Novartis will not file an NDA but is conducting a European trial.
Novartis is paying NexMed $3.5 million for a fungal treatment despite nixing the anticipated NDA submission. NM100060 is a treatment for onychomycosis, and in August, Novartis decided not to file the NDA after reviewing Phase III data.
Today’s milestone payments cover $2 million due to allowance of the patent application entitled “Antifungal Nail Coat and Method of Use,” for which NexMed paid the original issuance fee.
NexMed reports that due to the extensive delay in the review and processing of the patent application, the U.S. PTO added 756 days to the life of the patent. The patent thus allows coverage until April 17, 2026.
“In addition to the $2 million patent milestone,” notes Mark Westgate, CFO of NexMed, “NexMed will also receive $1.5 million from Novartis for the remaining 50% of the patient enrollment milestone.” This fee is linked to U.S. development.
NM100060, a topical application of terbinafine formulated with NexACT®. Novartis owns the exclusive, worldwide rights to the treatment and is conducting a comparator trial with loceryl in Europe, with data expected in the first quarter of 2009.
