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ROYCE’s GENERIC PIROXICAM IS "NOT APPROVABLE"

Executive Summary

ROYCE's GENERIC PIROXICAM IS "NOT APPROVABLE," FDA has told the firm. In an April 22 release, Royce said that FDA's April 21 letter included a "number of discrepancies and inconsistencies associated with manufacturing and testing records for the piroxicam applications." The company had filed two ANDAs, for 10 mg and 20 mg dosages. FDA's decision reportedly follows an April 17 meeting between agency headquarters personnel and Royce CEO Patrick McEnany in Washington. Royce received tentative ANDA approval for the nonsteroidal anti-inflammatory piroxicam (Pfizer's Feldene) in September ("The Pink Sheet" Sept. 16, 1991, T&G-2). When Pfizer's piroxicam patent expired on April 6, Royce announced that the generic launch would be delayed while FDA validated its application following the withdrawal of two other Royce ANDAs for minoxidil due to discrepancies ("The Pink Sheet" April 13, T&G-6). Piroxicam was one of the first drugs given "tentative" approval by FDA. The agency had previously given full approvals with delayed effective dates to products approved before the expiration of the innovator's patent. FDA adopted the "tentative" approval language to indicate that the drug's approved status is "subject to change on the basis of new information that may come to our attention" prior to marketing. In the case of piroxicam, FDA told the company that manufacturing of the test batches had not been satisfactorily documented, Royce said. According to Royce, FDA's letter concludes that "unless these issues are otherwise resolved to the satisfaction of the FDA... the only alternative would be to provide data on new test batches manufactured in accordance with current Good Manufacturing Practices including the results of new bioequivalence studies as appropriate, to support approval of the products." "The company is currently evaluating its options in light of this determination, as well as the long-term impact which this determination may have on its business," Royce said. The company may face a $1.5 mil. write-off for inventory produced to meet "substantial orders" for the product. Royce had been building up its sales and marketing force in anticipation of the launch ("The Pink Sheet" March 23, T&G-9). Royce reported 1991 sales of $2 mil. The company's poor financial position forced it to suspend R&D activities in 1989 and led to its delisting from the NASDAQ exchange. The company completed two rounds of equity financing and was relisted on the NASDAQ in 1991. "It presently is unknown whether the events leading to this determination will have an impact on other aspects of the company's relationship with FDA," Royce said. Royce has ANDAs pending for acetaminophen/codeine, propanolol/hydrochlorothiazide, doxepin, hydroxyzine, baclofen, and sulindac, all of which are multisource. "The company intends to continue to fully cooperate with FDA in this and all other matters in which the company is involved," the firm said. When the minoxidil applications were withdrawn, Royce noted that the ANDAs had been filed before the current top management joined the firm. The piroxicam applications, however, were filed in May 1989, after the appointment of new R&D and quality assurance execs. Abul Bhuiyan joined Royce after serving as director of technical services at Superpharm and Nilkenth Patel also joined from Superpharm. McEnany joined Royce in May 1990. The bioequivalence study for piroxicam was performed by PharmaKinetics. The Baltimore-based contract research firm said that to the best of its knowledge the discrepancies cited by FDA do not involve its work. PharmaKinetics also performed bioequivalence work for other Royce applications, apparently including minoxidil. The firm settled criminal charges last year resulting from the actions of its former chief scientist Mark Perkal, PhD, in obstructing investigations of Bolar's fraudulent generic Dyazide application ("The Pink Sheet" June 24, 1991, T&G- 15). PharmaKinetics announced April 9 that it had sold its stake in Royce of over 1 mil. shares between January and April for a total of $6.2 mil. PharmaKinetics is currently in Chapter 11 bankruptcy. FDA's action on Royce's application effectively extends Pfizer's exclusivity for Feldene. Royce had estimated that the NSAID generated about $340 mil. in U.S. sales in 1991. Pfizer reported worldwide Feldene sales of $680 mil. for the year. As of April 23, no other ANDAs for piroxicam had been approved. Royce has said, however, that it is "aware that other generic drug manufacturers have applied for FDA approval to manufacture this drug." Warner Chilcott may be one of several firms with an ANDA pending; however, the firm has not yet received approval to market (see related story, p. 10).

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