PharmaTher Signs Exclusive Worldwide License Agreement for Patented Formulation and Production Process for Ketamine and Ketamine Analogs

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PharmaTher will file ANDA and 505(b)(2) regulatory submissions with the FDA for new uses, dosage forms and formulations of ketamine for mental health, neurological disorders and pain

TORONTO, April 12, 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 PharmaTher has entered into an exclusive worldwide licensing agreement with Gesval SA , a public limited company incorporated by the University of Liège, Belgium, for the development and commercialization of a patented continuous flow process technology for the preparation of ketamine and ketamine analogues (the “Ketamine Technology”). The ketamine technology strengthens the company’s ketamine patent portfolio and will complement the company’s expanding ketamine pharmaceutical pipeline for use in hospitals, clinics and homes.

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PharmaTher develops and commercializes new uses, administration forms and formulations of ketamine and ketamine analogues. 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 areas 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.

The Ketamine Technology, developed at the Center for Integrated Technology and Organic Synthesis (CiTOS, ULiège) directed by Professor Jean-Christophe Monbaliu, concerns 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 ketamine batch processes to improve yield production, reproducibility, purity profile and requiring a smaller footprint for production. In addition to improving the production process of racemic ketamine, ketamine technology provides various methods to synthesize ketamine analogs (i.e., arylcycloalkylamine derivatives) using continuous flow conditions. with significantly improved efficiency compared to batch procedures, which is of paramount importance for the development of next-generation ketamines.

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“We are excited to advance the patented technology for the new development and production process of ketamine and ketamine analogues from the University of Liège,” said Fabio Chianelli, CEO of PharmaTher. “We remain committed to our goal of becoming a leader in the development and commercialization of new ketamine pharmaceutical products and this license not only strengthens our global patent portfolio for ketamine, but also complements our strategy to commercialize new uses. , delivery forms and formulations of ketamine and ketamine analogs to address unmet medical needs for mental health, neurological disorders and pain.

In addition, the Company plans to form partnerships with research laboratories, ketamine clinics and pharmaceutical companies that: seek a secure supply of cGMP ketamine and ketamine-based products for current portfolios; exploring alternative dosage forms for multiple existing indications; develop new ketamine analogues; and requiring support to develop and eventually commercialize specific ketamine products for new indications.

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Under the terms of the agreement, PharmaTher has obtained exclusive worldwide rights to develop and commercialize an intellectual property portfolio consisting of an issued patent (European patent: 3700887B1) and patent applications (PCT/EP2018/097033) titled “Methods for the Preparation of Arylcycloalkylamine Derivatives” in the United States, China, and Canada.

Consistent with industry standards, PharmaTher paid a one-time fee to enter into the agreement, and all other future payments are based on clinical trials and revenue milestones achieved by PharmaTher.

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, neurological and pain disorders. Learn more about PharmaTher.com.

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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

Neither the Canadian Securities Exchange nor its regulation services provider has reviewed or accepts responsibility for the adequacy or accuracy of this release.

Caution

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 period from November 30, 2021 (“MD&A”), dated January 27, 2022, available on the company profile at www.sedar.com.

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