The Germany's Federal Institute for Drugs and Medical Devices (BfArM) has granted national phase approval to Apricus Biosciences' Vitaros,  for treatment of patients with erectile dysfunction (ED). Apricus now received a total of five national phase approvals for Vitaros, including Germany, Ireland, the Netherlands, Sweden and the United Kingdom.

"National phase approval of Vitaros in Germany, one of the largest ED markets in Europe, is another important milestone for the Company," said Richard Pascoe, chief executive officer of Apricus Bio. "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."

In June 2013, Apricus Bio announced that its marketing application for Vitaros was approved through the European Decentralized Procedure (DCP). Under the DCP, Apricus Bio 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. The Company continues to work independently, as well as with its commercialization partners, to obtain country-by-country national phase approvals in the remaining CMS territories including France, Italy, Spain, Belgium and Luxembourg. Once the national phase approvals are secured on a country-by-country basis, marketing of Vitaros can then be initiated in each country by Apricus Bio's commercialization partners.

Once launched, Vitaros will become the first new and novel ED product in nearly a decade, and with its unique product profile that addresses a large number of patients who cannot or do not respond well to the existing therapies, or who are intolerant to the systematic effects of PDE5 inhibitors, it is well-positioned for commercial success. In Europe alone, the existing ED products generated over $1 billion in sales in 2012. Apricus Bio believes that a significant portion of the market remains untreated or under-treated, which represents a substantial commercial opportunity for Vitaros.

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 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 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 remains on track to complete this process in the fourth quarter of this year.

Apricus Biosciences, Inc. is a pharmaceutical company that develops and markets innovative treatments that help large patient populations across numerous, large-market therapeutic classes including male and female sexual health.