Research on the endocannabinoid system is one of the most promising avenues for new therapeutics in medicine at the moment. However, changing regulations and advances in cannabinoid research mean the ground is constantly shifting beneath the feet of operators in the cannabis industry. The ability of scientists and businesses to serve patients depends, in no small part, on their capacity to navigate a changing landscape of governance and new cannabis therapeutics. The Pharmaceutical Cannabis Report: 2nd Edition has been compiled to assist interested parties in understanding the market for the medical use of cannabinoids and where it may be heading.
The vast majority of medical cannabis used to date has been in the form of products such as flower and oils which have not been approved through the traditional clinical trials process. Instead, medical cannabis products have largely reached patients via special access pathways which allow for medically supervised treatment, in the absence of clinical trial results, for a given cannabinoid product. This system has allowed for the delivery of regulated, safe products to patients who might otherwise have sourced cannabis from the black market. However, the current system of regulation, e.g. in Europe and North America, raises issues around the precision of dosing, and the certainty around use of certain strains of cannabis for certain conditions.
There are two concurrent trends in the regulation of cannabis in many western states which will affect the balance of fully authorised and medical cannabis products. The first is that many regions are moving towards the use of more precise medical cannabis products such as extracts and pharmaceuticals. For example, the graph below shows how the popularity of oils in Canada potentially comes at the expense of cannabis flower use, and a similar trend can be seen in some European nations. There is a notable exception in that flower is maintaining its dominant position in most medical markets in the United States.
The second trend is the progress of adult-use cannabis legalisation which is already drawing some medical cannabis patients in, and will probably distil the population of patients down to those who are predominantly medical users.
As opposed to the use of unapproved medical cannabis products, the use of pharmaceutical cannabinoid products is on the rise globally. These are products such as Sativex® and Nabilone® which have been guided through the standard clinical trials process in order to be fully approved by bodies such as the Food and Drug Administration (FDA) in the United States and the European Medicines Agency (EMA) in Europe. Pharmaceutical cannabis products are favoured by many regulators, doctors and insurers as they are perceived as having a stronger evidence base and a higher level of production standards, both in terms of purity and the precision of cannabinoid content.
Epidiolex ® is currently the ‘poster child’ for the success of pharmaceutical cannabinoid products, garnering over €430 million of sales in 2020. The Pharmaceutical Cannabis Report: 2nd Edition traces a detailed history of how GW Pharmaceuticals managed to develop the most successful pharmaceutical cannabis drug to date, and explores how it could be replicated in the future.
What form future cannabinoid therapies will take is far from certain. The field is currently bursting with innovation and as such, this Pharmaceutical Cannabis Report provides an in-depth analysis on the advances being made in:
- The use of novel and minor cannabinoids such as cannabigerol (CBG) and cannabinol (CBN);
- The chemical and biosynthesis of cannabinoids outside of the cannabis plant and the commercial viability of this;
- The current and future patent and intellectual property issues around medical cannabis;
- New devices and methods of administering medical cannabinoids.
Within the report, Prohibition Partners speak with two figures on the leading edge of cannabis treatment innovation, Dr. Peter Grinspoon of Harvard Medical School and Sean Jarvis of Pureform Global (A biosciences company focused on the discovery and production of pure cannabinoids) with interview extracts provided here.
Interview Extract: Sean Jarvis, Chief Strategy Officer and Founder of Pureform Global
Q. Why did your company opt for the chemical synthesis route for cannabinoid production rather than biosynthesis or plant cultivation?
A. There are pros and cons of all methods. With plant production you have several cons such as the real difficulty in ensuring the product is ‘pure’ in the sense of being completely free of THC, other cannabinoids, terpenes, pesticides and other unwanted and unknown impurities. In addition, the environmental impact of plant cultivation and other methods of synthesis is significant and untenable. It might work right now. But when consumers and regulators begin to focus on the water use and carbon footprint for other methods, we think that will be a problem for them.
Q. Do you see synthesis replacing plant cultivation in the future?
A. While we see synthesis taking an increasingly large market share, we don’t see it replacing plant cultivation. This is mainly because of cultural reasons. There is a deeply embedded culture around the use of the cannabis plant both for recreation and in medicine. In many cases, you need the precision and purity that synthesis can offer, but in others, patients and customers just prefer consuming plant material. This is unlikely to change in the near future. There is always the option of enhancing plant material with chemically identical synthesised cannabinoids in post-harvest processes, something we are helping customers to do today.
Interview Extract: Dr. Peter Grinspoon, Harvard Medical School
Q. What aspect of minor cannabinoids are you most excited about?
A. I am most excited about the possibility that we will be able to use minor cannabinoids to tackle some of the most prevalent diseases in the western world. Foremost to my mind is the cannabinoid THC-V in the cannabis plant which has potential therapeutic efficacy against obesity and diabetes. THC-V can encourage weight loss in rodent models even when the administered doses are quite low. The prevalence of adult obesity in the US is above 40% and costs the country as much as $200 billion each year in healthcare and lost productivity. If we can find a way to safely harness the endocannabinoid system to treat this, the implications would be enormous.
Q. Should companies emulate groups such as GW in the development of cannabinoid medications?
A. This is a complicated subject, on one hand, groups like GW have been doing vital research when many other people were not able to, at that point in history. Some benefits that this brought were the acceleration of research and elucidation of the cannabinoid system, not to mention production of some of the first successful cannabinoid pharmaceuticals on the market (…) This is a bit of a double-edged sword as we would like patients to have access to un-patented, plant derived cannabinoids as an abundant health resource but also we rely on large institutions to carry out some of the costly research to investigate the endocannabinoid system clinical trials.
For more information, The Pharmaceutical Cannabis Report: 2nd Edition summary can be downloaded here. Please contact Michael Hoban (email@example.com) with any press enquiries.
About Prohibition Partners
Prohibition Partners unlocks the potential of cannabis through data, intelligence and strategy. We provide strategic solutions and consultancy services to an international client base of investors, operators, blue chip companies, FMCG brands and government bodies.