Apricus Biosciences has reported that the Italian Medicines Agency (AIFA) has approved Vitaros (alprostadil), indicated for the treatment of patients with erectile dysfunction (ED). The company has now received a total of six national phase approvals for Vitaros, including Germany, Ireland, Italy, the Netherlands, Sweden and the UK following its broad approval by the European health authorities in June 2013.
Apricus will work with Bracco to commercialise the product in Italy. Apricus added that it remained on track to obtain European approvals for the product in France, Spain, Belgium and Luxembourg during Q413 and Q114. The launch of Vitaros across Europe is expected in 2014. Once launched, Apricus claimed that Vitaros will become the first new and novel ED product in nearly a decade.
Vitaros is currently partnered in key markets, including with Takeda in the UK, Hexal ( Sandoz) in Germany, Bracco in Italy, Laboratoires Majorelle in France, Monaco and certain African countries, and Abbott in Canada.