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Watson Announces Silodosin NDA Accepted for Filing by FDA for the Treatment of Benign Prostatic Hyperplasia
Date:2/12/2008

bo, as measured by the International Prostate Symptom Score (IPSS), the primary endpoint. Secondary endpoints included improvements of maximum urine flow and quality of life. As expected, the most common side effects seen in the two studies greater than 2% were retrograde ejaculation (reduced semen) and dizziness.

Silodosin is highly uroselective for the alpha (1A) receptors located in the prostate and bladder neck. Blocking these receptors relaxes the smooth muscles, resulting in an improvement in urine flow and a reduction in BPH symptoms. The selective binding of silodosin to the alpha (1A) receptors is substantially greater than the binding to the cardiovascular-associated alpha (1B) receptors and thereby maximizes target organ activity while minimizing the potential for blood pressure effects.

The compound was originally developed by Kissei Pharmaceutical Co., Ltd., in Japan and licensed to Watson for the United States, Canada and Mexico. Kissei successfully launched Urief(R) (silodosin) in Japan in May of 2006 at a twice daily dosing of 4mg. Urief(R) is marketed in cooperation with Daiichi Sankyo Pharmaceutical Co., Ltd.

BPH, or an enlarged prostate, is a condition found only in men and is characterized by a non-cancerous enlargement of the prostate gland. Symptoms of BPH include urinary difficulty, urinary frequency and an inability to complete bladder emptying. The number of BPH patients has been increasing with the expansion of the elderly population. In the United States, BPH affects more than half of men in their 60's and as many as 90 percent of men by the age of 85. According to IMS data, BPH symptoms were the primary reason patients visited their urologists in 2006.

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. Watso
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SOURCE Watson Pharmaceuticals, Inc.
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