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Executive Summary

ROYCE LABS WILL LAUNCH GENERIC FELDENE (PIROXICAM) AT 41% DISCOUNT to Pfizer's brandname once-daily nonsteroidal anti- inflammatory product following the April 6 expiration of Feldene's market exclusivity. Royce's average wholesale price for 100 10 mg and 20 mg piroxicam capsules will be $75.75 and $129.62, respectively, compared to Pfizer's AWP of $128.50 and $219.89 for equivalent amounts listed in the January Red Book Update. Royce received the first approval for a generic version of Pfizer's NSAID Sept. 9. FDA approval is officially considered tentative until Pfizer's exclusivity expires ("The Pink Sheet" Sept. 16, T&G-2). Royce's plan to capitalize on its current position as the exclusive generic marketer of piroxicam includes an expanded sales force as well as an ad campaign in pharmaceutical trade publications. The Miami-based firm recently hired a new VP for sales and marketing, Eugene Sokol, and added four regional key account managers to sell Royce's line of nine prescription and three OTC drugs. Sokol was previously Barre-National's director of field sales. A print ad campaign announcing the upcoming introduction of piroxicam started running in March issues of trade journals and will be expanded with the April launch. Feldene worldwide sales reached $680 mil. in 1991, according to Pfizer's annual report. Royce estimates that the U.S. market represents roughly half of total sales for the product. In a Feb. 25 letter to shareholders, Royce notes that "we are aware that other generic drug manufacturers have applied for FDA approval to manufacture this drug and we do expect at some point to have competition on piroxicam." The September tentative ANDA approval for piroxicam was one of several events in 1991 that should help Royce recover from financial problems that caused the firm to "virtually cease active research and development of new products" for a nearly two-year period starting in late 1989. During the past year, Royce raised approximately $10 mil. in additional equity; completed a $1.2 mil. limited partnership to develop five new generic prescription drugs; and received ANDA approval for four additional generic drugs in 11 dosage strengths. The four approvals were for drugs that are already multisource: the antidepressents doxepin and perphenazine with amitriptyline; the tranquilizer lorazepam; and the anti- hypertensive amiloride. Royce has ANDAs pending for six other drugs, all of which are already available in generic forms.

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