European Commission Approved 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 on January 29, 2010, its licensee for Europe, Recordati　(Italy) has been granted a marketing authorization by the European Commission 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 to provide exclusive development and marketing rights of silodosin in Europe. Recordati has submitted the Marketing Authorization Application (MAA) for silodosin in November 2008. This approval follows a positive opinion adopted by CHMP (the Committee for Medicinal Products for Human Use) of EMEA (the European Medicines Agency) on November 19, 2009. Hereafter, following the negotiations of drug prices with each European country, Recordati and its partners will launch the medicinal products 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. In overseas, silodosin was launched in the U.S. in April 2009 by Watson Pharmaceuticals Inc and in South Korea in September 2009 by Choongwae Pharma Corporation. In China silodosin was filed for a new drug application (NDA) by Daiichi-Sankyo Co., Ltd, in December 2008, and in ASEAN countries, silodosin is under NDA preparation by Eisai Co., Ltd.

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- 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