Recordati has signed a license agreement with Barcelona-based Almirall, which will co-market the Italian company’s silodosin, a new compound for benign prostatic hyperplasia, in Spain.

A marketing approval authorisation request for silodosin was submitted to the European Medicines Agency in November 2008 and approval is expected in the first half of 2010. The drug blocks alpha-1 adrenergic receptors in the prostate, bladder and urethra to reduce prostate enlargement symptoms and is administered through a capsule taken once a day.

The compound was originally developed by Kissei in Japan and has been sold there (by Kissei and Daiichi Sankyo) as Urief since May 2006. At the end of last year, it had achieved a 20% market share. Watson Pharmaceuticals got approval from the US Food and Drug Administration for silodosin, to be marketed as Rapaflo, last October.

The Italian drugmaker’s chief executive Giovanni Recordati said "I am confident that the contribution of Almirall, the leading Spanish pharmaceutical company, will be fundamental to the success of this new therapeutic option in Spain”. His counterpart at Almirall, Jorge Gallardo, said that “by incorporating silodosin into our product portfolio we will enhance our urology area while offering an efficient solution to improve quality of life for BPH sufferers – an affliction with a social impact affecting a high percentage of men in Spain”.

Although it usually starts from the age of around 30, BPH rarely shows before the age of 40 and by 60, 50% of men suffer from the condition. Between the ages of 70 and 80, up to 90% of men experience some of the symptoms that can be irritative (frequency, urgency and nocturia) and obstructive (hesitancy, incomplete emptying, intermittency and weak stream).

This latest licensing deal for Almirall comes a few months after it signed a deal to co-market Pfizer’s Caduet (atorvastatin/amlodipine) in Spain under the brand name Astucor. The firm also signed up to sell Merck Sharp & Dohme’s type 2 diabetes drug Januvia (sitagliptin) under the brand name Tesavel and the combo Janumet (sitagliptin plus metformin) as Efficib.