Approval for SILODOSIN (Brand Name in Japan: Urief®) in the US

Kissei Pharmaceutical Co., Ltd. (President, CEO: Mutsuo Kanzawa) announced today that Watson Pharmaceuticals, Inc. (USA) has received approval for silodosin (generic name) (brand name in Japan: "Urief^®," US brand name: "RAPAFLO^TM") from the U.S. Food and Drug Administration (FDA). Silodosin, a drug to improve the signs and symptoms of benign prostatic hyperplasia (BPH), was originally developed by Kissei and licensed out to Watson.

Silodosin is a selective alpha 1A adrenergic receptor antagonist developed by Kissei and improves the signs and symptoms of BPH by binding to alpha 1A receptors, which is widely distributed in the prostate, relaxing muscle tone of the prostate and relieving urethral resistance. In addition to relatively fast improvement of subjective symptoms compared with existing medications, silodosin is characterized by improving both obstructive symptoms such as weak stream and irritative symptoms such as frequency and urgency of urination. In the study (QTc study) conducted by Watson to examine the influences of silodosin on the cardiovascular system, no abnormalities were observed.

In the US, half of men in their 60's, and as many as 90% of men by the age of 85, are affected by BPH. Since BPH is a common condition in elderly men, it is considered that many of the patients have complications of cardiovascular diseases such as hypertension. As silodosin has clear improving efficacy with minimal effects on the cardiovascular system, Watson places high expectations on its sales in the US, saying that silodosin can offer a new option in the treatment of the signs and symptoms of BPH. The drug has been jointly marketed in Japan under the brand name Urief^® by Kissei and Daiichi Sankyo Pharmaceutical Co., Ltd. since May 2006.

Kissei has been actively promoting international development of its original products such as silodosin and a diabetic medicine mitiglinide (generic name) （brand name in Japan: "Glufast^®"） through licensing-out. While Choongwae Pharma Corporation in South Korea has obtained the approval for silodosin, Recordati S.p.A is scheduled to file a new drug application for silodosin in Europe. In addition, phase III clinical trials are underway in China by Daiichi Sankyo and by Synmosa Biopharma Corporation in Taiwan, respectively.




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Company Profile of Watson Pharmaceuticals, Inc.
Headquarters: California, USA
Established: 1984
Chairman and Chief Executive Officer (CEO): Paul Bisaro
Sales: US$2,497 million (2007)
No. of employees: Approximately 5,300
URL: http://www.watson.com/