Being Facilitated Under a Schedule 1 Health Canada Dealer’s License
DENVER, Aug. 18, 2020 (GLOBE NEWSWIRE) — Mydecine Innovations Group, Inc., (CSE:MYCO) (OTC:MYCOF) (FSE:0NFA) (“Mydecine™” or the “Company”) is pleased to announce it is the first organization to exercise its cGMP(₁) capabilities under a special license to legally produce, transfer, sell, and export pharmaceutical-grade psilocybin, naturally derived from whole-mushroom extraction.
Under the coverage of a Health Canada Schedule 1 Controlled Drugs and Substances Dealer’s Licence, Mydecine™ has the full range of capabilities to extract fungi’s natural psychedelic compounds, such as psilocybin and psilocin from certain species of fruiting body mushrooms all the way through to distribution. Mydecine™ also has the ability to conduct the most advanced techniques to produce purified pharmaceutical-grade extract, then legally export its finished byproducts to its various research partners throughout the world, including but not limited to the Imperial College of London and Johns Hopkins University.
The Company is also capable of supporting commercial research institutions with product donations, including charitable contributions to provide its purified extracts and formulations to end-of-life distressed patients. The announcement comes on the heels of a recent landmark decision by Health Canada to permit four terminally ill patients to consume psilocybin mushrooms to ease their distress. This historic decision establishes a precedent that will pave the way for a wider adoption of psilocybin-based therapies.
“Mydecine’s breakthrough to legally supply naturally-sourced psilocybin within our spore-to-sale™ process will be a major advancement for mental therapeutics, due to the fact that these unique psychedelic compounds are both safe and effective for afflictions, such as depression, anxiety, and PTSD,” quoted Damon Michaels, COO and Co-Founder of Mydecine™.
There is still debate as to which is more successful in psychedelic-based treatments between naturally derived psilocybin or the use of a synthetic form. Given Mydecine’s full legal ability to access both types of active compounds, the Company is poised to internally answer that question as well as aid various qualified groups also conducting this type of research. In theory, there are a plethora of added benefits in regard to the entourage effect(₂) of naturally-sourced psilocybin versus the synthetic route. Additionally, Mydecine™ is developing a number of unique API’s(₃) from their naturally-sourced cGMP psychedelic extracts. Mydecine™ will also be conducting R&D to produce novel proprietary formulations by synergizing psychedelic fungi compounds with other various API’s; Mydecine™ will then attach their formulations to their exclusive delivery mechanisms. Mydecine™ plans to utilize these psychedelic medicinal formulations in various clinical environments around the world in aspiration to better the lives of many.
The Company notes that although several international companies and research institutions are permitted to utilize synthesized psilocybin, the process is extremely challenging and cost prohibitive(₄) with a single gram having the price tag of thousands of dollars. Being able to legally extract psilocybin from its natural source, Mydecine™ will hope to reduce these significant costs and improve the scalability of world-class research initiatives and novel therapies.
CEO and Director of Mydecine™, Joshua Bartch stated, “We are extremely grateful to have the ability to provide cGMP psychedelic API’s to qualified organizations, research partners, nonprofits, and clinical groups throughout the globe. We believe the reason current psilocybin-based research initiatives come with a very high cost using inefficiently produced synthetic psilocybin is simply due to a lack of capabilities and legal restraints. Mydecine’s legal capabilities through the dealer’s license will incorporate our range of abilities, which will be valuable for naturally-sourced medicine paired with new-age technology. We believe our achievement is the first-of-its-kind.”
1 Current Good Manufacturing Practices. GMP is a system for ensuring that products are consistently produced and controlled according to the best quality standards.
2 The “entourage effect” is a proposed mechanism by which active compounds act synergistically to modulate the overall effects of multiple active compounds working together to produce a polypharmaceutical medicine.
3 Active Pharmaceutical Ingredient/s are single or poly ingredients in pharmaceutical medicines that are biologically active.
4 Current synthesised psilocybin applied to recent psychedelic research sells for ~$7-10k USD per gram.
About Mydecine Innovations Group Inc.
Mydecine Innovations Group™ is a publicly traded life sciences parent company with offices in Denver, CO and Vancouver, BC. Mydecine™ is dedicated to the development and production of adaptive pathway medicine, natural health products and digital health solutions stemming from fungi. Mydecine’s experienced cross functional teams have the dynamic capabilities to oversee all areas of medicine development, including synthesis, genetic research, import/export, delivery system design, clinical trial execution, through to product commercialization and distribution. By leveraging strategic partnerships with scientific, medical, military, and clinical organizations, Mydecine is positioned at the forefront of psychedelic medicine naturally derived from fungi, therapeutic solutions, and fungtional™ mushroom vitality products. Our portfolio of unified companies, including Mydecine Health Sciences™, Mindleap Health™, and NeuroPharm™ focus on providing innovative and effective options that can provide millions of people with a healthier quality of life.
On behalf of the Board of Directors:
Joshua Bartch, Chief Executive Officer
Charles Lee, Investor Relations
Cynthia Salarizadeh, Public Relations
The Canadian Securities Exchange has neither approved nor disapproved the contents of this news release and accepts no responsibility for the adequacy or accuracy hereof. This news release contains forward-looking statements, which relate to future events or future performance and reflect management’s current expectations and assumptions. Such forward-looking statements reflect management’s current beliefs and are based on assumptions made by and information currently available to the Company. Readers are cautioned that these forward-looking statements are neither promises nor guarantees, and are subject to risks and uncertainties that may cause future results to differ materially from those expected including, without limitation, the availability and continuity of financing, the ability of the Company to adequately protect and enforce its intellectual property, the Company’s ability to bring its products to commercial production, continued growth of the global adaptive pathway medicine, natural health products and digital health industries, and the risks presented by the highly regulated and competitive market concerning the development, production, sale and use of the Company’s products. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such information. These forward-looking statements are made as of the date hereof and the Company does not assume any obligation to update or revise them to reflect new events or circumstances save as required under applicable securities legislation. This news release does not constitute an offer to sell securities and the Company is not soliciting an offer to buy securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. This news release does not constitute an offer of securities for sale in the United States. These securities have not and will not be registered under United States Securities Act of 1933, as amended, or any state securities laws and may not be offered or sold in the United States or to a U.S. Person unless so registered, or an exemption from registration is relied upon.