Watson Announces Top Line Uracyst U.S. Pilot Study Results
MORRISTOWN, N.J., Nov. 10, 2010 /PRNewswire via COMTEX/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI) today announced that the U.S. pilot study evaluating Uracyst(R) (sodium chondroitin sulfate solution 2.0%) for the treatment of interstitial cystitis did not meet predefined efficacy endpoints.
"Unfortunately, the results of the pilot study failed to demonstrate efficacy despite numerical separation of response between Uracyst(R) and placebo on certain measurements," said Fred Wilkinson, Watson's Executive Vice President, Global Brands. "We will work with Stellar Pharmaceuticals Inc. to further evaluate the response and assist in determining any next steps, but at this time we do not plan to allocate any additional resources to further pursue this development program. While regrettable, our decision will permit Watson to strategically refocus development resources on other product candidates in our development portfolio."
About Interstitial Cystitis
Interstitial cystitis is a chronic inflammatory disease of the bladder wall which causes pain, discomfort and frequent and urgent urination for those afflicted. The etiology of the disease is unknown. There is no known cure for the IC and currently approved products attempt to alleviate the symptoms of the disease. The quality of life for patients with IC is extremely poor, as they may need to void up to 60 times per day.
About Watson Pharmaceuticals, Inc.
Watson Pharmaceuticals, Inc. is a leading global specialty pharmaceutical company. The Company is engaged in the development and distribution of generic pharmaceuticals and specialized branded pharmaceutical products focused on urology and women's health. Watson has operations in many of the world's established and growing international markets.
In the U.S., the Watson brand portfolio includes RAPAFLO(R), GELNIQUE(R), Oxytrol(R), TRELSTAR(R), Crinone(R) , ella(R) and INFeD(R). In addition, Watson markets the following brands under co-promotion agreements: AndroGel(R), with Solvay Pharmaceuticals, Inc., and Femring(R), with Warner Chilcott Limited. The Watson brand pipeline portfolio includes a number of products in development in addition to URACYST(R), including three novel new contraceptives. All other trademarks are property of their respective owners.
Statements contained in this press release that refer to non-historical facts are forward-looking statements that reflect Watson's current perspective of existing information as of the date of this release. It is important to note that Watson's goals and expectations are not predictions of actual performance. Actual results may differ materially from Watson's current expectations depending upon a number of factors, risks and uncertainties affecting Watson's business. These factors include, among others, difficulties in predicting the timing or outcome of FDA and other regulatory agency approvals or actions, if any; the timing and success of product development efforts; the impact of competitive products and pricing; the timing and success of product launches; difficulties or delays in manufacturing; the availability and pricing of third party sourced products and materials; successful compliance with FDA and other governmental regulations applicable to Watson and its third party manufacturers' facilities, products and/or businesses; changes in the laws and regulations, including Medicare and Medicaid, affecting among other things, pricing and reimbursement of pharmaceutical products; and such 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 31,2009 and Watson's quarterly report on Form 10-Q for the period ended September 30, 2010. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements
Watson Pharmaceuticals, Inc.
SOURCE Watson Pharmaceuticals, Inc.
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