Recordati signed new marketing agreements for the benign prostatic hyperplasia (BPH) drug, silodosin, in Italy and South Africa. The deal with Nycomed’s Italian subsidiary covers the co-marketing of silodosin in Italy, and a separate agreement with Pharmaplan gives the South African company exclusive marketing and sales rights in South Africa.
For the South African market, Pharmaplan will also be responsible for filing an NDA to the country’s regulatory authorities. An MAA for silodosin was submitted to the EMEA in November 2008 and a decision is expected during the first half of 2010.
Pharmaplan is already Recordati’s South African licensee for the drugs Zanidip® (hypertension), Zaneril® (hypertension), and Lomexin® (vulvovaginal candidiasis).
Silodosin is an alpha-1 adrenergic receptor antagonist, indicated for the symptomatic treatment of BPH. The drug was originally developed by Kissei in Japan, where it has been marketed as Urief® since 2006. Recordati licensed the drug for Europe and a number of countries in the Middle East and Africa.
Silodosin was developed in North America by Watson Pharmaceuticals and was approved by the FDA in October 2008. Watson launched the drug as Rapaflo™ in April.