PharmAla Biotech and Shaman Pharma Granted First Ever Special Access Program Authorization for MDMA
This authorization is the first authorized treatment of a patient with MDMA outside of a clinical trial in Canadian history
VANCOUVER, British Columbia, May 16, 2023 (GLOBE NEWSWIRE) -- PharmAla Biotech Holdings Inc. (“PharmAla”)(CSE: MDMA), a biotechnology company focused on the research, development, and manufacturing of MDXX class molecules (including MDMA) and its distribution partner, CCrest Laboratories (operating as Shaman Pharma, “Shaman”) have received an authorization to provide a number of its LaNeo MDMA capsules to a Canadian physician for treatment of a patient under Health Canada’s Special Access Program. PharmAla has confirmed with Health Canada that this is the first-ever authorization of an MDMA-assisted therapy treatment under the Special Access Program.
“It’s absolutely thrilling to be able to say that our GMP LaNeo MDMA will be used for the treatment of a patient in Canada. Ultimately, that’s what all of our work should be about: improving lives for patients.” said Nick Kadysh, CEO of PharmAla. “This regulatory milestone isn’t about financial impact, but healthcare impact.”
PharmAla and Shaman will not be charging the patient or the physician for the drug product, which will be delivered on a compassionate-use basis. PharmAla will continue making available an amount of drug product for compassionate use under SAP, but ultimately plans to begin charging patients on a cost-recovery basis. Clinicians seeking to make a Special Access Program request for MDMA for their patients should submit a request directly to Health Canada’s Special Access Program.
Alexandre Grenier, CEO of Shaman Pharma, commented: "Working in concert with PharmAla Biotech on this historic authorization, we've marked a significant step in the evolving narrative of MDMA's potential therapeutic applications. But let's be clear: this is not a product promotion. It's a testament to our unwavering dedication to scientific discovery and advancement in patient care. As we take part in this landmark moment alongside PharmAla Biotech, our commitment is not just to follow progress, but actively lead it."
PharmAla is the first publicly traded company to manufacture GMP MDMA, and is the first company to make available to researchers two clinical-grade Psychedelic APIs: its. LaNeo MDMA, and GMP Psilocybin manufactured by Mindset Pharma. Shaman Pharma will be distributing all Special Access Program requests for PharmAla.
PharmAla will be hosting a webinar regarding its newly-formed Joint Venture in Australia, Cortexa, on the evening of May 16, 2023 at 7:00 Eastern Time. Those interested in learning more can register here: https://bit.ly/3MjJA3Q
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.
About Shaman Pharma:
Shaman Pharma Corp. is a catalyst for innovation in healthcare and cognitive improvement, utilizing a robust platform of cutting-edge facilities, world-class scientists, and strong industry partnerships. Our affiliate, CCrest Laboratories Inc., operates as a cGMP laboratory based in Montreal, under the auspices of Health Canada's Controlled Drugs and Substances Dealer's Licence, and pursues significant advancements in the field, demonstrating our unwavering commitment to progress in healthcare.
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.
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