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Moberg Pharma's MOB-015 Phase 3 Trial Shows Lower Than Expected Clinical Cure Rate

  • Moberg Pharma reports that a subset of patients in their North American Phase 3 study of MOB-015 achieved clinical cure for nail fungus at a rate lower than anticipated.
  • Cipher Pharmaceuticals, which holds Canadian marketing rights to MOB-015, acknowledges the update from Moberg Pharma regarding the clinical trial results.
  • Cipher Pharmaceuticals emphasizes that the outcome of the MOB-015 trial does not currently impact the company's sales and earnings profile.
  • Cipher Pharmaceuticals remains focused on the integration of the Natroba™ business and other potential growth opportunities.
Moberg Pharma AB has announced that its ongoing North American Phase 3 study of MOB-015, a treatment for nail fungus (onychomycosis), has yielded a lower-than-expected clinical cure rate in a subset of patients. The announcement was made public by Cipher Pharmaceuticals Inc., which holds the Canadian marketing rights to MOB-015 through a licensing agreement with Moberg.
Cipher Pharmaceuticals, based in Mississauga, ON, has a licensing agreement dating back to September 18, 2018, granting them exclusive rights to commercialize, promote, sell, and distribute MOB-015 in Canada. The agreement included an upfront payment of US$0.5 million, with potential additional payments of up to US$14.1 million contingent upon the achievement of specific clinical data results, as well as development, regulatory, and commercial sales milestones.

Impact on Cipher Pharmaceuticals

Cipher Pharmaceuticals has stated that it will continue to collaborate with Moberg Pharma as further results from the clinical trial become available. However, the company emphasized that this pipeline product does not currently affect the sales and earnings profile of Cipher's existing business. Cipher remains focused on its recent acquisition of the Natroba™ business from ParaPRO LLC, alongside exploring other potential growth opportunities.

Cipher's Strategic Focus

The company believes there is significant growth potential for the Natroba™ product in the U.S. and other international markets. Integrating this business into its existing North American platform remains a priority for Cipher in the near term. Cipher Pharmaceuticals is a specialty pharmaceutical company with a diverse portfolio of commercial and early to late-stage products, primarily in dermatology. The company acquires products that address unmet medical needs, manages clinical development and regulatory approval processes, and markets these products in Canada, the U.S., and South America.
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Reference News

[1]
Cipher Pharmaceuticals Partner Moberg Pharma AB Provides Update on MOB-015 Phase 3 Study
biospace.com · Sep 14, 2024

Cipher Pharmaceuticals announced that partner Moberg Pharma's clinical cure rate in Phase 3 MOB-015 study for nail fungu...

[2]
Cipher Pharmaceuticals Partner Moberg Pharma AB Provides Update on MOB-015 Phase 3 Study
finance.yahoo.com · Sep 13, 2024

Cipher Pharmaceuticals announced that partner Moberg Pharma's clinical cure rate in Phase 3 study for MOB-015 is lower t...

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