Gaithersburg, MD, July 11, 2002 -- MedImmune, Inc. (Nasdaq: MEDI) announced today that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its Biologics License Application (BLA) for FluMist™ (Influenza Virus Vaccine Live, Intranasal), a live attenuated influenza vaccine delivered as a nasal mist. FDA is requesting clarification and additional information relating to data previously submitted. No additional clinical trials have been requested.
“As expected, we received a Complete Response Letter from the FDA requesting additional information relating to our FluMist application,” said David M. Mott, MedImmune's chief executive officer. “We intend to respond promptly to the FDA's request and look forward to continuing to work with the agency toward the potential approval of FluMist.”
On January 8, 2002, MedImmune submitted answers to questions raised by the FDA in the first Complete Response Letter issued in August 2001 following a review of FluMist by the FDA's Vaccines and Related Biological Products Advisory Committee. The original BLA for FluMist was submitted to the FDA in October 2000 by Aviron, a California-based vaccines company MedImmune acquired in January 2002.
FluMist is a live, attenuated vaccine delivered as a nasal mist being developed by MedImmune for the prevention of influenza. Clinical trials suggest that FluMist is effective in reducing the incidence of influenza in healthy children and adults. FluMist also offers certain potential advantages in its administration by nasal spray, such as eliminating the unpleasantness of needle-based injectable vaccines and local injection site reactions.
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. The annual burden of the disease to society has been estimated at $15 billion.
MedImmune will hold a live webcast at 5:30 p.m. EDT on July 11, 2002 to discuss the Complete Response Letter for FluMist. The webcast may be accessed on MedImmune's website at www.medimmune.com.. A replay of the webcast will also be available via the company's website until midnight July 18, 2002.
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 11 products in clinical testing. MedImmune employs approximately 1,500 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.
This announcement may contain, in addition to historical information, certain forward-looking statements that involve risks and uncertainties. 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.