US-based pharmaceutical firm Apricus Biosciences has received national phase approval from Belgium’s Ministry of Social Affairs, Public Health and Environment for Vitaros, indicated for the treatment of patients with erectile dysfunction (ED).
Following approval from European health authorities in June 2013, the company has received a total of eight national phase approvals for Vitaros, including Belgium, France, Germany, Ireland, Italy, the Netherlands, Sweden and the UK.
The company is currently in an exclusive commercialisation partnership with Hexal, an affiliate within the Sandoz Division of the Novartis Group of Companies (Sandoz), for commercialisation of Vitaros in several European countries, including Belgium.
Apricus chief executive officer Richard Pascoe said: "We remain excited about the opportunity for all of our existing partners to bring the first and only on-demand, topical erectile dysfunction treatment to the market this year."
The company received marketing application for Vitaros through the European decentralised procedure (DCP) in June 2013. It also included an application for marketing approval designating, filed in the Netherlands as the reference member state (RMS) on behalf of nine other European concerned member states (CMS) participating in the procedure.
In addition, the company is seeking to secure the remaining national phase approvals in Spain and Luxembourg.
When launched, Vitaros will become the first new and novel ED product in nearly a decade, and with its product profile that addresses a large number of patients not responding well to the existing therapies, or who are intolerant to the systemic effects of PDE-5 inhibitors.
The drug is 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, and Abbott in Canada.
Vitaros is scheduled to be launched across Europe later this year by the company’s existing commercialisation partners in their respective territories.