Cipher Pharmaceuticals gets Health Canada NDS review

Executive Summary

• Health Canada has accepted Cipher Pharmaceuticals' New Drug Submission (NDS) for review for Natroba (Spinosad), a treatment for head lice and scabies.
• Cipher acquired Natroba in July 2024 and currently markets it in the U.S., where it is recognized as superior to permethrin for head lice and the only single-application cure for scabies meeting FDA criteria.
• If approved, Cipher intends to commercialize Natroba directly in Canada using its existing sales and distribution infrastructure, addressing unmet medical needs due to resistance in existing treatments.

Key Details

• Regulatory Action: Health Canada accepted the New Drug Submission (NDS) for Natroba (Spinosad) for review.
• Indications: Treatment of head lice and scabies.
• Product Status in U.S.:
  • Recognized as one of the most effective treatments for head lice and scabies in the U.S.
  • Superior to widely used permethrin 1% for treating head lice.
  • The only treatment in the U.S. meeting FDA criteria for a complete cure (elimination of all signs and symptoms) for scabies with a single application.
• Acquisition History: Cipher Pharmaceuticals acquired Natroba (Spinosad) in July 2024.
• Commercial Strategy:
  • Currently marketed and distributed in the U.S. through Cipher’s commercial infrastructure.
  • Plans to commercialize directly in Canada through existing Canadian sales and distribution infrastructure upon Health Canada approval.
• Market Context: Existing head lice and scabies products in Canada have faced ineffectiveness due to resistance developed by lice (gene mutation) and scabies mites. Natroba addresses this unmet need with a proven single-treatment option.

Notable Quotes

• "Health Canada's acceptance of our NDS and commitment to review puts us one step closer to providing Canadians with an effective single treatment option for head lice and scabies, which is an objective we had established upon acquiring the product." — Craig Mull, Interim Chief Executive Officer