Apricus Biosciences Announces National Phase Approval for Vitaros in Spain

Apricus Biosciences, Inc.

, a pharmaceutical company focusing on the development and commercialization of novel therapeutics for men's and women's health, today announced that the Spanish Agency for Medicines and Health Products (AEMPS) has granted national phase approval to Vitaros®, Apricus' novel topical on-demand treatment for erectile dysfunction ("ED"). With the approval in Spain, the Company has now received a total of ten national phase approvals for Vitaros®, including Luxembourg, Belgium, France, Germany, Ireland, Italy, the Netherlands, Sweden and the United Kingdom (the "U.K.") following its broad approval by European health authorities in June 2013. Apricus has an exclusive agreement with Recordati for the commercialization of Vitaros® in Spain, Russia, Turkey, Ireland and certain other European and African countries. "We are pleased to have now been granted national phase approval in all the countries participating in the European Decentralized Procedure ("DCP") process, which followed the Vitaros® approval last year," said Richard Pascoe, Chief Executive Officer of Apricus. "Moreover, we look forward to the first launch of Vitaros® in the United Kingdom, and in other countries where Vitaros® is approved, by our commercial partners." In June 2013, Apricus announced that its marketing application for Vitaros® was approved through the European DCP. Under the DCP, Apricus filed its application for marketing approval designating the Netherlands as the Reference Member State on behalf of nine other European Concerned Member States participating in the procedure. The Company has now received national phase approval for all ten of the member states. Once launched, Vitaros® will become the first new and novel ED product in nearly a decade, and with its unique product profile that has the potential to address a large number of patients who cannot or do not respond well to the existing therapies, or who are intolerant to the systemic effects of PDE-5 inhibitors, it is well-positioned for commercial success. Apricus 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 U.K., Sandoz in Germany, Switzerland and certain countries in Northern Europe, Bracco in Italy, Majorelle in France, Monaco and certain African countries, Recordati in Spain, Russia, Turkey, Ireland and certain other European and African countries, and Abbott in Canada. The Company's existing commercialization partners are preparing for Vitaros® product launches in their respective territories with product launches expected throughout 2014.