PharmaTher Announces Grant of U.S. Patent on Formulation and Production Process of Ketamine and Ketamine Analogs
TORONTO, May 5, 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 US Patent No: 11,286,230, titled “Ketamine Flow Synthesis” (the “Patent”), 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.
Fabio Chianelli, Chief Executive Officer of PharmaTher, commented: “Our goal is to become the leader in specialty ketamine pharmaceuticals. The recent grant of the U.S. patent strengthens our patent portfolio of novel uses, delivery forms, formulations, and production processes of ketamine and ketamine analogs to serve the unmet medical needs for mental health, neurological and pain disorders, and surgery.”
The Patent strengthens the Company’s global intellectual property portfolio of ketamine, which consists of novel uses (i.e. Parkinson’s disease, Amyotrophic Lateral Sclerosis), delivery forms (i.e. microneedle patch, injection, infusion and wearable pump), formulations (i.e. ketamine and betaine, analogs), production (i.e. process flow synthesis), 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.
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:
Chief Executive Officer
PharmaTher Holdings Ltd.
Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.
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 three and nine month periods ended February 28, 2022 and 2021 (“MD&A”), dated April 25, 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.