PharmaTher Closes Sale of Ketamine ANDA, Sharpening Focus on Long-Acting Injectable Ketamine Franchise

Executive Summary

• PharmaTher closed the sale of its ANDA for Ketamine Hydrochloride Injection USP, receiving a confidential upfront cash payment and securing rights to future milestone and profit‑sharing payments that could exceed US $25 million.
• The transaction allows PharmaTher to focus exclusively on its long‑acting injectable (LAI) ketamine program under an exclusive evaluation and option‑to‑license agreement with Oakwood Laboratories.
• Management outlined a catalyst‑rich near‑term plan, including CMC development, regulatory strategy refinement, FDA interactions, and pursuit of additional partnering or non‑dilutive financing.

Key Details

• Transaction: Sale of ANDA #217858 for Ketamine Hydrochloride Injection USP to an undisclosed sterile‑injectables pharmaceutical company.
• Consideration: Confidential upfront cash payment; eligibility for additional milestone payments tied to cumulative sales thresholds and profit‑sharing for seven years post‑first commercial sale.
• Potential Upside: Total prospective consideration could exceed US $25 million, contingent on commercial performance of the sold product.
• Strategic Impact: Converts a legacy generic asset into non‑dilutive capital, enabling full focus on LAI ketamine franchise targeting neuropsychiatric disorders (TRD, MDD, Parkinson’s disease).
• Oakwood Agreement: Exclusive evaluation and option‑to‑license arrangement for Oakwood’s microsphere‑based sustained‑release technology to develop the LAI program.
• Regulatory Pathway: Planned 505(b)(2) submission with emphasis on high‑value neuropsychiatric indications.
• Near‑Term Milestones (next ~6 months):
• Advance formulation and CMC activities with Oakwood for clinical‑grade supply.
• Refine 505(b)(2) regulatory strategy and clinical development plan.
• Prepare for FDA pre‑IND discussions and other formal interactions.
• Identify additional neuropsychiatric indications for LAI ketamine.
• Evaluate strategic partnering and non‑dilutive financing opportunities.

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.” – Fabio Chianelli, Chairman & CEO
• “We believe long‑acting ketamine is the natural evolution of today's ketamine treatment model…” – Fabio Chianelli, Chairman & CEO