Apricus Biosciences, Inc. announced that the Korean Patent Office will grant a patent for MycoVa, indicated for the treatment of onychomycosis (commonly referred to as nail fungus).
Specifically, the Korean Patent Office recently issued a “notice of allowance” for the company's patent application, entitled, “Antifungal Nail Coat and Method of Use.” Once issued, this will represent the fifth patent that Apricus Bio has received in Asia for MycoVa for onychomycosis, and the first in South Korea for this product. The patent will provide the Company with patent protection for MycoVa and its use for nail fungus in South Korea until March 2024.
“We are excited about the further expansion of our MycoVa patent portfolio in South Korea and Asia,” said Dr Bassam Damaj, chairman, president and chief executive officer of Apricus Bio. “Our prior patent expansion for MycoVa in the US and Europe, combined with a reanalysis of the data from an earlier phase III study on MycoVa, has led us to seek guidance from the regulatory authorities in the US and Europe to file for marketing approval in those countries. We look forward to eventually expanding these regulatory filings internationally to certain other countries, such as those in Asia, in which we currently plan to develop future commercial partnerships” he added.
Apricus Bio currently holds 17 patents related to the treatment of nail fungus, with 12 patent applications pending, and has patent protection for its underlying NexACT technology used in the nail fungus treatment in South Korea, Asia, as well as in a number of other countries and regions.
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 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.
The advantage of Apricus Bio's MycoVa product is that it is easy to apply, and is therefore expected 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.
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. While occurring in approximately 2.6% of children younger than 18 years, it occurs in as much as 90% of the elderly population (eMedicine.medscape.com). As of 2008, Thomson Reuters Pharma has stated that the worldwide market is approximately $2.8 billion in size and is expected to grow to approximately $2.9 billion by 2014.
Apricus Bio, a revenue-generating, biopharmaceutical 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.