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Executive Summary

SYNTEX' GANCICLOVIR WILL NOT BE SUBJECT OF TREATMENT IND application to FDA: the company believes that testing under an ongoing compassionate IND program is adequate for the assessment of ganciclovir as a treatment for cytomegalovirus (CMV) retinitis in AIDS patients while Syntex continues to pursue NDA approval. Since the compassionate IND program began in 1984, 2,500 patients have been treated with ganciclovir in the U.S., Syntex said. A total of 3,000-3,500 patients have been treated worldwide. Syntex has decided against seeking a Treatment IND for the drug despite encouragement from FDA. At a recent hearing before the Presidential AIDS Commission, FDA Commissioner Young noted that the agency had asked Syntex to apply but the company declined. Young cited the Syntex decision as an example of a general reluctance on the part of industry to seek Treatment INDs for AIDS drugs. To counter the industry's reluctance, Young said FDA "is being more proactive." Young said the agency has "to be more clear in the signals that we send out . . . [and] we're going to correct that." Two concerns holding back Treatment IND applications, according to Com. Young, are liability and the early stage of development of many Treatment IND compounds. Young said that he and a "leading plaintiff lawyer," in an attempt to dispel the liability worries surrounding the Treatment IND, "are going to write an article together in the published literature dealing with the litigious nature and why it shouldn't be applicable to Treatment INDs." Discussions between FDA and Syntex over need for additional clinical studies to support its NDA for ganciclovir in CMV retinitis are ongoing, the firm said. The company expects a final resolution shortly on what further studies, if any, should be conducted. FDA's Anti-Infective Drug Products Advisory Committee expressed concern over the company's existing data at an Oct. 26 meeting, concluding that the existing data were insufficient to support approval of the NDA ("The Pink Sheet" Nov. 2, 1987, p. 4). Syntex had submitted retrospective data on 716 patients.

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