About Mob-015
Moberg Pharma’s goal is to make MOB-015 the leading treatment for nail fungus globally. Moberg Pharma has signed license agreements with partners in Europe, Canada and Israel, and the product is approved in thirteen European countries. MOB-015 is available in Sweden and Norway under the brand name Terclara®
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.
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 has been granted marketing authorization in 13 countries. 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.
MOB-015 (Terclara® in Sweden and Norway)
WORLD-LEADING ANTI-FUNGAL EFFECT
- 76% mycological cure in Phase 3
- Topical terbinafine for treatment of nail fungus
- Negligible systemic levels of terbinafine
POTENTIAL TO BE THE GLOBAL MARKET LEADER
- Partners for all approved countries and additional markets in the EU, Canada, and Israel
- Estimated global sales potential USD 250-500 million
- Terclara® is now available in Swedish and Norwegian pharmacies, additional European rollout to follow
- Nail fungus affects 10%, more common among older people
MARKET LEADER IN SWEDEN AND NORWAY UNDER BRAND NAME TERCLARA®
- National marketing authorization approvals received in 13 European countries, whereof 7 granted OTC status
- Launch ongoing in Sweden and Norway under the brand name Terclara®
- Phase 3 studies completed in North America, n=365, and Europe, n=452. Primary endpoints reached without serious side effects
PATENT PROTECTION UNTIL 2032 AND ADDITIONAL ONGOING PATENT APPLICATIONS
- Patents granted in major markets, including the U.S., the EU, Canada, Japan and China
- Patents include new topical formulations of allylamines (including terbinafine) and treatment methods for nail fungus using the new formulations