PharmaTher Holdings Ltd. announced that the United States Patent and Trademark Office granted US Patent No. 11,286,230, titled "Ketamine Flow Synthesis," marking a significant advancement in ketamine pharmaceutical manufacturing. The patent covers a continuous-flow process technology for producing ketamine and ketamine analogs, addressing longstanding inefficiencies in traditional production methods.
The company obtained exclusive worldwide development and commercial rights to the patent, along with European patent no. 3700887B1 and pending applications in China and Canada, from Gesval S.A., a public limited company incorporated by the University of Liège, Belgium.
Manufacturing Innovation Addresses Industry Limitations
Traditional ketamine production methods have been hampered by time-consuming, stepwise macroscopic batch processes that result in low productivity, reproducibility, and flexibility due to poor mixing and heat transfer. The patented technology, developed at the Center for Integrated Technology and Organic Synthesis (CiTOS, ULiège) under Professor Jean-Christophe Monbaliu, utilizes scalable, safe, and efficient continuous-flow processes in micro/mesofluidic reactors.
The innovation improves yield production, reproducibility, and purity profile while requiring a smaller manufacturing footprint. Beyond enhancing racemic ketamine production, the patent provides methods for synthesizing ketamine analogs (arylcycloalkylamine derivatives) using continuous-flow conditions with drastically improved efficiency compared to batch procedures.
Strategic Development Pipeline
PharmaTher CEO Fabio Chianelli stated, "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 company is developing its own Ketamine Injection and Infusion product to support expected pivotal clinical studies for Parkinson's disease and Amyotrophic Lateral Sclerosis (Lou Gehrig's disease). These products will also support future FDA 505(b)(2) regulatory submissions for mental health, neurological, and pain disorders, as well as commercialization plans in the U.S. through an FDA Abbreviated New Drug Application (ANDA) for anesthesia and procedural sedation.
PharmaTher expects to file the ANDA in Q4-2022 for U.S. commercialization.
Expanding Intellectual Property Portfolio
The patent strengthens PharmaTher's global intellectual property portfolio, which encompasses novel ketamine uses for Parkinson's disease and Amyotrophic Lateral Sclerosis, innovative delivery forms including microneedle patches, injections, infusions, and wearable pumps, and specialized formulations combining ketamine with betaine and other analogs.
The company holds FDA orphan drug designations for ketamine in treating Amyotrophic Lateral Sclerosis, Complex Regional Pain Syndrome, and Status Epilepticus.
Long-term Innovation Strategy
PharmaTher's long-term product strategy focuses on developing novel ketamine formulations and drug delivery systems, including its patented microneedle patch and proposed wearable pump device for intradermal and subcutaneous ketamine delivery, respectively.
Ketamine, originally approved by the FDA in 1970 for analgesia, sedation, and anesthetic induction, is emerging as a viable treatment option for various mental health, neurological, and pain disorders. The enhanced production technology positions PharmaTher to capitalize on ketamine's expanding therapeutic applications while addressing manufacturing challenges that have limited the field's development potential.
