MISSISSAUGA, ON, March 22, 2022 /CNW/ - Cipher Pharmaceuticals Inc. (TSX: CPH) ("Cipher" or "the Company") today announced that the Company's partner, Moberg Pharma AB, ("Moberg Pharma") has submitted a regulatory filing for the next clinical Phase 3 study for MOB-015 (nail fungus treatment) to the U.S. Food and Drug Administration ("FDA").
Cipher holds the exclusive Canadian rights to MOB-015, a new topical treatment of onychomycosis based on Moberg's patented proprietary formulation of terbinafine. In Canada, according to IQVIA, the total prescription market for Onychomycosis was greater than $75 million CDN at December 31, 2021, with a single product having over 90% market share.
The randomized, multicenter, vehicle-controlled Phase 3 study will include approximately 350 patients in North America. The patients will be evaluated over 52 weeks and the primary endpoint will be the proportion of subjects achieving complete cure of their target nail. Moberg Pharma expects to start enrolling patients in the second quarter of this year. The study design builds on the experience gained from the previous Phase 3 studies. Moberg Pharma will cooperate with the same CRO, lead investigator and successful sites from the previous North American study. The purpose of the new study is to facilitate market approval in the US as well as strengthen the product's clinical evidence and marketing claims globally.
"We are pleased to see the continued progress that Moberg is making to commercialize MOB-015," said Craig Mull, Interim CEO of Cipher. "The product is showing promising results and we look forward to competing in this large market with an innovative topical product that would provide a new safe and effective treatment option for the many Canadians who suffer from onychomycosis," added Mr. Mull.
About Moberg Pharma
Moberg Pharma AB is a Swedish pharmaceutical company focused on commercializing proprietary innovations based on drug delivery of proven compounds. The company's main asset, MOB-015, is a novel topical treatment for onychomycosis. Data from phase 3 clinical trials in more than 800 patients for MOB-015 indicate that the product has the potential to become the future market leader in onychomycosis. Moberg Pharma has agreements with commercial partners in place in Europe and Japan, among others, and the company's goal is to receive its first market approval and launch MOB-015 in 2023. Moberg Pharma is headquartered in Stockholm and the company's shares are listed on the Small Cap list of the Nasdaq Stockholm (OMX: MOB). www.mobergpharma.se
About Cipher Pharmaceuticals Inc.
Cipher Pharmaceuticals (TSX: CPH) is a specialty pharmaceutical company with a robust and diversified portfolio of commercial and early to late-stage products. Cipher acquires products that fulfill unmet medical needs, manages the required clinical development and regulatory approval process, and currently markets those products either directly in Canada or indirectly through partners in Canada, the U.S., and South America. For more information, visit www.cipherpharma.com.