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Gilead terminates adefovir program

Executive Summary

Development of anti-HIV agent adefovir dipivoxil has been halted after FDA indicates to the company that it intends to issue a "not approvable" letter by the Dec. 29 user fee deadline. An FDA advisory committee recommended Nov. 1 that Gilead gather additional efficacy data to support the proposed 60 mg dose of adefovir. However, "Gilead has determined that an additional investment of time and resources in this products is not appropriate given the other opportunities in Gilead's clinical pipeline," including the related compound tenofovir, which has moved into Phase III. Adefovir will continue to be developed at lower doses for hepatitis B. Patients in HIV trials will be able to join the adefovir expanded access program, Gilead said. Gilead expects only "minimal" obligations by the end of 2000

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