VANCOUVER, British Columbia, Feb. 14, 2023 (GLOBE NEWSWIRE) -- PharmAla Biotech Holdings Inc. (“PharmAla”)(CSE: MDMA) is pleased to announce that, in the wake of a landmark decision by the Therapeutic Goods Agency (“TGA”) of Australia on February 3rd, it has completed an agreement to sell a shipment of its GMP LaNeo MDMA to Emyria Ltd. Amidst growing interest in its products and technologies, PharmAla has submitted a trademark application for ‘LaNeo’ in Australia. The TGA's regulatory change will make Australia the first country in the world to allow specially-licensed psychiatrists to prescribe MDMA and Psilocybin for certain conditions, beginning July 1st.
“Forward-looking companies are already moving to supply their clinical operations following the TGA’s regulatory change that will take effect on July 1st. While this is a nascent industry, we are committed to responsibly supplying our customers as they develop operational capacity,” said Nick Kadysh, CEO of PharmAla Biotech. “PharmAla has already been active in Australia - supporting no less than 3 different clinical trials with our LaNeo MDMA. We’re very pleased that, just 10 days after the change was announced, we’re in advanced discussions with a number of interested parties, and have already closed a new purchase order.”
PharmAla is the only publicly-traded company currently manufacturing and exporting clinical-grade MDMA, and the only entity in the world that offers its customers both EU-GMP MDMA and EU-GMP Psilocybin. PharmAla’s current offerings include both API and EU-GMP encapsulated drug product. Its trademark filings in Australia also include the PharmAla brand name.
“We currently have a historic opportunity before us: to not only supply customers with high-quality EU-GMP API and drug products, but also to build one of the preeminent psychedelics operations in Australia - the country leading the world with regulations to support treatment,” said Dr. Shane Morris, COO, PharmAla Biotech. “PharmAla has worked hard to develop world class excellence in manufacturing and regulatory compliance. We look forward to the opportunity to share our product data not only with our partners and clinicians but with the TGA in future meetings.”
For more information, please visit www.PharmAla.ca, where you can sign up to receive regular new updates.
PharmAla Biotech Holdings Inc. (CSE: MDMA) is a biotechnology company focused on the research, development, and manufacturing of MDXX class molecules, including MDMA. PharmAla was founded with a dual focus: alleviating the global backlog of generic, clinical-grade MDMA to enable clinical trials, and to develop novel drugs in the same class. PharmAla is the first publicly-traded company to manufacture clinical-grade MDMA. PharmAla’s research and development unit has completed proof-of-concept research into ALA-002, PharmAla’s lead drug candidate. PharmAla is a “regulatory first” organization, formed under the principle that true success in the psychedelics industry will only be achieved through excellent relationships with regulators.
For more information, please contact:
Chief Executive Officer
PharmAla Biotech Holdings Inc.
Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.
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”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on PharmAla’s 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 PharmAla 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. The forward-looking information contained in this press release is made as of the date hereof, and PharmAla 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. 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 PharmAla’s management’s discussion and analysis which is available on PharmAla’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