US-based pharmaceutical firm Apricus Biosciences has received national phase approval from the Spanish Agency for Medicines and Health Products (AEMPS) for Vitaros, a topical on-demand treatment for erectile dysfunction (ED).
Following broad approval by European health authorities in June 2013, Apricus secured a total of ten national phase approvals for Vitaros, including Luxembourg, Belgium, France, Germany, Ireland, Italy, the Netherlands, Sweden and the UK.
Go deeper with GlobalData
The company has an exclusive partnership in place with Recordati for the commercialisation of the drug in Spain, Russia, Turkey, Ireland and certain other European and African countries.
Apricus chief executive officer Richard Pascoe said: "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 secured marketing application approval for Vitaros through the European DCP, which the company 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.
The company said that it has now received national phase approval for all ten of the member states.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataFollowing the launch, Vitaros will become the first new ED product in nearly a decade, and has potential to help a large number of patients who do not respond well to existing therapies, or who are intolerant to the systemic effects of PDE-5 inhibitors.
The drug is currently partnered in major markets such as 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.
Apricus’s existing commercialisation partners are preparing for the launch of Vitaros in their respective territories throughout 2014.
