The European Patent Office has issued a patent for Moberg PharmaAB’s topical treatment MOB-015 for onychomycosis (toenail fungus). The patent is expected to be in effect until 2032. Moberg Pharma reported positive results last September from a Phase II study of MOB-015 and in January 2015, received similar patent approval in the U.S.
“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,” says Peter Wolpert, CEO of Moberg Pharma AB.
“The rapid growth of the value of the U.S. prescription onychomycosis market during the last nine months further strengthens the attractiveness of the indication,” Wolpert adds in a statement. “Based on the phase II results, MOB-015 has the potential to become superior to other topical treatments, including the recently launched products.”
The company expects the U.S. market alone to exceed $2 billion by 2020 and estimates the peak sales potential for MOB-015 at between $250 and $500 million.
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. Oral terbinafine is the most effective treatment for onychomycosis, but associated with safety issues including drug interactions and liver damage, according to information from the company.
In a recent Phase II study, MOB-015 showed delivery of high microgram levels of terbinafine into the nail, as well as through the nail plate into the nail bed. Mycological cure rate of 54 percent and significant clear nail growth was observed in patients who completed the recent phase II study.