While many Canadian medical cannabis outfits cover the entire value chain, from research and development through to manufacturing and distribution, others – such as Canopy Health and Tetra Bio-Pharma – are taking their cues from the biotechnology industry and strictly focusing on clinical trials.
I believe that across the board, pharma players should be looking into the field of cannabis and cannabinoids and if they are not, they are missing a huge opportunity
Marc Wayne, Canopy Health
Large pharmaceutical companies are often wary of the inflated costs and risks associated with early-stage clinical research, especially in complex fields such as biotechnology. Marc Wayne, CEO of Canopy Health, the R&D arm of Canopy Growth, feels the same is true in the cannabinoid-based medicines industry and is pushing his organization to fulfil an equivalent role. He notes, “Similar to traditional biotech, Canopy Health, as a specialty pharma-type play, aims to take away some of the risk associated with early stage clinical testing for larger pharma companies. We are dedicated to carrying out the Phase I and robust regulatory scale Phase II clinical work.”
Wayne continues, “We believe that pharma companies will become much more receptive to taking a Phase III ready asset through final development and would be open to discussing potential partnerships with larger companies on later stage projects. I believe that across the board, pharma players should be looking into the field of cannabis and cannabinoids and if they are not, they are missing a huge opportunity.”
Wayne further underlines the similarities and synergies between traditional pharma and biotech and the emergent cannabinoid industry, pointing out that “Drug development is expensive but also quite valuable. An approved drug with protection commands strong valuations. An approved cannabis medicine in our view is no different. However, cannabis is also unique in this regard. We believe the path to proving safety and efficacy will be shorter and in fact, less risky than traditional synthetic molecules.”
Another Canadian company focused on cannabis research rather than production is Tetra Bio-Pharma, which aims to be the first Canadian pharmaceutical company to launch a cannabis-based drug in breakthrough pain. Bernard Fortier, Tetra’s CEO, explains the company’s lofty ambitions. “Tetra Bio-Pharma wants to be the first company to see a dried cannabis drug become a real prescription drug,” he proffers. “We are on the best way with our PPP001 drug for cancer-related pain that has just been approved for Phase III trial, which promises to be a landmark trial.”
Tetra has seen significant success in recent months, with Fortier declaring that “a major milestone was achieved in March 2018, when the FDA granted our PPP001 orphan drug designation for the treatment of complex regional pain syndrome. Not only will this give Tetra Bio-Pharma seven-year marketing exclusivity following approval, but it is also the first time that a cannabis-based product has been granted this designation.” With such a breakthrough into the established pharmaceutical world, Fortier is perhaps justified in proclaiming that “We can definitely sense that we are on the verge of disruption in the medical cannabis industry.”