A　Positive　Opinion from European Regulatory Authorities for SILODOSIN (Brand Name in Japan: Urief®) for The Treatment of Dysuria Associated with Benign Prostatic Hyperplasia

Kissei Pharmaceutical Co., Ltd. (President, CEO: Mutsuo Kanzawa) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion, recommending to grant a market authorization for silodosin (brand name in Japan: "Urief^®") which was originally developed by Kissei, indicated to improve the signs and symptoms of benign prostatic hyperplasia (BPH).

In December, 2004, Kissei has entered into a technology licensing-out agreement with Recordati Corporation (Italy) to provide exclusive development and marketing rights of silodosin in Europe. Recordati has submitted the Marketing Authorization Application (MAA) for silodosin in November, 2008.
Hereafter, the marketing authorization by European Commission (EC), take charge of approval for a new drug in the EU, will normally be expected within two or three months from adoption of the CHMP Opinion. And following the Commission Decision and nationalization procedures, Recordati and its partners will launch the medicinal product Urorec^® and Silodyx^TM (brand names in Europe).

By selectively blocking alpha 1A-adrenoceptors that primarily exist in the prostate gland, silodosin, originally developed by Kissei, removes the tension of the prostate gland to improve urethral resistance, thereby improving dysuria associated with BPH. Compared with existing drugs, silodosin offers faster onset and improves both symptoms such as difficulty of urination (obstructive symptoms), and frequent urination, urinary incontinence (irritative symptoms).

In Japan, silodosin has been co-developed and jointly marketed by Kissei and Daiichi-Sankyo Co., Ltd. since 2006. Overseas, silodosin was launched in the U.S. in April 2009 by Watson Pharmaceuticals Inc, in the South Korea in September 2009 by Choongwae Pharma Corporation. In the China silodosin was filed for a new drug application (NDA) by Daiichi-Sankyo Co., Ltd. in December 2008, and in the ASEAN countries, silodosin is under NDA preparation by Eisai Co., Ltd.


- Company Profile of Recordati -
Location of head office: Milan, Italy
Established: 1926
Chief Executive officer (CEO): Giovanni Recordati
No. of employees: Approximately 2,950
Consolidated Revenue (2008): € 690 million
URL: http://www.recordati.com