Article content material

The announcement follows a nationwide reclassification of MDMA and psilocybin for therapeutic makes use of in Australia because of the years-long effort of Thoughts Medication Australia and its devoted supporters

Highlights: 

Article content material

Article content material

VANCOUVER, British Columbia, March 01, 2023 (GLOBE NEWSWIRE) — Optimi Well being Corp. (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN) (“Optimi” or the “Firm”), an end-to-end Canadian-based drug producer and formulator licensed by Well being Canada to provide and provide psychedelic substances equivalent to 3,4-Methylenedioxymethamphetamine (“MDMA”) and GMP-grade psilocybin, is happy to announce that it has entered right into a long-term distribution settlement with Thoughts Medication Australia (“MMA”), a number one charitable group and affected person advocacy group searching for to alleviate struggling attributable to psychological sickness in Australia by increasing entry to psychedelic assisted therapies in extremely regulated medical environments, to produce its MDMA formulation, OPTI-MHCL, and GMP psilocybin capsules.

Article content material

Underneath the signed Buy Order, Optimi has agreed to export merchandise to Australia by July 1, 2023, when licensed psychiatrists can start prescribing MDMA and psilocybin for particular psychological well being situations via the Authorised Prescriber’s Scheme of the nation’s Therapeutic Items Administration (TGA). The settlement additionally offers MMA the choice to rearrange the provision of extra doses as they decide market demand.

Merchandise earmarked for the Australian market will likely be manufactured, encapsulated, and packaged solely within Optimi’s Well being Canada Licensed Facility below GMP compliant protocols, and can observe Well being Canada’s Managed Substances Export legal guidelines. 

Optimi CEO, Invoice Ciprick, says the worldwide distribution settlement represents a historic milestone within the ever-evolving psychedelic trade. He additional credit the unprecedented effort of Thoughts Medication Australia leaders, Tania de Jong AM and Peter Hunt AM, in bringing about this necessary change for Australian sufferers and what he hopes is a tipping level for expanded international regulatory entry to psychedelic therapies.

Article content material

Article content material

“Australia, very similar to Canada and different international locations exploring psychedelic rules, is within the midst of a crippling post-Covid psychological well being disaster,” stated Ciprick. “We consider this deal is step one in fulfilling a better humanitarian goal, one which our founders absolutely assist by way of offering a scalable and reasonably priced product that’s accessible to all Australians,” he added. 

The Firm has been contracted to proceed supplying OPTI-MHCL and GMP psilocybin capsules below the preparations with MMA on an ongoing foundation, as Australia begins the implementation of its expanded therapeutic psychedelic entry for sufferers affected by post-traumatic stress problems and treatment-resistant despair. Provides will likely be coordinated via a community of pharmacists in every State and Territory of Australia and are topic to all regulatory approvals being obtained.

Article content material

“Within the wake of the reclassification on the a part of the TGA and with the worldwide curiosity we’ve seen expressed in its implementation, Thoughts Medication Australia has acquired a gentle stream of inquiries from docs and psychiatrists, lecturers, potential sufferers, and odd residents all through the nation, questioning exactly how and from the place these medicines would attain Australian sufferers by July 1 of this yr,” stated Thoughts Medication Australia Chair Peter Hunt. “It was necessary for us to ascertain a long-term partnership with an organization that manufactures its merchandise in-house with their very own licence. Provide stability is essential, and Optimi is the clear chief in that class as the one end-to-end provider.”

Article content material

All through the Firm’s 2022 Yr of Commercialization, Optimi maintained regular communication with MMA in anticipation of significant developments ensuing from the group’s tireless advocacy on behalf of sufferers.

Following the February 3, 2023 publication of the Australian Therapeutic Items Administration’s Closing Resolution on the “rescheduling of MDMA and psilocybin to allow prescribing by authorised psychiatrists,” Optimi is now in a position to guarantee that MMA has the capability via its provide preparations to fulfill the wants of psychiatrists and their sufferers following this ground-breaking regulatory improvement.

Additional, as a part of its plan to supply equitable entry to its merchandise below the proposed therapeutic rules in Australia, Optimi will allocate a share of product gross sales in the direction of a fund managed by MMA to help low-income earners and others who face systemic boundaries to entry. Particulars of the fund, together with MMA’s dedication to matching Optimi’s contribution, will likely be introduced within the coming weeks.

Article content material

Optimi co-founders JJ Wilson, Dane Stevens, and Bryan and Jacob Safarik, together with senior advisor, Mr. Chip Wilson, are pledging the Firm’s full operational assist.  

“To be engaged by a corporation equivalent to Thoughts Medication Australia to supply entry to those medicines for a jurisdiction of tens of tens of millions of individuals, of which a major share will endure from remedy resistant PTSD or remedy resistant despair sooner or later of their lives, is an incredible validation of the targets and values with which Optimi Well being was based,” they added. “This can be a accountability of the best order, and we stay up for delivering on our promise to supply a secure and trusted provide of GMP MDMA and psilocybin for psychiatrists and their remedy resistant sufferers in Australia. We consider our place as a real end-to-end producer of GMP psychedelic medicines permits us to successfully reply to the decision for secure provide from MMA.”

