November 01, 1999
Gilead Sciences Announces Results of FDA Advisory Panel on Anti-HIV Agent, Adefovir Dipivoxil 60 Mg
Gaithersburg, MD -- November 1, 1999
Gilead Sciences today presented evidence to the U.S. Food and Drug Administration’s (FDA) Antiviral Drugs Advisory Committee on the safety and efficacy of adefovir dipivoxil 60 mg for patients infected with HIV.
Following the company's presentation, the Committee recommended that the FDA not approve adefovir dipivoxil 60 mg based on the currently available data. Gilead Sciences will be meeting with the FDA staff to further discuss the Committee’s views.
"We are obviously disappointed with the Committee's decision. However, we plan to work closely with the FDA to resolve the outstanding issues and respond to the questions they have raised," said John C. Martin, Ph.D., Chairman and Chief Executive Officer of Gilead Sciences.
Gilead filed its New Drug Application for adefovir dipivoxil in June 1999. While under review, Gilead has made adefovir dipivoxil available in the United States and Canada to patients in need through an Expanded Access Program, free of charge.
Gilead also is seeking approval to market adefovir dipivoxil for the treatment of HIV infection in Europe and in October 1999 filed a marketing application through the centralized procedure of the European Medicines Agency. Earlier this year, Gilead began making the drug available in France to patients with HIV infection through an Expanded Access Program. The program will begin in additional countries throughout the European Union as regulatory approvals are obtained.
In addition to adefovir dipivoxil, Gilead has other product candidates in human testing for the potential treatment of viral diseases caused by the human immunodeficiency virus (HIV), chronic hepatitis B, bacterial infections and cancer.
Gilead Sciences, 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. The Company 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, and Cambridge, UK, and sales and marketing organizations in the United States, Europe and Australia. Gilead common stock is traded on The Nasdaq Stock Market under the symbol GILD.