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Executive Summary

BMS' SECOND ACE: MONOPRIL WILL BE DETAILED BY OVER 1,300 REPS under a copromotion effort by Boehringer Ingelheim and Bristol- Myers Squibb's Mead Johnson and Hospital and Institutional Products Divisions. Monopril (fosinopril) was approved for treatment of hypertension May 16. The second generation angiotensin-converting enzyme inhibitor received a "IC" rating from FDA (new molecular entity with little or no therapeutic advantage over existing products). Squibb filed the fosinopril NDA on Nov. 15, 1988. Bristol-Myers Squibb said it has yet to set a launch date. Monopril is the fifth ACE inhibitor approved by FDA and the third once-a-day product. Squibb's Capoten (captopril), approved in 1981, was the first. Capoten was followed by Merck's Vasotec (enalapril) and Prinivil (lisinopril), the first once-a-day ACE inhibitor, and Hoechst-Roussel's Altace (ramipril), which was approved on Jan. 29 as the second once-daily product. ICI comarkets lisinopril under the tradename Zestril. Like Merck, Bristol-Myers Squibb has a partner for its second ACE inhibitor: under a 1988 deal with Squibb, Boehringer Ingelheim will copromote Monopril ("The Pink Sheet" Jan. 11, 1988, T&G-1). The two companies will promote the product with a total of 1,344 reps: 667 from BMS' Mead Johnson Division, 463 from Boehringer Ingelheim, and 214 from BMS' Hospital and Institutional Products Division, the company said. Monopril 10 mg once-a-day is indicated "for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics," approved labeling states. The indication statement carries a warning that FDA has required all ACE inhibitors to carry: "consideration should be given to the fact that another angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particulary in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that Monopril does not have a similar risk." Monopril's other warning statements and information for patients are also typical of the ACE class: in addition to agranulocytosis/neutropenia, the label warns of the possibility of angiodema, hypotension, renal impairment and hyperkalemia. Labeling includes an additional precaution against the possibility of liver impairment, since "fosinopril is mainly metabolized by hepatic and gut wall esterases." A Bristol-Myers Squibb press release characterizes the "dual elimination" of Monopril by the liver and the kidneys as a feature distinguishing its product: "most marketed ACE inhibitors are eliminated primarily by the kidneys," the release states. "The dual elimination profile of Monopril may prove beneficial to a broad range of patients, especially to older hypertensive patients, since kidney function may decline both with age and as a result of hypertension." BMS stressed Monopril's efficacy in geriatric populations. The label notes that 13% of the over 1,600 patients involved in clinical trials with Monopril were 65 or older. "No overall difference in safety and efficacy" was seen in the elderly, labeling states, although "greater sensitivity of some older individuals cannot be ruled out."

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