CORONA, Calif., June 13 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. , a leading specialty pharmaceutical company, today announced that it has commenced Phase 3 clinical studies on silodosin, its investigational drug being studied to treat the signs and symptoms of Benign Prostatic Hyperplasia (BPH). This condition is characterized by a non- cancerous enlarged prostate that leads to obstructive and irritative urinary symptoms. In the United States (US) BPH affects more than half of men in their sixties and as many as 90 percent of men by the age of 85. Additionally, approximately $1.2 billion is spent annually on BPH prescription drug treatment.
Silodosin is a novel alpha(1)-adrenoceptor antagonist with high uroselectivity. The company licensed silodosin from Kissei Pharmaceuticals Co., LTD of Japan in April 2004, to develop and market silodosin in the US, Canada and Mexico.
“The initiation of the silodosin Phase 3 studies is an important milestone for Watson and is the first of several Watson specialty brand products moving into late stage development this year,” noted Allen Chao, Ph.D., Watson’s chairman and CEO. “These products will further expand our growing urology franchise and will allow us to offer an extended product line to a body of physicians that know us well.”
Phase 3 Protocol
Watson has begun to enroll patients for two large silodosin Phase 3 studies. These studies, which are being managed by Watson’s Brand Research and Development group in Salt Lake City, will further evaluate the efficacy and safety of 8 mg once-daily silodosin in patients with signs and symptoms of BPH.
These multi-center (approximately 90 sites), double-blind, placebo- controlled trials, which will run for 12 weeks, will evaluate a total of 1,200 patients with signs and symptoms of BPH, in the United States. Watson plans to submit a New Drug Application (NDA) for silodosin in 2008.
The primary objective of the trials is to demonstrate that the effectiveness of 8mg silodosin given once daily for 12 weeks is superior to placebo for the relief of BPH symptoms, as measured by a baseline-to-endpoint change in the total score of the International Prostate Symptom Score-1 (IPSS- 1).
A long-term open-label extension study will also be available for patients who complete these double-blind studies. The company noted that Kissei Pharmaceuticals has completed Phase 3 studies in Japan under different protocols and dosage levels and has filed a marketing application with the Pharmaceutical and Medical Device Agency in Japan.
About Watson Pharmaceuticals, Inc.
Watson Pharmaceuticals, Inc., headquartered in Corona, California, is a leading specialty pharmaceutical company that develops, manufactures, markets, sells and distributes brand 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 clinical studies, product development efforts and FDA or other regulatory agency approvals or actions; successful compliance with FDA and other governmental regulations applicable to Watson’s products and/or business; 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, 2004 and its Quarterly Report on Form 10-Q for the quarter ended March 31, 2005.
(Logo: http://www.newscom.com/cgi-bin/prnh/20020214/WATSONLOGO )
Photo: http://www.newscom.com/cgi-bin/prnh/20020214/WATSONLOGO /Watson Pharmaceuticals, Inc.
CONTACT: Patty Eisenhaur of Watson Pharmaceuticals, Inc., +1-951-493-5611
Web site: http://www.watsonpharm.com//
