European Commission Approves Almirall's BPH Drug

Published: 08-Feb-2010

Almirall has reported that the European Commission has granted a marketing authorisation for Silodosin. The product will be marketed in Spain by Almirall and Recordati under the trademarks, Silodyx and Urorec, respectively. It will be available in 4mg and 8mg in hard capsules, for the treatment of benign prostatic hyperplasia (BPH).

In April 2009, Almirall signed a co-marketing agreement with Recordati, by virtue of which, Recordati grants Almirall marketing rights in Spain for Silodosin.

Enrique Dominguez, general manager of Almirall Spain, said: "This is good news as authorisation from the European Commission to market Silodosin will offer a new therapeutic option for the medical collective and BPH sufferers.

"Almirall will be marketing the product under the trademark Silodyx. This will be available in Spain when the national registration procedure has been completed at the end of 2010 and could contribute to Almirall sales in the second half of this financial year.”

Silodosin blocks alpha-1 adrenergic receptors in the prostrate, bladder and urethra to reduce prostate enlargement symptoms. It is administered through a capsule taken once a day.

The FDA approved Silodosin in 2008 for the treatment of BPH symptoms.

The drug has been marketed in Japan since May 2006, by Kissei. In Europe, Africa and the Middle East, Silodosin is being marketed by Recordati, in collaboration with other pharmaceutical companies through co-marketing agreements (like the one with Almirall in Spain).

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