Apricus Biosciences, Inc, a specialty pharmaceutical company, and Stellar Pharmaceuticals Inc., a Canadian public company, has signed the exclusive license agreement.

Under the agreement, Stellar Pharma has the exclusive right to sell Apricus Bio's MycoVa product for the treatment of onychomycosis (nail fungus) in Canada, following receipt of Canadian regulatory approval for such product. The exclusive license agreement provides for an upfront payment, regulatory approval milestone, sales achievement milestones and royalty payments during the term of the agreement.

Onychomycosis is a chronic persistent fungal infection of the nail bed resulting in thickening and discoloration 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 aging population. While occurring in approximately 2.6 per cent of children younger than 18 years, it occurs in as much as 90 per cent of the elderly population. As of 2008, Thomson Reuters Pharma had stated that the worldwide market was approximately $2.8 billion in size and is expected to grow to approximately $2.9 billion by 2014.

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.

Dr Bassam Damaj, chairman, president and chief executive officer of Apricus Bio commented, “We are very pleased with our exclusive license agreement with Stellar Pharma and we look forward to the future commercialization in the Canadian market of MycoVa, our second major product utilizing our proprietary NexACT technology. We are very impressed with the experience of Rob Harris and his team at Stellar Pharma, and we are very excited about this first potential launch of this important drug in that market. We also hope that our partnership with Stellar Pharma will produce additional collaborations among multiple NexACT products in the future.”

Rob Harris, president and chief executive officer of Stellar Pharma stated, “We are excited about this opportunity and are very pleased to be able to strengthen our dermatology portfolio in Canada. I would like to thank Bassam and his excellent team at Apricus Bio for providing us with this opportunity to launch MycoVa in the Canadian market. We will be assisting Apricus Bio in the filing of a New Drug Submission for MycoVa for onychomycosis and look forward to its commercial launch in Canada following Canadian regulatory approval.”

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

Stellar Pharma and its subsidiary, Tribute Pharmaceuticals, is an emerging Canadian specialty pharmaceutical company focused on the acquisition, licensing, development and management of pharmaceutical and healthcare products with its primary focus on the Canadian market.