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Watson Receives US FDA Approval for RAPAFLO(TM) (silodosin) for the Treatment of Benign Prostatic Hyperplasia (BPH)
Date:10/8/2008

- RAPAFLO launch anticipated in early 2009 -

CORONA, Calif., Oct. 8 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI), a leading specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved RAPAFLO(TM) (silodosin), the company's new alpha blocker for the treatment of the signs and symptoms of BPH.

BPH is the number one reason patients visit urologists and is characterized by urination problems, including decreased urine flow, more frequent urination and nocturia. The U.S. BPH market is growing and currently exceeds $2 billion annually, of which $1.7 billion is attributed to alpha blockers.

"RAPAFLO's approval is the most important milestone for the Company's Brand division thus far," said Paul Bisaro, Chief Executive Officer of Watson. "RAPAFLO is a novel product that provides strong efficacy and an exceptional safety profile for patients managing their BPH. RAPAFLO provides an excellent long term opportunity for Watson and will be the foundation for future growth of our urology franchise."

Today's approval is based on data from two Phase 3, 12-week, randomized, double-blind, placebo-controlled, multi-center studies as well as a 40 week open label study. In the two Phase 3 studies, 923 patients (mean age 64.6 years) were randomized to receive either RAPAFLO 8 mg once-daily or placebo. In the two trials, 8 mg once-daily RAPAFLO for 12 weeks resulted in significant and rapid relief of BPH symptoms, compared with placebo, as measured by the International Prostate Symptom Score (IPSS). IPSS includes irritative (frequency, urgency, and nocturia), and obstructive (hesitancy, incomplete emptying, intermittency, and weak stream) symptoms. RA
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SOURCE Watson Pharmaceuticals, Inc.
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