Apricus Biosciences, Inc. has received the Belgium's Ministry of Social Affairs, Public Health and Environment national phase approval to Vitaros, indicated for the treatment of patients with erectile dysfunction (ED). The company has now received a total of eight national phase approvals for Vitaros, including Belgium, France, Germany, Ireland, Italy, the Netherlands, Sweden and the UK following its broad approval by European health authorities in June 2013.
Apricus has an exclusive commercialization partnership in place with Hexal AG, an affiliate within the Sandoz Division of the Novartis Group of Companies, for the commercialization of Vitaros in several European countries, including Belgium.
"We are pleased to be working with our partner Sandoz as they make progress towards preparing Vitaros for commercial launch in their licensed territories including Belgium," said Richard Pascoe, chief executive officer of Apricus. "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."
In June 2013, Apricus announced that its marketing application for Vitaros was approved through the European Decentralized 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 toward obtaining the remaining national phase approvals in Spain and Luxembourg.
Once launched, Vitaros will become the first new and novel ED product in nearly a decade, and with its unique product profile that addresses 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. In Europe alone, the existing ED products generated over $1 billion in sales in 2012. 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, 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.
Vitaros has been approved for the treatment of ED by the European health authorities and by Health Canada. Vitaros is a topically-applied cream formulation of alprostadil, a vasodilator, combined with our proprietary permeation enhancer DDAIP.HCl, which directly increases blood flow to the penis, causing an erection. Alprostadil is a widely accepted alternative to the PDE-5 inhibitors for difficult to treat patients, and Vitaros, which was determined to be safe and effective by the European health authorities and previously by Health Canada, offers greater market opportunity due to its patient-friendly form versus other alprostadil dosage forms and also relative to oral ED products. With nearly 150 million men worldwide who suffer from ED and an ED market size of approximately $1 billion in revenue in Europe alone, Vitaros represents a major market opportunity for Apricus and its commercial partners given its unique product profile and its potential to treat a large underserved population.
Apricus Biosciences, Inc. is a pharmaceutical company that develops and markets through its licensing partners innovative treatments that have the potential to help large patient populations across numerous, large-market therapeutic classes including male and female sexual health.