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Executive Summary

MEDICIS LICENSING DEAL WITH SYOSSET LABS FOR GENERIC RETIN-A and other prescription dermatologicals was announced by New York-based Medicis Pharmaceuticals July 25. Under the agreement, Medicis will hold exclusive marketing rights to: a generic version of Ortho Pharmaceutical's Retin-A (tretinoin) for acne; an erythromycin anti-bacterial for acne; a benzoyl peroxide razor bumps treatment; and two late-stage acne research products. Medicis, with its 20-person national sales force, will also have non-exclusive rights to market Syosset Labs' other dermatological products. Syosset is a privately-held New York manufacturer of over 100 prescription and non-prescription topical dermatological products. The company's leading products include erythromycins, hydrocortisones, triamcinolones and benzoyl peroxide treatments. Terms of the agreement were not disclosed. The Syosset ANDA for generic Retin-A is pending at FDA. Filed in mid-1989, the application includes a 120-patient clinical study. The three-way comparison looks at the Syosset-Medicis product, Retin-A and the product vehicle alone. Syosset's application is for a .05% concentration cream and a .01% gel. Ortho's use patent for Retin-A expired April 24. However, the Johnson & Johnson subsidiary has a formula patent that is valid until Sept. 16, 1992. To avoid the formula patent, Herbert Labs recently filed an ANDA suitability petition for a generic Retin-A product made without xanthan gum ("The Pink Sheet" July 9, T&G-6). Medicis estimates that the Retin-A market now controlled by Ortho is approximately $150 mil. Ortho has an NDA pending for use of Retin-A in treating sun-damaged skin and has obtained a patent for the use. Retin-A has generated considerable attention in recent years as a wrinkle-smoothing product, although FDA has cautioned against widespread use for the unapproved indication. Medicis said it will expand marketing and distribution of the erythromycin 2% acne product under the brandname Theramycin-Z. The product contains zinc as an inactive ingredient. The benzoyl peroxide product, BenzaShave, is indicated for pseudo folliculitis barbae and shaving irritation. Both products are currently sold by Syosset, but will be marketed solely by Medicis beginning in September. Medicis also plans the September introduction of a prescription benzoyl peroxide product developed in-house called Theroxide, which will be available in 5% and 10% lotions and a 10% wash for the treatment of acne vulgaris. Introduction of the three products will follow by one month Medicis' launch of its first products, the Theraplex skin moisturizer and therapeutic shampoo line. Medicis acquired rights to the products from the Swiss firm ViFor ("The Pink Sheet" Feb. 12, T&G-7). The firm is planning to market the five-product line to dermatologists, pharmacies and other stores selling H&BAs. Medicis has raised $10.1 mil. from a public offering through D.H. Blair of nearly 1.5 mil. units, each unit consisting of six shares plus six Class A and Class B warrants. The offering was completed March 28. Proceeds are being used to "establish a sales force in dermatology, to begin a marketing campaign [for Theraplex], to repay short-term debt, to conduct research and development and to add to working capital," the firm said. Medicis was founded in 1987 by its current chairman and CEO, Jonah Shacknai, a D.C. attorney with experience in federal legislation.

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