Apricus Biosciences, Inc. (Apricus Bio), announced that it has entered into a licensing agreement granting Neopharm Group (Neopharm) the exclusive rights to market and sell Vitaros, Apricus Bio's treatment for erectile dysfunction (ED) and, when and if available, its formulation for the treatment of premature ejaculation (PE), in Israel and the Palestinian Territories of the Gaza Strip and the West Bank.
On November 12, 2010, Apricus Bio announced that Health Canada had approved Vitaros for marketing as the first topical treatment for ED in that country. The application for approval to market Vitaros for ED in Israel is scheduled to be filed in the first half of 2011 and later, in the Palestinian Territories.
Under the terms of the licensing agreement, Neopharm has been granted exclusive rights in Israel and the Palestinian Territories to commercialize and market Vitaros under the Vitaros trademark for ED and, when and if available, Apricus Bio's formulation for PE. In return, Apricus Bio is entitled to receive up to a total of $4.35 million in up-front, regulatory and sales milestone payments for the products. Further, over the life of the agreement, Apricus Bio will receive tiered, double-digit royalties based on Neopharm's sales of the products.
Commenting on the announcement, Dr. Bassam Damaj, president and chief executive officer of Apricus Bio, stated, "We are delighted to be able to announce yet another licensing and commercialization agreement for our first product, Vitaros, that utilizes our proprietary NexACT technology. Since December 22, 2010, we have closed three licensing and commercialization transactions covering 14 countries. We also continue to talk with numerous other potential partners to increase the number of these transactions and to broaden the potential market for Vitaros."
David Fuhrer, chairman of the Neopharm Group, commented, "I am confident that our well established expertise and heritage in partnership with innovative biopharmaceutical companies will make Vitaros a success in Israel. We see Vitaros as an excellent addition to our group's strong and growing portfolio of innovative products."
According to Neopharm, the ED market in Israel and the Palestinian Territories is 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 marketed ED drug, known by the chemical name of 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. Viagra is a registered trademark of Pfizer, Inc.; Cialis is a registered trademark of Lilly, USA; Levitra, is a registered trademark of Bayer A.G.; Vitaros is a registered trademark in Israel held by Apricus Bio through its subsidiary NexMed International Limited, and in the US held by Warner Chilcott Company.
Established in 1941, Neopharm Group is one of Israel's leading providers of innovative integrated solutions across the pharmaceutical, medical and healthcare markets. Neopharm has a long heritage of collaboration with leading multinational corporations and is positioned as the partner-of-choice and one-stop-shop for multinational corporations seeking to enter or expend their business in the Israeli healthcare market.
Apricus Bio, a San Diego based revenue-generating pharmaceutical company, has leveraged the flexibility of its clinically-validated NexACT drug delivery technology to enable multi-route administration of new and improved compounds across numerous therapeutic classes.