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Executive Summary

MERCK PROSTATE REDUCING AGENT MK-906 IS IN CLINICALS, Chairman Roy Vagelos, MD, indicated in remarks at the company's annual meeting April 28. "We are moving ahead with tests in patients with enlarged prostates to determine whether this compound does in fact reduce the size of the affected gland," Vagelos said. An inhibitor of dihydrotestosterone, the hormone linked to the overgrowth of the prostate gland, MK-906 could give Merck the inside track on the development of a new drug class with significant market potential. Vagelos noted that prostatic hypertrophy, or enlargement, affects "the vast majority of men over 50" and often requires surgery. Developed by Merck scientists, the compound is designed to inhibit an enzyme that converts testosterone to dihydrotestosterone. "Initial studies of MK-906 in humans have produced biochemical evidence that the drug does reduce the level of dihydrotestosterone in the body," he added. In the cardiovascular area, the company is planning a second generation product follow up to the cholesterol-lowering drug Mevacor (lovastatin), which is still awaiting approval by the FDA. "Zocor (epistatin), which has a mechanism of action similar to that of Mevacor but is more potent, is in advanced clinical trials," Vagelos said. "By the end of this year we expect to apply for its approval in the U.S. and other countries." Merck said it has worldwide marketing rights to Zocor [formerly synvinolin], while its rights to Mevacor are limited to the U.S., Canada and "a number of smaller markets abroad." The company also plans to file an NDA "this year or early next year" for the anti-ulcer drug Losec (omeprazole), an acid pump inhibitor licensed from Astra. "In clinical trials, Losec has not only demonstrated usefulness in peptic ulcer therapy but also has achieved dramatic results in healing reflux gastroesophagitis and Zollinger-Ellison syndrome," Vagelos said. "We intend to include all three indications in our application for approval of the drug." Merck restarted Phase III trials of omeprazole in late 1985 after a nearly 18-month hiatus. Clinical testing had been suspended while animal study data concerning carcinogenesis was reviewed by the firm. Emphasizing the firm's broad product mix, Vagelos noted that eight Merck drugs surpassed the $100 mil. sales mark during 1986: Aldomet, Moduretic, Vasotec, Clinoril, Indocin, Mefoxin, Sinemet and Timoptic. Joining the $100 mil. club in 1987, the exec predicted, will be Dolobid, Pepcid, Primaxin and Noroxin.

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