New Drug Application for Silodosin (Brand name in Japan: Urief®) has been filed with FDA.

Kissei Pharmaceutical Co., Ltd (President, C.E.O. Mutsuo Kanzawa) announced today that a new drug application for Silodosin (Brand name in Japan: Urief^®), a novel drug for dysuria associated with Benign Prostatic Hyperplasia (BPH), originally developed by Kissei Pharmaceutical Co., Ltd, previously licensed-out to Watson Pharmaceuticals, Inc. (US), has been filed with U.S. Food and Drug Administration (FDA).

In the US, half of men in their 60's, and as many as 90% of men by the age of 85, are affected by BPH. Urief^® is expected to broaden the medication therapy options for BPH in the US.

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 Sankyo Pharmaceutical Co., Ltd. since May 2006. Urief^®reduces urethral resistance by preferentially binding to the alpha (1A) receptors that mainly exist in the prostate, thereby improving dysuria associated with BPH. Compared to previous drugs, Urief^® has features to improve urinary outlet obstruction quickly after dosing and to improve not only symptoms in urinary voiding but also symptoms in urinary retention. In addition, Urief^® showed its usefulness widely in patients with mild to severe symptoms, thus, Urief^® is the drug that contributes to improvement of Quality of Life (QOL) of many patients with BPH suffering from urination trouble.

Kissei has been aggressively promoting international development of its original products such as silodosin, mitiglinide (a diabetic medicine, brand name in Japan: Glufast^®), etc, through outlicensing. In advance of the overseas launch of silodosin, Kissei established a section in charge of international product management last April and has been working closely with partners, including Watson.　In South Korea, Choongwae Pharma Corporation has filed a NDA and it is under review. In Europe, clinical development by Recordati S.p.A is near completion prior to NDA, which is scheduled for the 4th quarter in 2008. Furthermore, phase III studies of silodosin are being conducted by Daiich Sankyo Pharmaceutical Co., Ltd in China and by Synmosa Biopharma Corporation in Taiwan, respectively.

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Profile of Watson Pharmaceuticals, Inc.
Location of headquarters: California, USA
Establishment: 1984
CEO: Paul Bisaro
Amount of sales: US$1,979 Million (2006)
Employees: 5,900
ＵＲＬ：http://www.watson.com/