PharmaTher provides update on ketamine development, commercial strategy

PharmaTher (PHRRF) providef a corporate update following its recently announced sale of the Company’s Abbreviated New Drug Application for Ketamine Hydrochloride Injection USP. The transaction was a strategic sale of a single generic ketamine asset and the sale did not include PharmaTher’s broader ketamine portfolio. The Company continues to own its ketamine-based programs, including for Parkinson’s disease, amyotrophic lateral sclerosis, complex regional pain syndrome, as well as its ketamine microneedle patch and wearable pump programs for mental health, neurological, and pain disorders. The sale of the Ketamine ANDA was a strategic decision that provides PharmaTher with potential non-dilutive capital tied to U.S. commercial sales only. Successfully launching and scaling a generic ketamine injectable on its own would require significant capital, inventory commitments, sales infrastructure, and specialized expertise. By partnering with a well-established global pharmaceutical company specializing in sterile injectables and complex generics, as well as having a growing U.S. commercial division, the Ketamine ANDA would have a better chance of achieving its commercial potential. The pharmaceutical partner has the manufacturing scale, regulatory track record, and commercial infrastructure to compete directly with existing generic ketamine competitors in the U.S. market. Importantly, the investment made in developing the Ketamine ANDA was also intended to support and strengthen PharmaTher’s broader ketamine strategy, advancing its other proprietary ketamine-based programs. The work completed to secure the Ketamine ANDA also provides a validated CMC package that would be leveraged for future New Drug Applications via the 505(b)(2) regulatory pathway, potentially saving substantial time and development costs since the foundational work has already been reviewed by the FDA. The Ketamine ANDA sale does not limit PharmaTher’s ability to research, develop, manufacture, and commercialize any strengths, dosage forms, or formulations of ketamine for any indications in any territories worldwide, including the U.S., provided that the Company does not, directly or indirectly, develop, file, or seek regulatory approval for the exact same product approved under the Ketamine ANDA, which the Company would not seek since future ketamine products will be differentiated and non-generic. The pharmaceutical partner has requested that specific terms remain confidential at this time for competitive and regulatory reasons. Over the next six months, PharmaTher is concentrating on several key initiatives aimed at realizing the commercial potential of its ketamine portfolio. The Company is actively pursuing new global partnerships that could provide additional non-dilutive funding and accelerate the development and commercialization of its ketamine-based products. PharmaTher is planning meetings with the U.S. FDA to define an expedited clinical and regulatory path for ketamine in CRPS and to seek agreement on a Phase 3 study design for Parkinson’s disease. Both the CRPS and Parkinson’s programs, if supported by positive FDA guidance and outcomes, would be positioned as attractive candidates for potential partnerships with larger pharmaceutical companies, as well as for the Company’s ketamine microneedle patch and wearable pump programs.