PurMinds(TM) NeuroPharma Awarded Synthetic Psilocybin API Import Permit from Health Canada to Develop GMP-Compliant Psychedelic Drug Product Formulations for Clinical Trial Supply

October 11, 2023 9:04 AM EDT | Source: PurMinds NeuroPharma

Toronto, Ontario and Boston, Massachusetts--(Newsfile Corp. - October 11, 2023) - PurMinds NeuroPharma ("PurMinds™" or the "Company"), a clinical-stage neuroscience company focused on neurological and neurodegenerative disorders and advancing a robust clinical development pipeline of small molecules, psychedelic compounds and other modalities, is pleased to announce that under its Health Canada Schedule 1 Dealer's License for Controlled Drugs and Substances ("Dealer's License"), it has been awarded its first Psychedelic Import Permit from the Controlled Substances Directorate of Health Canada.

Revenue Producing Activities
PurMinds™ Dealer's License authorizes the production, formulation and global supply of psychedelic compounds, and the Company's newly awarded Import Permit allows for the legal importation of synthetic psilocybin active pharmaceutical ingredient (API) from PurMinds™ US-based API supplier to its Ontario-based neurolab and production facility. This import will be closely followed by the completion of upgrades to the facility's drug substance formulation suite to fulfill International GMP requirements, and by the subsequent launch of PurMinds™ in-house psychedelic drug product formulation activities, which will ensure sufficient inventory to provide a legal, reliable supply of GMP-compliant, standardized, pharma-grade synthetic formulations of Psilocybin and MDMA in finished dosage forms for use as an investigational drug product in authorized clinical trials and research studies worldwide.

With MDMA therapy inching closer to receiving FDA approval, Alberta's regulation of psychedelic drugs for therapeutic use, and Australia's drug policy reform to reschedule MDMA and psilocybin, PurMinds™ anticipates a surge in the demand for investigatory psychedelic drug sales. "These pivotal legislative reforms present a large growth opportunity for the Company that should greatly accelerate the pathway to positive cash flow," said Robin Shugar, J.D., Chief Commercial Officer and General Counsel. "As one of the very few, licensed psychedelic mushroom cultivation and investigational drug product production facilities worldwide, and with a strong focus on safety, efficacy, and accessibility, PurMinds is ideally positioned to be at the forefront of clinical trial psychedelic drug product supply."


PurMinds™ is a neurological drug development company pursuing breakthrough solutions to neurological and neurodegenerative disorders. Its clinical pipeline includes innovative therapeutics that combine proven mechanisms of action with the powerful ability of psychedelics and other psychoplastogens to rapidly promote neuroplasticity and neuro-rejuvenation, and its drug development program includes the potential for FDA "Breakthrough Designation" with a fast track to Phase IIa. The company's Ontario NeuroLab and Production Facility was granted a Schedule 1 Health Canada Controlled Drugs and Substances Dealer's License authorizing the production, formulation and global supply of pharma-grade Psychedelic compounds including Psilocybin and MDMA for clinical trials and research studies. PurMinds™ champions a de-risked business model that includes a multi-target approach to drug development, progressing short and mid-term revenue paths accompanied by long-term value creation through the accelerated development of novel therapeutics. For further information about PurMinds™ NeuroPharma, please visit the Company's website at PurMinds.com.

Media Contacts
Kristina Spionjack
HLTH Communications

Forward-Looking Statements
This press release contains forward-looking statements. Forward-looking statements are based on the opinions and estimates of management at the date the statements are made and are subject to known and unknown risks, uncertainties and assumptions and accordingly, actual results and future events could differ materially from those expressed or implied in such statements. You are hence cautioned not to place undue reliance on forward-looking statements. All statements other than statements of present or historical fact are forward-looking statements, including statements with respect to PurMinds™' future business plans and partnerships. Forward-looking statements include words or expressions such as "proposed", "anticipated", "will", "subject to", "near future", "in the event", "would", "expect", "prepared to" and other similar words or expressions and include, but are not limited to: the ability of PurMinds™ to secure patent protection; the regulatory environment in which PurMinds™ operates; the ability of PurMinds™ to carry out its business plans and unforeseen challenges in carrying out such plans; trends in the future use of psychedelics; general business, economic, competitive, political and social uncertainties; the state of capital markets; and other unforeseen events, developments, or factors causing any of the aforesaid expectations, assumptions, and other factors ultimately being inaccurate or irrelevant. The forward-looking information contained in this news release is expressly qualified by this cautionary statement. We disclaim any obligation to update or revise these forward-looking statements, except as required by applicable law.

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