Article content material

A joint briefing will likely be held on-line this Thursday, March 2 at 4:00 p.m. EST. Media and different events could be a part of the reside broadcast right here.

FOR INTERVIEW REQUESTS OR FURTHER INFORMATION PLEASE CONTACT:

Michael Kydd
Optimi Well being, Investor & Public Relations
[email protected]
Cellphone: +1 (902) 880 6121
www.optimihealth.ca

Peter Hunt AM
Chair, Thoughts Medication Australia
[email protected] 

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

Optimi Well being Corp. is an end-to-end Canadian-based drug producer and formulator licensed by Well being Canada to provide and provide psychedelic substances equivalent to 3,4-Methylenedioxymethamphetamine (“MDMA”) and GMP-grade psilocybin, in addition to purposeful mushrooms that target the well being and wellness markets. Constructed with the aim of manufacturing scalable psychedelic formulations for transformational human experiences, the Firm’s aim is to be the primary trusted, compassionate provider of secure drug merchandise all through the world. Optimi’s merchandise are grown and manufactured at its two amenities comprising a complete of 20,000 sq. toes in Princeton, British Columbia, making it the biggest psilocybin and MDMA producer in North America.

Article content material

Operational Power:

ABOUT MIND MEDICINE AUSTRALIA

Thoughts Medication Australia is a registered Australian charity which exists to assist alleviate the struggling and scale back suicides attributable to psychological sickness in Australia via increasing the remedy choices out there to medical practitioners and their sufferers. We assist the institution and availability of secure and efficient psychedelic-assisted remedies via the Australian medical system to deal with a variety of psychological diseases.

Article content material

Thoughts Medication Australia was based by Australian philanthropists Tania de Jong AM and Peter Hunt AM in 2019. We search to attach medical practitioners, shoppers, academia, authorities, trade, regulatory our bodies, philanthropists, buyers and different stakeholders to facilitate innovation and simpler remedies for psychological diseases in Australia. We’re concerned in consciousness constructing, medical coaching, developments within the college sector and medical trials and within the improvement of enabling ecosystems. Our focus is solely on the alleviation of human struggling.

Thoughts Medication Australia is at the moment targeted particularly on the medical utility of medicinal psilocybin and medicinal MDMA therapies for the remedy of related psychological diseases via the Australian psychological well being system with curiosity within the medical use of different psychedelics as optimistic proof emerges. Our focus is wholly medical.

Article content material

FORWARD-LOOKING STATEMENTS

This information launch incorporates ahead‐trying statements and ahead‐trying data inside the that means of Canadian securities laws (collectively, “ahead‐trying statements”) that relate to Optimi’s present expectations and views of future occasions. Any statements that categorical, or contain discussions as to, expectations, beliefs, plans, targets, assumptions or future occasions or efficiency (typically, however not all the time, via the usage of phrases or phrases equivalent to “will doubtless outcome,” “are anticipated to,” “expects,” “will proceed,” “is anticipated,” “anticipates,” “believes,” “estimated,” “intends,” “plans,” “forecast,” “projection,” “technique,” “goal,” and “outlook”) are usually not historic information and could also be ahead‐trying statements and should contain estimates, assumptions and uncertainties which may trigger precise outcomes or outcomes to vary materially from these expressed in such ahead‐trying statements. No assurance might be on condition that these expectations will show to be appropriate and such ahead‐trying statements included on this information launch shouldn’t be unduly relied upon. These statements converse solely as of the date of this information launch. Specifically and with out limitation, this information launch incorporates ahead‐trying statements pertaining to actions proposed to be carried out below the Firm’s authorized Well being Canada supplier’s licence and related enterprise associated to Psilocybin, Psilocin, different psychedelic substances, some being synthetically formulated, and Optimi’s plans, focus and targets.

Article content material

Ahead‐trying statements are based mostly on various assumptions and are topic to various dangers and uncertainties, lots of that are past Optimi’s management, which may trigger precise outcomes and occasions to vary materially from these which can be disclosed in or implied by such ahead‐trying statements. Such dangers and uncertainties embody, however are usually not restricted to, the impression and development of the COVID‐19 pandemic and different components set forth below “Ahead‐Trying Statements” and “Threat Elements” within the Firm’s Annual data Kind dated January 9, 2023, and different steady disclosure filings out there below Optimi’s profile at www.sedar.com. Optimi undertakes no obligation to replace or revise any ahead‐trying statements, whether or not because of new data, future occasions or in any other case, besides as could also be required by legislation. New components emerge infrequently, and it’s not potential for Optimi to foretell all of them or assess the impression of every such issue or the extent to which any issue, or mixture of things, could trigger outcomes to vary materially from these contained in any ahead‐trying assertion.

Any ahead‐trying statements contained on this information launch are expressly certified of their entirety by this cautionary assertion.