Results of a Phase III Double-blinded Comparative Study of Silodosin (Brand name in Japan: Urief®) conducted in Europe

Kissei Pharmaceutical Co., Ltd (President, C.E.O. Mutsuo Kanzawa) announces results of a European Phase III Double-blinded comparative study of Silodosin (Brand name in Japan: Urief^®), a novel drug for dysuria associated with Benign Prostatic Hyperplasia (BPH), originally developed by Kissei Pharmaceutical Co., Ltd and licensed out to Recordati S.p.A. (Italy).

A phase III double-blinded comparative study, that was designed to show superiority of silodosin 8 mg once daily over placebo and non-inferiority to tamsulosin following a treatment period of 12 weeks, was conducted in 70 clinical centers of eleven European countries with 1128 BPH patients. Silodosin was shown to be significantly superior to placebo in all parameters, with scores that were always equal to or better than those of tamsulosin. There were no safety issues.

Recordati S.p.A. is completing the long-term part of the Phase III study and plans to file for approval in Europe and in other countries of the licensed territory during the last quarter of 2008. Our US licensee, Watson Pharmaceuticals, Inc., expects to submit a New Drug Application to FDA in the first half of 2008 with their encouraging US phase III results.

Urief^® is a novel, highly uroselective alpha (1A)-adrenoceptor antagonist originally developed by Kissei Pharmaceutical Co., Ltd. In Japan, Urief^® has been marketed in cooperation with Daiichi Pharmaceutical Co., Ltd. (now Daiichi Sankyo Co., Ltd.) since May 11, 2006.

Urief^® reduces urethral resistance by preferentially binding to the alpha (1A) receptors that mainly exist in the prostate, and thereby improves dysuria associated with BPH. Compared to previous drugs, Urief^® has features to improve urinary outlet obstruction early after dosing and to improve not only symptoms in urinary voiding but also symptoms in urinary retention. In addition, Urief^® is expected to broaden options of medication therapies for BPH because the drug showed its usefulness widely in patients with mild through severe symptoms.

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Profile of Recordati S.p.A.
Address of headquarters: Milan, Italy
Establishment: 1926
Chairman and CEO: Giovanni Recordati
Employees: Approx. 2,200
ＵＲＬ：http://www.recordati.com