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Executive Summary

NOVEN's ESTROGEN AND NITROGLYCERIN TRANSDERMAL PATCH will be studied for bioequivalency "in the near future," Miami-based Noven Pharmaceuticals said in a Sept. 15 release. The two products, which incorporate Noven's "unique proprietary inter-polymeric drug delivery platform," are two of several drug delivery systems in development at the company. Noven was founded in January 1987 by Steven Sablotsky, who invented the Nitro-Dur II transdermal nitroglycerin patch while at Key. The bioequivalency studies will be conducted in conjunction with an outside research firm, said Sablotsky, who is president and chairman of the company. Sablotsky was with Key from January 1982 to January 1987. His last position there was associate director for produce and process development. The Noven system includes a mixture of polymers that make up a matrix for the drug; the adhesive, which attaches the patch to the wearer's skin; and the "communicator" between the drug matrix and adhesive. Advantages offered over other systems include a smaller surface area for the patch and a backing for the patch that allows skin to breathe and maintain a more natural condition, Sablotsky maintained. Other patches, according to Sablotsky, have a more occlusive backing. The company has filed for a patent on its system. Noven also plans to incorporate five other drugs into its transdermal systems: albuterol, diltiazen, piroxicam, mazindol and alprazolam. The firm expects to file NDAs for those products, Sablotsky said. Thee products are still in early development. while Noven is considering out-licensing or other arrangements for marketing, the company plans to manufacture its own products. The firm has made no licensing agreements to date. Noven has raised seed money for its operations from both private and public stock offerings. Public stock offerings have brought in approximately $ 2.4 mil. to date, the firm said. Noven currently has 10 employees, including Secretary/Treasurer Noreen Sablotsky, who is the chairman's wife and previously worked in marketing and sales with Ciba-Geigy. The firm's chief financial officer is Sheldon Blecher, and Mitch Goldberg is executive vice president.

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