Cipher Pharma Reports Moberg Pharma's MOB-015 Fails Phase 3 Primary Endpoint

Cipher Pharmaceuticals Inc, a specialty pharmaceutical company with a robust and diversified portfolio of commercial and early to late-stage products, has announced that its partner, Moberg Pharma AB, issued a news release stating that MOB-015, a product for the treatment of nail fungus, did not meet the primary endpoint in the North American phase 3 study being conducted by Moberg.

The results of the North American phase 3 study communicated by Moberg confirms the initial indications previously informed to the market by Moberg, and accordingly announced by Cipher, on September 13, 2024.

The North American phase 3 study involved reducing the dosage – 8 weeks daily dosing followed by weekly maintenance treatment for 40 weeks, compared to daily dosing throughout the entire treatment period. The primary endpoint, achieving the desired complete cure of the patient’s target toenail at 52 weeks, was not achieved. Complete cure requires both a completely clear nail and mycological cure.

Cipher owns the Canadian marketing rights to Moberg’s MOB-015 through a licensing agreement dated September 18, 2018, to commercialize, promote, sell and distribute the product exclusively in Canada. Cipher has no further financial obligations in respect of the Agreement if the applicable development and regulatory milestones outlined in the Agreement are not attained.

The company will be reviewing the full results from the clinical trial once they become available from Moberg and formulating its decision with respect to moving forward with this pipeline product, however this does not impact the sales and earnings profile of Cipher’s existing business today.

The company continues to be focused on its recent acquisition of the Natroba business from ParaPRO LLC as announced on July 29, 2024, as well as other potential growth opportunities. The Company believes the growth potential for the Natroba product in the US market and other markets internationally is significant, and the integration of this business into its existing profitable North American platform, along with pursuing other potential growth opportunities remains Cipher’s focus and priority in the near term."

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