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

Core Insights - PharmaTher Holdings Ltd. has successfully closed the sale of its Abbreviated New Drug Application (ANDA 217858) for Ketamine Hydrochloride Injection USP to a leading sterile-injectables pharmaceutical company, marking a strategic shift towards long-acting injectable ketamine development [1][2][3] Financial Aspects - The transaction includes a confidential upfront cash payment and potential additional milestone payments based on cumulative sales thresholds, with the total potential to exceed US$25 million over time, contingent on commercial performance [2] Strategic Focus - The sale allows PharmaTher to concentrate on the patented long-acting injectable (LAI) ketamine program, which is being developed under an exclusive agreement with Oakwood Laboratories, LLC [3][4] - The LAI ketamine program utilizes microsphere-based sustained-release technology for subcutaneous or intramuscular administration, aiming to address high-value neuropsychiatric indications such as treatment-resistant depression (TRD), major depressive disorder (MDD), and Parkinson's disease [4] Development Plans - PharmaTher is focused on executing a catalyst-rich plan that includes advancing formulation and CMC activities, refining regulatory strategies, preparing for FDA interactions, and exploring additional neuropsychiatric indications [5][7] - Successful execution of these milestones could lead to multiple data, regulatory, and partnering inflection points within the next six months [8]