Optimi Health Enters Australian Medical MDMA And Psilocybin Market With Mind Medicine Australia Distribution Agreement
Thursday, March 02, 2023
Optimi Health Corp., an end-to-end Canadian-based drug manufacturer and formulator licensed by Health Canada to produce and supply psychedelic substances such as 3,4-Methylenedioxymethamphetamine (“MDMA”) and GMP-grade psilocybin, is pleased to announce that it has entered into a long-term distribution agreement with Mind Medicine Australia (“MMA”), a leading charitable organization and patient advocacy group seeking to alleviate suffering caused by mental illness in Australia by expanding access to psychedelic assisted therapies in highly regulated clinical environments, to supply its MDMA formulation, OPTI-MHCL, and GMP psilocybin capsules.
Under the signed Purchase Order, Optimi has agreed to export products to Australia by July 1, 2023, when authorized psychiatrists can begin prescribing MDMA and psilocybin for specific mental health conditions through the Authorised Prescriber’s Scheme of the country’s Therapeutic Goods Administration (TGA). The agreement also gives MMA the option to arrange the supply of additional doses as they determine market demand.
Products earmarked for the Australian market will be manufactured, encapsulated, and packaged entirely inside of Optimi’s Health Canada Licensed Facility under GMP compliant protocols, and will follow Health Canada’s Controlled Substances Export laws.
Optimi CEO, Bill Ciprick, says the international distribution agreement represents a historic milestone in the ever-evolving psychedelic industry. He further credits the unprecedented effort of Mind Medicine Australia leaders, Tania de Jong AM and Peter Hunt AM, in bringing about this important change for Australian patients and what he hopes is a tipping point for expanded global regulatory access to psychedelic therapies.
“Australia, much like Canada and other countries exploring psychedelic regulations, is in the midst of a crippling post-Covid mental health crisis,” said Ciprick. “We believe this deal is the first step in fulfilling a higher humanitarian purpose, one which our founders fully support in terms of providing a scalable and affordable product that is accessible to all Australians,” he added.
The Company has been contracted to continue supplying OPTI-MHCL and GMP psilocybin capsules under the arrangements with MMA on an ongoing basis, as Australia begins the implementation of its expanded therapeutic psychedelic access for patients suffering from post-traumatic stress disorders and treatment-resistant depression. Supplies will be coordinated through a network of pharmacists in each State and Territory of Australia and are subject to all regulatory approvals being obtained.
“In the wake of the reclassification on the part of the TGA and with the global interest we’ve seen expressed in its implementation, Mind Medicine Australia has received a steady stream of inquiries from doctors and psychiatrists, academics, prospective patients, and ordinary citizens throughout the country, wondering precisely how and from where these medicines would reach Australian patients by July 1 of this year,” said Mind Medicine Australia Chair Peter Hunt. “It was important for us to establish a long-term partnership with a company that manufactures its products in-house with their own licence. Supply stability is key, and Optimi is the clear leader in that category as the only end-to-end supplier.”
Throughout the Company’s 2022 Year of Commercialization, Optimi maintained steady communication with MMA in anticipation of meaningful developments resulting from the organization’s tireless advocacy on behalf of patients.
Following the February 3, 2023 publication of the Australian Therapeutic Goods Administration’s Final Decision on the “rescheduling of MDMA and psilocybin to enable prescribing by authorised psychiatrists,” Optimi is now able to assure that MMA has the capacity through its supply arrangements to meet the needs of psychiatrists and their patients following this ground-breaking regulatory development.
Further, as part of its plan to provide equitable access to its products under the proposed therapeutic regulations in Australia, Optimi will allocate a percentage of product sales towards a fund managed by MMA to assist low-income earners and others who face systemic barriers to access. Details of the fund, including MMA’s commitment to matching Optimi’s contribution, will be announced in the coming weeks.
Optimi co-founders JJ Wilson, Dane Stevens, and Bryan and Jacob Safarik, along with senior advisor, Mr. Chip Wilson, are pledging the Company’s full operational support.
“To be engaged by an organization such as Mind Medicine Australia to provide access to these medicines for a jurisdiction of tens of millions of people, of which a significant percentage will suffer from treatment resistant PTSD or treatment resistant depression at some point in their lives, is a tremendous validation of the objectives and values with which Optimi Health was founded,” they added. “This is a responsibility of the highest order, and we look forward to delivering on our promise to provide a safe and trusted supply of GMP MDMA and psilocybin for psychiatrists and their treatment resistant patients in Australia. We believe our position as a true end-to-end manufacturer of GMP psychedelic medicines allows us to effectively respond to the call for safe supply from MMA.”