Creso Pharma Limited (ASX:CPH, OTC:COPHF, FRA:1X8) (‘Creso Pharma’ or ‘the Company’) is
pleased to advise that wholly-owned, Canadian based psychedelics company, Halucenex Life Sciences
Inc. (“Halucenex”) has secured an amendment to its Controlled Drugs and Substances Dealer’s Licence
from Health Canada (“Dealer’s Licence”) on 29 November 2021 (refer ASX announcement: 16 August
2021).
The amendments allow the Company to now produce, package and assemble psychedelic substances
including psilocybin, ketamine, LSD, salvia divinorum, harmaline, salvinorin A, and MDMA amongst
others (“Approved Controlled Substances”).
The additions follow the receipt of an initial Dealer’s Licence in August 2021, allowing Halucenex to
possess, sell, transport, deliver and conduct R&D on the Approved Controlled Substances. The final
amendments provide Creso Pharma with the most comprehensive approvals that can be awarded by
Health Canada in relation to controlled substances.
Following the receipt of the amendments, Halucenex intends to commence the growing of its own
botanical psilocybin and manufacturing of synthetic psilocybin. This will allow for detailed
comparative studies, formulation testing, internal clinical trials, additional extraction opportunities
and the sale of finished goods and products to other licenced dealers unlocking another potential
revenue stream for the Company.
Given the supply bottleneck of psilocybin for research purposes, Halucenex is witnessing a high level
of demand for both botanical and synthetic psilocybin and has fielded a number of enquiries from
potential customers. Once growing and formulation processes are complete, Halucenex will be well
placed to progress the sale of its products to other licenced dealers across Canada. This is expected to
unlock an additional revenue stream for the Company.
Further, should the legislation regarding the use of psilocybin and other controlled substances change,
Halucenex would be able to provide both synthetic and botanic psilocybin to doctors, clinics and
patients for medical purposes.
Halucenex will also be able to conduct more in-depth R&D on both its own botanic and synthetic
psilocybin. This will include extraction studies, product formulation and genetic studies, allowing the
Company to gain a much better understanding of psilocybin-based Active Pharmaceutical Ingredients
and how these can be used across multiple delivery methods.
The Company is confident that further in-house studies will add to the growing body of evidence for
the use of psilocybin and may lead to potential shifts towards reimbursement from large regulatory
and government bodies. The ongoing R&D will also assist Halucenex to cater specific formulations for
potential licencing and joint venture opportunities.
The licence amendment will provide a strong basis for the Company to lodge its Clinical Trial
Authorisation with Health Canada to progress its planned phase II clinical trial to test the efficacy of
psilocybin on treatment resistant Post Traumatic Stress Disorder (PTSD). The Company continues to
work through the application and expects to lodge the application with the regulatory body in the
coming weeks.
The amended Dealer’s Licence will be valid until 31 August 2022 and thereafter, be subject to Health
Canada’s standard licence renewal process, which in is line with Health Canada’s standard policies.
Further details on the scope of the Dealer’s Licence are set out in the Company’s release dated 16
August 2021
Halucenex CEO and Founder Mr Bill Fleming, added: “To be awarded the final components of our
Dealer’s Licence from Health Canada is a major achievement for Halucenex. It follows extensive reviews
of documentation and site security from the regulator, illustrating the high standard of our operations.
“The amendments provide Halucenex with the most comprehensive licence it could possibly obtain at this
stage and is anticipated to unlock significant competitive advantages. We will now begin the steps
towards synthetic psilocybin manufacture and botanical psilocybin growing immediately. Both of these
initiatives have the potential to deliver a number of commercial and R&D benefits and will shape future
product development, clinical trials and potential licencing agreements. Further, this will allow the
Company to leverage its extraction facilities and begin working towards completing our clinical trial
authorisation with Health Canada.
”This development has placed us ahead of some of our competition and we look forward to expediting a
number of activities to drive growth.”
This announcement has been authorised for release by the Board of Directors of Creso Pharma
Limited.
For further information, please contact:
Investor Enquiries
Creso Pharma Limited
E: info@cresopharma.com
P: +61 (0) 497 571 532
Creso Pharma Limited (ASX:CPH) brings the best of cannabis to better the lives of people and animals.
It brings pharmaceutical expertise and methodological rigor to the cannabis world and strives for the
highest quality in its products. It develops cannabis and hemp derived therapeutic, nutraceutical, and
life style products with wide patient and consumer reach for human and animal health.
Creso Pharma uses GMP (Good Manufacturing Practice) development and manufacturing standards
for its products as a reference of quality excellence with initial product registrations in Switzerland. It
has worldwide rights for a number of unique and proprietary innovative delivery technologies which
enhance the bioavailability and absorption of cannabinoids. To learn more please visit:
www.cresopharma.com
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