Aviron announced that the U.S. Food and Drug Administration (FDA) accepted for review a Biologics License Application (BLA) for FluMist, an investigational intranasal influenza vaccine.

On October 31, 2000, Aviron submitted a BLA to the FDA seeking U.S.licensure of FluMist to prevent influenza in healthy children and healthy adults. The decision by the FDA to accept the submission for review was the next step in the regulatory process. If approved, FluMist would be the first flu vaccine delivered as a nasal mist to be commercially available in the U.S.

The BLA acceptance triggers a $15.5 million payment to Aviron from American Home Products Corporation as part of an ongoing global collaboration agreement for the development and marketing of FluMist. The payment will appear as revenue in Aviron's fourth quarter 2000 financial statements.

Annual influenza epidemics in the United States typically affect 10 to 20 percent of the general population and cause approximately 20,000 deaths. FluMist, which is delivered as a nasal mist, could be an important new way to protect people from the flu. FluMist may be particularly significant for children, who suffer high influenza attack rates and are thought to be important in the spread of influenza.