- Creso Pharma’s target acquisition firm Halucenex has signed a consultancy agreement with HeteroGeneity to support US expansion for psilocybin products.
- With this deal, HeteroGeneity will assist Creso and Halucenex with the required regulatory approvals in the US.
- The agreement represents an important first step in Halucenex’s strategy to enter the US psychedelics market, which offers a considerable opportunity for Creso Pharma.
- The HeteroGeneity agreement also allows Creso to commence discussions with large-scale pharmaceutical players over licensing agreements.
Creso Pharma’s (ASX:CPH, FRA:1X8) acquisition target Halucenex Life Sciences Inc has marked a significant first step in its strategy to enter the US market by signing a consultancy agreement with US-based HeteroGeneity LLC, a renowned consultancy and scientific management organisation.
The agreement will help Halucenex move forward with its US market entry strategy for the licensing and use of botanical psilocybin compounds and products. The two parties will look at all the requirements for a potential US market launch.
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Terms of the Agreement
- As part of the deal, Halucenex and HeteroGeneity will perform a technology assessment to advance the development plan for a new botanical drug for the US market.
- The evaluation will comprise advisory for clinical indications, manufacturing and formulation, sourcing, regulatory status of proposed ingredients, as well as the compilation of supporting data and IP (intellectual property) considerations.
- HeteroGeneity will be paid on an hourly basis, and the agreement may be terminated without any specific reason by either party upon giving a 30-day written notice.
Halucenex seeks FDA nod for botanical psilocybin
Halucenex is looking forward to securing the Food and Drug Administration (FDA) approval for its botanical psilocybin products, with its defined strategy.
With the agreement, HeteroGeneity will assist Creso and Halucenex with any required regulatory authorisations in the US. Besides, it will also allow Creso Pharma to commence negotiations with large-scale pharmaceutical players about licensing deals for its extracts and psychedelic compounds.
Halucenex has built a market-leading team of consultants and strategic partners ahead of its imminent Phase 2 clinical trial, evaluating the effects of psilocybin on Treatment-Resistant Depression in Post-Traumatic Stress Disorder (PTSD) in war veterans.
Halucenex’s strategic partners will provide a substantial competitive advantage as it progresses its clinical studies and moves forward with the US market entry strategy, subject to required legislative reform.
HeteroGeneity in a nutshell
- HeteroGeneity is a US-based consultancy and scientific management organisation.
- The group provides strategic and technical assistance to companies conducting R&D and commercialising biologics, drugs, and medical devices for the US and Canadian markets.
- The scientific consultancy specialises in the policy, regulation, and science of complex and heterogeneous products.
- The group also focuses on unique use areas for traditional medicine practice and historically complex products.
- HeteroGeneity has been instrumental in assisting several players in achieving the New Drug Approval Applications for the US market through the FDA.
Halucenex Founder and CEO Mr Bill Fleming commented:
Adding to this, Adam Blumenthal, Non-executive Chairman of Creso, said:
On 26 May 2021, CPH shares were trading at AU$0.135 at AEST 03:33 PM.