WATSON ANNOUNCES POSITIVE DATA ON TREATMENT FOR BPH

Watson Pharmaceuticals has announced positive top-line data from two Phase III 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 8 mg of 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. 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.

Watson's ongoing one-year safety study remains on track, and the company expects to submit a new drug application to FDA in the first half of 2008.

Silodosin is a novel, highly uroselective alpha (1A)-adrenoceptor antagonist originally developed by Kissei Pharmaceutical and licensed to Watson for the marketing in the U.S., Canada and Mexico. 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. The drug is currently approved in Japan.