The Ministry of Health of Luxembourg has granted national phase approval to Apricus Biosciences' Vitaros, a novel topical on-demand treatment for erectile dysfunction (ED).
The company has now received a total of nine national phase approvals for Vitaros, including Luxembourg, Belgium, France, Germany, Ireland, Italy, the Netherlands, Sweden and the United Kingdom ("UK") following its broad approval by European health authorities in June 2013. Apricus has an exclusive commercialisation partnership in place with Hexal AG, an affiliate within the Sandoz Division of the Novartis Group of Companies (Sandoz), for the commercialisation of Vitaros in several European countries, including Luxembourg.
"We are pleased with the continued progress we have made, together with our partners, towards obtaining Vitaros national phase approvals in Europe," said Richard Pascoe, chief executive officer of Apricus. "We continue to support our partners as they prepare to launch Vitaros in their respective territories later this year. Importantly, we have successfully manufactured commercial product, which has met all required release and shelf-life specifications for Europe, and we look forward to the planned launch of Vitaros throughout this year by our partners."
In June 2013, Apricus announced that its marketing application for Vitaros was approved through the European Decentralised Procedure ("DCP"). Under the DCP, Apricus filed its application for marketing approval designating the 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 towards obtaining the remaining national phase approval in Spain.
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 UK, 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 commercialisation partners are preparing for Vitaros product launches in their respective territories with product launches expected throughout 2014.
Apricus Biosciences, Inc. (APRI) is a pharmaceutical company focused on the development and commercialization of novel therapeutics for men's and women's health.