EPO to grant patent for Apricus MycoVa product to treat nail fungus

Mar 2 2011

Apricus Biosciences, Inc. ("Apricus Bio") (Nasdaq:APRI) announced today that the European Patent Office ("EPO") will grant a patent for the company's MycoVa^™ product for treating onychomycosis (commonly referred to as nail fungus).

The European Patent Office recently issued a "notice of allowance" for the Company's patent entitled "Antifungal Nail Coat and Method of Use." Once issued, this will be the second patent that Apricus has received in Europe for MycoVa and onychomychosis.

The patent will give Apricus Bio patent protection for MycoVa^™ and its use for nail fungus in Europe until 2024. "This expanded patent coverage will enable us to move forward with our plans to seek regulatory approval for MycoVa^™, and to potentially market the product as a treatment for mild nail fungus in Europe," said Dr. Bassam Damaj, President and Chief Executive Officer of Apricus Bio. "We are also seeking similar patents worldwide."

The Company currently holds 16 patents related to the treatment of nail fungus, with 13 patent applications pending and has patent protection for its underlying NexACT^® technology used in the nail fungus treatment in Europe, and well as in a number of other countries.

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). Those results convinced the Company to seek regulatory guidance meetings from certain health agencies in Europe.

The advantage of Apricus Bio's MycoVa^™ is that it is easy to apply, thus improving 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 that causes thickening and discoloration of the nail. The infection sometimes causes serious pain and disability. According to the Merck Manual, about 10% of people around the world suffer from onychomycosis. Recent studies (such as one by Iorizzo and Piraccini in 2007) show that the incidence is rising due to diabetes, immunosuppression and an aging population. The infection may hit as much as 90% of the elderly (eMedicine.medscape.com). As of 2008, Thomson Reuters Pharma estimated that the worldwide market is approximately $2.8 billion per year, and predicted that the market would grow to approximately $2.9 billion by 2014.

Source: Apricus Biosciences, Inc.