Creso Pharma’s (ASX: CPH) soon-to-be-subsidiary Halucenex Life Sciences Inc has inked a deal with US-based scientific consultancy HeteroGeneity LLC to progress a US market entry strategy for its range of botanical psilocybin products and compounds.
Under the terms of the agreement, the companies will conduct a technology assessment to progress a US market development plan for a botanical drug currently under pharmaceutical development.
The assessment will include advisory around clinical indications; regulatory status of proposed ingredients; sourcing, manufacturing and formulation; compilation of supporting data; and intellectual property considerations.
Important first step
Halucenex chief executive officer Bill Fleming said the agreement marks an important first step in the Canadian company’s approach to the US market.
“The US is set to become the most important and lucrative market for psychedelic medicines as an alternative treatment, so it is imperative that [we] begin to plan our market entry now,” he said.
“We are confident that HeteroGeneity is the right partner to assist us moving forward, given its track record with FDA approvals for new drugs, medical devices and treatments [and] we look forward to working with the group to establish the immediate requirements for this new market.”
Mr Fleming said HeteroGeneity’s local experience would help in obtaining regulatory approvals and progressing licencing discussions with large-scale pharmaceutical companies.
HeteroGeneity provides strategic and technical assistance to clients looking to commercialise new drugs, biologics and medical devices for the US and Canadian markets.
The group specialises in the regulation, policy and science of complex, heterogeneous mixtures and addresses novel use areas for products from traditional medicine practice, as well as other naturally or historically-complex products.
HeteroGeneity markets itself as a “virtual research and development” arm of client companies, bringing together experts from areas such as botany, pharmacology, pharmacognosy, toxicology, microbiology, chemistry and compliance.
It has been instrumental in assisting a number of companies achieve new drug approvals through the US Food and Drug Administration (FDA).
US market value
Psychedelic-assisted therapy is a relatively new alternative treatment route which has shown considerable promise when used in medical settings.
The US psychedelic therapeutic drug market is expected to reach a total value of $8.62 billion by 2027.
Mr Fleming believes forthcoming results from Halucenex’s Phase II clinical trial into the efficacy and safety of psilocybin (the active ingredient in magic mushrooms) in individuals with treatment-resistant post-traumatic stress disorder will give the company “considerable competitive advantage”.