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Executive Summary

SMITHKLINE STREPTOKINASE MARKETING AGREEMENT WITH KABIVITRUM is a first step toward the creation of an acute care cardiology specialty joint venture in the U.S. Announced Oct. 29, the agreement makes Smith Kline & French the exclusive U.S. distributor of KabiKinase, the Swedish firm's brand of streptokinase. Currently approved for administration via a catheter, streptokinase is marketed in the U.S. by both KabiVitrum and Hoechst Roussel (Streptase). SmithKline Chairman Henry Wendt noted that a new specialty sales force will be established beginning Nov. 2 to market the antithrombolytic agent. SmithKline's 300-rep acute care detail force, established this year, will also assist in the product's introduction. It is understood that approximately 30-35 reps will comprise the new detail force. A product license application is currently pending for intravenous administration of streptokinase in the treatment of heart attacks. At its May 29 meeting, FDA's Cardio-Renal Drugs Advisory Committee recommended the I.V. streptokinase for approval. At that same meeting, the advisory committee decided not to recommend Genertech's recombinant TPA product, Activase. Citing a need for additional mortality data, the committee did, however, acknowledge TPA's efficacy in dissolving clots. While Activase appears likely to be approved in the near future, SmithKline sees a place for both types of antithrombolytic agents. SmithKline is working with three firms on TPA products. In addition to Kabikinase, SmithKline and KabiVitrum are each committing a compound from the R&D pipeline to the acute care venture. KabiVitrum is putting in its low molecular weight heparin anticoagulant product Fragmin, and SmithKline is adding the vasodilator fenoldopam, currently under development, as a treatment for congestive heart failure. The agreement with KabiVitrum is one of several moves SmithKline has made to develop its cardiovascular presence as the market share for its highly successful diuretic combo product Dyazide begins to erode in the face of generic competition. At a December 1986 analysts meeting, the company reported 14 cardiovascular compounds in clinical development. During the same month, the company also licensed a number of cardiovascular products, including the vasodilator carvedilol, from Boehringer Mannheim. The KabiVitrum deal gives the SK&F sales force a product to sell in the short-term as well as development projects for the future. Wendt noted that U.S. sales of streptokinase have been growing steadily the last two years. With use of the drug currently limited only to hospitals with cardiac catheter labs, about 20% of U.S. hospitals, sales of streptokinase could take off once I.V. use is approved. The pending TPA application, of course, could limit the size of the initial streptokinase market. According to American Heart Association estimates, approximately 1.5 mil. Americans will suffer heart attacks in 1987.

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