Company funded to meet upcoming milestones over the next 24 months
Expected FDA approval for KETARX™ (racemic ketamine) via the ANDA pathway in Q1-2024 and international approvals after that
Company advancing PharmaPatch™ (microneedle patch) for psychedelics and infectious diseases
Streamlined clinical development programs to focus on near-term investment and revenue opportunities with KETARX™ and PharmaPatch™
TORONTO, June 12, 2023 — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a commercial-focused specialty pharmaceutical company, provides a corporate update outlining the development and commercialization plans and upcoming milestones for its KETARX™ (racemic ketamine) products and PharmaPatch™ (microneedle patch) delivery system. With approximately CAD $6 million in cash as of end-May 2023, the Company is funded to meet its upcoming milestones targeting near-term investment and revenue opportunities over the next 24 months.
Fabio Chianelli, CEO of PharmaTher, commented: “Since our inception, we focused on developing novel uses and delivery forms of ketamine for mental health, neurological and pain disorders. We dedicated our resources to working with the FDA to obtain agreement on our regulatory and clinical development plans for our ketamine-based product pipeline. In parallel, we developed our own racemic ketamine product, KETARX™, to meet the growing demand for ketamine in the U.S. and international markets. Currently, ketamine is on the FDA drug shortages list, and we aim to recover ketamine’s shortage issue in the U.S. and become a global leader for ketamine-finished products. We expect to receive FDA approval for KETARX™ in Q1-2024. Also, we are adding a new investment and revenue stream by partnering our proprietary microneedle patch delivery system, PharmaPatch™, with biotech and pharmaceutical companies globally. As for our proposed clinical development programs involving ketamine, we are pausing capital allocations to these programs for 2023 to focus on entering the next phase of our growth cycle in becoming a commercial-focused specialty pharmaceutical company.”
KETARX™ (racemic ketamine)
PharmaTher’s priority is to commercialize KETARX™ under ketamine’s FDA-approved label. The Company expects to market various dosage forms of KETARX™, such as 10 mg/ml, 50 mg/ml and 100 mg/ml, with the option to increase concentration and ready-to-administer applications for the U.S. and international markets. Ketamine is currently on the FDA’s drug shortage list. Outside of the FDA approved indications, ketamine is also being administered in hospitals and clinics to treat various disorders encompassing mental health, neurological and pain.
The Company expects to file its abbreviated new drug application (“ANDA”) with the FDA in early July and obtain FDA approval in Q1-2024. Also, the Company will pursue international approvals for KETARX™ to support the growing global demand for ketamine. The Company is in discussion with a specialty pharmaceutical company to market, distribute and sell KETARX™ in the U.S.
PharmaPatch™ (microneedle patch)
PharmaPatch™ is a proprietary microneedle-enhanced delivery system offering an efficient and painless method for delivering drugs, including psychedelics and medicines to treat infectious diseases. PharmaPatch™ may enable flexible drug load capacity and combinations, controlled released delivery, and the ability to present desired pharmacokinetic and safety profiles. In addition, PharmaPatch™ aims to empower patients to dose their medication remotely, safely and conveniently rather than under the supervision of a healthcare provider at a clinic or hospital due to its potential anti-tampering and anti-abuse features.
The Company has completed research studies demonstrating that PharmaPatch™ can deliver ketamine, psilocybin, MDMA, DMT and LSD and is now initiating final product, clinical and regulatory plans for a potential clinical study with the KETARX™ (ketamine) patch in 2024.
In addition, the Company is expanding its commercialization efforts with PharmaPatch™ in providing research, development and manufacturing services to potential pharmaceutical partners. PharmaPatch™ offers potential partners a differentiated and validated delivery system, desired pharmacokinetic profiles, intellectual property protection, and cGMP materials for IND-enabling and clinical studies to support regulatory approvals. The Company is actively engaged in partnering discussions for the use of PharmaPatch™ to deliver psychedelics and potential infectious disease treatments in addition to the various collaborations already in place with several pharmaceutical companies. Such partnerships may offer an additional investment and revenue stream through equity, licensing, milestones, royalties and development fees.
Clinical Programs Update
Following numerous interactions with the FDA regarding clinical programs involving ketamine, the various development and clinical studies requirements to advance them towards FDA approval, and with the current market environment, the Company will focus resources on potential near-term investment and revenue opportunities that exist and that are synergistic with KETARX™ and PharmaPatch™. As such, the Company has decided to pause allocating funds for its product and clinical programs, including its on-body pump system, Parkinson’s disease, Amyotrophic Lateral Sclerosis, Rett Syndrome, and Complex Regional Pain Syndrome for the remainder of 2023. The Company will evaluate these programs quarterly to determine a potential rationale to reviving one or more of them internally or with potential pharmaceutical partners.
About PharmaTher Holdings Ltd.
PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) develops and commercializes specialty pharmaceuticals exhibiting growing adoption and permitting novel delivery methods to enhance patient outcomes. The Company’s lead product is KETARX™ (racemic ketamine) to fill the global unmet medical needs for anesthesia, sedation, pain, mental health, and neurological indications. The Company is commercializing PharmaPatch™ (microneedle patch) with its partners to deliver psychedelics and drugs to treat infectious diseases. 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: [email protected]
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”, “would”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated”, “potential”, “aim”, “may”, “plan”, “proposed”, “lead”, “toward”, 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 months ended February 28, 2023 (“MD&A”), dated April 28, 2023, 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.
