April 8, 2009
SILODOSIN Launched (Brand Name in Japan: Urief®) in the US
Matsumoto, Japan, April 8, 2009 --- Kissei Pharmaceutical Co., Ltd. (President, CEO: Mutsuo Kanzawa) today announced that Watson Pharmaceuticals, Inc. (USA) has launched silodosin (generic name) (US brand name: "RAPAFLOTM," brand name in Japan: "Urief®") on April 6, 2009 (local time) in the United States. Indicated to improve the signs and symptoms of benign prostatic hyperplasia (BPH), silodosin was originally developed by Kissei with North America rights licensed to Watson.
By selectively blocking alpha 1A adrenergic receptors that primarily exist in the prostate gland, Urief® originally developed by Kissei removes the tension of the prostate gland to improve urethral resistance, thereby improving dysuria associated with BPH. Compared with existing drugs, Urief® offers fast onset and improves symptoms such as difficulty of urination, frequent urination, and urinary incontinence. In the study (QTc study) conducted by Watson to examine the influences of silodosin on the cardiovascular system, no abnormalities were observed. Therefore, it was confirmed that Urief® was safe on the cardiovascular system.
In the US, more than about half of men age 50 and older, and as many as 90% of men by the age of 80, 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 improves efficacy with minimal effects on the cardiovascular system, Watson places high expectations on its performance 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, and the efficacy of Urief® has been recognized since its introduction, with annual sales growing to approximately 15 billion yen.
Overseas, development is currently being conducted by companies which Kissei granted development and marketing rights. The drug received approval in Korea in April 2008. An application was filed for the drug in the European Medicines Agency (EMEA) in November 2008, and one more application was filed for the drug in the China's State Food and Drug Administration (SFDA) in December 2008. Kissei expects this drug to contribute to improvements in the quality of life of patients worldwide.
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Company Profile of Watson Pharmaceuticals, Inc.
Headquarters: California, USA
Established: 1984
President and Chief Executive Officer (CEO): Paul Bisaro
Sales: US$2,536 million (2008)
No. of employees: Approximately 5,100
URL: http://www.watson.com/