Apricus Biosciences, Inc. has signed an exclusive license agreement with Recordati S.p.A., an international pharmaceutical group, dedicated to the research, development, manufacturing and marketing of pharmaceuticals, to market Vitaros, its topical on-demand product for the treatment of erectile dysfunction (ED), in Spain, Russia, Turkey, Ireland and certain other European and African countries (the Territory).
Under the terms of the agreement, Apricus is eligible to receive up to approximately $3.8 million from Recordati in upfront and pre-commercialization milestone payments. Apricus is also eligible to receive up to approximately $47 million in sales milestone payments, plus double-digit tiered royalties based on Recordati's net sales of the product in the Territory. In exchange, Recordati will have the exclusive right to commercialize Vitaros in the Territory, which covers a number of countries and regions including Spain, Russia, Turkey, Ireland, Portugal, Greece, Cyprus, Bulgaria, Croatia, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Poland, Romania, Slovakia, Slovenia, Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Moldova, Tajikistan, Turkmenistan, Uzbekistan, Ukraine, Georgia and certain African countries. Recordati has agreed to obtain all necessary regulatory approvals at its sole cost.
"We look forward to building a long-term relationship with Recordati in support of their efforts to introduce the first and only topical on-demand treatment for erectile dysfunction in these valuable markets," said Richard Pascoe, chief executive officer of Apricus. "This agreement, which marks the completion of our Vitaros licensing efforts in Europe, reflects our continued commitment to commercializing Vitaros through leading pharmaceutical companies such as Recordati in an effort to bring this best in class erectile dysfunction treatment to patients in 2014."
Vitaros is 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, Recordati in Spain, Russia, Turkey, Ireland and certain other European and African countries, and Abbott in Canada. The Company's existing commercialization partners are currently preparing for Vitaros product launches in their respective territories with product launches expected throughout 2014.
Vitaros is approved for the treatment of ED by a number of 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.
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.