Apricus Biosciences, Inc., a biopharmaceutical company advancing innovative medicines in urology and rheumatology, announced that Vitaros, a topical cream indicated for the treatment of patients with erectile dysfunction (ED), has been approved through the European Decentralised Procedure (DCP) in twelve additional countries.
Those countries are: Austria, Cyprus, the Czech Republic, Denmark, Finland, Greece, Iceland, Norway, Poland, Portugal, Romania and the Slovak Republic. Apricus' commercialisation partners that hold the license for these additional territories will be responsible for the next step of obtaining national phase approvals in order to make Vitaros ready to launch.
In 2013, Vitaros was approved under a separate DCP in Belgium, France, Germany, Ireland, Italy, Luxembourg, the Netherlands, Spain, Sweden and the United Kingdom. Under the DCP, Apricus or its partners filed applications for marketing approval designating the Netherlands as the Reference Member State on behalf the twenty-one other European Concerned Member States participating in the procedure.
"Since the first European approval of Vitaros in 2013, together with our commercial partners, we have made significant progress in making Vitaros available to men suffering from erectile dysfunction in Europe. These additional approvals, under the DCP, further enhance the value of Vitaros for our partners and potentially our shareholders," said Richard W. Pascoe, chief executive officer of Apricus.
"Vitaros has a unique product profile that meets the needs of a large number of patients suffering from erectile dysfunction to include those patients who are intolerant to or do not respond to current treatment options. With its rapid onset of action and unique topical delivery, we believe that Vitaros will capture a significant share of the approximately $1 billion PDE-5 inhibitor market in Europe."
"Moreover, with the recent successful launches in Spain and France, Vitaros unit sales in Europe more than doubling from the first quarter of 2015 to the second quarter of 2015, and an expected launch in Italy later this year, we are confident that Vitaros will continue to generate meaningful revenue for Apricus to help advance our clinical-stage pipeline."