MOB-015 is already marketed as Terclara in Sweden and Norway, where it holds a leading market position. Lunches are also ongoing in additional markets through Moberg Pharma’s partner Karo Healthcare, under the Lamisil brand.
While the European rollout is the near-term focus, the US remains an important long-term opportunity for Moberg Pharma. As the company retains all commercial rights to MOB-015 in the US, the market represents significant potential for future value creation.
New US patent protects improved dosing regimen
The newly granted patent covers an improved dosing regimen for MOB-015, making the US the first market to grant patent protection for the improved dosing. this is the first granted patent in a new patent family, with corresponding applications under review in other markets. The significance therefore extends beyond the US, as the patent establishes the first granted protection for this new dosing concept within the broader international patent strategy. With an expected expiry in December 2041, the patent strengthens the intellectual property protection for MOB-015 in the US. Corresponding patent applications are currently under review in other markets.
The patent is based on findings from Moberg Pharma’s clinical development program, including the studies supporting European approval and the company’s most recent North American Phase III study. The new patent provides additional long-term protection as Moberg Pharma evaluates its next steps in the U.S. market.
New scientific findings support MOB-015’s antifungal activity
Moberg Pharma has also strengthened the scientific evidence supporting MOB-015 through new analyses published in the Journal of Fungi in October.
The research, conducted in collaboration with Professor Mahmoud Ghannoum at Case Western Reserve University, was based on the company’s North American Phase III study in which patients received daily treatment with MOB-015 for 48 weeks.
The analyses examined 506 dermatophyte isolates collected from patients with onychomycosis (fungal nail infections), focusing on their susceptibility to terbinafine, the active ingredient in MOB-015. The results showed that terbinafine maintained strong antifungal activity against the vast majority of isolates. Only 3.2% showed elevated minimum inhibitory concentration (MIC) values associated with reduced susceptibility. Among patients with evaluable results at the end of treatment, 74.3% achieved mycological cure, meaning that the fungal infection was no longer detectable.
Importantly, mycological cure was observed across the full range of baseline terbinafine susceptibility, including in two of the three patients with elevated MIC values. Although the number of patients with elevated MIC values was small, the findings provide further evidence of MOB-015’s antifungal activity. The growing attention of antifungal resistance makes these findings extra relevant.
CEO Anna Ljung on the US opportunity
With a new US patent in place and additional scientific findings supporting MOB-015, BioStock spoke with Moberg Pharma CEO Anna Ljung about the company’s progress and its long-term plans for the US market.
The new US patent protects an improved dosing regimen for MOB-015 until December 2041. What does this mean for the product’s long-term potential ?
– Strengthening our patent protection is an important part of our long-term strategy. This new patent provides protection for an improved dosing regimen until December 2041 in the U.S., giving us a stronger intellectual property position in the world’s largest market for nail fungus treatments.
– One of the strengths of MOB-015 is the extensive clinical development work behind the product, including the strong antifungal efficacy. Over the years, we have generated valuable insights into how to optimize treatment, and the new patent is a result of that work.
– The US is the first market where this patent has been granted, and we have corresponding applications under review in other markets.
– While the grant of patent has no near-term financial impact, it adds roughly a decade of potential protection beyond the existing patents expiring in 2032, and it meaningfully strengthens the long-term value.
Moberg Pharma retains full commercial rights to MOB-015 in the US. How are you approaching the next steps in development, including potential partnerships?
– Retaining full commercial rights in the US gives us significant strategic flexibility and allows us to choose the development and partnering path that creates the most value.
– Our experience from the European development and commercialization of MOB-015 provides a valuable foundation for the US opportunity. We know that an additional Phase 3 study will be required for FDA approval, so the next step needs to be carefully planned from both a clinical and financial perspective. We are therefore evaluating different ways to advance the program, including potential partnerships.
– The newly granted US patent extends the protection for the improved dosing regimen and strengthens our position when assessing the opportunities ahead.
The recent Journal of Fungi publication provides further evidence of MOB-015’s antifungal activity across different levels of terbinafine susceptibility. Why are these findings important, particularly as antifungal resistance is drawing more attention?
– We continue to strengthen the scientific foundation for MOB-015. New analyses from our North American Phase 3 study were published in the Journal of Fungi in October. The findings show potent antifungal activity of terbinafine against the vast majority of the dermatophyte isolates tested. In addition, mycological cure with MOB-015 was achieved across the full range of terbinafine susceptibility at baseline, including in patients whose isolates showed reduced susceptibility in vitro.
– These findings are particularly encouraging as antifungal resistance is receiving increasing attention. Having the data published in a peer-reviewed journal adds further scientific credibility and helps deepen the understanding of MOB-015’s antifungal profile.
You have been involved in the development of MOB-015 for many years. Looking back at the progress made so far, what does reaching this stage mean to you personally?
– It is a fantastic feeling to see our product on pharmacy shelves and to meet satisfied patients and physicians who are using it.
– That makes me especially proud of what we have achieved with MOB-015. We have demonstrated strong antifungal efficacy, including 76% mycological cure in Phase 3, rapid onset of effect and high terbinafine concentrations at the site of infection with negligible systemic exposure.
– We have also translated that into strong commercial performance. Terclara is now market leader in both Sweden and Norway, with more than 40% value share.
– And we have put the platform in place for international expansion, with 13 European approvals and commercial partners covering all major OTC markets in Europe as well as APAC, Israel, China and Canada.
– So for me, the key point is that MOB-015 has moved from being a development project to a commercially validated product with a broad international rollout ahead.
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