Moberg Pharma AB has submitted an application to include the proposed terbinafine supplier in the company's registration dossier for its nail fungus drug MOB-015. Approval is expected before the end of the year. Together with its intended terbinafine supplier, Moberg Pharma has submitted an application to add the manufacturer for MOB-015. In addition, Moberg Pharma is actively working to secure an additional terbinafine supplier and thus has two parallel tracks to ensure a stable long-term supply of terbinafine. Approximately 10% of the general population suffer from onychomycosis and a majority of those afflicted go untreated. The global market opportunity is significant with more than hundred million patients worldwide and a clear demand for better products. Moberg Pharma estimates the annual worldwide peak sales potential for MOB-015 to be in the range of USD 250-500 million. MOB-015 is an in-house developed topical formulation of terbinafine, enabling effective concentrations of terbinafine to the
nail and nail bed while avoiding the risk of systemic exposure seen with oral terbinafine use. Oral terbinafine is currently the gold standard for treating onychomycosis but associated with safety issues, including drug interactions and liver damage. MOB-015 is recommended for national approval in 13 European countries and is launched in Sweden under the brand name Terclara®. The approval is supported by two Phase 3 trials where MOB-015 demonstrated superior levels of mycological cure (76% vs up to 42% for comparators), and a significantly better complete cure rate compared to vehicle, without any serious adverse reactions.