marketed products, visit the company's website at www.medimmune.com.
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women's health care, cardiovascular disease, central nervous system, inflammation, hemophilia, oncology and vaccines. Wyeth is one of the world's largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing, and marketing of pharmaceuticals, vaccines, biotechnology products and non-prescription medicines that improve the quality of life for people worldwide. The Company's major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health.
This announcement may contain, in addition to historical information, certain forward-looking statements that involve risks and uncertainties, including risks and uncertainties surrounding the potential approval, launch and successful acceptance of FluMist in the marketplace. Such statements reflect management's current views and are based on certain assumptions. Actual results could differ materially from those currently anticipated as a result of a number of factors, including risks and uncertainties discussed in the company's filings with the U.S. Securities and Exchange Commission. The company is developing several products for potential future marketing. There can be no assurance that such development efforts will succeed, that such products will receive required regulatory clearance or that, even if such regulatory clearance were received, such products would ultimately achieve commercial success.