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ZILA PLANNING ZILACTIN NDA FILING FOR SHINGLES

Executive Summary

ZILA PLANNING ZILACTIN NDA FILING FOR SHINGLES (herpes zoster), the Phoenix-based OTC company disclosed in a recent S-4 registration filed with the Securities & Exchange Commission. "An NDA seeking approval of the marketing of Zilactin as a topical application for the treatment of shingles will be filed in the near future, and an NDA . . . for genital herpes will be filed by the company at a later date," the document states. A topical tannic acid product in a gel formulation, Zilactin is currently available as an OTC treatment for cold sores, fever blisters and canker sores. Zilactin is also being evaluated in three dental schools for the treatment of oral muscosal lesions and dental abrasions. Zilactin, the firm's only product to date, is contract manufactured and sold through 14 manufacturers' reps. Introduced in Phoenix in 1986, the product is now carried by major drug stores in Denver, San Francisco, Salt Lake City, Seattle, Portland, Dallas/Fort Worth, Birmingham, Atlanta and Los Angeles, according to the firm. "The company plans to continue to expand the distribution of Zilactin through major pharmaceutical wholesalers, drug stores, and dentists in western and southeastern states, and ultimately to introduce Zilactin nationwide," the filing notes. Zila is planning a number of product line extensions on completion of Zilactin's national introduction. These include: Zilaplex-S, an oral supplement for vitamin A, vitamin C, and carotene deficiency; Zilex, a treatment for athletes foot and other fungal disorders of the skin; and Deliquesce, a dermatological emulsion for eradicating age spots. Founded in 1980 by Chairman James Tinnell, MD, Zila Pharmaceuticals generated revenues of $ 318,000 for the most recent fiscal year ended July 31, and booked a net loss $ 441,000. Former Rexall Drug exec Joseph Hines has served as president and chief operating officer since 1983. The S-4 registration covers the merger of Zila Pharmaceuticals, a Nevada corporation, into a Delaware subsidiary established in November 1987.
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