Pharmather closes sale of ketamine ANDA

Executive Summary

• Pharmather Holdings Ltd. has closed the sale of its abbreviated new drug application (ANDA No. 217858) for ketamine hydrochloride injection USP to a leading sterile-injectable pharmaceutical company.
• The transaction provides an immediate confidential upfront cash payment and potential future milestone payments based on cumulative sales thresholds, plus profit-sharing for seven years, with total potential value exceeding $25 million (U.S.).
• The sale allows Pharmather to sharpen its strategic focus on its patented long-acting injectable (LAI) ketamine program, developed under an exclusive evaluation and option-to-license agreement with Oakwood Laboratories LLC.

Key Details

• Transaction Structure: Sale of ANDA No. 217858 for ketamine hydrochloride injection USP.
• Financial Terms:
  • Confidential upfront cash payment received at closing.
  • Eligibility for additional milestone payments based on cumulative sales thresholds.
  • Profit-sharing payments for seven years following the first commercial sale.
  • Total potential value: >$25 million (U.S.), subject to commercial performance.
• Strategic Shift: Proceeds and focus shift toward the development and commercialization of the LAI ketamine program.
• LAI Ketamine Program Details:
  • Technology: Leverages Oakwood Laboratories LLC’s microsphere-based sustained-release technology.
  • Administration: Designed for subcutaneous or intramuscular injection with controlled drug release over weeks to months.
  • Regulatory Pathway: 505(b)(2).
  • Target Indications: Treatment-resistant depression (TRD), major depressive disorder (MDD), and Parkinson’s disease.
• Near-Term Milestones & Priorities:
  • Advancing formulation and CMC activities with Oakwood for clinical-grade supply.
  • Refining 505(b)(2) regulatory strategy and clinical development pathway.
  • Preparing for FDA interactions, including potential pre-IND discussions.
  • Evaluating strategic partnering and non-dilutive financing opportunities.
  • Company expects multiple data, regulatory, and partnering inflection points over the next six months.

Notable Quotes

• "Closing the ANDA sale marks the start of Pharmather's next chapter. We have converted a legacy generic asset into non-dilutive capital and long-term upside, and we are now fully focused on building a differentiated, long-acting ketamine franchise for neuropsychiatric disorders." — Fabio Chianelli, Chairman and CEO
• "We believe long-acting ketamine is the natural evolution of today's ketamine treatment model. A convenient, less frequent injectable option has the potential to improve adherence, reduce clinic burden and expand access while preserving ketamine's rapid antidepressant benefits." — Fabio Chianelli, Chairman and CEO