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Executive Summary

PARKE-DAVIS' IMAZODAN IS IN PHASE II CLINICAL DEVELOPMENT for congestive heart failure, Medical Research Director Richard Downie, MD, told security analysts during a Nov. 6 presentation at the company's Ann Arbor, Michigan research facility. "In comparison with other currently available drugs for congestive heart failure, imazodan may possess a greater degree of cardiac safety than digitalis, and is orally effective, in contrast to dobutamine and dopamine, which must be given intravenously," Downie said. The Warner-Lambert researcher noted that the oral cardiotonic agent, which inhibits cardiac and vascular phosphodiesterase, has the added advantage of peripheral vasodilatation, "more than either [Sterling's] amrinone or milrinone." Amrinone is currently approved in an I.V. form only. Sterling has an NDA pending for I.V. milrinone and an oral dosage form in the late stages of development. Imazodan, formerly designated compound CI-914, is one of two Parke-Davis drugs being developed for heart failure. The company is also studying the ACE inhibitor quinipril for that indication as well as for hypertension. A quinipril NDA for hypertension is planned for 1987, Downie indicated, as are studies of the drug in combination with the diuretic hydrochlorothiazide. Warner-Lambert is also planning an entry into the already crowded U.S. beta blocker market, where eight such drugs are currently available. An NDA for Bevanol (bevantolol) was filed in June 1984, and followed a year later by a filing for Bevanol in combination with hydrochlorothiazide. When approved, the once-daily, cardioselective beta blocker will compete with three established cardioselective agents -- Ciba-Geigy's Lopressor, Wyeth/American Home's Sectral and Stuart/ICI's Tenormin. Downie cited controlled studies of Bevanol against Tenormin, in which Bevanol was found to have similar efficacy but a superior side effect profile. Downie also discussed the company's activities in the anti-arrhythmic area, where pirmenol, currently in Phase III trials, is the lead compound. Pirmenol is being studied for three indications, symptomatic premature ventricular contractions, ventricular tachycardia and postinfarction arrhythmias. Downie pointed out that pirmenol's efficacy at low potassium levels gives the drug an advantage over one existing drug therapy, dysopyramide.

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