Apricus Biosciences Gets National Phase Approval For ED Cream Vitaros In Germany

(RTTNews) - Apricus Biosciences Inc (APRI) announced that Germany's Federal Institute for Drugs and Medical Devices or BfArM has granted national phase approval to Vitaros, indicated for the treatment of patients with erectile dysfunction or "ED".

The company said it has now received a total of five national phase approvals for Vitaros, including Germany, Ireland, the Netherlands, Sweden and the United Kingdom.

"We look forward to working with Sandoz, our commercialization partner in Germany, to move Vitaros toward a successful launch in this key territory. Our regulatory efforts, along with actions taken by our existing European partners, continue to be on track to obtain the remaining five of ten European approvals from the fourth quarter of 2013 through the first quarter of 2014," said Richard Pascoe, Chief Executive Officer of Apricus Bio.

Apricus Bio noted that Vitaros is currently partnered in key markets, including with Takeda in the UK, Sandoz in Germany, Bracco in Italy and Abbott in Canada. Apricus Bio noted that it has launched a comprehensive partnering process with the goal of licensing Vitaros in the remaining un-partnered territories in Europe, Latin America and North Africa.

Apricus Bio stated that it has received and reviewed multiple bids for the available territories and has narrowed the number of potential partners to a select group with which it will negotiate terms. Moreover, the company said it remains on track to complete this process in the fourth quarter of this year.