Ketamine development and commercialization
Search documents
PharmaTher Provides Corporate Update on Ketamine Development and Commercial Strategy
Globenewswire· 2025-10-02 12:00
Core Insights - PharmaTher Holdings Ltd. has strategically sold its Abbreviated New Drug Application (ANDA 217858) for Ketamine Hydrochloride Injection USP, focusing on unlocking the pharmaceutical potential of ketamine while retaining its broader ketamine portfolio [1][2] Group 1: Strategic Sale and Partnerships - The sale of the Ketamine ANDA is aimed at providing non-dilutive capital linked to U.S. commercial sales, allowing the company to leverage a well-established pharmaceutical partner with expertise in sterile injectables and complex generics [2][6] - The partnership enhances the likelihood of commercial success for the Ketamine ANDA, as the partner possesses the necessary manufacturing scale and regulatory track record to compete in the U.S. market [2][6] Group 2: Broader Ketamine Strategy - The investment in the Ketamine ANDA was intended to support PharmaTher's broader ketamine strategy, facilitating the advancement of its proprietary ketamine-based programs for conditions such as Parkinson's disease and ALS [3][4] - The development work for the Ketamine ANDA has resulted in a validated Chemistry, Manufacturing, and Controls (CMC) package, which can be utilized for future New Drug Applications (NDAs), potentially reducing time and costs [3] Group 3: Future Initiatives - Over the next six months, PharmaTher will focus on key initiatives to realize the commercial potential of its ketamine portfolio, including pursuing international partnerships and engaging with the U.S. FDA for expedited clinical paths [5][7] - The company aims to position its CRPS and Parkinson's programs as attractive candidates for partnerships with larger pharmaceutical companies, alongside its ketamine microneedle patch and wearable pump programs [7]