Apricus Biosciences Files Marketing Application for Vitaros as a Treatment for Erectile Dysfunction in Switzerland

Apricus Biosciences APRI announced today its filing of a marketing application for Vitaros as a treatment for patients with erectile dysfunction in Switzerland, with Swissmedic, the Swiss Agency for Therapeutic Products. "We are excited about making our third major filing for our flagship product, Vitaros® for the treatment of ED," said Dr. Bassam Damaj, Chairman, Chief Executive Officer and President of Apricus Bio. According to IMS Health data, the annual ED market in Switzerland in 2010 was estimated at €27 million. The potential market for a drug approved in Switzerland, however, is much larger than just the Swiss market. Swissmedic approval is relied upon by the regulatory authorities in numerous European countries that are not members of the European Union, as well as by many other countries worldwide. The approval time for Swissmedic is currently approximately 15 months from the time of submission. The Company received marketing approval for Vitaros® as a first-line treatment for ED from Health Canada in November 2010, for sales of the product in that country. In April 2011, Apricus Bio filed a marketing application in the European Union, under the Decentralized Procedure ("DCP"), for Vitaros® for the treatment of ED. Under the DCP, approval in a Reference Member State means that a drug may be sold in all of the European Union countries that were filed with the DCP as Concerned Member States. Switzerland, however, is not part of the European Medicines Agency ("EMA"). Marketing drugs in Switzerland requires an independent application and approval from Swissmedic. "Swissmedic is considered one of the most well-respected drug regulatory authorities that is relied on by many countries throughout the world," said Damaj. "As we have stated previously, we look forward to applying for approval for this product and for the ED indication in other important international markets in the future."