Strategic licensing plan prepares Company for future regulatory approvals
VANCOUVER, British Columbia, Jan. 19, 2024 (GLOBE NEWSWIRE) -- Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN) (“Optimi” or the “Company”), a Health Canada licensed drug researcher and formulator specializing in controlled psychedelic substances such as natural psilocybin and MDMA, is pleased to announce it has been granted an amendment to its Health Canada Controlled Drugs and Substances Licence. Effectively implemented on January 16, 2024, the amendment allows substantial increases in the quantities of MDMA, MDA, and 2CB under subsection J.01.059(4) of Part J of the Food and Drug Regulations.
Terms of the amendment now permit the following increases:
- N-METHYL-3,4-METHYLENEDIOXY AMPHETAMINE (MDMA) – from 2kg to 20kg.
- 3,4-METHYLENEDIOXYAMPHETAMINE (MDA) – from 1kg to 2kg.
- 4-BROMO-2,5-DIMETHOXYBENZENE ETHANAMINE (2C-B) – from 400g to 4kg.
The obtained amendment is a crucial component of Optimi's strategy to solidify its position as an industry-leading psychedelics drug manufacturer, strategically positioning itself in anticipation of the potential approval of MDMA by the U.S. Food and Drug Administration in 2024.
Bill Ciprick, Optimi's CEO, underscored the strategic importance of the amendment, stating, "This marks a pivotal achievement in Optimi's strategic licensing plan, positioning us with one of the most robust licensing portfolios globally. It enhances our competitive advantage and perfectly aligns with our vision to be the leading global supplier of GMP MDMA and other psychedelic substances."
In its year end Annual Review, the Company laid out its 2024 strategic licensing plan which includes approvals for a Drug Master File (DMF) and Drug Establishment Licence (DEL). This critical documentation affirms Optimi’s commitment to regulatory compliance and transparency, laying the foundation for streamlined communication with regulatory authorities and delivering high-quality APIs and controlled substances that meet global standards for pharmaceutical manufacturing and control.
Optimi now has Health Canada approval to manufacture the following controlled substances:
2,5-DIMETHOXYPHENETHYLAMINE
3,4-METHYLENEDIOXYAMPHETAMINE (MDA)
4-BROMO-2,5-DIMETHOXY-N-(2-METHOXYBENZYL)PHENETHYLAMINE (25-BNBOME)
4-BROMO-2,5-DIMETHOXYBENZENE ETHANAMINE (2C-B)
4-CHLORO-2,5-DIMETHOXY-N-(2METHOXYBENZYL)PHENETHYLAMINE(25C-NBOME)
4-HYDROXYBUTANOIC ACID (GHB)
4-IODO-2,5-DIMETHOXY-N-(2-METHOXYBENZYL)PHENETHYLAMINE (25I-NBOME)
HARMALINE
HARMALOL
KETAMINE
LYSERGIC ACID DIETHYLAMIDE (LSD)
MESCALINE
N,N-DIMETHYLTRYPTAMINE (DMT)
N-METHYL-3,4-METHYLENEDIOXY AMPHETAMINE
PHENCYCLIDINE
PSILOCIN
PSILOCYBIN
SALVINORIN A
For media inquiries, please contact Michael Kydd:
michaelk@optimihealth.ca
For investor inquiries, please contact:
investors@optimihealth.ca
www.optimihealth.ca
ABOUT OPTIMI (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN)
Optimi Health Corp. an end-to-end drug researcher and formulator licensed by Health Canada to produce and supply, for clinical research purposes, psychedelic substances such as 3,4-Methylenedioxymethamphetamine (“MDMA”), natural GMP-grade psilocybin, as well as functional mushrooms that focus on the health and wellness markets. Built with the purpose of producing scalable psychedelic formulations for transformational human experiences, the Company’s goal is to be the number one trusted, compassionate supplier of safe drug candidates throughout the world. Optimi’s products are grown and manufactured at its two facilities comprising a total of 20,000 square feet in Princeton, British Columbia.
FORWARD‐LOOKING STATEMENTS
This news release contains forward-looking statements and forward-looking information within the meaning of Canadian securities legislation (collectively, “forward-looking statements”) that relate to Optimi’s current expectations and views of future events. Any statements that express, or involve discussions as to, expectations, beliefs, plans, objectives, assumptions or future events or performance (often, but not always, through the use of words or phrases such as “will likely result,” “are expected to,” “expects,” “will continue,” “is anticipated,” “anticipates,” “believes,” “estimated,” “intends,” “plans,” “forecast,” “projection,” “strategy,” “objective,” and “outlook”) are not historical facts and may be forward-looking statements and may involve estimates, assumptions and uncertainties which could cause actual results or outcomes to differ materially from those expressed in such forward-looking statements. No assurance can be given that these expectations will prove to be correct and such forward-looking statements included in this news release should not be unduly relied upon. These statements speak only as of the date of this news release.
Forward-looking statements are based on a number of assumptions and are subject to a number of risks and uncertainties, many of which are beyond Optimi’s control, which could cause actual results and events to differ materially from those that are disclosed in or implied by such forward-looking statements. Such risks and uncertainties include, but are not limited to, the impact and progression of the COVID-19 pandemic and other factors set forth under “Forward-Looking Statements” and “Risk Factors” in the Company’s Annual Information Form dated January 9, 2023, and other continuous disclosure filings available under Optimi’s profile at www.sedarplus.ca. Optimi undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law. New factors emerge from time to time, and it is not possible for Optimi to predict all of them or assess the impact of each such factor or the extent to which any factor, or combination of factors, may cause results to differ materially from those contained in any forward-looking statement.
Any forward-looking statements contained in this news release are expressly qualified in their entirety by this cautionary statement.
