Pharmaceutical Business review

Recordati, Zambon Ink Silodyx License Agreement In France

Silodyx is a new compound indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) and recently approved by the European Medicines Agency (EMA). Zambon is expected to co-market the product together with Recordati in France.

Recordati said that Silodyx is a powerful antagonist of the a1 adrenergic receptors. In particular, silodosin has a very high affinity for the a1A receptor. Blockade of the a1A receptor leads to a rapid increase in urinary flow-rate and to an improvement in symptoms associated with BPH.

The compound was originally developed by Kissei in Japan and has been obtained under license by Recordati for the whole of Europe and for a number of countries in the Middle East and Africa. Recordati also has the right to appoint co-marketers where deemed appropriate.

Worldwide development of the drug was conducted by Recordati for its territories, by Watson Pharmaceuticals in North America and by Kissei Pharmaceutical and its other partners for the rest of the world. Under the brand Urief silodosin is successfully marketed in Japan since May 2006 and has achieved a market share of over 25% in 2009.

Giovanni Recordati, chairman and CEO of Recordati, said: “We are delighted to have Zambon as our co-marketer in France for this new drug. I am confident that the contribution of Zambon, an important international pharmaceutical company, will be fundamental to the success of this new therapeutic option in France.”

Pascal Brossard, GM of Zambon France, said: “We are very honoured to have been selected by Recordati for the co- marketing of this new product. The reasons for this choice are mainly based on our strong and confident knowledge in urology, acquired by the marketing of Monuril, an antibiotic indicated in the treatment of acute cystitis.

“This agreement is a major step for the development of our affiliate, based on organic growth but also on launches of new products such as Rhinomaxil (in 2009) and Silodyx today.”