Ketamine Hydrochloride

The Assigned FDA Approval Goal Date is June 4, 2025TORONTO, March 11, 2025 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company hyper-focused on the commercialization of Ketamine, is pleased to announce today that the Company has received an Amendment Acknowledgement Letter (“AAL”) from the U.S. Food and Drug Administration (“FDA”) for its New Drug Application for Ketamine. In the AAL, the FDA determined this is a minor amendment, meets the criteria for priority review, and assigned an approval goal date of June 4, 2025. Fabio Chianelli, Chairman and CEO of PharmaTher, commented: “I am very pleased with the new FDA approval goal date of June 4, 2025 for our Ketamine drug. We are focused on solving the shortage issue of Ketamine and becoming the leading supplier of Ketamine to fill the demand gap in the U.S. market.” Expecting FDA approval of Ketamine on or before June 4, 2025 As announced on March 3, 2025, PharmaTher provided its resubmission to the complete response amendment and has addressed the deficiencies classified as MINOR in the complete response letter (“CRL”) dated October 22, 2024. In the CRL, the FDA requested new and updated information and clarifications related to drug substance, drug product, manufacturing, and microbiology. The FDA did not express concern about the stability of the Ketamine submission batches and no new preclinical and clinical studies were requested. No additional deficiencies were mentioned in the AAL. The Company, demonstrating its commitment to quality and compliance, promptly completed the necessary tests and responses to address the FDA’s comments and submitted them to the FDA for their review, which resulted in a new approval goal date of June 4, 2025. Solving the Ketamine shortage problem in the U.S. PharmaTher is committed to solving the Ketamine shortage problem in the United States of America and adhering to the FDA’s strict manufacturing guidelines. Ketamine has been on the FDA’s drug shortage list since February 2018, which is believed to have encouraged the widespread availability of compounded Ketamine products. On October 10, 2023, the FDA published a compounding risk alert describing the potential risks associated with compounded Ketamine products for psychiatric disorders. The outcome with resolving Ketamine’s drug shortage issue would be similar to the recent news of Wegovy and Ozempic being removed from the FDA drug shortage list and compounders have a 60- to 90-day grace period to stop supplying them (see FDA letter). With ketamine removed from the FDA drug shortage list, the FDA is expected to restrict compound pharmacies from supplying it, opening the door for PharmaTher to fill the demand gap in the U.S. market. Unlocking the pharmaceutical potential of Ketamine With pending FDA approval for Ketamine on the horizon, the Company remains focused on its mission to be a leading innovator and provider of Ketamine to treat unmet medical needs. It is well-known that Ketamine is an essential medicine used for anesthesia and analgesia (pain relief), listed on the WHO Essential Medicines List, and used as a sedative and painkiller in hospital settings. Outside of the FDA and Health Canada approved indications, Ketamine is also being administered in hospitals and clinics to treat various pain, neurological, and mental health disorders. A published peer-reviewed study on the real-world effectiveness of Ketamine intravenous therapy demonstrated significant patient improvement for depression, anxiety and suicidal ideation. The potential of Ketamine to significantly impact patient lives is immense. PharmaTher, with its innovative approaches and commitment to patient care, is poised to play a pivotal role in making Ketamine available to millions of people globally. About PharmaTher Holdings Ltd. PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is hyper-focused on the development and commercialization of KETARX™ (Ketamine) to fill the unmet medical needs for surgery, pain, mental health, neurological, and medical countermeasures indications. Learn more at PharmaTher.com. For more information about PharmaTher, please contact: Fabio ChianelliChief Executive OfficerPharmaTher Holdings Ltd.Tel: 1-888-846-3171Email: info@pharmather.com 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 “closer”, "could", “confident”, "would", "intend", "expect", "believe", "will", "projected", "estimated", "potential", "aim", “may”, “plan”, “proposed”, “lead”, “toward”, “anticipate”, “provide”, 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 six months ended November 30, 2024 dated January 21, 2025, which is available on the Company's profile at www.sedarplus.ca. 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.

iStock, Sundry Photography Despite comments made by a Novo Nordisk official this week, the company confirmed to BioSpace that it has no additional clinical trials of its GLP-1 drugs in addiction beyond a Phase II trial testing semaglutide and two other drugs with alcohol use as a secondary endpoint. Thursday, Reuters reported that Martin Holst Lange, head of development at Novo, had told an online conference on Thursday that his company plans to investigate how its GLP-1 medicines can help people with addiction. However, in response to questions from Biospace , a Novo spokesperson said that Lange was referring to already ongoing work studying semaglutide on liver damage and alcohol use, and that the company has no plans to study the drug in broader addiction indications. “There is nothing else in terms of clinical trials we have ongoing in this space at the moment,” the spokesperson said in an email. Novo currently markets its GLP-1 treatments, which both contain the active ingredient semaglutide, as Wegovy for weight loss and Ozempic for type II diabetes. However, there is an early but growing interest in the potential of these molecules to treat substance abuse disorders, their related effects and a bevy of other conditions . The Phase II trial, launched in May 2024 and currently recruiting globally, is studying the effectiveness of semaglutide and two other drugs—cagrilintide, an amylin analogue, and NNC0194-0499, an FGF21 analog—used alone or in combination, in patients with alcoholic liver disease. Treatment of liver damage is that trial’s primary endpoint and alcohol consumption is a secondary endpoint. Three months ago, Novo’s biggest competitor Eli Lilly shared its plans to study its own GLP-1 medicines in alcohol and drug abuse. While Lilly has not officially announced any trials, CEO David Ricks said at an event in December that the company would begin large studies of its obesity drugs in alcohol and drug abuse next year, according to  Endpoints News . Currently, pharmaceutical treatment for addiction and substance-use disorders is limited, with most treatments aimed at avoiding overdoses or reducing withdrawal symptoms. But the industry is attempting inroads, with psychedelic therapies like LSD and ketamine drawing attention from researchers and biopharma companies. Another area of interest is in vaccination. In 2021 the NIH awarded a $25 million grant to scientists at Boston Children’s Hospital to study a vaccine against opioids. The hope is that the vaccine would generate antibodies to prevent the molecules from crossing into the brain. Novo is making progress with GLP-1 on another neurological front. In October 2024, semaglutide was linked with a significant reduction—40% to 70%—in the risk of Alzheimer’s disease in a real-world study of patients with type 2 diabetes. Novo is running two Phase III trials, EVOKE and EVOKE Plus, formally testing semaglutide in patients with Alzheimer’s. Those trials are expected to read out in September of this year.