Australia Allows Prescription of MDMA and Psilocybin in Groundbreaking Regulatory Change

VANCOUVER, British Columbia, Feb. 03, 2023 (GLOBE NEWSWIRE) — PharmAla Biotech Holdings Inc. (“PharmAla”)(CSE: MDMA) applauds the Australian Therapeutic Goods Administration (TGA) in allowing for specially-licensed psychiatrists to prescribe MDMA and Psilocybin. 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 GMP MDMA and GMP Psilocybin.

“This is a critically important announcement by the TGA, allowing for the direct prescription and treatment of patients with PTSD and Treatment-Resistant Depression with Psychedelic molecules,” said Nick Kadysh, CEO of PharmAla. “As the registered supplier to three different Australian clinical trials using MDMA – more than any other Psychedelics API supplier – PharmAla is the only company which has both GMP MDMA and Psilocybin in inventory, and stands ready to ship these molecules to Australia.”

PharmAla is the first publicly traded company to manufacture GMP MDMA, and is the first company to make available to customers two clinical-grade Psychedelic APIs. Before being authorised by the TGA under this scheme, psychiatrists must obtain approval for the use of the substances for patients under their care by a human research ethics committee (HREC) that is registered by the National Health and Medical Research Council (NHMRC). PharmAla has already been contracted to supply several HREC-approved trials.

“The TGA decision absolutely sets a new global standard for treatment with molecules like MDMA and Psilocybin,” said Dr. Shane Morris, COO of PharmAla Biotech. “Allowing specially-licensed psychiatrists to prescribe these molecules directly to patients is an excellent approach, and will certainly help drive other countries to re-assess how they regulate these molecules to meet patients’ medical needs.”

Customers interested in acquiring MDMA or Psilocybin for human use under the new TGA guidance should contact PharmAla’s Head of Sales, David Purcell, at [email protected]

For more information, please visit www.PharmAla.ca, where you can sign up to receive regular new updates.

About PharmAla
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:
Nicholas Kadysh
Chief Executive Officer
PharmAla Biotech Holdings Inc.
Email: [email protected]
Phone: 1-855-444-6362
Website: www.PharmAla.ca

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”, “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

A video accompanying this announcement is available at: https://www.globenewswire.com/NewsRoom/AttachmentNg/decc8434-adad-47d6-9107-658682c820ae