Pharmather
PRODUCTS: An IV/injectable called KETARX, a microneedle patch by the name of KET-101, a sub-q pump called KET-102 and an oral entereic coated tablet by the name of KET-103.
Granted US Patent No. 10,576,077 for CEP-001 which expires in 2036.
DRUG PROGRAMS TARGET:
SUBSTANCE FOCUS: Ketamine.
OWNERSHIP:
Sairiyo Therapeutics is a spin-off which the company owns 49% of and has the potential to own up to 90%.
NEWS & PARTNERSHIPS:
2020
The company entered into an exclusive research collaboration agreement with Revive to expand Revive’s development plans with psilocybin to treat cancer and to discover novel uses of undisclosed psychedelic compounds. The collaboration will give Revive the exclusivity to advance the research of psilocybin in the treatment of cancer and leverage PharmaTher’s panaceAI psychedelic discovery AI platform to screen, identify and evaluate undisclosed psychedelic compounds directed at pre-specified targets for use with Revive’s drug delivery technology.
The company entered into an exclusive license agreement with BioRAE for the development and commercialization of a novel biocompatible and biodegradable gelatin methacryloyl microneedle delivery technology developed at the University of California, Los Angeles for use with psychedelic pharmaceuticals, including but not limited to Psilocybin, Ketamine, Ibogaine, LSD, MDMA, DMT, and cannabinoids.
The company entered into an exclusive license agreement with the University of Arizona for the development and commercialization of ketamine in the treatment of Parkinson’s disease.
2021
The company entered into a research collaboration with Revive Therapeutics to evaluate the delivery of psilocybin with PharmaTher’s proprietary microneedle patch technology for neuropsychiatric disorders.
The company entered into a process development agreement for the clinical trial scale up of PharmaTher’s proprietary Ketamine microneedle patch product with LTS LOHMANN Therapie-Systeme. LTS will be responsible for the development and non-commercial manufacturing activities and support PharmaTher’s investigational new drug submission to the FDA in the US and the investigational medicinal product dossier submission to EMA in the EU. PharmaTher will be responsible for the planning and execution of clinical studies with the Ketamine microneedle patch product.
The company was granted Japanese Patent No. 6967532 for KETABET, a combination formulation of FDA-approved ketamine and betaine anhydrous, which has shown in research to enhance the antidepressant effect while having the potential to reduce the known negative side effects of ketamine significantly with patent title: ‘Method and Composition for Decreasing the Psychotomimetic Side Effect and Addictive Disorder of Ketamine’ and it is expected to provide protection into 2036.
The company entered into an agreement with Alcami Corporation for the clinical and commercial manufacturing of the company’s proprietary ketamine products.
The company was granted FDA Orphan Drug Designation for ketamine to treat amyotrophic lateral sclerosis and complex regional pain syndrome.
The company entered into a co-development agreement with TSRL to jointly develop a microneedle array patch with the aim to control the manufacturing and supply of microneedle patches for the companies’ respective clinical and commercial drug programs. PharmaTher and TSRL share the commitment to commercialize a patented hydrogel-forming microneedle patch delivery technology licensed from Queens University of Belfast.
The company entered into a collaboration agreement with MediSynergics to develop MediSynergics patented ketamine derivatives for pain and other CNS disorders and to investigate drug discovery and development of next-generation psychedelic derivatives, such as psilocybin, DMT, MDMA and LSD, mescaline, and ibogaine. PharmaTher and MediSynergics will initially collaborate to advance the research of MediSynergics patented ketamine derivatives as an alternative to opioid medications for pain disorders using predictive preclinical animal models.
The company entered into an exclusive license agreement with The University of Kansas for the development and commercialization for the intellectual property of ketamine in the treatment amyotrophic lateral sclerosis, also known as Lou Gehrig’s disease. This gave PharmaTher gained exclusive worldwide development and commercial rights to provisional patent no. 63/025,778 titled Ketamine to Extend Survival after Muscle Wasting in Amyotrophic Lateral Sclerosis. The company paid a one-time fee for entering into the Agreement, and all other future payments will be based on clinical trial and revenue milestones reached by PharmaTher.
The company entered into a sponsored research agreement with the Terasaki Institute to develop a novel microneedle patch that aims to deliver psychedelic pharmaceuticals such as psilocybin, MDMA, LSD, and DMT through microdosing for unmet medical needs.
The company entered into an asset purchase agreement with Revive Therapeutics to sell the full rights to PharmaTher’s intellectual property pertaining to psilocybin. Revive will pay an aggregate consideration of up to 10 million CAD as well as a low single digit royalty on all future net sales of products derived from the acquired assets.
