Apricus Biosciences, Inc. has expanded its exclusive license agreement with Hexal AG, an affiliate within the Sandoz Division of the Novartis Group of Companies (Sandoz), for the commercialization of Vitaros, indicated for the treatment of patients with erectile dysfunction (ED). In addition to the in-place collaboration in Germany, this expanded agreement now includes Austria, Belgium, Denmark, Finland, Iceland, Luxemburg, the Netherlands, Norway, Sweden and Switzerland (the "Expanded Territory").
In combination with the previously signed license agreement for Germany, Apricus is now eligible to receive up to approximately $63 million from Sandoz in upfront, regulatory, launch and sales milestone payments for Vitaros in Germany and the Expanded Territory, which includes up to $4.5 million in new upfront and launch milestone compensation for the Expanded Territory.
"This expanded commercialization agreement with Sandoz accomplishes one of our key corporate objectives – the expansion of an existing Vitaros partnership in Europe," said Richard Pascoe, chief executive officer of Apricus. "We are pleased with the strong working relationship we have with Sandoz and we look forward to supporting their team as they bring this novel, topical, on-demand ED treatment option to physicians and patients throughout Northern Europe."
Vitaros was approved in Europe under the Decentralized Procedure (DCP) in June 2013. Since then, the product has received six national phase approvals in Europe, including Germany, Ireland, Italy, the Netherlands, Sweden and the United Kingdom. Apricus continues to work independently, as well as with its license partners, to obtain country-by-country national phase approvals in the remaining CMS territories, including France, Spain, Belgium and Luxembourg. The Company's regulatory efforts, along with actions taken by its existing European license partners, are on track to obtain the remaining four European approvals during the fourth quarter of 2013 and the first quarter of 2014.
Vitaros is currently licensed to Takeda in the United Kingdom, Sandoz in Germany, Austria, Benelux and the Nordics, Bracco in Italy, Laboratoires Majorelle in France, Monaco and certain Africa countries, and Abbott in Canada.
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.