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COPLEY LEVERAGING PRIVATE-LABEL VERSION OF J&J's MONISTAT 7

This article was originally published in The Tan Sheet

Executive Summary

COPLEY LEVERAGING PRIVATE-LABEL VERSION OF J&J's MONISTAT 7 cream to expand its OTC business, the generic drug firm indicated in a March 31 filing with the Securities and Exchange Commission. Following approval of its ANDA for miconazole nitrate 2% vaginal cream in October 1992, Copley Pharmaceutical began shipping the product in February through private-label distributor Perrigo. Apart from the Perrigo arrangement, Copley reportedly is considering selling its own branded version of miconazole vaginal cream. Canton, Mass.-based Copley is the only company cleared by FDA to market a generic version of the vaginal candidiasis treatment. FDA's approval of Johnson & Johnson's OTC switch application for Monistat 7 did not provide market exclusivity for the product, which went off patent in October 1991. Reportedly, FDA is requiring the submission of clinical studies to support ANDA approval for the vaginal antifungal. In the March 31 preliminary prospectus for a secondary offering of 2 mil. shares of stock, Copley stated that private- label OTCs accounted for 14% (approximately $ 7.3 mil.) of the firm's $ 52 mil. in fiscal 1993 sales. In addition to selling to the private-label market, Copley sells some OTCs under its own trademarks. The company's core business is generic prescription drugs. While it is the first to market with a generic OTC for vaginal yeast infections, Copley faces competition from Schering-Plough's FemCare and Miles' Mycelex-7 (clotrimazole 1% cream and vaginal tablets), which have been positioned as lower-priced alternatives to the two premium-priced products in the category -- Monistat 7 and Schering's Gyne-Lotrimin (clotrimazole 1% cream and vaginal tablets). Additional sources of competition may soon come from combination packs of Monistat 7 and Gyne-Lotrimin that include both suppository and cream dosage forms ("The Tan Sheet" April 5, In Brief). According to the prospectus, Copley's best-selling OTCs in FY 1993 (ended Jan. 31, 1993) were versions of Schering Plough's Drixoral (pseudoephedrine and dexbrompheniramine extended-release) and A. H. Robins' Dimetapp Extentabs (brompheniramine and phenylpropanolamine extended-release), both of which were the subjects of ANDAs. Sold primarily as private-label brands through Perrigo, Pennex and others, the two products were the only OTCs among Copley's top-ten selling products for the year. Overall, OTC and prescription antihistamines accounted for 29% of Copley's sales in FY 1993. The only prescription antihistamine marketed by the firm is clemastine syrup. In addition to copying previously marketed OTCs, Copley "has identified a limited number of opportunities in which it intends to develop and market unique, over-the-counter branded drug products, focusing on the company's expertise in specialized delivery systems," the prospectus states. Copley already markets one such product, the pediculicide Lice Enz, a mousse dosage form of pyrethrins and piperonyl. The prospectus states that the company has two more such products in development. Copley is also trying to enter the contact lens and eye care businesses through a collaboration with Ocular Research of Boston ("The Tan Sheet" March 29, In Brief). That deal gives Copley exclusive manufacturing and worldwide marketing rights to a line of lubricating and rewetting solutions and artificial tear products. ORB filed a premarket approval application for the products in April 1992.
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