A Canadian biotechnology organization has recently celebrated a historic milestone and signed a substantial contract agreement with a party choosing to remain anonymous.
On Wednesday, PharmAla Biotech Inc. (CSE: MDMA) proudly announced that it was now the only publicly traded company producing GMP MDMA at a considerable scale, and on Monday, the company revealed that it had been selected as the MDMA manufacturing partner for a “major” Australian research institute’s Phase 3 Clinical Trial.
PharmAla now believes that it is the only reliable source for GMP MDMA aside from the Multidisciplinary Association for Psychedelic Studies (MAPS), and the new Australian contract will be valued at approximately US$175,000.
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PharmAla is a company that claims to have created a one-of-a-kind cGMP MDMA value chain business model unique within North America. That value chain is said to involve GMP production of active pharmaceutical ingredients (APIs) along with drug product formulation. The biotechnology outfit is also involved with pre-clinical and proof-of-concept studies for other psychoactive compounds.
With the release of the company’s first large-scale batch of clinical-grade LaNeo MDMA, PharmAla says its value chain is equipped to support clinical trial customers and partners internationally.
Photo via PharmAla Biotech – Plastic bottle containing clinical-grade MDMA
“After a year of intensive work, we’re thrilled to be able to announce this historic milestone for the company. As the only GMP MDMA manufacturer in the Americas, we’re excited to do our part to alleviate the global backlog of clinical-grade MDMA,” said Nick Kadysh, CEO of PharmAla Biotech and Board of Directors Chair at Psychedelics Canada.
“As research into MDMA dramatically increases and a number of countries begin to move to more permissive ‘expanded access’ regimes, PharmAla Biotech is perfectly positioned to continue to support scientific discovery by providing the clinical-grade drug product our research partners need,” added Kadysh.
PharmAla says that the new Phase 3 Trial it will be supplying product to in Australia is the first of its kind. The MDMA will be delivered to the research organization in two portions, with the first anticipated to be received in Q1 next year. The Australian research institute has requested to remain anonymous in order to not adversely impact patient recruitment for its upcoming studies.
“Having completed our value chain for MDMA here in Canada, we’re incredibly pleased to be able to provide it to researchers worldwide. I’m excited to see PharmAla’s LaNeo MDMA be used for such a vital purpose, and we’re glad that our customers continue to find value in our work, alleviating the global supply chain crunch for GMP MDMA,” said Nick Kadysh.
The biotechnology outfit says that its LaNeo MDMA API is scheduled to have an assortment of dosage forms in the near future, beginning with a 40 milligram capsule. The company also says it can be directly compounded by pharmacists wherever local regulations permit.
“Over the past 6 months, we’ve heard endlessly about the global supply chain crisis in Psychedelic molecules. It’s gratifying to now be in a position to assist our partners worldwide by shipping Drug Substance and Product to them, allowing them to get on with their vital research,” said Dr. Shane Morris, Chief Operating Officer at PharmAla.
“We’re confident that, once researchers initiate clinical work with PharmAla’s LaNeo MDMA, it will help drive interest in clinical trials for this impressive drug that several patient groups are urgently requesting.”
