Moberg Pharma today announced that the European Patent Office has issued Patent no. 2 672 962, relating to its topical treatment MOB-015 for onychomycosis (nail fungus). The patent is expected to be in effect until 2032.
In September 2014, Moberg Pharma reported positive results from a Phase II study of MOB-015 and in January 2015, received similar patent approval in the U.S.
The new EU patent comprises composition of matter claims directed to novel topical formulations of antifungal allylamines (including terbinafine), as well as claims directed to methods of treatment of onychomycosis using these novel formulations, which enable enhanced penetration of antifungal allylamines into and through the nail. Moberg Pharma is pursuing corresponding patent approval in all major territories.
Peter Wolpert, CEO of Moberg Pharma AB, said: “The granted European patent in addition to the recently approved U.S. patent strengthens the value of our MOB-015 asset. We continue to progress discussions with potential partners and are preparing for start of phase III in 2016.”
“The rapid growth of the value of the U.S. Rx onychomycosis market during the last 9 months further strengthens the attractiveness of the indication. Based on the phase II results, MOB-015 has the potential to become superior to other topical treatments, including the recently launched products.”
10% of the general population suffer from onychomycosis
Approximately 10% of the general population suffer from onychomycosis and a majority of those afflicted go untreated. The prescription market is growing rapidly after the recent introduction of new topical treatments in North America and Japan. Moberg Pharma expects the U.S. market alone to exceed $2 billion by 2020 and estimates the peak sales potential for MOB-015 to be in the range of $250-$500 million.
MOB-015 is an internally developed topical formulation of terbinafine building on Moberg Pharma’s experience from the OTC market. Oral terbinafine is the gold standard for treating onychomycosis, but associated with safety issues including drug interactions and liver injury. Prior to MOB-015, developing a topical terbinafine treatment without the safety issues of oral terbinafine has been highly desirable, but unsuccessful due to insufficient delivery of the active substance through the nail.
In a recent Phase II study, MOB-015 demonstrated delivery of high microgram levels of terbinafine into the nail, as well as through the nail plate into the nail bed. Mycological cure of 54% and significant clear nail growth was observed in patients who completed the recent phase II study. The majority of the patients treated had severely affected nails – on average, approximately 60% of the nail plate was affected by the infection.