The company entered into an exclusive worldwide patent and know-how license agreement with The Queen’s University of Belfast for the development and commercialization of a patented hydrogel-forming microneedle delivery technology developed by Professor Ryan Donnelly to support PharmaTher’s product and clinical development initiatives with ketamine. PharmaTher will incorporate KETABET, its licensed patented formulation that combines FDA-approved ketamine and betaine, with Professor Donnelly’s patented hydrogel-forming microneedle patch technology.
The company entered into an exclusive worldwide license agreement with The National Health Research Institutes for the development and commercialization of a patented combination formulation of FDA-approved ketamine and betaine as a potential next-generation ketamine treatment for mental health, neurological and pain disorders.
2022
The company was granted FDA Orphan Drug Designation for ketamine to treat status epilepticus and also the prevention of ischemia-reperfusion injury from organ transplantation.
The company was awarded US Patent No. 11,213,495, titled “Method and Composition for Decreasing the Psychotomimetic Side Effect and Addictive Disorder of Ketamine.” The patent refers to the combination formulation of FDA-approved ketamine and betaine anhydrous KETABET, which has been shown in research to enhance the antidepressant effect while potentially reducing the known negative side effects of ketamine significantly.
The company entered into an exclusive worldwide license agreement with Gesval with commercial rights to an intellectual property portfolio consisting of a granted European patent: 3700887B1 and patent applications (PCT/EP2018/097033) titled, “Methods for the preparation of arylcycloalkylamine derivatives” in the US, China and Canada for the development and commercialization of a patented continuous-flow process technology for the preparation of ketamine and ketamine analogs. The company 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.
The company was awarded US Patent No: 11,286,230, titled “Ketamine Flow Synthesis” which refers to a continuous-flow process technology for the preparation of ketamine and ketamine analogs.
The company entered into a development agreement to combine PharmaTher’s ketamine formulation with CC Biotechnology Corporation’s Felice Dose wearable delivery device to create a proprietary wearable ketamine delivery solution for mental health, neurological and pain disorders. PharmaTher’s proposed wearable ketamine delivery device aims to convert IV and IM delivery of ketamine to a subcutaneous format, which may improve safety and efficacy, reduce side effects, enhance patient comfort and adherence, and reduce the time burden of treatment on patients and healthcare providers whether at hospital, clinic or home, and therefore may expand the adoption of ketamine for unmet medical needs. The company will cooperate with CCBIO to develop PharmaTher’s wearable ketamine delivery device. CCBIO will be responsible for the development and clinical manufacturing activities and support PharmaTher’s regulatory submissions.
The company was awarded US Patent No: 11,426,366, titled “Compositions and Methods for Treating Motor Disorders,” which includes claims intended to cover ketamine in the potential treatment of Parkinson’s Disease and motor disorders that cause involuntary or uncontrollable movement or actions of the body.
The company entered into an evaluation and exclusive option agreement with Case Western Reserve University in the development and commercialization for the intellectual property of ketamine in the treatment Rett Syndrome, a rare genetic neurological disorder. The company gained an exclusive option for up to 12 months to evaluate the regulatory, clinical development and commercialization plan for CWRU’s intellectual property portfolio, which includes, US issued patent no. 11,213,494 and US provisional patent no. 62/312,749 entitled, “Composition and method for the treatment of pervasive development disorders”, and US provisional patent no. 62/004,695 entitled, “Acute and sustained effects of low-dose ketamine treatment in mouse models of Rett Syndrome.” The company paid a one-time fee for entering into the Agreement, and should the company elect to exercise its option, both the company and CWRU will negotiate a license agreement.
2023
The company was granted FDA Orphan Drug Designation to KETARX for the treatment of Rett Syndrome.
The company invested 300,000 CAD in Sairiyo Therapeutics for a 49% ownership. The company also entered into a unanimous shareholders agreement with respect to their holdings of Sairiyo, as long as PharmaDrug owns a majority of the shares of Sairiyo it shall have the ability to appoint the officers of Sairiyo, the board of directors shall be comprised of three members a majority of whom are to be nominated by PharmaDrug for so long as it holds at least 50% of the outstanding shares of Sairiyo and the shareholders shall be entitled to subscribe for new share issuances on a pro rata basis. If PharmaDrug does not participate in any new issuance, PharmaTher may increase its ownership from 49% to 51% with an investment of 250,000 CAD. Either side may increase its ownership by 10% for additional $100,000 investments and neither side may be diluted beyond a 10% carried interest.
The FDA accepted the abbreviated new drug application for KETARX.
