The Irish Medicines Board and the Netherlands' Medicines Evaluations Board have granted national phase approvals to Apricus Biosciences' Vitaros, indicated to treat patients with erectile dysfunction (ED).
Vitaros now has four national phase approvals, including Ireland, the Netherlands, Sweden and the United Kingdom (UK).
Apricus Bio chief executive officer Richard Pascoe said Vitaros has now received national approvals in four of the ten European countries where marketing authorization applications are being pursued.
"We believe that Vitaros is on track to obtain the remaining European approvals beginning in the third quarter of this year and continuing through the first quarter of 2014," Pascoe added.
"Our regulatory efforts, along with the actions taken by our existing European partners, Takeda, Sandoz and Bracco, continue to move successfully toward making Vitaros ready to launch in each of the included territories across Europe."
Marketing application for Vitaros was approved through the European Decentralized Procedure (DCP), under which the company filed its application for marketing approval designating Netherlands as the Reference Member State (RMS) on behalf of nine other European Concerned Member States (CMS) participating in the procedure.
Presently, Vitaros is in partnership with Takeda in the UK, Sandoz in Germany, Bracco in Italy and Abbott in Canada.
Additionally, a comprehensive partnering process with the goal of licensing Vitaros in the remaining un-partnered territories in Europe, Latin America and North Africa is launched.
Vitaros is expected to become the first new and novel erectile dysfunction product suitable for large number of patients not responding well to existing therapies, or intolerant to the systematic effects of PDE5 inhibitors.
