Pharmather Holdings signs evaluation deal with Oakwood

Executive Summary

• Pharmather Holdings Ltd. has entered into an exclusive evaluation and option-to-license agreement with Oakwood Laboratories LLC to develop and commercialize Oakwood's patented long-acting injectable (LAI) ketamine program.
• The agreement grants Pharmather a 12-month exclusive evaluation period and an exclusive option to obtain global development and commercialization rights for all fields of use.
• The LAI ketamine program utilizes Oakwood’s sustained-release microsphere platform for subcutaneous or intramuscular dosing, targeting neuropsychiatric indications including treatment-resistant depression (TRD), major depressive disorders, and Parkinson's disease-related levodopa-induced dyskinesia (LID).

Key Details

• Transaction Structure: Exclusive evaluation period and exclusive option to license; 12-month evaluation term.
• Target Asset: Oakwood's patented long-acting injectable (LAI) ketamine program.
• Technology Platform: Oakwood's proven sustained-release microsphere platform enabling controlled release over multiple weeks to months via subcutaneous or intramuscular dosing.
• Regulatory Pathway: Intended to pursue a 505(b)(2) pathway, leveraging established ketamine safety and efficacy literature to streamline clinical development.
• Target Indications: Initial focus on treatment-resistant depression (TRD) and major depressive disorders; potential expansion to Parkinson's disease-related levodopa-induced dyskinesia (LID).
• Near-Term Milestones: Finalize CMC (chemistry, manufacturing and controls) activities; engage with the U.S. FDA to align on regulatory path, clinical study design, and safety package.
• Market Context: Comparison to Johnson & Johnson’s Spravato (intranasal ketamine), which generated ~$1.64 billion in trailing-12-month sales as of Q3 2025, with projected annual sales of $3–3.5 billion by 2027–2028.
• Strategic Rationale: Aim to improve patient adherence, reduce acute adverse events (e.g., dissociation, blood pressure spikes), and reduce treatment burden compared to frequent in-clinic dosing models.

Notable Quotes

• "The long-acting ketamine program is a pivotal step in our strategy to build the most comprehensive ketamine franchise in neuropsychiatric disorders. We believe a convenient, durable LAI profile can expand ketamine's clinical utility in treatment-resistant depression and major depressive disorders, improve adherence, and open new indications where steady exposure is critical." — Fabio Chianelli, Chairman and CEO, Pharmather Holdings Ltd.