Apricus ED drug gains national phase approval in Germany

Germany's Federal Institute for Drugs and Medical Devices (BfArM) has granted national phase approval for USA-based Apricus Biosciences’ (Nasdaq: APRI) Vitaros (alprostadil), indicated for the treatment of patients with erectile dysfunction (ED).

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

"National phase approval of Vitaros in Germany, one of the largest ED markets in Europe, is another important milestone for the company," said chief executive Richard Pascoe, adding: "We look forward to working with Sandoz [a unit of Swiss drug major Novartis], 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."