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Executive Summary

STERLING HAS EXCLUSIVE U.S. LICENSE TO ICI's VISACOR under an agreement between the two companies announced Sept. 14. Sterling will develop and market the beta blocker as an anti-anginal agent in the U.S. and Canada. ICI said it "intends to register and market the anti-anginal in other major markets of the world." Visacor, a betasub 1-blocker with intrinsic sympathomimetic activity, is currently in late Phase III studies for ICI in Europe. Sterling said it "expects to begin its own clinical trials in the U.S. before the end of the year to prepare for eventual filing of an NDA." In one recently-published study in exercise-induced angina, Visacor was compared with propranolol. The study, conducted at University Libre de Bruxelles (Brussels), was conducted on 24 stable angina patients. The study concluded that "Visacor seems to be at least as efficient as propranolol in exercise-induced angina." A 1985 U.K. study on nine normotensive patients indicated that the intrinsic sympathomimetic activity may "contribute to the apparent protective effects of epanolol on renal function." Visacor (epanolol) will help round out Sterling's growing cardiovascular line, which includes two new inotropic agents for congestive heart failure. An NDA for oral Corotrope (milrinone) was filed with FDA in March. Sterling's Winthrop division already markets Inocor I.V. (amrinone). In a Sept. 14 press release, Sterling noted that, in studies to date, the cardioselective beta blocker "has been shown to be effective in normotensive patients -- people who suffer angina but who do not have high blood pressure." In addition, the company said that Visacor "has been demonstrated to have an improved side effect profile compared with other drugs used in the treatment of angina." Visacor probably became available for license from ICI for the U.S. market when the company cross-licensed the second generation ACE inhibitor lisinopril from Merck in return for exclusive co-marketing rights to the antidiabetic drug, Statil. An NDA for Stuart's lisinopril under the brand name Zestril is currently pending at FDA. In addition, ICI's other U.S. drug marketing division, ICI Pharma, markets the very successful cardioselective beta blocker Tenormin (atenolol), which is indicated for angina and hypertension.

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