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

TORONTO, May 05, 2022 (GLOBE NEWSWIRE) — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a leader in ketamine-based specialty pharmaceuticals, is pleased to announce that the United Nations Patent and Trademark Office United States granted U.S. Patent No. 11,286,230, entitled “Ketamine Flow Synthesis” (the “Patent”), which refers to a continuous flow process technology for the preparation of ketamine and ketamine analogs. The company has obtained exclusive worldwide development and commercialization rights to the patent as well as European patent no. 3700887B1 and patent applications in China and Canada of Gesval SA, a limited company incorporated by the University of Liège, Belgium.

Fabio Chianelli, CEO of PharmaTher, said: “Our goal is to become the leader in ketamine-based specialty pharmaceuticals. Recent U.S. patent grant strengthens our patent portfolio of new uses, dosage forms, formulations and processes for producing ketamine and ketamine analogs to address unmet medical needs in mental health, neurological disorders and pain and surgery.

The patent strengthens the company’s global intellectual property portfolio on ketamine, which consists of new uses (i.e. Parkinson’s disease, Amyotrophic Lateral Sclerosis)delivery forms (i.e. microneedle patch, injection, infusion and portable pump)formulas (i.e. ketamine and betaine, analogues)production (i.e. process flow synthesis)and the company’s FDA orphan drug designation portfolio for ketamine for amyotrophic lateral sclerosis, complex regional pain syndrome and status epilepticus.

As part of its near-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’s disease). Gehrig), future FDA 505(b)(2) regulatory submissions in the area of ​​mental health, neurological disorders, and pain, and its plans to commercialize in the United States via an Abbreviated New Drug Application (“ANDA”) ) of the FDA for procedural anesthesia and sedation. The company expects to file ANDA in the fourth quarter of 2022 for commercialization in the United States. Additionally, the company’s long-term product strategy is to develop new ketamine formulations and drug delivery systems, including its patented micro-needle patch and proposed portable pump device for injection. intradermal. and subcutaneous administration of ketamine, respectively.

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Ketamine was approved by the FDA in 1970 and is used clinically for analgesia, sedation, and anesthetic induction. Ketamine is also emerging as a viable treatment option for various mental health, neurological, and pain conditions. However, the methods typically used for ketamine production are time consuming and are usually 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) directed 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 analogues. , thereby addressing the shortcomings of ketamine batch processes to improve yield production, reproducibility, purity profile, and requiring a smaller footprint for production. In addition to improving the process for producing racemic ketamine, the patent provides various methods for synthesizing ketamine analogs (i.e., arylcycloalkylamine derivatives) using continuous flow conditions with a Significantly improved efficacy compared to batch procedures, which is of paramount importance for the development of next-generation ketamines.

About PharmaTher Holdings Ltd.

​PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is focused on the development and commercialization of ketamine-based specialty pharmaceutical products for mental health, neurological disorders and pain. Learn more about PharmaTher.com.

For more information about PharmaTher, please contact:

Fabio Chianelli
Chief executive officer
PharmaTher Holdings Ltd.
Tel: 1-888-846-3171
E-mail: info@pharmather.com
Website: www.pharmather.com

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This press release contains “forward-looking information” within the meaning of applicable Canadian securities laws. These statements relate to future events or future performance. The use of any of the words “could”, “intends”, “expects”, “believes”, “will”, “projected”, “estimated”, “potential”, ” aims, “may” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on the current beliefs or assumptions of PharmaTher Holdings Ltd. (the “Company”) as to the outcome and timing of such future events. Forward-looking information is based on reasonable assumptions that have been made by the Company as of the date of the information and is subject to known and unknown risks, uncertainties and other factors that may cause results or events actuals differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not place undue reliance on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and the Company undertakes no obligation to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the heading “Risk Factors” in the Company’s MD&A for the three- and nine-month periods ended February 28, 2022 and 2021 (“MD&A”), dated April 25, 2022, available on the company profile at www.sedar.com.

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