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MERCK PRODIAX U.S. RETINOPATHY STUDIES TO BEGIN: CLINICAL HOLD ENDED

Executive Summary

MERCK PRODIAX U.S. RETINOPATHY STUDIES TO BEGIN: CLINICAL HOLD ENDED for aldose reductase inhibitors. A limited clinical hold was imposed by FDA on the class of research-stage anti-diabetes drugs in late 1987 based on exacerbation of neuropathy normally encountered in the aging rat. The limited hold permitted the companies to continue long-term trials with the drugs but halted the initiation of new long-term clinical studies. New short-term clinical studies were allowed to begin during the hold period. The halt was lifted by FDA in a letter to ICI in mid-October. ICI is the NDA co-developer with Merck of ponal-restat. ICI calls the product, Statil. According to a joint statement from Merck and ICI, the FDA decision will permit "sponsor companies including ICI and Merck... to continue existing studies to completion and to initiate new long-term controlled studies in the U.S." The statement reports that "the first results" of the on-going neuropathy studies will be available in 1989. "The limited clinical hold," Merck and ICI said, "has not significantly affected the development of ponalrestat as the core clinical studies both in the U.S. and Europe have continued as planned in the last year." Merck announced its intention to start new long-term clinical studies on the compound at its early November meeting with security analysts in New York. Merck Chairman Roy Vagelos pointed out that Merck would be handling the retinopathy trials separately from ICI. In his prepared remarks, Vagelos said: "Current trials in patients with neuropathy are sponsored by ICI, which has licensed the drug to us. Merck is initiating studies of another complication of diabetes: retinopathy." During Q&A, Vagelos stressed that the retinopathy trials will take a long time. He said it "is going to take easily a year or more before we know we have a product candidate." He explained that the aldose reductase inhibitors continue to have to prove clinical effectiveness. "There were a series of publications recently," Vagelos commented, that indicate "biochemically and morphologically" that the class of drugs does "what it is supposed to" in humans, "but the problem is to translate that into clinical improvement."
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