License allows PharmAla to drive revenue and growth while remaining true to its “regulatory first” mission
VANCOUVER, BC - January 25, 2024 - PharmAla Biotech Holdings Inc. (“PharmAla” or the “Company”) (CSE: MDMA) (OTC:MDXXF), a biotechnology company focused on the research, development, and manufacturing of LaNeo™ MDMA and novel derivatives of MDMA (MDXX class molecules), is pleased to announce that it has been granted a Controlled Drugs & Substances Dealer’s License (CDSL) by Health Canada, Canada’s federal health regulator. The CDSL allows PharmAla to offer for sale both 3,4 Methylenedioxymethamphetamine (MDMA) and Psilocybin to those authorized to legally hold these materials.
“PharmAla is breaking new ground in the Canadian market. MDMA-Assisted Therapy is still very new – with PharmAla’s LaNeo™ MDMA having been used for the first time through the Special Access Program (SAP) in May of 2023 – and while the potential benefits are significant, its application must be made in a careful and reasonable way,” said Dr. Shane Morris, COO of PharmAla Biotech. “Over the past number of months, we have been working with Health Canada officials, we are pleased and grateful that they have both understood and seen the validity of our goals in ensuring supply of regulated, secure, clinical-grade MDMA drug product to patients deemed appropriate by the SAP. This license will assist in that process by allowing PharmAla to educate relevant stakeholders about our products.”
PharmAla’s CDSL allows the Company to communicate directly with appropriate individuals about its MDMA and Psilocybin offerings. At this time, PharmAla will not change its business model regarding physically holding these materials, and will continue to rely on licensed partners to physically hold and distribute the materials as required.
“The granting of this License is an important milestone for our LaNeo™ MDMA business here in Canada, and absolutely critical for the many potential Special Access Program patients who could benefit significantly from MDMA-Assisted Therapy,” said Nick Kadysh, CEO, PharmAla Biotech. “This license could drive revenue growth for the Company, and allow us to educate potential prescribers on the relevant science behind LaNeo™ and MDMA Therapy. In the long run, we believe that the focus on execution as a Regulatory First company, and our unwavering focus on patient outcomes, is what will differentiate us from others in the field.”
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