Kissei Pharmaceutical Co., Ltd (TSE: 4547) announced today that a new drug application for Silodosin (Brand name in Japan: Urief(R)), a novel drug for dysuria associated with Benign Prostatic Hyperplasia (BPH), originally developed by Kissei Pharmaceutical Co., Ltd, and 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(R)), 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.
About Kissei Pharmaceutical Co., Ltd.
Kissei Pharmaceutical Co., Ltd., (TSE: 4547) is an R&D-oriented pharmaceutical company with a management vision from the patient's perspective, striving to manufacture the highest quality pharmaceuticals while providing and collecting information necessary to use the products safely, while successfully launching a number of new drugs as scheduled. Glufast(R), a rapid onset and short-acting insulin secretagogue, was launched in 2004; Salagen(R), a therapeutic agent for dry mouth induced by radiation therapy for head and neck cancer was introduced in 2005; and Urief(R), used for the treatment of dysuria associated with benign prostatic hyperplasia (BPH), was put on the market in 2006. In addition, in May 2007, we received approval in Japan for an additional indication of Glufast(R) for combination therapy with alpha-glucosidase inhibitor, Alpha-GI. For more information, please visit www.kissei.co.jp .
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