Recordati is celebrating the news that regulators in Europe have this morning approved silodosin for benign prostatic hyperplasia.

The European Commission has granted marketing authorisation for the drug, which will be sold as Urorec and Silodyx for treatment of the signs and symptoms of BPH. Launches will take place by the end of the year or early 2011.

BPH is characterised by urination difficulties, eg increased frequency, and although it usually starts from the age of around 30, it rarely shows before the age of 40 and by 60, 50% of men suffer from the condition. Silodosin was originally developed by Japan’s Kissei Pharmaceutical Co and Recordati has the licence for the whole of Europe and for a further 18 countries in the Middle East and Africa.

Chief executive Giovanni Recordati noted that during 2009 a number of licensing and co-marketing agreements were entered into with pharmaceutical companies for both European and non-European markets (eg Spain’s Almirall). These deals “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", he added.

The compound has been sold by Kissei and Daiichi Sankyo in Japan as Urief since May 2006, while Watson Pharmaceuticals markets the drug as Rapaflo, in the USA.