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Executive Summary

STIEPEL LABS/ROCHE WILL CO-MARKET TOPICAL ACCUTANE IN THE U.S under the trade name Isotrex. An NDA for the .05% isotretinoin gel is currently pending at FDA for the treatment of acne vulgaris and milder forms of severe recalcitrant acne based on pre-clinical and clinical work conducted by Stiefel. The two companies are currently working on additional studies requested by FDA and are anticipating approval in "late 1987-early 1988." Roche's agreement with Stiefel fits a pattern of licensing/comarketing arrangements Roche has used to broaden its product base, including agreements with DuPont for Versed and with Glaxo for Zantac. Roche recently announced a comarketing agreement covering Miles' calcium channel blocker Baypress (nitrendipine) ("The Pink Sheet" Aug. 25, T&G-1). Steifel will market Isotrex through its 37-person U.S. detail force. Founded in 1847, Stiefel is a closely-held dermatological drug manufacturer based in Coral Gables, Florida. The company's product line includes the top selling Rx wart product, Duofilm, and the Scabene line of pediculucide Rx products. Steifel has wholly owned subsidiaries in 18 foreign countries and Puerto Rico, which generate most of the company's sales.

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