MERCK GIVES UP SINEMET IN U.S. TO SHARE RIGHTS TO DuPONT's ANGIOTENSIN II BLOCKERS IN EARLY CLINICALS; MERCK WILL LEAD RESEARCH COLLABORATION

Executive Summary

DuPont will begin exclusive marketing in the U.S. of Merck's Sinemet beginning in 1990 in return for granting Merck development and co-marketing rights to a new class of angiotensin II receptor antagonist antihypertensives, under an agreement announced in a joint Sept. 28 release. "Beginning in 1990, DuPont will have exclusive rights in North America to Sinemet ]carbidopa/levodopa[," the press release states. A DuPont spokesman said that Dupont "will take over everything except for manufacturing," which Merck will continue for DuPont. Sales of the Merck drug in North America "exceeded $ 100 mil. in 1988," the release adds. DuPont will also receive marketing rights to a new controlled release form of the anti-Parkinson's drug, called Sinemet CR, which is currently pending at FDA. Approval is "expected in 1990," the two companies said. Once approved, DuPont will conduct the U.S. launch of the new formulation. The addition of Sinemet to DuPont's product line extends a franchise in that field. The company already markets Symmetrel (amantadine) as an anti-Parkinson's agent. Labeling for Symmetrel notes that the drug is "less effective than levodopa." However, labeling also recommends concomitant therapy with anticholingeric anti-parkinson drugs, such as Sinemet, with patients who do not respond to anticholinergic agents or receive "marginal benefit" from single-agent therapy. In addition, the agreement gives DuPont co-promotion rights to Merck's ACE inhibitor/diuretic combination Vaseretic (enalapril/hydrochlorothiazide) in the U.S. and several countries in Europe, and calls for Merck and DuPont "to collaborate on the development" of angiotensin II receptor antagonists and "share various worldwide marketing responsibilities for them," a joint press release says. DuPont will begin co-detailing enalapril/hydrochlorothiazide in four unspecified countries in Europe in 1990. The Merck product is called Co-Renitec in Europe. Co-promotion of Vaseretic in North America will begin in 1992. The co-promotion effort with Merck will be DuPont's third co-detailing arrangement in the U.S. DuPont already co-promotes Roche's Versed and SmithKline Beecham's Tagamet. Both of those agreements are year-to-year. DuPont indicated that it would be renewing the co-promotion agreements with SmithKline and Roche "at least" into 1990. Due to the increased co-promotion activities and the significantly expanded sales base from Sinemet, a DuPont spokesman noted that the company "will obviously have to increase the size of its sales force and DuPont is currently making plans to do that." DuPont's U.S. pharmaceutical sales force is now "about 400." Under the terms of the research collaboration on angiotensin II receptor antagonists, "Merck will lead the combined program to bring angiotensin II compounds through clinical trials and the regulatory review process," the release states. "Both companies will be working together on the same studies under the leadership of Merck," the DuPont spokesman said. Both companies will contribute to the funding of clinical trials for drugs in this class and Merck will be responsible for submission of any marketing applications. The deal indicates that Merck is using its enviable current regulatory record as part of its trading strength with license partners (see related story, p. 9). DuPont's lead compound in the angiotensin II receptor antagonist class is DUP 753, which is currently in early Phase II trials in the U.S. and Europe. The company also has several back-up compounds that are part of the overall package with Merck, DuPont said. To date, DuPont has not published any of its work in the angiotensin II receptor antagonist area; however, several studies are expected to appear in medical journals by early 1990. Angiotensin II receptor antagonists "act with great specificity in the body by blocking the first step in the action of a major hormone, angiotensin II, which is a factor in most cases of high blood pressure,'" the joint release explains. "The selectivity of action should result in a good safety profile, which is now being confirmed in human trials" with DUP 753, the release adds. DuPont has not gotten very much credit in the financial press for its efforts to build a pharmaceutical business. Much speculation has centered on how long DuPont would stay in the business. The company described the Merck deal as a sign of the value of its pipeline. "This agreement with Merck represents a recognition of the strength of our research effort as well as a way to increase both the short- and long-term payoff of that research effort," DuPont VP-Pharmaceuticals Joseph Mollica, PhD, stated. DuPont says it commits about $ 250 mil. annually across-the-board for biomedical research and development. He added that "the addition of established medicines to ]DuPont's[ line will add significantly to ]the company's[ sales and marketing efforts."