Apricus Biosciences, Inc., a pharmaceutical company that develops and markets innovative treatments, announced that its marketing application for Vitaros, indicated for the treatment of patients with erectile dysfunction (ED), has been approved through the European Decentralized Procedure (DCP).
"The approval of Vitaros in Europe marks a significant milestone for Apricus Bio as we continue to execute on our core strategy of developing, seeking regulatory approval, and partnering our sexual health products," said Richard Pascoe, CEO of Apricus Bio. "Vitaros has a unique product profile that meets the needs of a large number of patients suffering from erectile dysfunction and who are intolerant to or do not respond to current treatment options. With its rapid onset of action and unique topical delivery, we believe that Vitaros will capture a significant share of the approximately $1 billion PDE-5 inhibitor market in Europe once it is launched by our commercial partners."
"Moreover, partnering interest in Vitaros remains strong and we are actively seeking to secure additional partnerships in the remaining European and global markets," continued Pascoe. "With the completion of a $17.1 million financing, the divestiture of multiple non-core assets, and streamlining of our global operations in the second quarter of 2013, Apricus Bio is now well positioned to advance our lead assets for male and female sexual health, Vitaros and Femprox, in an effort to create long-term shareholder value."
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 CMS include France, Germany, Italy, UK, Ireland, Spain, Sweden, Belgium and Luxembourg. The Company will continue to work independently as well as with its commercialization partners, Sandoz, Takeda, and Bracco for the next step of obtaining national phase approvals in order to make Vitaros ready to launch in each of the included territories across Europe.
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 a market affecting nearly 150 million men worldwide and representing approximately $1 billion in revenue in Europe, Vitaros represents a major market opportunity, particularly as a distinct product that addresses a significant underserved population.
Femprox is our product candidate for the treatment of female sexual arousal disorder (FSAD) which contains a topically-applied cream formulation of alprostadil, a vasodilator, and our proprietary permeation enhancer DDAIP.HCL. Seven clinical studies have been successfully completed to date, including one, 98-subject phase II study in the US and a nearly 400-subject phase III study in China. To date, no product has been approved in the US to treat FSAD, a persistent or recurring inability to attain or maintain adequate sexual excitement, causing personal distress. Estimates of the FSAD market size put it on par with erectile dysfunction in males, and possibly larger.
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.