Apricus Biosciences, Inc. (Apricus Bio), a pharmaceutical company that develops and markets innovative treatments, has received $2.5 million payment from Abbott Laboratories Limited (Abbott) under its commercial partnership for Apricus Bio's Vitaros drug for erectile dysfunction (ED) in Canada. Also, Apricus Bio successfully produced six consecutive commercial size validation batches of Vitaros, the company's treatment for ED in 220 mcg and 330 mcg forms.
"The successful manufacturing of Vitaros has been a great accomplishment for Apricus Bio as this was the first time that this drug has been manufactured on a commercial scale," said Dr. Bassam Damaj, the company's president and CEO. "This is an important step in placing Vitaros into the hands of urologists in Canada and represents another completed milestone in our strategic collaboration with Abbott and in our global commercial strategy for Vitaros. Now that we have completed our commercial size validation batches for Canada, our manufacturing team is focusing on producing additional Vitaros commercial batches for Abbott in Canada and for our US partner, Warner Chilcott, as disclosed by us recently."
Dr. Damaj continued, "We believe that Vitaros will be an attractive alternative for many patients with erectile dysfunction, both for its safety profile and rapid onset. We look forward to giving erectile dysfunction patients in Canada and in other countries the choice of a new non PDE5 based drug. These attributes have contributed to its licensing in a variety of territories by world-class pharmaceutical companies including Abbott, Takeda, Novartis-Sandoz, Warner Chilcott, Bracco, Elis and Neopharm."
According to IMS Health data, the annual ED market in Canada in 2010 was approximately $180 million (CAD). The current leading medications are sildenafil citrate, tadalafil and vardenafil HCI which are taken in pill form and work by inhibiting an enzyme called PDE5.
There is still a need for new, safe and effective treatments, however, especially for those patients who cannot or do not respond well to oral medications. Vitaros is applied topically which helps to reduce side effects and offers men who do not do well with the existing oral drugs a patient-friendly alternative. When absorbed through the skin, Vitaros directly boosts blood flow, thereby causing an erection within minutes -- much faster than the results achieved from the oral medications.
The key innovation behind Vitaros was combining alprostadil with Apricus Bio's NexACT delivery technology, which allows the drug to pass through the skin and makes the treatment much easier to apply and provide patients with a safer alternative treatment.
In clinical studies, Vitaros worked in patients suffering from mild to severe ED, including men who did not respond to sildenafil citrate. The side effects reported were localized and transient.