Watson Announces Positive Phase 3 Study Results on Silodosin for Treatment of Benign Prostatic Hyperplasia- Statistical Significance Reached on Primary and Secondary Endpoints -
CORONA, Calif., January 16, 2007 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. , a leading specialty pharmaceutical company, today announced positive top-line data from two Phase 3 studies of silodosin, the Company's investigational drug being studied for the treatment of signs and symptoms of benign prostatic hyperplasia (BPH).
The primary objective of the trials was to demonstrate that 8mg silodosin given once daily for 12 weeks was superior to placebo for the relief of BPH symptoms, including both obstructive and irritative symptoms, as measured by a baseline-to-endpoint change in the total score of the International Prostate Symptom Score-1 (IPSS-1). Secondary endpoints included improvements in maximum urine flow (Qmax). Very rapid and statistically significant improvements were seen in both of these endpoints.
Silodosin was well tolerated in both studies. Cardiovascular and blood pressure related side effects, including dizziness and orthostasis, were low in both trials. As expected with highly uroselective alpha blockers, ejaculations with little or no semen were the most commonly reported side effect seen in the trials. The vast majority of these reports were mild to moderate in intensity and patient withdrawal from the trial was low. Results from these studies will be submitted for presentation at a medical meeting at a later date.
"We are extremely encouraged with the efficacy that was demonstrated in these trials, supporting the potential clinical utility of silodosin in treating BPH," said Dr. Charles Ebert, Watson's Senior Vice President, Research and Development. "Our ongoing one year safety study remains on track to be completed this fall and we expect to submit a New Drug Application to FDA in the first half of 2008."
"The completion of the silodosin Phase 3 studies is an important milestone for Watson," continued Dr. Ebert. "As BPH is one of the most commonly treated disorders by urologists, silodosin is expected to greatly enhance our growing urology franchise."
Benign Prostatic Hyperplasia (BPH)
BPH 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 $1.7 billion is spent annually on BPH prescription drug treatment.
Silodosin is a novel, highly uroselective alpha (1A)-adrenoceptor antagonist originally developed by Kissei Pharmaceutical Co., Ltd. in Japan and licensed to Watson for the US, Canada and Mexico markets. Silodosin preferentially binds to the alpha (1A) receptors in the prostate and bladder neck relative to cardiovascular associated receptors, thereby maximizing target organ activity while minimizing the potential for blood pressure effects. Urief(R) (silodosin) 4mg, dosed twice daily, was launched in Japan in May 2006 and is marketed in cooperation with Daiichi Pharmaceutical Co., Ltd.
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.
About Kissei Pharmaceutical Co., Ltd.
Kissei Pharmaceutical Co., Ltd., headquartered in Matsumoto, Nagano prefecture, founded in 1946, is a Japanese pharmaceutical company that develops, manufactures, markets, sells and distributes brand pharmaceutical products. Kissei is primarily focused on three important fields of new drug research: urogenital, endocrinology & metabolism and immunology & allergy.
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; whether the results of clinical trials for silodosin and other information will be sufficient to support approval of silodosin by FDA and other regulatory authorities; delays regarding the regulatory approval process, including the timing and scope of approval received, if any; market acceptance and continued demand for Watson's products, including silodosin, if approved; patents and other intellectual property rights held by competitors and other third parties; 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, 2005 and its Quarterly Report on Form 10-Q for the quarter ended September 30, 2006.
CONTACT: Patty Eisenhaur of Watson Pharmaceuticals, Inc., +1-951-493-5611
Web site: http://www.watsonpharm.com/
Ticker Symbol: (NYSE:WPI)
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Posted: January 2007