Cipher Pharmaceuticals Inc. (TSX:CPH) today  announced it has acquired the exclusive Canadian rights to commercialize, promote, sell and distribute MOB-015 from Moberg Pharma (OMX:MOB). MOB-015 is a topical formulation of terbinafine for treatment of onychomycosis, a common and destructive nail infection caused predominately by dermatophyte fungi. 

In Canada, according to IMS, the total prescription market for Onychomycosis was $58M CDN in 2017, 72% of which were topical drugs, growing steadily at 18.3% in 2017 and at a CAGR of 25.4% for the period 2014-2017.

“We are excited at the prospect of bringing an innovative topical product to market that would provide a new safe and effective treatment option for the many Canadians who suffer from onychomycosis,” said Robert Tessarolo, President and CEO of Cipher. “The addition of MOB-015 represents our sixth transaction of the year and demonstrates the continued execution of our growth strategy as we build a pipeline of diversified and differentiated near term products for the Canadian market.”

“The license agreement with Cipher is a key step in preparing the global launch of MOB-015 and it confirms the significant market potential for our product. Cipher has excellent capabilities to make MOB-015 a success in Canada. We look forward to this exciting partnership and continue to progress commercialization plans in other key markets as we approach Phase 3 results,” says Peter Wolpert, Moberg’s CEO.

Under the terms of the licensing agreement, Moberg will receive an upfront payment of USD$0.5 million and is eligible for USD$14.1 million in development and regulatory milestones including USD$10 million in total sales milestone payments if predefined escalating annual net sales targets are achieved, with the first threshold at USD$10 million. The agreement also includes royalties from net product sales in Canada. The agreement provides that Moberg will be responsible for manufacturing and supplying finished product to Cipher.

About MOB-015 and Onychomycosis 

Approximately 10% of the general population suffer from onychomycosis and a majority of those afflicted go untreated. The global market opportunity is significant with more than a hundred million patients worldwide and a clear demand for better products. Moberg Pharma estimates the global peak sales potential for MOB-015 to be in the range of USD $250-$500 million.

MOB-015 is an internally developed topical formulation of terbinafine based on Moberg Pharma’s experience from its leading OTC product Kerasal Nail®/Emtrix®. Oral terbinafine is currently the gold standard for treating onychomycosis but associated with safety issues, including drug interactions and liver damage. For many years, 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.

In a previous phase 2 study, MOB-015 demonstrated delivery of high microgram levels of terbinafine into the nail and through the nail plate into the nail bed. Mycological cure of 54% and significant clear nail growth was observed in patients who completed the phase 2 study. Plasma levels of terbinafine with MOB-015 were substantially lower than after oral administration, reducing the risk of liver toxicities observed with oral terbinafine.

MOB-015 is currently being evaluated over 52 weeks in two randomized, multicenter, controlled Phase 3 studies. The primary endpoint in both studies is the proportion of patients achieving complete cure of their target nail. In total, approximately 750-800 patients are expected to be enrolled in the two studies in North America and Europe.

About Moberg Pharma

Moberg Pharma AB (publ) is a rapidly growing Swedish pharmaceutical company with OTC sales operations in the U.S. and a distributor network in more than 40 countries. The company’s portfolio includes the OTC brands Kerasal®, Kerasal Nail®, New Skin®, Dermoplast® and Domeboro®. Kerasal Nail® (Emtrix®, Zanmira® or Nalox™ in certain markets) is a leading OTC treatment of nail disorders in the U.S., Canada as well as in several markets in EU and Southeast Asia. The company is growing organically as well as through acquisitions. Internal development programs focus on innovative drug delivery of proven compounds and include two assets in late-stage clinical development, MOB-015 (onychomycosis) and BUPI (pain management in oral mucositis). Moberg Pharma has offices in Stockholm and New Jersey and the company’s shares are listed on the Small Cap list of the NASDAQ OMX Nordic Exchange Stockholm (OMX: MOB).

About Cipher Pharmaceuticals Inc.

Cipher 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 markets those products either directly in Canada or indirectly through partners in Canada, the U.S., and South America. Cipher is focused on a three-pronged growth strategy – including acquisitions, in-licensing, and selective investments in drug development – to assemble a broad portfolio of prescription products that serve unmet medical needs.