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MOB-015 is our next-generation nail fungus treatment targeting both over-the-counter (OTC) and prescription markets around the world. The company’s patented formulation technology facilitates delivery of high concentrations of a proven antifungal substance (terbinafine) into and through the nail, and has emollient and keratolytic properties that contribute to rapid, visible improvement.

Nail fungus is very common and affects around 10% of the general population. There are a number of topical treatments on the market, both OTC and prescription. The most effective treatment at present is oral, however it is associated with the risk of serious liver damage. Dermatologists and podiatrists around the world agree on the great need for better topical treatments without the risk of systemic side effects. MOB-015 is developed to meet this need and is patent protected until 2032 in most major markets, including the US, EU, Japan and China.

Clinical development

MOB-015 has recently been evaluated over 52 weeks in two randomized, multicenter, controlled Phase 3 studies, including in total more than 800 patients in North America and Europe. The primary endpoint was met in both studies, the proportion of patients achieving complete cure of their target nail.

In a previous phase 2 study, MOB-015 demonstrated delivery of high microgram levels of terbinafine into the nail and through the nail plate into the nail bed. Plasma levels of terbinafine with MOB-015 were substantially lower than after oral administration, reducing the risk of liver toxicities observed with oral terbinafine.

Market overview
The commercialization plans for MOB-015 include a combination of direct sales, co-promotion with partners and out-licensing in certain regions and markets. The strategy is based on valuable experience from the category with Kerasal Nail® which currently is marketed in numerous markets, including the US, the most important market for Moberg Pharma.

Around five million nail fungus treatments are prescribed each year in the North American market. Underlying growth in the last five years has been around 5% per year driven by an aging population. Many patients don’t treat their problem and others who do begin treatment don’t complete it for various reasons. Previous launches have shown that the market is highly receptive to new products and that the patient base increases when a new product is well promoted. With 30–40 million Americans suffering from nail fungus, there is significant opportunity to grow the market with a new, effective treatment.

Market conditions vary from one region to the next, with prescription treatments, high list prices (more than USD 500/month) and extensive discount systems in the US, Japan and Canada among other countries, and lower-priced over-the-counter treatments (about USD 15-40/package) in other regions such as the EU, Russia and Asia. With a conservative assumption of 8-12% market share in the US and industry standard discounts, the potential revenue for MOB-015 the U.S. alone is USD 200–300 million and USD 50–100 million each in Japan/Canada and the EU/rest of the world, respectively.

A survey conducted in 2017 of 90 US physicians (podiatrists and dermatologists) concluded that there is high demand for better topical treatments without the safety issues associated with oral treatments. Seven of ten stated that they avoid prescribing oral terbinafine due to the risk of liver damage. More than 6 of 10 stated that they would prefer a topical treatment with this effective compound over other topical treatments available on the market today, compared with just 6-15% who would continue to prescribe existing treatments. In a follow-up question for the physicians who prescribe oral treatment, 65% said they would prefer a topical treatment with the current product profile, alone or in combination with oral terbinafine, just to avoid the risk of liver damage.

License agreements
Several attractive licensing agreements for MOB-015 are already in place in Europe (Bayer), Japan (Taisho), South Korea (Dongkoo), Canada (Cipher) and Israel (Padagis) and we look forward to entering into more exciting partnerships in the future.

An open, single center pilot study of efficacy and safety of topical MOBO15B in the treatment of distal subungual onychomycosis; Jan Faergemann, Kjell Rensfeldt; Poster presented at American Academy of Dermatology, March 2015