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ANGELINI's REV-EYES APPROVED; LEDERLE/STORZ PREPARING FOR APRIL LAUNCH

Executive Summary

Angelini Pharmaceuticals' Rev-Eyes eyedrop to reverse pupillary dilation caused by mydriatic agents commonly used during ophthalmic examinations was approved by FDA on Dec. 31. Rev-Eyes (dapiprazole) was given a "1-B" rating by FDA, designating a new molecular entity representing a modest therapeutic advantage. It is the first product approved for this indication, Angelini said, and the first alpha blocker approved for any ophthalmic use. The product is the first approval for the River Edge, N.J.- based company, which was established seven years ago. Angelini Pharmaceuticals is the U.S. subsidiary of the Rome-based Angelini Group, a privately owned company with interests in consumer and health-care products. Rev-Eyes was codeveloped by American Cyanamid's Lederle Labs/Storz Ophthalmic Division, which has marketing rights in the U.S. and Canada. Storz estimates that the product could potentially be used in up to half of the 60 mil. ophthalmic exams performed in the U.S. annually. Storz said that it is aiming for an April launch, and anticipates a late 1991 approval in Canada. Storz will detail the product with 100 sales reps in the U.S. Because Rev-Eyes will be used by physicians in their own offices rather than by prescription, Storz said, most sales are expected to be directly to physicians rather than to wholesalers. While the exact price has not yet been determined, Storz said it expects the list price to be approximately $ 20 for a multidose bottle with enough product for 15 patients. Dapiprazole will be manufactured in Aprilia, Italy by Angelini, although the product will be reformulated and packaged in the U.S. by Abbott under contract from Angelini. Angelini has not disclosed specific terms of its agreements with either Storz or Abbott.
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