August 21, 2001
Gilead’s Viread™ for the Treatment of HIV Infection to be Reviewed by FDA Antiviral Advisory Committee on October 3, 2001
Foster City, CA -- August 21, 2001
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that Viread™ (tenofovir disoproxil fumarate), an investigational agent for the treatment of HIV infection, is scheduled to be reviewed by the Antiviral Advisory Committee of the U.S. Food and Drug Administration (FDA) on October 3, 2001.
The company submitted the New Drug Application (NDA) for marketing approval of Viread to the FDA on May 1, 2001. In late June 2001, Gilead was notified that the Viread NDA received priority review classification, which should allow for action by the FDA by November 1, 2001.
Viread is dosed as a single tablet taken once daily and works by blocking reverse transcriptase, an enzyme crucial to the replication of HIV. Viread is an investigational drug and has not yet been determined safe or efficacious in humans for its ultimate intended use.
Gilead Sciences, Inc., headquartered in Foster City, CA, is an independent biopharmaceutical company that seeks to provide accelerated solutions for patients and the people who care for them. Gilead discovers, develops, manufactures and commercializes proprietary therapeutics for challenging infectious diseases (viral, fungal and bacterial infections) and cancer. Gilead maintains research, development or manufacturing facilities in Foster City, CA; Boulder, CO; San Dimas, CA; Cambridge, UK and Dublin, Ireland and sales and marketing organizations in the United States, Europe and Australia.
This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that are subject to risks, uncertainties and other factors that could cause actual results to differ materially from those referred to in the forward-looking statements. Such risks and uncertainties include risks related to regulatory approval of Viread. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in the Gilead Annual Report on Form 10-K for the year ended December 31, 2000 and in Gilead's Quarterly Reports on Form 10-Q, all of which are on file with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead and Gilead assumes no obligation to update any such forward-looking statements.