PharmaTher Sells Ketamine ANDA, Focuses on Proprietary Programs
PharmaTher Holdings Ltd. (PHRRF, PHRM) has sold its Abbreviated New Drug Application (ANDA #217858) for Ketamine Hydrochloride Injection USP to a well-established global pharmaceutical company with a growing U.S. commercial division. This strategic move allows PharmaTher to capitalize on the generic injectable ketamine market while advancing its proprietary ketamine-based programs.
The sale, which provides PharmaTher with potential non-dilutive capital tied to U.S. commercial sales only, does not include PharmaTher's broader ketamine portfolio. PharmaTher retains the right to research, develop, manufacture, and commercialize ketamine for any indications worldwide, excluding the exact same product approved under the Ketamine ANDA. The work completed for the Ketamine ANDA provides a validated CMC package for future NDAs via the 505(b)(2) pathway.
Fabio Chianelli, CEO of PharmaTher, expressed that the sale allows the company to advance its proprietary ketamine-based programs. Over the next six months, PharmaTher will focus on international partnerships, regulatory engagements, and pharma opportunities. The company will actively pursue international partnerships to potentially secure additional non-dilutive capital and accelerate the development and commercialization of its ketamine-based products, including programs for CRPS and Parkinson's disease, while maintaining ownership of its broader ketamine portfolio.
PharmaTher's stock is traded on the OTCQB (PHRRF) and the CSE (PHRM). The company remains committed to unlocking the pharmaceutical potential of ketamine for mental health, pain, and neurological disorders. The sale of the Ketamine ANDA is a strategic step forward in achieving this goal.
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