Apricus Biosciences, Inc. and UAE based Elis Pharmaceuticals announced that the two companies have entered into a licensing agreement granting Elis the exclusive rights to market MycoVa, Apricus Bio's drug for onychomycosis (nail fungal infection), in the Middle East and the Gulf Countries, excluding Israel. The license agreement with Elis follows the recent announcement by the company of a similar license agreement granting Stellar Pharmaceuticals, Inc. the exclusive right to market MycoVa in Canada.

Under the terms of the agreement, Elis has exclusive rights in part of the Middle East, including Saudi Arabia, Kuwait, Lebanon, Syria, Jordan, Iraq and Yemen, and in the Gulf Countries (United Arab Emirates, Oman, Bahrain, Qatar), excluding Israel, to commercialize and market MycoVa. Apricus Bio is entitled to receive up to $2.1 million in payments for signing, regulatory and sales milestones. Further, Apricus Bio will receive tiered double digit royalties based on Elis' sales of the product.

“We believe that MycoVa is following Vitaros in its development, commercialization and marketing phase. We are very happy to have entered into our second licensing agreement for MycoVa as we execute on our announced partnering plan for this product,” said Dr Bassam Damaj, chairman, president and CEO of Apricus Bio. “This is an important milestone for us as we have moved a second product in our pipeline to the partnered phase. We are looking forward to working further with Elis on launching MycoVa in the Middle East and the Gulf Countries.”

Rashed Assouma, chief executive officer of Elis, commented, “In addition to our agreement relating to Vitaros for the treatment of erectile dysfunction, we are excited to enter into a second license agreement with Apricus Bio for MycoVa for the treatment of onychomycosis. This additional collaboration with Apricus Bio will permit us to utilize our sales and marketing expertise in the Middle East to bring these two products to the market once we have received the applicable regulatory approval for each product.”

Onychomycosis is a chronic persistent fungal infection of the nail bed resulting in thickening and discolouration of the nail, which sometimes can be accompanied by serious pain and disability. According to the Merck Manual, the worldwide incidence rate of onychomycosis is approximately 10%. As described by Iorizzo and Piraccini (2007), the incidence has been increasing due to diabetes, immunosuppression and an ageing population.

The advantage of Apricus Bio's MycoVa product is that it is easy to apply, and is therefore believed to improve patient compliance. MycoVa is applied to the infected nails, typically at bedtime, with minimal preparation, such as simply washing with soap and water. The formulation allows significant amounts of the drug to penetrate through the nail plate to the nail bed and surrounding area where fungus is located without significant systemic exposure.

MycoVa combines an existing, approved drug for nail fungus, terbinafine, with the NexACT technology that enhances the absorption of the drug through the skin. In January 2011, the Company announced that an additional analysis showed that MycoVa is as effective for the treatment of nail fungus as the current European standard of care for topical therapy, Loceryl (an ointment made by Galderma).

In June 2011, the Company announced that based on a reanalysis of its phase III trials for its MycoVa product for treating onychomycosis (nail fungus), it is revisiting its regulatory strategy for the drug and will seek guidance from regulatory authorities in the US, Canada and Europe. A combined post-hoc analysis of two randomized, double-blind, vehicle controlled, multi-centre, parallel group phase III studies to assess the efficacy, safety and tolerability of MycoVa demonstrated statistically significant results in primary and secondary efficacy endpoints in favour of active treatment in patients who did not present with comorbid tinea pedis (athlete's foot), as these patients are considered at higher risk of reinfection.

Apricus Bio is a revenue-generating, specialty pharmaceutical company, with commercial products and a broad pipeline across numerous therapeutic classes.

Elis Pharmaceuticals is one of the region's leading companies dedicated to developing, manufacturing and marketing prescription and generic, pharmaceuticals.