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Executive Summary

WARNER-LAMBERT AND BOOTS WILL COPROMOTE LOPID AND MANOPLAX, Boots' arteriovenous vasodilator for congestive heart failure, in the U.S. Under the cross-copromotion agreement, announced July 23, Warner-Lambert's Parke-Davis division will copromote Boots' Manoplax (flosequinan) for CHF once the drug is approved by FDA. Boots Pharmaceuticals, the U.S. arm of The Boots Company plc, will copromote Warner-Lambert's cholesterol-regulating drug Lopid (gemfibrozil) beginning in January 1992. Although the terms of the agreement were not disclosed, Warner-Lambert said the agreement is royalty-based. Warner-Lambert noted that "additional territory" could be added to the copromotion arrangement in the future. The agreement is the first between the two firms. The copromotion agreement gives Boots access to a large sales force for the company's first U.S. cardiovascular product, and Manoplax ties in with Lopid's coronary heart disease reduction claim. Warner-Lambert has approximately 1,300 U.S. pharmaceutical sales reps. Boots has approximately 200 U.S. sales reps at present and plans to expand its sales force to 350 sales reps by the time Manoplax is approved. Lopid, which is indicated for Type IV and V hyperlipidemia patients who do not respond to diet and as a second-line treatment for reducing the risk of coronary heart disease in Type IIb patients, has paced Warner-Lambert's pharmaceutical sales in recent years. In 1990, Lopid worldwide sales topped $ 370 mil. and sales through the first six months of 1991 exceeded $ 223 mil., putting the drug on course to reach $ 450 mil. this year. In addition, Lopid has managed to hold on to a 33% share of new prescriptions in the lipid-lowering market in the U.S., Warner- Lambert said. In 1989, Warner-Lambert gained a three-and-one-half year extension on the Lopid patent to Jan. 4, 1993. Warner-Lambert hopes to further protect its Lopid franchise via the introduction of a once-a-day, sustained-release form, Lopid SR, that it hopes to have on the market in 1992, one year prior to the patent expiry. The NDA for Lopid SR was filed in February. Boots filed an NDA for Manoplax for congestive heart failure in September 1990 based on clinical trial data from more than 3,000 patients worldwide. Results of a 193-patient study of flosequinan, presented at the American Heart Association meeting last November, showed significant improvement in patient "well being" and exercise tolerance with flosequinan compared to placebo ("The Pink Sheet" Nov. 19, T&G-10). In addition, patients on flosequinan did not develop tolerance to the drug, which is a frequent occurrence with nitrate therapy for CHF. Manoplax was almost shelved by Boots in September 1989 when a preliminary analysis of Phase III trial results showed an unusually high rate of exercise tolerance improvement in placebo patients, making it difficult to show efficacy with Manoplax. Upon re-analysis of the data, however, Boots decided a month later to proceed with filing an NDA for the drug.

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