Following national post-authorization procedures, as relevant, product launch could take place by the end of 2010 or beginning of 2011.
The compound was originally developed by Kissei Pharmaceutical in Japan and was obtained under license by Recordati for the whole of Europe and 18 countries in the Middle East and Africa. Recordati also has the right to appoint co-marketers where deemed appropriate.
Development of the drug was conducted by Recordati for its territories, by Watson Pharmaceuticals in North America and by Kissei Pharmaceutical for the rest of the world. Silodosin is already available in North America, Japan and other countries in Asia.
In two phase III placebo-controlled clinical trials conducted in the US by Watson Pharmaceuticals and in one placebo-and active-controlled trial conducted in Europe by Recordati, over 800 patients received Silodosin 8mg once daily. In these studies, patients treated with Silodosin had a significant decrease in BPH symptoms, both irritative (frequency, urgency, nocturia) and obstructive (hesitancy, incomplete empting, intermittency, weak stream).
In addition, an improvement in the quality of life linked to urinary symptoms was observed with Silodosin. Furthermore, in the active-controlled study conducted in Europe, Silodosin 8mg once daily was not inferior to tamsulosin 0.4mg once daily, with an adjusted mean difference between treatments in the IPSS Total Score in favour of Silodosin.
The improvement in BPH symptoms was observed within the first week of treatment, and was maintained long-term. In addition, improvements in the maximum urine flow-rate (Qmax) were evident within a few hours after the first dose of Silodosin, and were also maintained long-term.
Giovanni Recordati, chairman and CEO of Recordati, said: "The authorization to market Silodosin confirms the validity of this new treatment for the symptoms of benign prostatic hyperplasia. The product, under the brands Urorec and Silodyx, will be available in all European markets upon finalization of the national registration procedures. During 2009 a number of licensing and co-marketing agreements were entered into with leading pharmaceutical companies for both European and non-European markets which will allow us to obtain wide coverage and the acceptance of the medical community for this modern treatment for a condition which increasingly affects the male population."