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]

Core Insights - PharmaTher Holdings Ltd. has entered into a definitive Asset Purchase Agreement for the sale of its Abbreviated New Drug Application for Ketamine Hydrochloride Injection to a global pharmaceutical company specializing in sterile injectables and complex generics [1][3] - The transaction is seen as a validation of the significant value in PharmaTher's ketamine assets and allows the company to share in the future sales growth of the ketamine market while advancing its proprietary next-generation therapies [2][5] Transaction Details - PharmaTher will receive a confidential upfront cash payment at closing, milestone payments based on cumulative sales thresholds, and ongoing profit-sharing for seven years post-first commercial sale, with potential total consideration exceeding US$25 million [3] - The Buyer is a credible, FDA-approved manufacturer with a strong track record in securing ANDA approvals and has a portfolio of over 40 approved ANDAs in the U.S. [4] Strategic Implications - The Agreement enables PharmaTher to maintain exposure to the global ketamine market while focusing on advancing next-generation ketamine programs, including long-acting injectables and novel delivery methods for various medical indications [5] - The closing of the Agreement is subject to customary conditions, with an expected near-term effective date [6]