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MOB-015

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.

Focus in 2019/2020 will be on completing both Phase 3 studies in time, deliver compelling Phase 3-results and begin the process of registering the finished product. Topline results from the North American Phase 3 study are expected in the fourth quarter of 2019, while the corresponding European results are expected in the second quarter of 2020. In the meantime, we are establishing relationships with additional commercialization partners and developing commercialization strategies for prospective markets.

Clinical development
Two parallel Phase 3 studies are currently underway for MOB-015 in North America and Europe together with TFS International. The Phase 3 program comprises more than 800 patients.  The U.S. study comprises 365 patients randomized at 32 clinics in the U.S. and Canada, while the number of patients recruited in Europe is 452, randomized at 48 clinics. and the primary endpoint is a complete cure after 52 weeks and topline results are expected in the fourth quarter 2019 and second quarter 2020 respectively.

The results of the Phase 2 program were presented in the fall of 2014 and exceeded expectations. The open clinical study included 25 patients and was conducted by Sahlgrenska University Hospital in Gothenburg. The study included patients with severe

(60% of the nail on average), who were treated with MOB-015 for 12 months and followed up for a total of 15 months. Of those who completed the study, 54% reached the primary endpoint, a mycological cure defined as negative microscopy and negative fungal culture after 15 months from the start of treatment. All the patients (100%) demonstrated negative fungal culture after 15 months, which included a wash-out period of three months after treatment was completed. Biopsies confirmed high levels of terbinafine in the nail and nail bed, while the risk of liver damage was negligible since plasma levels were a thousand times lower than with oral treatments. MOB-015 was generally well tolerated.

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
In fall 2018, Moberg Pharma signed an exclusive license agreement with Cipher Pharmaceuticals for the commercialization of MOB-015 in Canada. Under the terms of the agreement, Moberg Pharma is eligible to receive development and regulatory milestones up to USD 4.6 million, whereof US 0.5 million is an up-front fee at the time of signing. Pending commercial targets, Moberg Pharma is entitled to further payments up to USD 10 million, as well as royalties and supply fees for delivered products.

In February 2019, Moberg Pharma entered the second major license agreement for MOB-015, this time for commercialization in Europe. The Consumer Health division of Bayer AG will be marketing, distributing and selling MOB-015 in Europe upon completion of Phase 3 clinical development and registration. Under the terms of the license agreement, Moberg Pharma will finalize the ongoing Phase 3 program, complete registration in Europe and provide supply for the product. Moberg Pharma is eligible to receive up to EUR 50 million in milestone payments, including EUR 1.5 million paid at signing. The majority of the milestone payments are contingent on sales targets, with the balance contingent on development and regulatory milestones. Moberg Pharma will also receive supply fees including royalties.

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