Approval is expected in the first half of 2010.
Recordati has entered into an agreement with Almirall to market silodosin, which is indicated for treatment of symptoms of benign prostatic hyperplasia, in Spain. The marketing approval authorization request is expected to be approved in the first half of 2010, with Almirall to co-market the compound with Recordati’s Spanish subsidiary, Recordati Espana.
The compound is an antagonist of the the alpha1 adrenergic receptors, which can lead to an increase in urinary flow rate and an improvement of BPH symptoms.
Recordati obtained the license from Kissei Pharmaceutical for marketing solodosin in Europe and some countries in the Middle East and Africa. It may also enter into agreements with co-marketers per the terms of the licensing. In North America, Watson Pharmaceuticals completed worldwide development and obtained FDA approval.
Under the brand name Urief, as of December 2008, the compound achieved a 20% market share in Japan, where it was launched in May of 2006 and marketed by Kissei. The firm yesterday signed a licensing agreement with Eisai to market the therapy in ASEAN countries as well as India and Sri Lanka.