The company entered into a collaboration agreement with Vitruvias Therapeutics for the commercialization of the company’s KETARx products in the US.
2025
The company launched KetaVault, a proprietary data-access platform designed to accelerate the development, regulatory approval and commercialization of ketamine-based therapies. he platform provides pharmaceutical companies, biotech firms, academic researchers, and government organizations access to PharmaTher’s extensive ketamine-related regulatory, manufacturing and clinical data accumulated through years of research. KetaVault includes resources such as IND filings, investigator brochures, chemistry, Manufacturing and Controls information, clinical trial protocols, orphan drug designation materials, and data from innovative delivery systems including ketamine patches and wearable pumps. The company believes the platform can reduce development timelines, lower clinical risks, and create new partnership opportunities by allowing external organizations to leverage existing ketamine expertize.
The company was granted a patent covering the use of ketamine for treating amyotrophic lateral sclerosis, extending intellectual property protection until 2041.
The company announced further development of its ketamine transdermal patch as a potential next-generation, non-opioid pain treatment following FDA approval of its intravenous ketamine product KETARx. The company believes the patch could expand ketamine’s medical applications by providing controlled, sustained delivery for acute postoperative pain and chronic pain conditions while addressing the growing need for alternatives to opioid-based therapies.
The company sold its Abbreviated New Drug Application #217858 for Ketamine Hydrochloride Injection USP to a global pharmaceutical company specializing in sterile injectables and complex generic medicines. The agreement includes an upfront cash payment, milestone payments tied to cumulative sales, and profit-sharing over seven years following commercialization, with potential total consideration exceeding US$25 million.
The company announced the creation of KetAImine, an artificial intelligence-powered drug discovery platform designed to expand the company’s ketamine pipeline and accelerate development of new therapies. The platform will combine artificial intelligence, scientific literature, clinical data, real-world evidence, and PharmaTher’s proprietary ketamine database from KetaVault to identify new medical applications, drug combinations, dosing strategies, and intellectual property opportunities.
The company entered into an exclusive evaluation and option-to-license agreement with Oakwood Laboratories for a patented long-acting injectable (LAI) ketamine technology. The sustained-release formulation is intended to provide weeks or months of therapeutic benefit for treatment-resistant depression, major depressive disorder, and Parkinson’s disease while utilizing the efficient 505(b)(2) regulatory pathway.
2026
The company expanded its proprietary PharmaPatch microneedle platform into GLP-1 therapies for obesity, leveraging its previous work with ketamine and psychedelic patches. The company aims to develop a needle-free patch capable of providing long-acting GLP-1 delivery, potentially lasting up to one month, while addressing one of the fastest-growing pharmaceutical markets.
The company announced a strategic initiative to pursue Health Canada approval for generic semaglutide, the active ingredient in Ozempic and Wegovy. Building on its regulatory experience with FDA-approved ketamine, the company intends to become an early supplier in the Canadian market while establishing a scalable sterile injectable manufacturing platform for future obesity and diabetes products.
The company expanded its PharmaPatch platform into therapeutic peptides, including BPC-157, GHK-Cu, TB-500, and KPV. Leveraging its experience developing ketamine and psychedelic microneedle patches, the company plans to evaluate needle-free peptide delivery for improved patient convenience, controlled drug release and future intellectual property generation while targeting a rapidly growing peptide therapeutics market.
The company announced the launch of PatchPrint, an automated tabletop 3D printer for manufacturing microneedle patches, alongside a US provisional patent filing covering the technology. The company aims to expand beyond developing its own PharmaPatch™ products into supplying manufacturing systems, proprietary formulations, and partnership opportunities. PatchPrint™ is designed to automate the entire production process, enabling on-demand manufacturing of patches containing drugs, peptides, biologics, supplements, and vaccines for pharmaceutical companies, hospitals, pharmacies, and other healthcare providers.
Sairiyo Therapeutics, its 49%-owned joint venture, will evaluate its patented oral cepharanthine formulation, PD-001, as a potential treatment for Hantavirus following encouraging independent research. The published study found that cepharanthine inhibited Hantavirus infection in laboratory models by interfering with viral entry and membrane fusion. PharmaTher believes PD-001’s improved oral bioavailability could overcome a major limitation of traditional cepharanthine formulations.
The company announced the evolution of its manufacturing strategy by replacing PatchPrint with MEDBOTX, a broader robotic 3D printing platform designed for personalized medicines and advanced pharmaceutical manufacturing. Unlike PatchPrint, which focused on microneedle patches, MEDBOTX is intended to produce a wide range of dosage forms including tablets, oral films, gels, patches, suppositories, and personalized peptide formulations.