Cipher Pharmaceuticals Inc. announced that the Company's partner, Moberg Pharma AB, has obtained European Union approval for MOB-015 (nail fungus treatment) as a result of demonstrating superior levels of mycological cure (76% vs. 42% for comparators) and a significantly better complete cure rate. MOB-015 has been recommended for national approval in 13 European countries, which will be commercialized through partners such as Bayer and Allderma, and is expected to be launched in Nordic countries such as Sweden during 2023.

Cipher holds the exclusive Canadian rights to MOB-015, a new topical treatment of Onychomycosis (nail fungus) based on Moberg's patented proprietary formulation of terbinafine. In Canada, according to IQVIA, the total prescription market for Onychomycosis was greater than $82 million at December 31, 2022 with a single product having over 90% market share. Moberg Pharma continues to invest and advance MOB-015 through an additional phase 3 trial of a total of 350 patients with sites across the United States and Canada.

The purpose of this study is to facilitate market approval in North America as well as further strengthen the product's clinical evidence beyond the mycological and complete cure rates already demonstrated to the European Union. Patient enrollment in the clinical trial is progressing according to plan with full enrollment expected in 2023.