Toronto, ON March 10, 2025 - PharmAla Biotech Holdings Inc. (“PharmAla” or the “Company”) (CSE: MDMA) (OTC:MDXXF), a biotechnology company focused on the research, development, and manufacturing of novel MDXX class molecules (including its LaNeo™ MDMA), is excited to announce that it has signed a distribution agreement with Duchefa Farma B.V. (“Duchefa”) of Haarlem, Netherlands, to act as exclusive distribution agent for its LaNeo MDMA in the Netherlands market.
“Last year, the Dutch State Commission on MDMA made a strong recommendation that the Government of the Netherlands allow for the use of MDMA in the Dutch healthcare system,” said Marten Teves, Owner, Duchefa Farma. “We believe that PharmAla is the most diligent and reputable manufacturer of pharmaceutical MDMA in the world, and are proud to exclusively partner with them to bring this drug to the EU where it can help Dutch patients.”
The distribution agreement includes an annual purchase minimum, as well as restrictions on re-export and price controls. It also includes an escalator provision which would significantly increase the minimum purchase amounts in the 24 months following regulatory changes which allow for use of MDMA in the healthcare system. Duchefa will also act as Importer of Record as well as providing Qualified Person (“QP”) Release of PharmAla’s products; under EU regulations, QP release is necessary prior to use of a drug product in either commercial use or in clinical trial.
“We are confident that this deal will open significant new opportunities for both Duchefa and PharmAla. This is the first new market we have officially opened since entering Australia in late 2023,” said Nick Kadysh, CEO, PharmAla Biotech. “In looking for a partner we can rely on, we were pleased to see that Duchefa has not only an incredible presence in the Netherlands, but exceptional relationships with partners from the Galenos Group across Europe. We are excited to fulfill the demand for clinical trial materials in the Netherlands, and to assist in pushing the Government of the Netherlands towards greater acceptance of MDMA-Assisted Therapy for the treatment of PTSD.”
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