Filing a Marketing Authorization Application for Silodosin(Brand Name in Japan: Urief®) in Europe

Kissei Pharmaceutical Co., Ltd. (President & CEO: Mutsuo Kanzawa) announced that Recordati (a European pharmaceutical group based in Italy) filed a marketing authorization application (MAA) for silodosin (Brand name in Japan: Urief^®) to the European Medicines Agency (EMEA), and the application was accepted on November 21 (local time). Silodosin is a novel drug for the treatment of signs and symptoms associated with benign prostatic hyperplasia (BPH), which was originally developed by Kissei and was licensed-out to Recordati.

Recordati conducted phase III randomized double-blind comparison study among the 3 groups which were dosed placebo, silodosin or tamsulosin in Europe. In this study, silodosin was well tolerated and showed significant efficacy within all of the endpoints that were investigated compared with placebo. Additionally, silodosin revealed not to be inferior to tamsulosin, and in terms of the total International Prostate Symptom Score (I-PSS), silodosin has shown excellent results. Favorable efficacy and safety were observed also in the long-term study.

Silodosin binds to α1A adrenoceptors, which exist mainly in the prostate. Blocking the receptors relaxes smooth muscles, improving the urinary tract resistance, thereby improving urinary disturbance associated with BPH. Improvement of subjective symptoms would be observed earlier than existing drugs of the same category. In addition, it is characterized by the ability to improve both voiding symptoms, including reduced urinary stream, and storage symptoms, such as increased frequency of micturition and inability to control urination.

In Japan, silodosin has been co-marketed with Daiichi-Sankyo Company Limited under the brand name Urief^® since May 2006. With regard to the overseas activities of silodosin, Watson Pharmaceuticals, Inc. obtained an approval from US FDA in October 2008 prior to completion of the designated investigation period, and preparations for marketing of the product are in progress. In South Korea, Choongwae Pharma Corporation has obtained an approval, and in China, Daiichi-Sankyo Company Limited is preparing to file a new drug application. In Taiwan, Synmosa Biopharma Corporation is presently carrying out a phase III clinical trial. Silodosin has been distributed in Japan preceding foreign countries as a new drug invented in Japan, and is continuously growing as a new international drug.



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Company Profile of Recordati
Location of head office:　Milan, Italy
Established:　1926
Chief Executive officer (CEO):　Giovanni Recordati
Number of employees:　Approximately 2,400
Consolidated net sales (2007):　EUR628,000,000
URL:　http://www.recordati.com