Launch of URIEF® Capsule, a Novel Drug for Dysuria associated with Benign Prostatic Hyperplasia

Kissei Pharmaceutical Co., Ltd. (President and CEO: Mutsuo Kanzawa) and Daiichi Pharmaceutical Co., Ltd. (President and CEO: Kiyoshi Morita), a Daiichi Sankyo Group subsidiary, announces that they will launch on May 11, URIEF^® Capsule 2 mg and URIEF^® Capsule 4 mg (generic name: silodosin), which are drugs for dysuria associated with benign prostatic hyperplasia. UrielR was included in the NHI drug list on April 28.

URIEF^® was originally created and developed by Kissei Pharmaceutical. Beginning with Phase III clinical studies, Kissei and Daiichi Pharmaceutical have carried out joint development, and the two companies will jointly market the drug in Japan under the same product name.

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. Histological hypertrophy is seen in about 50% of males over the age of 60, and, with a continuing aging population, the number of patients afflicted with this disease is anticipated to grow further from here on.

The degree of patients' satisfaction with the current pharmacotherapy for dysuria associated with benign prostatic hyperplasia is said to be low. Development of a drug that provides even more solid relief of the symptoms of urinary disturbance was therefore being sought.

By selectively blocking α-1A receptor subtypes that primarily exist in the prostate gland, URIEF^® Capsule, a selectiveα-1A receptor antagonist, 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 studies, using the International Prostate System Scores (I-PSS) for the first time in Japan. The 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^® Capsule is therefore expected to greatly contribute to improving patients' QOL. Moreover, at the time of NHI drug price listing, a "usefulness premium (II)" was applied since the drug was recognized to show an improvement in the treatment method for the disease which the drug targets.

Overseas, development is currently being carried out by companies to which Kissei had granted development and marketing rights, such as Watson Pharmaceuticals, Inc. (areas for which the company has rights: the US, Canada and Mexico); Recordati S.p.A. (areas for which the company has rights: Europe, the Middle East, etc.); Daiichi Pharmaceutical Co., Ltd. (area for which the company has rights: China); and Choongwae Pharma Corporation (area for which the company has rights: South Korea).

With companies all over the world competing fiercely to develop selective α-1A receptor antagonists, URIEF^® Capsule will be launched in Japan ahead of all other countries.

The sales goal for this drug is approximately 40 billion yen in Japan as the total of the two companies during peak periods, and approximately 100 billion yen throughout the world.