Optimi Health Awarded Drug Establishment Licence From Health Canada

Rhea-AI Summary

Optimi Health has been granted a Drug Establishment Licence (DEL) from Health Canada, allowing the company to manufacture and sell MDMA and psilocybin capsules. This accreditation confirms their compliance with Good Manufacturing Practices (GMP) and enables the global distribution of these drugs, pending export documentation. Optimi plans to register these drugs with the U.S. FDA through Mutual Recognition Agreements (MRAs). The company will provide 160 doses to Australia under the Therapeutic Goods Administration's Authorized Prescriber Scheme. This milestone is expected to enhance Optimi's position in the global psychedelics market, offering comprehensive GMP psychedelic drug solutions for manufacturing, export, and distribution.

Positive

• Optimi Health received a Drug Establishment Licence from Health Canada.
• The company now complies with Good Manufacturing Practices (GMP).
• Optimi can supply MDMA and psilocybin capsules globally, pending export documentation.
• 160 doses have been authorized for initial patient prescriptions in Australia.
• The pre-authorized Australian Psychiatrist Portal launches on June 24, 2024.
• Optimi plans to register these drugs with the U.S. FDA using MRAs.
• This achievement positions Optimi as a leader in the global psychedelics market.

Negative

• The company must await export documentation from Health Canada before global distribution.
• Potential regulatory hurdles in registering drugs with the U.S. FDA.

VANCOUVER, BC, June 3, 2024 /PRNewswire/ - Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN) ("Optimi" or the "Company"), a leading Health Canada-licensed psychedelics pharmaceutical manufacturer specializing in controlled substances such as botanical psilocybin and MDMA, is pleased to announce that it has been awarded a Drug Establishment Licence (DEL) from Health Canada for the manufacturing and sale of its MDMA and psilocybin capsules. This milestone designation affirms a compliant rating for Good Manufacturing Practices (GMP), enabling the Company to supply MDMA and psilocybin capsules to patients with PTSD and Treatment-Resistant Depression under Australia's Authorised Prescriber Scheme, and to regulated jurisdictions globally pending export documentation from Health Canada.

Key Highlights:

• Optimi is officially a GMP-compliant pharmaceutical drug manufacturer after receiving the internationally recognized Drug Establishment Licence for MDMA and psilocybin capsules, and for the fabrication of Active Pharmaceutical Ingredients (API's) extracted from plant sources.
• The Company will now prioritize the registration of both drugs with the U.S. Food and Drug Administration through the implementation of Mutual Recognition Agreements (MRAs).
• Psychiatrists in Australia who are authorized by the Therapeutic Goods Administration (TGA) can request the importation of Optimi's MDMA and psilocybin capsules for use in patients. The available drugs include:
  • MDMA Capsules (40mg and 60mg) for PTSD; and
  • Psilocybin Capsules (5mg) for Treatment-Resistant Depression.
• Optimi was recently issued an import certificate to supply 160 doses of MDMA and psilocybin to fulfill initial patient prescriptions by Mind Medicine Australia.
• The pre-authorized Australian Psychiatrist Portal is expected to launch on June 24th, 2024 to approximately 2,800 psychiatrists.
• The Company can now provide comprehensive GMP psychedelic drug solutions for worldwide drug commercialization, covering manufacturing, export, and distribution.

A Message from The Board of Optimi:

Dear Shareholders,

Obtaining a Drug Establishment Licence (DEL) from Health Canada is a significant milestone in our efforts to build a robust, GMP-compliant company capable of supplying MDMA and psilocybin capsules to regulated markets. This licence, a requirement set forth by Health Canada, now allows us to ship both MDMA and psilocybin capsules as treatment options to Australia to help patients suffering from PTSD and Treatment-Resistant Depression.

It has been imperative for us to deliver on our promise to build the necessary infrastructure, obtain the required licenses, and develop our business to be ready to participate in the global psychedelics market. Optimi possesses capabilities that very few companies in the world have—the ability to commercialize our pharmaceutical-grade psychedelics, starting with Australia.

On a global scale, with the acquisition of the DEL, Optimi can now provide comprehensive GMP psychedelic drug solutions for worldwide drug commercialization, covering manufacturing, export, and distribution. This achievement firmly establishes Optimi as the leader in the rapidly growing psychedelic supply market.

As a shareholder in Optimi, you have helped us bring two drugs to a prescription market for patient use imminently. We believe this licence has tremendous value going forward as markets around the world open, and we thank you for your continued support and confidence in our vision.

Everyone at Optimi looks forward to sharing more successes with you as we advance our mission to be a global leader in psychedelics.

Thank you,

On Behalf of the Board of Directors

JJ Wilson
Chairman of the Board

ABOUT OPTIMI (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN)

Optimi Health Corp. is a leading Health Canada licensed psychedelics pharmaceutical manufacturer, specializing in controlled substances such as psilocybin and MDMA, 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. forward-looking statements made in this news release include the proposed use of the proceeds of the Offering. 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. 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.

Neither the Canadian Securities Exchange nor the Investment Industry Regulatory Organization of Canada accepts responsibility for the adequacy or accuracy of this release.

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SOURCE Optimi Health Corp.

FAQ

What is the significance of Optimi Health receiving a Drug Establishment Licence from Health Canada?

This licence allows Optimi Health to manufacture and sell MDMA and psilocybin capsules globally, confirming their compliance with Good Manufacturing Practices (GMP).

What drugs can Optimi Health now supply with the new licence?

Optimi Health can supply MDMA capsules (40mg and 60mg) for PTSD and psilocybin capsules (5mg) for Treatment-Resistant Depression.

When will the Australian Psychiatrist Portal launch?

The pre-authorized Australian Psychiatrist Portal is expected to launch on June 24, 2024.

How many doses are authorized for initial patient prescriptions in Australia?

160 doses of MDMA and psilocybin have been authorized for initial patient prescriptions in Australia.

What are Optimi Health's plans for the U.S. market?

Optimi plans to register their MDMA and psilocybin capsules with the U.S. FDA through Mutual Recognition Agreements (MRAs).

What does the Drug Establishment Licence mean for Optimi Health's global market position?

The licence enhances Optimi Health's position in the global psychedelics market, allowing them to offer comprehensive GMP psychedelic drug solutions for manufacturing, export, and distribution.