Sandoz Buys Rights to Apricus Biosciences' Drug for $28 Million

Apricus Biosciences, Inc. recently announced its wholly owned subsidiary NexMed, Inc. has signed with Sandoz, a division of Novartis, an exclusive collaboration for Germany to market Apricus Bio’s Vitaros drug for the treatment of erectile dysfunction. Pursuant to the collaboration, Sandoz will pay Apricus Bio up to EURO21 million – divided into a fixed up-front payment and specific regulatory and commercial milestones – as well as, double digit royalties on net sales. Total up-front and milestone payments represent approximately $28 million based on today’s exchange rate.

“We are very excited about this major European collaboration with such an important international pharmaceutical company as Sandoz,” said Bassam Damaj, Chairman, President, and CEO of Apricus Bio commented. “We are happy to work again with Novartis through their division Sandoz, and we look forward to expanding the reach of our Vitaros product for erectile dysfunction in Germany. This is yet another important milestone in our strategy to make Vitaros available worldwide and the successful continuation of the execution of our commercialization strategy of Vitaros.”

The ED market in Europe is presently dominated by oral PDE5 treatments. However, there is still a need for new, safe, and effective treatments, especially for those patients who cannot or do not respond well to oral medication. Vitaros differs from oral PDE5 drugs like Viagra, Cialis, and Levitra in two ways. First, it is applied directly to the penis as a cream, instead of as a pill that is absorbed systemically. The topical application helps to reduce side effects and enables men who cannot take, or do not do well with the existing drugs, to have a patient-friendly alternative.

Second, Vitaros operates by a different biochemical mechanism than oral ED medications and causes erections to occur in a more localized fashion and more quickly when compared to oral treatments. Vitaros contains a previously known compound, with the chemical name alprostadil. When absorbed through the skin, alprostadil, a vasodilator, directly boosts blood flow, thereby causing an erection. Clinical studies have shown that Vitaros works on average in approximately 15 minutes, compared to a reported onset time of 30 minutes or more for oral medications indicated for the treatment of ED. The side effects reported were localized and transient.

Alprostadil is currently marketed as an injectable drug. Apricus Bio incorporated alprostadil with its NexACT delivery technology, resulting in a rapid and efficient topical delivery of the drug into the penis. In clinical studies, Vitaros worked in patients suffering from mild-to-severe ED, including men who did not respond to Viagra.

Apricus Bio is a San Diego-based, revenue-generating, specialty pharmaceutical company, with commercial products and a broad pipeline across numerous therapeutic classes. Revenues and growth are driven from the sales of the company’s commercial products through its Apricus Pharmaceuticals USA, Inc. and NexMed (USA), Inc. subsidiaries and through out-licensing in certain territories of its product pipeline and NexACT technology.