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

Rhea-AI Summary

PharmaTher Holdings Ltd. announced its plan to file ANDA and 505(b)(2) submissions with the FDA for innovative ketamine formulations aimed at mental health and neurological disorders. The company secured an exclusive license agreement with Gesval S.A. for a patented continuous-flow technology to enhance ketamine production efficiency. The company aims to launch its Ketamine Injection product and address various medical needs, including future pivotal studies for Parkinson's and ALS. Notably, PharmaTher's strategy includes partnerships for secure cGMP ketamine supply and novel dosage forms.

Positive

• Entered exclusive license agreement for a patented continuous-flow process technology to enhance ketamine production.
• Plans to file ANDA for Ketamine Injection by Q4-2022, indicating potential market entry.
• Aims to address unmet medical needs in mental health and neurological disorders.

Negative

• None.

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

TORONTO, April 12, 2022 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a leader in specialty ketamine pharmaceuticals, is pleased to announce that PharmaTher has entered into an exclusive worldwide license agreement with Gesval S.A., 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 analogs (the “Ketamine Technology”). The Ketamine Technology strengthens the Company’s patent portfolio of ketamine and it will complement the Company’s expanding ketamine pharmaceutical pipeline for use in hospitals, clinics and homes.

PharmaTher is developing and commercializing novel uses, delivery forms and formulations of ketamine and ketamine analogs. 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.

The Ketamine Technology, developed at the Center for Integrated Technology and Organic Synthesis (CiTOS, ULiège) headed by Professor Jean-Christophe Monbaliu, 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 Ketamine Technology 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.

“We are excited to advance patented technology for the novel development and production process of ketamine and ketamine analogs 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 novel ketamine pharmaceuticals and this license not only strengthens our global patent portfolio for ketamine, but also complements our strategy in commercializing novel uses, delivery forms and formulations of ketamine and ketamine analogs to serve the unmet medical needs for mental health, neurological and pain disorders.”

In addition, the Company expects to form partnerships with research labs, ketamine clinics and pharmaceutical companies that are: seeking a secure supply of cGMP ketamine and ketamine products for current portfolios; exploring alternative dosage forms for multiple existing indications; developing novel ketamine analogs; and requiring support to develop and eventually commercialize specific ketamine products for new indications.

Under the terms of the Agreement, PharmaTher gained exclusive worldwide development and commercial rights to an intellectual property portfolio consisting of a granted patent (Europe patent: 3700887B1) and patent applications (PCT/EP2018/097033) titled, “Methods for the preparation of arylcycloalkylamine derivatives” in the U.S., China and Canada.

Consistent with industry standards, PharmaTher paid a one-time fee for entering into the Agreement, and all other future payments are based on clinical trial and revenue milestones reached by PharmaTher. 

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.

For more information about PharmaTher, please contact:

Fabio Chianelli
Chief Executive Officer
PharmaTher Holdings Ltd.
Tel: 1-888-846-3171
Email: info@pharmather.com
Website: www.pharmather.com

Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.

Cautionary Statement

This press release contains 'forward-looking information' within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words "could", "intend", "expect", "believe", "will", "projected", "estimated", "potential", "aim", “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 PharmaTher Holdings Ltd. (the "Company") current belief or assumptions 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 at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Company is not obligated 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 caption "Risk Factors" in Company's management's discussion and analysis for the period of November 30, 2021 ("MD&A"), dated January 27, 2022, which is available on the Company's profile at www.sedar.com.

This news release does not constitute an offer to sell or the solicitation of an offer to buy, and shall not constitute an offer, solicitation or sale in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction.

FAQ

What regulatory submissions is PharmaTher planning for ketamine?

PharmaTher is planning to file ANDA and 505(b)(2) submissions with the FDA for novel uses, delivery forms, and formulations of ketamine.

What is the significance of the exclusive license agreement with Gesval S.A.?

The agreement allows PharmaTher to utilize a patented continuous-flow process technology for improved ketamine production, enhancing efficiency and scalability.

When does PharmaTher expect to file its ANDA for ketamine?

PharmaTher expects to file its ANDA for ketamine Injection in Q4-2022 for U.S. market commercialization.

What are PharmaTher's long-term strategies regarding ketamine products?

PharmaTher aims to develop novel ketamine formulations, including microneedle patches and wearable devices for drug delivery.

How does the new technology improve ketamine production?

The continuous-flow process technology enhances yield, reproducibility, purity, and reduces production footprint compared to traditional batch methods.