Kissei and Daiichi Sankyo to Launch Urief® Tablet, a Treatment for Dysuria Associated with Benign Prostatic Hyperplasia

Kissei Pharmaceutical Co., Ltd.
DAIICHI SANKYO COMPANY, LIMITED

February 4, 2009 - Kissei Pharmaceutical Co., Ltd. and Daiichi Sankyo Company, Limited announced that they will launch Urief^® tablet 2 mg and Urief^® tablet 4 mg (generic name: silodosin) on February 5 in Japan. Urief® is used for the treatment of dysuria associated with benign prostatic hyperplasia.

The Urief® tablet is a new formulation of Urief^® capsule 2 mg and Urief^® capsule 4 mg, which were jointly marketed by Kissei and Daiichi Sankyo in Japan since 2006. Urief^® was originally discovered by Kissei and was co-developed by Kissei and Daiichi Sankyo. The efficacy of Ufief® capsule is appreciated since its introduction. Its annual sales is growing to approximately 15 billion yen.

Dysuria associated with benign prostatic hyperplasia is a condition specific to males. The prostate gland that surrounds the urethra in the lower part of the bladder becomes hypertrophied with age, and the hypertrophied prostate gland contracting excessively and compressing the urethra causes dysuric symptoms such as difficulty of urination, frequent urination and residual urine. With the continuing aging population of Japan, the number of afflicted patients is anticipated to grow further.

The tablet makes it easier for elderly patients and patients with dysphagia to swallow compared with the capsule. Additionally, Urief^® tablet 4 mg has a cleavage line to allow for dosage adjustment and thus improves the convenience for patients and medical professionals.

By selectively blocking alpha 1A-adrenoceptors that primarily exist in the prostate gland, Urief^® removes the tension of the prostate gland to improve urethral resistance, thereby improving dysuria associated with benign prostatic hyperplasia. Compared with existing drugs, Urief^® offers faster onset and improves symptoms such as difficulty of urination, frequent urination, and urinary incontinence.

Overseas, development is currently being conducted by companies which Kissei granted development and marketing rights. The drug received approval in Korea in April 2008 and in the U.S. in October 2008. An application was filed for the drug in the EU in November 2008. In December 2008, Daiichi Pharmaceutical (Beijing) Co., Ltd., a subsidiary of Daiichi Sankyo in China, filed an application to China's State Food and Drug Administration (SFDA).

Kissei and Daiichi Sankyo expect this drug to contribute to improvement in the quality of life in patients worldwide.