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Executive Summary

HOECHST-ROUSSEL ONCE-DAILY ACE INHIBITOR ALTACE (RAMIPRIL) APPROVED on Jan. 29 for the treatment of hypertension after a 27- month review at FDA. Hoechst-Roussel filed the NDA in November 1988. FDA designated the Altace approval as a "1C" (new chemical entity representing little or no therapeutic gain). The new angiotensin-converting enzyme inhibitor will be co- promoted in the U.S. by Hoechst-Roussel's roughly 700-person sales force and Upjohn, which has roughly 1,400 sales reps in the U.S. but is unlikely to involve the entire sales group in promoting Altace. Hoechst-Roussel said Altace would be introduced "very soon." Altace will enter an already crowded ACE inhibitor field in the U.S. Bristol-Myers Squibb's Capoten (captopril) has been on the market in the U.S. since 1981 and Merck's Vasotec (enalapril) is firmly established. Both products now generate over $ 1 bil. in sales worldwide. In addition, Merck and ICI market different brands of lisinopril under the names Prinivil and Zestril, respectively. Labeling for Altace notes the product is indicated "for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics." The indications section also contains an ACE inhibitor class warning for agranulocytosis, which showed up in an early trial of Bristol-Myers Squibb's Capoten. That Altace labeling notes that "available data are insufficient to show that Altace does not have a similar risk." The pharmacodynamics section of the labeling notes that "doses of 5-20 mg of Altace lowered blood pressure within 1-2 hours, with peak reductions achieved 3-6 hours after dosing. The antihypertensive effect of a single dose persisted for 24 hours." However, the labeling adds that "in comparisons of peak vs. trough effect, the trough effect represented about 50%-60% of the peak response. In a titration study comparing divided (b.i.d.) vs. q.d. [once-daily] treatment, the divided regimen was superior, an indication that for some patients the antihypertensive effect with once-daily dosing is not adequately maintained." The labeling states that in "most trials" Altace "was approximately as effective as other ACE inhibitors and as atenolol [ICI's beta blocker Tenormin]. In both Caucasians and Blacks, hydrochlorothiazide (25 or 50 mg) was significantly more effective than ramipril." The labeling also notes that Altace "was less effective in Blacks than in Caucasians." FDA's approval letter notes that Hoechst-Roussel has "committed to conduct further clinical trials in patients with hypertension to improve the dosage and administration section" of Altace labeling. The letter adds that the company will meet with FDA's Cardio-Renal division "to plan a program of post-marketing studies to provide this information." Ramipril was first approved in France in 1989 and has since been introduced in Germany, Italy, Sweden, Austria, Belgium and the U.K. The product is currently in clinical trials for the treatment of congestive heart failure. Hoechst-Roussel will manufacture Altace in the U.S.

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