PharmaTher Announces Grant of U.S. Patent on Formulation and Production Process of Ketamine and Ketamine Analogs

PharmaTher Holdings Ltd. (CSE: PHRM), a leader in specialty ketamine pharmaceuticals, is pleased to announce that the United States Patent and Trademark Office granted US Patent No: 11,286,230, titled “Ketamine Flow Synthesis”, which refers to a continuous-flow process technology for the preparation of ketamine and ketamine analogs. The Company gained exclusive worldwide development and commercial rights of the Patent along with Europe patent no. 3700887B1 and patent applications in China and Canada from Gesval S.A., a public limited company incorporated by the University of Liège, Belgium.

The Patent strengthens the Company’s global intellectual property portfolio of ketamine, which consists of novel uses, delivery forms, formulations, production, and the Company’s FDA orphan drug designation portfolio of ketamine for Amyotrophic Lateral Sclerosis, Complex Regional Pain Syndrome and Status Epilepticus.

As part of its short-term product strategy, the Company is developing its own Ketamine Injection and Infusion product to support the Company’s expected pivotal clinical studies for Parkinson’s disease and Amyotrophic Lateral Sclerosis (Lou Gehrig’s disease), future FDA 505(b)(2) regulatory submissions in mental health, neurological and pain disorders, and its commercialization plans in the U.S. via an FDA Abbreviated New Drug Application (“ANDA”) for anesthesia and procedural sedation. The Company expects to file the ANDA in Q4-2022 for commercialization in the U.S. In addition, the Company’s long-term product strategy is to develop novel ketamine formulations and drug delivery systems, including its patented microneedle patch and proposed wearable pump device for the intradermal and subcutaneous delivery of ketamine, respectively.

Ketamine was approved by the FDA in 1970 and is clinically used for analgesia, sedation, and anesthetic induction. Ketamine is also emerging as a viable treatment option for various mental health, neurological and pain disorders. However, the methods generally used for the production of ketamine are time-consuming and typically based on stepwise macroscopic batch processes resulting in low productivity, reproducibility and flexibility due to poor mixing and heat transfer.

Developed at the Center for Integrated Technology and Organic Synthesis (CiTOS, ULiège) headed by Professor Jean-Christophe Monbaliu, the Patent relates to a scalable, safe and efficient continuous-flow process in micro/mesofluidic reactors for the production of ketamine and ketamine analogs, thereby addressing the shortcomings of the ketamine batch processes to improve yield production, reproducibility, purity profile, and requiring smaller footprint for production. In addition to improving the production process of racemic ketamine, the Patent provides various methods for synthesizing ketamine analogs (i.e. arylcycloalkylamine derivatives) by using continuous-flow conditions with a drastically improved efficiency relative to batch procedures, which is of paramount importance for developing next-generation ketamines.

​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.