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.
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 plans 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 microneedle patch and proposed portable pump device for injection. intradermal. and subcutaneous administration of ketamine, respectively.
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.
“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 secure cGMP supply of 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.
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.
For more information about PharmaTher, please contact:
Chief executive officer
PharmaTher Holdings Ltd.
Email: [email protected]
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