Shipment marks the first batch of Psychedelic molecules explicitly for the Authorized Prescriber Scheme
VANCOUVER, BC November 7, 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 it has completed its first shipment of MDMA and psilocybin to Cortexa, its 50:50 Australian Joint Venture with Vitura Health Limited (ASX: VIT). This shipment marks the first time that any molecules recently re-scheduled under the Authorized Prescriber Scheme were brought into Australia explicitly for use under that scheme, rather than for clinical trial purposes. The shipment, completed in several parts, includes both psilocybin and MDMA, and contains a both API and finished drug product capsules.
“As the Australian market continues to develop we are seeing significant interest among both clinical trial practitioners and clinic operators who are racing to establish themselves as the most capable actors in the provision of treatments to patients,” said Nick Kadysh, CEO, PharmAla Biotech. “However, when it comes to the provision of pharmaceutical grade medicines which underpin those treatments, I don’t believe there is competition: Cortexa stands as the industry leader in the import, sale and distribution of psilocybin and MDMA for medical purposes.”
The provision of these materials for Cortexa’s commercial use, as well as the transfer of relevant intellectual property to Cortexa, allows for Cortexa to subsequently rely on domestic manufacturing within Australia, rather than imports. This should allow for lower cost-of-goods and a shorter time to market, for these products.
“As PharmAla’s JV partner in Cortexa, we at Vitura Health are proud to continue to lead the industry in the provision of both of GMP grade Psilocybin and MDMA, which will be used in treating patients as soon as possible. However, as almost anyone involved in this industry can attest, the import of these materials presents significant logistical and regulatory challenges.” said Rodney Cocks, CEO of Vitura Health. “That’s why I’m pleased that Cortexa, as demand grows, can embark upon its next logical step, scaling domestic manufacture of GMP grade psilocybin and MDMA to fulfill local demand without the difficulty, cost, and lag of foreign-made materials”
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