Creso Pharma Ltd (ASX:CPH, OTCQB:COPHF)’s wholly-owned, Canadian-based psychedelics company, Halucenex Life Sciences Inc. has secured an upgrade to its Controlled Drugs and Substances Dealer’s Licence from Health Canada to include production and packaging amendments.
The amendments allow Halucenex to produce, package and assemble psychedelic substances including psilocybin, ketamine, LSD, salvia divinorum, harmaline, salvinorin A, and MDMA.
Halucenex now has the most extensive licence with regards to Controlled Drugs and Substances that can be awarded by Health Canada, which could be a major competitive advantage – with all five possible licence categories now granted.
“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,” Halucenex CEO and founder Bill Fleming said.
“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 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.”
'Grow your own' could lead to revenue streams and customers
Despite internal issues which saw executive director Adam Blumenthal step down from his post and a boardroom shuffle, CPH continues to forge ahead in expanding its product range and global footprint.
This latest development not only enables Halucenex to possess, sell, transport, deliver and conduct R&D on the Approved Controlled Substances, but it also gives them a leg up to commence growing its own botanical psilocybin and manufacturing of synthetic psilocybin.
Detailed comparative studies, formulation testing, internal clinical trials, additional extraction opportunities and the sale of finished goods and products to other licenced dealers are set to follow and could unlock another potential revenue stream.
A supply bottleneck of psilocybin for research purposes has led to a high level of demand for both botanical and synthetic psilocybin and Halucenex has thus fielded a number of enquiries from potential customers.
Sales to progress
When it has completed its growing and formulation processes, Halucenex will be well placed to progress the sale of its products to other licensed dealers across Canada and unlock revenue.
Halucenex is also waiting on legislation regarding the use of psilocybin and other controlled substances that would allow it 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, including extraction studies, product formulation and genetic studies, allowing it to gain a much better understanding of psilocybin-based Active Pharmaceutical Ingredients and how these can be used across multiple delivery methods.
Further in-house studies will also 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 licensing and joint venture opportunities.
Progressing Phase 11 clinical trial
The licence amendment will provide a strong basis for Halucenex 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).
Halucenex is working through its application and expects to lodge it with the regulatory body in the coming weeks.
The amended Dealer’s Licence will be valid until August 31, 2022, and will then be subject to Health Canada’s standard licence renewal process, which in is line with Health Canada’s standard policies.