PharmAla Continues to Support Clinical Trials as the Foremost Supplier of GMP LaNeo MDMA in Australia.
VANCOUVER, BC August 10th, 2023 -- PharmAla Biotech Holdings Inc. (“PharmAla” or the “Company”) (CSE: MDMA) (OTC:PMBHF), a biotechnology company focused on the research, development, and manufacturing of novel MDXX class molecules (including MDMA), is pleased to announce that is has issued a shipment of its GMP LaNeo MDMA to Mind Medicine Australia, a charity which seeks to alleviate the suffering caused by mental illness in Australia through expanding treatment using psychedelic molecules.
"When MMA approached us a year ago, they did so because they recognized that we were the only entity in the world which had the manufacturing capability – and the operational execution – to deliver MDMA to them along their desired timelines. While the road to this execution wasn’t easy, I’m glad to say that we have delivered,” said Nick Kadysh, Chief Executive Officer of PharmAla. “In the future, we anticipate that Cortexa – our joint venture with Vitura Health – will be more than capable of fulfilling all demand in the Australian market, and without the additional regulatory burden of import/export.”
The contract with Mind Medicine Australia was announced in May of 2022, and is now considered complete. PharmAla remains, at this time, the only publicly traded company in the world to have successfully manufactured GMP MDMA drug product – appropriate for human use – and to have shipped that product to Australia.
Shipment to University of Melbourne
PharmAla is also pleased to announce that it, and its manufacturing partners, have completed shipment of its GMP LaNeo MDMA capsules to the Orygen Institute, affiliated with the University of Melbourne. This shipment represents the first of two shipments which will support a Clinical Trial registered by the Orygen Institute, with the second shipment scheduled for 2024. The contract was previously announced in a press release dated August 22, 2022.
“PharmAla continues to prove that we deliver on our commitments, and do so at the highest levels of regulatory compliance,” said Shane Morris, COO, PharmAla Biotech. “Our best-in-class value chain continues to execute deliveries to customers – even on the other side of the world – and we look forward to expanding our capabilities further in the coming months as Cortexa fully comes online.”
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 a “regulatory first” organization, formed under the principle that true success in the psychedelics industry will only be achieved through excellent relationships with regulators. Our team of dedicated professionals includes regulatory experts, scientists, and biomanufacturing professionals. PharmAla has built what it believes to be North America’s first cGMP MDMA value chain, encompassing GMP manufacturing of Active Pharmaceutical Ingredient (API), and drug product formulation. PharmAla’s research and development unit has also begun preclinical research into two patented Novel Chemical Entities (NCEs) based on MDXX class molecules, with proof-of-concept research currently ongoing at the University of Arkansas Medical School.
Nicholas Kadysh, CEO
press@pharmala.ca