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January 15, 2016

Announcement of the Launch of Urief® OD Tab. (Orally Disintegrating Tablets) for the Treatment of Dysuria Associated with Benign Prostatic Hyperplasia in Japan

KISSEI PHARMACEUTICAL CO., LTD.



Kissei Pharmaceutical Co., Ltd. (Head Office: Matsumoto-city, Nagano, Japan; Chairman and CEO: Mutsuo Kanzawa) announced that they will launch Urief® OD Tab. 2mg and Urief® OD Tab. 4mg (generic name: silodosin, hereinafter referred to as the "drug") for the treatment of dysuria associated with benign prostatic hyperplasia on January 18.

The dosage form of the drug is an orally disintegrating tablet, a new formulation of Urief® Tab. 2mg and Urief® Tab. 4mg, which were originally discovered by Kissei and jointly developed and marketed by Kissei and Daiichi Sankyo Company, Limited. The tablets are designed to rapidly disintegrate with saliva or a small amount of water in the mouth, which is suitable for use by the elderly and patients with swallowing dysfunction.

Urief® eliminates tension of the prostate gland and reduces urethral resistance by selectively blocking alpha 1A receptors that primarily exist in the prostate gland; thus, it can improve dysuria associated with benign prostatic hyperplasia. The usefulness of Urief® has been highly recognized since its release and it is marketed in 38 overseas countries by companies that have been granted development and marketing rights by Kissei.

We expect that the addition of the new formulations of Urief® will enhance convenience for patients and help us further contribute to healthcare.


〈Urief®OD Product Reference〉

Brand Name:
URIEF® OD Tab. 2mg
URIEF® OD Tab. 4mg

Generic Name:
Silodosin

Indications:
Dysuria associated with benign prostatic hyperplasia

Dosage and administration:
The usual adult oral dosage of silodosin is 4 mg twice daily, after breakfast and dinner. The dose should be reduced as appropriate depending on symptoms.

NHI price:
URIEF® OD Tab. 2mg one tablet ¥41.70
URIEF® OD Tab. 4mg one tablet ¥81.30

Date of NHI price listing: December 11, 2015

Date of launch: January 18, 2016

Manufactured and Distributed by:
KISSEI PHARMACEUTICAL CO., LTD.