Kissei Acquired Marketing Approval for URIEF® Capsule, a Novel Drug for Dysuria associated with Benign Prostatic Hyperplasia

Kissei Pharmaceutical Co., Ltd. (President and CEO: Mutsuo Kanzawa) announced today that it has obtained a marketing approval for URIEF^® Capsule 2 mg and URIEF^® Capsule 4 mg (generic name: silodosin), a novel drug that improves dysuria associated with benign prostatic hyperplasia.

URIEF^® Capsule is a novel, highly uroselective α-1A receptor antagonist which Kissei had originally created and developed as a drug for the improvement of dysuria associated with benign prostatic hyperplasia. Application for approval was submitted to the Ministry of Health, Labour and Welfare in June 2004, and approval was granted today.

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

As treatment for dysuria associated with benign prostatic hyperplasia, α-1 receptor antagonists are widely used as the first-line drug. However, development of a drug that provides even more solid relief of the symptoms of dysuria was being sought.

By selectively blocking α-1A receptors that primarily exist in the prostate gland, URIEF^® Capsule removes the tension of the prostate gland to improve urethral resistance, thereby improving dysuria associated with benign prostatic hyperplasia.

Evaluations were made in a domestic Phase III double-blind comparative study, using the International Prostate System Scores (I-PSS) for the first time in Japan. Results confirmed the effects of URIEF^® Capsule, with the drug significantly improving the symptoms of dysuria from the early stage of drug therapy in the group receiving the drug compared to those in the group receiving a placebo. URIEF^® Capsules are therefore expected to greatly contribute to improving patients' QOL.

After the NHI drug price listing, URIEF^® Capsules will be sold jointly in Japan by Kissei and Daiichi Pharmaceutical Co., Ltd. with which Kissei has carried out joint development since the Phase III clinical studies.

As for other countries, an overseas development strategy is being adopted, featuring the licensing-out method of providing exclusive development and marketing rights to other companies. We have executed the following licensing agreements to grant rights: Watson Pharmaceuticals, Inc. for the US, Canada and Mexico; Recordati S.p.A. of Italy for Europe; Daiichi Pharmaceutical Co., Ltd. for China; and Choongwae Pharma Corporation for South Korea.




® Capsule>
Product name: URIEF^® Capsule 2 mg and URIEF^® Capsule 4 mg
Generic name: Silodosin
Indications: Dysuria associated with benign prostatic hyperplasia
Dosage and administration: The usual adult dosage for oral use is 8 mg of silodosin daily in two divided doses, after breakfast and dinner.
Decrease the dose depending on the symptoms.
Marketing authorization holder: Kissei Pharmaceutical Co., Ltd.
Co-marketing: Kissei Pharmaceutical Co., Ltd. and Daiichi Pharmaceutical Co., Ltd