There has been no shortage of signs that Canopy Growth Corporation is steering off the course set out for it by co-founders and former co-CEOs Bruce Linton and Mark Zekulin. Perhaps the biggest has been current CEO David Klein’s admission that the company will no longer pursue the development of pharmaceutical-grade cannabis products.
Speaking to investors, analysts, and media at a virtual event in June, Klein said: “We’re going to track away from pure pharmaceutical drug development. I don’t think that’s our sweet spot. It is quite costly and takes a long time.”
Klein noted the difficulty of obtaining drug identification numbers (DINs), which require extensive clinical research and trials. In Canada, which continues to be Canopy’s primary marketplace, DINs are required to list products as drugs under the federal Food and Drug Act and to sell products as either prescription or over-the-counter (OTC) medications. As set out by Health Canada, a DIN informs users that the product has undergone and passed a review of its formulation, labeling, and instructions for use.
In the US, prospective prescription pharmaceuticals must be tested and the results submitted for approval by the Center for Drug Evaluation and Research, which operates under the Federal Food and Drug Administration (FDA). Medications intended for OTC dispensing also fall under FDA approval, but the process is aimed at proving safety and effectiveness, and was significantly streamlined under the Over-the-Counter Monograph Safety, Innovation, and Reform Act, which President Donald Trump signed into law in March.
Klein said Canopy will continue a small amount of research aimed at creating OTC products for the US market.
Klein’s announcement marks a significant shift from the company’s focus on efforts to develop “diversified treatment options for Canadians and for patients and consumers in other (legal) jurisdictions.”
The company has invested heavily in clinical research through its Spectrum Therapeutics subsidiary, as well as through the Canopy Innovation Lab, Apollo Applied Research, and Scientus Pharma.
Currently, there are an estimated 60 clinical trials related to cannabis underway in Canada.