==========================================START OF PAGE 1====== UNITED STATES SECURITIES AND EXCHANGE COMMISSION Litigation Release No. 14902 / May 7, 1996 SECURITIES AND EXCHANGE COMMISSION v. ROYCE LABORATORIES, INC. and PATRICK J. MCENANY, 96 Civ. 3335 (LLS) (S.D.N.Y.) The Securities and Exchange Commission announced today that it filed a Complaint in the United States District Court for the Southern District of New York against Patrick J. McEnany ("McEnany") and Royce Laboratories, Inc. ("Royce"). The Complaint alleges that McEnany, the 48 year old president of Royce, a Florida pharmaceutical manufacturer, drafted a materially false and misleading press release ("Release"), which Royce then issued via P.R. Newswire. The Release concerned the approval status of Piroxicam, a generic drug manufactured by Royce, with the U.S. Food and Drug Administration ("FDA"). In its Complaint, the Commission seeks to permanently enjoin Royce and McEnany against future violations of Section 10(b) of the Securities Exchange Act of 1934 ("Exchange Act") and Rule 10b-5 thereunder, and seeks civil penalties of $25,000 against McEnany. The Release stated that "the FDA is completing its review of the Company's [Piroxicam] application, and upon the anticipated receipt of final approval the Company intends to commence shipments of Piroxicam." Royce and McEnany allegedly omitted to disclose in the Release that Royce had been advised by the FDA at a meeting on April 3, 1992, that the agency was prepared to withdraw the tentative approval of Piroxicam, which had been granted on September 9, 1991, and that the FDA was not prepared to grant final approval to Piroxicam because of problems and discrepancies in other Royce products. Royce and McEnany also allegedly omitted to state in the Release that the FDA had advised Royce that the it would not grant final approval to Piroxicam until: (a) the FDA had determined the significance of the discrepancies in Royce's other products to the reliability of data and information in the Piroxicam application; and (b) the FDA had completed a detailed inspection of Royce's Piroxicam production facilities and a complete review of its Piroxicam application. Simultaneously with the filing of the Complaint, the Commission submitted Royce's and McEnany's consents to the entry of final judgments permanently enjoining each of them from future violations of Section 10(b) of the Exchange Act and Rule 10b-5 thereunder. McEnany's final judgment also orders him to pay a civil penalty of $25,000. Royce and McEnany neither admit nor deny the allegations in the Complaint.