August 26, 2002
MedImmune Responds To FluMistTM Complete Response Letter
Gaithersburg, MD, August 26, 2002 -- MedImmune, Inc. (Nasdaq: MEDI) today announced that it has completed the submission of information requested by the U.S. Food and Drug Administration (FDA) for FluMist(TM) (Influenza Virus Vaccine Live, Intranasal), a live attenuated influenza vaccine delivered as a nasal mist, currently under FDA review. The information submitted over the last several weeks was in direct response to questions raised by the FDA in a Complete Response Letter issued on July 10, 2002. The Biologics License Application (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 being developed by MedImmune for the prevention of influenza in healthy individuals. 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 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 1,600 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, visit the company's website at www.medimmune.com.
DISCLOSURE NOTICE: 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.