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SMITHKLINE R&D PIPELINE INCLUDES 14 CARDIOVASCULAR COMPOUNDS IN CLINICAL DEVELOPMENT; LEAD COMPOUNDS ARE IBOPAMINE AND FENOLDAPAM IN PHASE III TRIALS

Executive Summary

SmithKline's R&D program has 14 cardiovascular compounds in clinical development, including four agents obtained through a recent agreement with Boehringer Mannheim. The company noted in an R&D presentation at its biennial security analysts meeting in Philadelphia Dec. 16. The company's two lead compounds are two inotropic agents for congestive heart failure, fenoldapam and ibopamine, both in Phase III clinicals. SK&F-R&D President Stanley Crooke, MD, PhD, noted that ibopamine is in "late Phase III" and the company "intends to register it in 1987." Fenoldapam, Crooke said, "is in Phase III trials in several indications [including congestive heart failure] and we are expanding the number of indications." Overall, SmithKline reported a total of 21 products in clinical development, including six compounds in Phase III. Commenting further on ibopamine, Crooke reported that "all of the elements of the ibopamine registration have been completed other than completing the final Phase III clinical trial and looking in a comparative way at [ibopamine] versus other agents." He indicated that the company is targeting the dug as a replacement therapy for digitalis. Crooke noted that the other inotropic agent, fenoldapam, "has performed in excellent fashion in the treatment of acute hypertension and it's the best looking compound I've ever seen for . . . acute congestive heart failure as a parenteral agent." The oral activity of fenoldapam in congestive heart failure, Crooke added, "has also been demonstrated." He said that the company is preparing to re-enter clinicals with a sustained release fenoldapam in hypertension. Asked why SmithKline was concentrating R&D resources on inotropic agents when such therapy for congestive heart failure is being reconsidered, Crooke asserted that "an approach with inotropic therapy is valid." He acknowledged, however, that "the precise role and what kind of patient is served by pushing the heart further needs to be defined. Naturally, a class IV patient in congestive heart failure may not be a candidate" for such therapy. To complement its cardiovascular R&D, SmithKline reached a co-development and marketing agreement with Boehringer Mannheim covering three to six heart drugs for the U.S. market ("The Pink Sheet" Dec. 15, T&G 5). Crooke said SmithKline plans to file an NDA for the vasodilating beta blocker carvedilol in 1989 and enter the clinic with two thromboxane receptor antagonist agents in the U.S. next year. Asked about Boehringer Manneheim's loop diuretic torasemide, Crooke said that agent, currently in Phase III study, was not included in the preliminary agreement. He noted, however, that torasemide licensing for the U.S. is "under discussion." Crooke said that in addition to ibopamine, fenoldapam and carvedilol, the company's other lead compounds include a second generation tissue plasminogen activator product and the nonsedating antihistamine temelastine -- all of which are expected to reach the NDA stage "in the next two to three years." Crooke also highlighted SmithKline's leukotriene basic research, which will begin to produce agents for clinical development beginning in 1987. He reported that SmithKline's lead leukotriene D-4 antagonist, SK&F 104353, is slated to enter Phase I clinicals in January. Calling the drug a "very potent" antagonist, Crooke said that the drug will be tested in bronchial asthma, glomerulonephritis, and endotoxic shock.
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