Apricus Biosciences, Inc. has received national phase approvals from the Irish Medicines Board and the Netherlands' Medicines Evaluations Board to Vitaros, indicated for the treatment of patients with erectile dysfunction (ED). The company has now received a total of four national phase approvals for Vitaros including Ireland, the Netherlands, Sweden and the United Kingdom (UK).
In June 2013, Apricus Bio announced that its marketing application for Vitaros was approved through the European Decentralized Procedure (DCP). Under the DCP, Apricus Bio filed its application for marketing approval designating 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 independently, as well as with its commercialization partners, to obtain country-by-country national phase approvals in the remaining CMS territories including France, Germany, Italy, Spain, Belgium and Luxembourg. Once the national phase approvals are secured on a country-by-country basis, marketing of Vitaros can then be initiated in each country by Apricus Bio's commercialization partners.
"Vitaros has now received national approvals in four of the ten European countries where marketing authorization applications are being pursued," said Richard Pascoe, chief executive officer of Apricus Bio. "We believe that Vitaros is on track to obtain the remaining European approvals beginning in the third quarter of this year and continuing through the first quarter of 2014. Our regulatory efforts, along with the actions taken by our existing European partners, Takeda, Sandoz and Bracco, continue to move successfully toward making Vitaros ready to launch in each of the included territories across Europe."
Vitaros is currently partnered in key markets, including with Takeda in the UK, Sandoz in Germany, Bracco in Italy and Abbott in Canada. Apricus Bio recently launched a comprehensive partnering process with the goal of licensing Vitaros in the remaining un-partnered territories in Europe, Latin America and North Africa. The Company is reviewing bids recently received from multiple interested parties for the available territories and Company expects the Vitaros partnering process to be completed in the fourth quarter of 2013.
Once launched, Vitaros will become the first new and novel erectile dysfunction 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 these existing therapies, or who are intolerant to the systematic effects of PDE5 inhibitors, it is well-positioned for commercial success. In Europe alone, the existing erectile dysfunction products generated over $1 billion in sales in 2012. Apricus Bio believes that a significant portion of the market remains untreated or under-treated, which represents a substantial commercial opportunity for Vitaros.
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.
Femprox is a product candidate for the treatment of female sexual interest/arousal disorder (FSIAD). Seven clinical studies have been successfully completed to date, including one, 98-subject phase II study in the US and a nearly 400-subject proof of concept study in China. To date, no product has been approved in the US to treat FSIAD, a persistent or recurring inability to attain or maintain adequate sexual excitement, causing personal distress.
Apricus Biosciences, Inc. is a pharmaceutical company that develops and markets innovative treatments that help large patient populations across numerous, large-market therapeutic classes including male and female sexual health.