To: chirodoc who wrote (3111 ) 6/1/1999 2:21:00 AM From: David C. Burns Respond to of 10280
Sepracor and UCB Announce ZYRTEC(R) Isomer Licensing Agreement in Europe MARLBOROUGH, Mass., June 1 /PRNewswire/ -- Sepracor Inc. (Nasdaq: SEPR) today announced a licensing agreement with UCB Farchim SA, an affiliate of UCB, relating to levocetirizine, an isomer of ZYRTEC (racemic cetirizine). ZYRTEC, discovered and marketed by UCB, is Europe's leading antihistamine with sales of approximately $250 million in 1998, and anticipated worldwide sales approaching $1 billion in 1999. UCB has announced that it intends to file a marketing authorization application (MAA), the European equivalent of a new drug application (NDA), for levocetirizine in early 2000. Levocetirizine is currently in Phase III clinical trials in Europe. The companies believe, based on preclinical and clinical studies, that the levocetirizine isomer offers the opportunity for an improved treatment for patients with allergies. Sepracor has issued patents on levocetirizine in the United States and Europe, which expire in 2013 and pending patent applications in other major countries. Under the terms of the agreement, Sepracor has exclusively licensed to UCB all of Sepracor's issued patents and pending patent applications regarding levocetirizine in Europe and all other countries, except the United States and Japan. UCB will begin to pay Sepracor royalties upon first product sale, and royalties will escalate upon achievement of sales volume milestones. Sepracor is a specialty pharmaceutical company that develops and commercializes potentially improved versions of widely prescribed drugs. Referred to as Improved Chemical Entities ("ICE"), Sepracor's ICE(TM) Pharmaceuticals are being developed as proprietary, single-isomer or active- metabolite versions of these leading drugs. ICE Pharmaceuticals are designed to offer meaningful improvements in patient outcome through reduced side effects, increased therapeutic efficacy, improved dosage forms, and in some cases the opportunity for additional indications. This news release contains forward-looking statements that involve risks and uncertainties, including statements with respect to the safety, efficacy and potential benefits of the company's ICE Pharmaceuticals under development. Among the factors that could cause actual results to differ materially from those indicated by such forward-looking statements are: the results of the company's clinical trials with respect to its products under development; the scope of the company's patent protection with respect to such product candidates; the availability of sufficient funds to continue research and development efforts; and certain other factors that may affect future operating results and are detailed in the company's periodic reports filed with the Securities and Exchange Commission. Zyrtec is a registered trademark of UCB Societe Anonyme. NOTE: To receive a copy of this release or any recent release via fax, call Sepracor's automated news fax line at 1-800-758-5804 ext. 780960. SOURCE Sepracor Inc.