US-based pharmaceutical firm Apricus Biosciences has received national phase approval from the Ministry of Health of Luxembourg for Vitaros, a topical on-demand treatment for erectile dysfunction (ED).
Following broad approval by European health authorities in June 2013, the company has secured a total of nine national phase approvals for Vitaros, including Luxembourg, Belgium, France, Germany, Ireland, Italy, the Netherlands, Sweden and the UK.
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The company has an exclusive partnership in place with Hexal, an affiliate within the Sandoz Division of the Novartis Group of Companies (Sandoz), for the commercialisation of Vitaros in several European countries, including Luxembourg.
Apricus chief executive officer Richard Pascoe said: "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 secured marketing application approval for Vitaros through the European decentralised procedure (DCP), which the company has Apricus filed its application under 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.
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By GlobalDataThe company said that it continues to work toward securing the remaining national phase approval in Spain.
Vitaros has currently partnered in major 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 launch of Vitaros in their respective territories throughout 2014.
