PharmaTher Advances Strategy to Build Next-Generation Ketamine Franchise for Neuropsychiatric Disorders; Secures Exclusive Rights to Evaluate and License Patented Long-Acting Ketamine Program

Executive Summary

• PharmaTher Holdings Ltd. entered an exclusive 12‑month evaluation and option‑to‑license agreement with Oakwood Laboratories to assess and potentially acquire a global development and commercialization license for Oakwood’s patented long‑acting injectable (LAI) ketamine program.
• The partnership targets the neuropsychiatric market, initially focusing on treatment‑resistant depression (TRD), major depressive disorder, and Parkinson’s disease‑related dyskinesia, leveraging Oakwood’s sustained‑release microsphere technology.
• PharmaTher plans to advance CMC activities, engage the U.S. FDA on a 505(b)(2) regulatory pathway, and initiate clinical study design within the next three months, creating near‑term catalysts for value creation.

Key Details

• Agreement Scope: Exclusive evaluation period of 12 months with an exclusive option to obtain a worldwide development and commercialization license for all fields of use of Oakwood’s LAI ketamine program.
• Technical Support: Oakwood will provide technical information and support to enable PharmaTher’s assessment of chemistry, manufacturing & controls (CMC), clinical strategy, and regulatory pathway.
• Target Indications: Treatment‑resistant depression (TRD), major depressive disorder, and Parkinson’s disease‑related levodopa‑induced dyskinesia (LID).
• Delivery Platform: Oakwood’s Chroniject™ polymer microsphere platform enabling subcutaneous or intramuscular dosing with controlled release over weeks to months.
• Regulatory Strategy: Planned 505(b)(2) pathway leveraging existing ketamine safety/efficacy data; PharmaTher will seek alignment with the U.S. FDA on study design and safety package.
• Near‑Term Milestones (next ~3 months):
• Finalize CMC activities to support upcoming clinical studies.
• Engage FDA for regulatory path clarification and clinical trial design.
• Initiate pre‑clinical/early clinical work aimed at TRD as the first indication.
• Market Context: SPRAVATO® (intranasal ketamine) generated ~$1.64 B TTM sales; Johnson & Johnson projects $3–$3.5 B annual sales by 2027‑28, highlighting sizable market opportunity for a more convenient LAI formulation.
• Strategic Rationale (CEO Quote): “The long‑acting ketamine program is a pivotal step… expands clinical utility, improves adherence, and opens new indications where steady exposure is critical.”

Notable Quotes

Fabio Chianelli, Chairman & CEO: “The long‑acting ketamine program is a pivotal step in our strategy to build the most comprehensive ketamine franchise… ensuring that our prior investments continue to compound while supporting a clear path to value‑creating catalysts.”