SMITHKLINE LICENSES CARVEDILOL, VASODILATOR IN LATE CLINICALS
SMITHKLINE LICENSES CARVEDILOL, VASODILATOR IN LATE CLINICALS, from Boehringer Mannheim as part of an effort to bring in a stable of cardiovascular drug candidates for the U.S. market. Carvedilol is a vasodilator beta blocker for hypertension and angina. SmithKline announced Dec. 11 that it will also get rights in the U.S. to two thromboxane receptor antagonists. The agreement also includes development of "other cardiovascular compounds emerging from Boehringer Mannheim research." Under the agreement, "Boehringer Mannheim and SmithKline Beckman will form a series of individual partnerships under which SmithKline Beckman will have responsibility for development and marketing in the United States and Canada," the release states. "The two companies may co-market certain of the products in the United States and other major world markets." The agreement is subject to approval by the boards of directors of the two companies. SmithKline projects a carvedilol NDA submission in 1989. The vasodilator is furthest along in Germany where a regulatory filing is expected "this month," the release states. SmithKline commented that "carvedilol's balance of vasodilation and beta blockade will make it possible to treat patients who do not respond to current beta-blocker therapy, such as those with both hypertension and peripheral vascular disease." The thromboxane receptor antagonists covered under the agreement, BM 13,177 and BM 13,505, are "in clinical evaluation in Europe and will enter the clinic in the United States in 1987," SmithKline said. "These compounds are a new class of medicines that inhibit platelet aggregation. They will treat acute myocardial infarction, coronary artery disease, and may prove useful in patients with renal and peripheral vascular disease," the firm said. The agreement with Boehringer Mannheim will expand SmithKline's cardiovascular R&D pipeline. The company has at least three cardiovascular agents in the clinical study stage of development. SmithKline's fenoldopam mesylate, a dopamine receptor agonist, is currently in Phase II studies in an oral dosage form for chronic renal failure. The oral product is in Phase III clinicals for the treatment of congestive heart failure. SmithKline also has an I.V. form of fenoldopam in Phase III development for hypertension and for congestive heart failure. SmithKline's SK&F 86466, an alpha-2 receptor antagonist, is in Phase II studies for the treatment of hypertension. The firm also has an inotropic agent, ibopamine, in Phase III clinicals for congestive heart failure. SmithKline licenses ibopamine from the Italian firm Simes Zambon.
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