Cipher Pharmaceuticals & Moberg Pharma: MOB-015's Phase 3 Study Topline Data

Cipher Pharmaceuticals Inc. (TSX: CPH) (OTCQX: CPHRF) and its partner, Moberg Pharma AB (OMX: MOB), recently announced the topline data from the North American Phase 3 study of MOB-015, a product for the treatment of nail fungus. The results have significant implications for the companies' strategic plans and the market's perception of the drug's efficacy.

The primary endpoint of the study, which was to achieve complete cure of the target toenail at 52 weeks, was not met. Only 1.5% of patients treated with MOB-015 achieved complete cure, compared to none in the vehicle group (p=ns). However, the study did show promising results in terms of mycological cure and treatment success. Mycological cure, defined as both negative KOH and negative dermatophyte culture, was achieved in 25.0% of patients on active treatment (p=0.030). Treatment success, assessed by the investigator, was achieved in 11.2% of patients in active treatment (p=0.003).



The study's design differed from previous studies, with a reduced dosage of 8 weeks of daily dosing followed by weekly maintenance treatment for 40 weeks. This change in dosage may have contributed to the lack of complete cure, as daily treatment for a longer period is required for topical treatment of onychomycosis, as approved in EU.

As a result of the study's outcome, Bayer Consumer Health has decided to stop the upcoming launch of MOB-015 due to strategic reasons and the topline data received. Moberg Pharma and Bayer have expressed a mutual intent to terminate the license agreement, allowing Moberg Pharma to regain the full rights for MOB-015 in EU and retain milestone revenues already paid by Bayer.

Moberg Pharma remains confident in the competitive profile of MOB-015, as demonstrated by its successful launch in Sweden, where it is the clear market leader and has grown the market by 44%. The company is now reassessing its plans for the US and shifting its focus to the European market, which presents the greatest opportunities for growth. Moberg Pharma aims to secure a larger share of the value chain in Europe by taking an active role in commercialization and establishing a stronger direct presence, including ownership of the brand.



In conclusion, the topline data from the North American Phase 3 study of MOB-015 has significant implications for Cipher Pharmaceuticals and Moberg Pharma. While the primary endpoint was not met, the study's results suggest that MOB-015 may still have potential in the European market. Moberg Pharma's regain of full rights for MOB-015 in EU presents an opportunity to strengthen its competitive position and market share in the region. As the company reassesses its plans and shifts focus to Europe, investors should monitor the situation closely to determine the potential impact on the companies' financial performance and the market's perception of MOB-015's efficacy.