February 16, 2022 — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a leader in specialty ketamine pharmaceuticals, is pleased to announce that the United States Patent and Trademark Office granted to the Company U.S. Patent No. 11,213,495, titled “Method and Composition for Decreasing the Psychotomimetic Side Effect and Addictive Disorder of Ketamine.” The patent refers to the combination formulation of FDA-approved ketamine and betaine anhydrous (“KETABET™”), which has been shown in research to enhance the antidepressant effect while potentially reducing the known negative side effects of ketamine significantly.
“We are extremely pleased about the grant of this patent in the U.S. as it further validates the potential of KETABET™, strengthens our intellectual property position, and highlights our commitment to innovation of ketamine for mental health, neurological and pain disorders,” said Fabio Chianelli, CEO of PharmaTher.
The granted patent strengthens the Company’s global patent portfolio. It provides for broad potential of KETABET™ for uses in various mental health, neurological and pain disorders, and novel delivery forms, including the Company’s patented hydrogel-forming microneedle patch delivery system.
In addition, granted patents of KETABET™ are issued in Japan (Patent no. 6967532) and Taiwan (Patent no. I648049). The Company expects to convert the current patent applications in Europe, Canada, Israel and China into granted patents. Patent protection is expected to expire in 2036.
The granted patents and published studies further validate the potential of KETABET™ and support the Company’s ongoing investigator-led observational studies evaluating the impact of betaine on the unwanted ketamine side effects seen post ketamine treatment for subjects with either depression or pain. Based on the outcome from the ongoing studies, the Company will advance the KETABET™ program with its microneedle patch technology in Phase 2 clinical studies.
The Company previously announced the publication of a scientific article demonstrating the potential of KETABET™ to prevent the potential adverse psychiatric effects of repeated ketamine treatment for depression and other indications, including suicidal ideation, substance abuse, post-traumatic stress disorder, and chronic pain. The article titled, “Betaine prevents and reverses the behavioral deficits and synaptic dysfunction induced by repeated ketamine exposure in mice,” is published in Biomedicine & Pharmacotherapy and can be found here.
About PharmaTher Holdings Ltd.
PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is focused on the development and commercialization of specialty ketamine pharmaceuticals for mental health, neurological, and pain disorders. Learn more at PharmaTher.com.