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Executive Summary

COPLEY ANNUAL SALES APPROACH $20 MIL.; FIRM EXPANDING TO OTCs with the introduction of a metered-dose pyrethrin mousse pediculicide, Lice-Enz. The OTC product was launched in May as the first offering for the consumer products division of the firm based in Canton, Mass. Copley Pharmaceutical, better known as a generic drug and delivery systems company, generated sales of$19.6 mil. in its most recent fiscal year, ended Jan. 31. The firm currently has 25 ANDAs pending at FDA. Since 1987, Copley revenues have grown at an average annual rate of 55%, climbing from $5.4 mil. in FY 1987, to $8.7 mil.,$15.5 mil. and finally to $19.6 mil. Copley's growth in fiscal 1990 was achieved despite the slowdown in FDA generic approvals. The firm had only one ANDA approved during the difficult year for FDA generic reviews. Copley's fiscal 1990 approval was for clindamycin phosphate 1%, on Jan. 11, 1989. Lice-Enz is the first of several new non-prescription products the company intends to introduce and promote to professionals. A product for canker sores is forecast for launch in the first quarter of 1991. Lice-Enz (AWP of $11.95 per 2 oz. cannister) claims several advantages over other available pyrethrin products. The metered-dose application protects against children's overexposure to the active pediculicide; it also provides four applications. In the mousse formulation, the ingredient stays on the head in a foam and may avoid dripping like regular lice shampoos. Copley also maintains that the product leaves no residual pyrethrins on the scalp in the period before the follow-up application. Copley is headed by President and Chairperson Jane Hirsh, who was a staff pharmacist at Massachusetts General Hospital and the Shriners' Burn Institute in Boston before founding the firm. Copley's new CEO is Barbara Morse; Stephen Tannenbaum is chief financial officer; Bernard Grubstein is the director of R&D; and Mark Hirsh is VP-marketing. Copley, founded in South Boston in 1972, began as a product development firm focusing on tablet dosage forms for a variety of industrial applications. The company's first ANDA submission was for amitriptyline in 1984. The privately held firm has been built with internally generated funds, but recently expanded its capital with a $7.5 mil. Massachusetts Industrial Bond. The company is in the process of shifting operations from facilities in South Boston to Canton, where it opened a new 85,000 square foot headquarters last year. Copley employs 140 people, including 28 in R&D and 18 in quality assurance.

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