CORONA, Calif., Nov. 24 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. , a leading specialty pharmaceutical company, announced today that the European Agency for the Evaluation of Medicinal Products’ (EMEA) Committee for Proprietary Medicinal Products (CPMP) provided a positive opinion on the Company’s European marketing authorization application for its oxybutynin transdermal product for the treatment of overactive bladder. The CPMP opinion serves as the basis for a European Commission approval, which is typically issued in approximately three months. The EMEA initiated review of the application on February 24, 2003 as part of a qualified centralized procedure.
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Watson currently markets the product in the United States under the name OXYTROL(R). OXYTROL(R) is the first and only transdermal therapy for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency. On September 24, 2003, the Company announced that it had entered into a marketing and supply agreement with UCB Pharma, pursuant to which UCB Pharma will market the oxybutynin transdermal product in Europe.
About OXYTROL(R)
OXYTROL(R) is a thin, flexible and clear patch applied to the abdomen, hip or buttock twice weekly. The OXYTROL(R) transdermal delivery system delivers 3.9 milligrams per day of oxybutynin consistently and continuously. OXYTROL(R) offers OAB patients proven efficacy and a low incidence of anticholinergic side effects, such as dry mouth and constipation. In clinical studies, the difference in dry mouth, constipation and dizziness between OXYTROL(R) and placebo was not statistically significant. The most common adverse events occurring with OXYTROL(R) were application site reactions, dry mouth, constipation, diarrhea, dysuria and abnormal vision. Patients who have urinary retention, gastric retention, uncontrolled narrow-angle glaucoma or hypersensitivity to oxybutynin or other components of OXYTROL(R) should not use OXYTROL(R).
About Watson Pharmaceuticals, Inc.
Watson Pharmaceuticals, Inc., headquartered in Corona, CA, is a leading specialty pharmaceutical company that develops, manufactures, markets, sells and distributes branded and generic pharmaceutical products. Watson pursues a growth strategy combining internal product development, strategic alliances and collaborations and synergistic acquisitions of products and businesses.
For press releases and other company information, visit Watson Pharmaceuticals’ Web site at http://www.watsonpharm.com/ .
Forward-Looking Statement
Any statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Watson’s current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Watson’s current expectations depending upon a number of factors affecting Watson’s business. These factors include, among others, the difficulty of predicting the timing or outcome of product development efforts and regulatory agency approvals and actions, successful compliance with governmental regulations, the impact of competitive products and pricing, market acceptance of and demand for Watson’s products, and other risks and uncertainties detailed in Watson’s periodic public filings with the Securities and Exchange Commission, including but not limited to Watson’s Annual Report on Form 10-K for the year ended December 31, 2002 and its Quarterly Report on Form 10-Q for the quarters ended March 31, June 30, and September 30, 2003.
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CONTACT: investors, Patty Eisenhaur, +1-909-493-5611, or media, ChrisEso, +1-909-493-4013, both of Watson Pharmaceuticals, Inc.
Web site: http://www.watsonpharm.com/
