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Executive Summary

MERCK AND ICI TO CO-MARKET ACE AND ALDOSE REDUCTASE INHIBITORS as part of a cross-licensing and co-marketing agreement announced Oct. 1. The agreement gives Merck a shot at an early entry into the aldose reductase oral anti-diabetic class (ICI's Statil), and simultaneously provides ICI with an ACE inhibitor (lisinopril) to support its strong beta blocker position in cardiovasculars. The deal has a complicated, occult balance. Merck is giving away exclusive rights to a second-generation follow-up to Vasotec (enalapril) to get a come-from-behind entry in the aldose reductase race. ICI is giving up exclusive rights to a compound just entering Phase III to get an ACE inhibitor which already has an NDA pending. Both parties have hedged their bets by retaining the rights to market their products under their own brandnames. "Both products will be marketed separately by both companies under separate trademarks," an Oct. 1 press release explained. The companies will have "close cooperation" on the development of the two products. The agreement is Merck's first venture in co-marketing -- indicating (1) the extent of the company's desire to get into the diabetic market, and (2) the growing vogue in cross-licensing arrangements to make use of the "fixed" asset of large existing sales forces. Lisinopril, a lysine analogue of enalapril, appears to be closer to the U.S. market. An NDA was filed for the compound in April. The ICI compound in the deal, generically called by its ICI research code (ICI 128,436), is currently in early Phase III clinical trials. However, because of recent difficulties experienced by the leaders in that category, the aldose reductase product may be able to catch the frontrunners in the field. The two leading aldose reductase inhibitors in research are Ayerst's Alredase (tolrestat) and Pfizer's sorbinil. Both have experienced delays in regulatory approval. FDA's Endocrinologic and Metabolic Drugs Advisory Committee advised the agency recently that more studies with tolrestat are required for an NDA ("The Pink Sheet" Sept 15, p. 3). Sorbinil was in Phase III trials when further studies were delayed by an incidence of skin rash ("The Pink Sheet" March 10, p. 7). While Stuart, ICI's U.S. arm, will be getting rights to a me-too ACE product, the company has shown skill in breaking into a crowded market of the cardiovascular field in the past. Tenormin was one of the late-comers to the beta-blocker market but it has reached the second position in the U.S. market in terms of sales. Lisinopril may be a once-daily ACE inhibitor. In a hemodynamic study of the drug in congestive heart failure reported in the July American Heart Journal, the researchers reported "potent inhibition of the renin-angiotensin-aldosterone system along with hemodynamic efficacy over a period exceeding 24 hours." Long-term therapy has shown no adverse effects, the authors stated in the July report from a Norwegian study.

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