Synthetic CBD vs. Natural: Which is Better for Pharma Development?
March 13th, 2019
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Historically, the only FDA-approved drugs incorporating cannabinoids were created and manufactured synthetically. Dronabinol, a synthetic version of THC, was first approved in 1986 and is now sold as a treatment for chemotherapy-induced nausea and for AIDS-induced anorexia. In June 2018, the FDA approved Epidiolex, the first plant-derived cannabinoid drug approved by the agency, for the treatment of two rare childhood epilepsy syndromes, Dravet and Lennox-Gastaut. Epidiolex utilizes cannabidiol (CBD) purified from botanical sources.
There is still a legal grey area for naturally-derived drug candidates in the United States which may be cleared up soon as the 2018 Farm Bill gets codified into federal law across a variety of agencies. For now, marijuana is still illegal federally and classified as a Schedule I drug by the DEA. CBD derived from hemp may be removed from Schedule I, but only if it is completely pure, without any trace of THC. The DEA has made it clear it doesn’t consider 100% pure CBD extracted from hemp to be possible. Still, with cannabinoid science expanding in lockstep along with the international legalization of cannabis, it might be a good time to compare the benefits of utilizing synthetic cannabinoids versus natural cannabinoids for pharmaceutical drug development.
One company that is active on the synthetic side of the equation is Cardiol Therapeutics (TSX: CRDL) (OTC: CRTPF). The company is taking two approaches, advancing its own chemically synthesized CBD candidates for the treatment of heart failure and glioblastoma multiforme while preparing for the imminent commercial launch of pharmaceutical CBD into the Canadian medical market. Initially intended to support Canadian medical marijuana patients who have found CBD to be in short supply in the wake of recreational legalization, Cardiol’s launch of ultra-pure synthetic CBD could also serve as supply for the quickly expanding pharmaceutical CBD drug development industry.
Benefits of Synthetic and Natural
In terms of pharmaceutical drug development, as opposed to recreational and nutraceutical product development, standardization and purity of ingredients is essential. These are two of the major advantages of synthetic cannabinoids, which can be manufactured without the specter of impurities or inconsistencies from a plant or from the extraction process making it into the final product. Importantly, synthesized CBD is chemically identical to the natural form.
Noramco, Inc. is a manufacturer of active pharmaceutical ingredients, producing controlled substances like codeine for the legal drug industry for the last 40 years. The company has aggressively developed its cannabinoid production capabilities over the last two years or so and is currently ramping up synthetic THC and CBD production to unmatched commercial levels.
Noramco’s CEO James Mish, who has overseen the new focus on cannabinoids, sees the market dividing along regulatory lines. Speaking of the regulatory requirements for pharmaceutical development, he said “In order to get the quality needed by regulatory bodies, the only way to do that is synthetically.” He predicted that the less strict regulations surrounding recreational and nutraceutical development could mean that plant-based cannabinoids end up supplying those markets, while pharma companies would find it difficult to get “grow and extract” formulations through the FDA.
Advocates for plant-based cannabinoids point to the entourage effect, whereby it is thought that some of the benefits of cannabis plant extracts are dependent on a mix of minor active ingredients in addition to the major cannabinoid component, rather than the isolation of just one highly purified active. To be clear, evidence to date does not point to health benefits of terpenes or other less prevalent compounds in the cannabis plant. While this entourage effect may or may not be important in some applications, the clinical trial process, a proven, rigorous, scientific method for proving efficacy of a drug in a controlled setting, will be able to answer this question. In other words, if pure cannabinoid actives prove effective in treating certain conditions, debates about the source of that active ingredient will be moot.
The pharma market seems to be moving in the direction of synthetic cannabinoids, due not only to the consistency and purity issues, but also to the high costs and complex management issues associated with large-scale cultivation, production, and extraction of plant-based actives. For pharma companies, it makes more sense to focus resources on drug development and contract with API contractors like Noramco, in line with how the industry has functioned for many years. In the last year or so, Noramco’s customer base has exploded from 10 companies to about 120 and growing.
One of Noramco’s customers is Cardiol Therapeutics, which uses Noramco’s synthetic CBD in its own drug development pipeline. Cardiol is advancing CTX01, a CBD formulation which has shown pre-clinical potential in the treatment of heart failure. Cardiol is also investigating two other non-CBD candidates for the same condition and plans to move the most promising candidates forward to clinical trials in the second half of 2019. Heart failure affects more than 6 million adults in Canada and the United States and accounts for more than $30 billion of spending in the US alone.
Following closely on the heart failure program’s heels, Cardiol plans to initiate clinical trials in the first half of 2020 for its CRxIMT candidate. The drug is a combination CBD/immunotherapy treatment for glioblastoma multiforme (GBM), an incurable and deadly form of brain cancer that recently took the life of Sen. John McCain. The indication is eligible for Fast Track development under Orphan Drug status with the FDA, highlighting the urgency behind the search for an effective treatment.
Meanwhile, Cardiol is diving headfirst into the pharmaceutical CBD market. The company has an exclusive manufacturing agreement with Dalton Pharma Services, a Health Canada approved, FDA registered, cGMP manufacturer of over 200 APIs, including pharmaceutical cannabinoids, with manufacturing capability scalable to support all stages of the regulatory process (Phase I, II, III, and commercial). The agreement gives Cardiol access to industrial quantities of THC-free ultra-pure pharmaceutical CBD. Dalton is the only company in Canada currently producing pharmaceutical CBD with Health Canada approval and FDA registration.
Cardiol plans to market the synthetic CBD to Canada’s medical cannabis patients, who currently spend about $1.2 billion annually and are projected to nearly double that amount by the year 2025. Medical users are currently experiencing major problems accessing product in the wake of full legalization, prompting James O’Hara of the advocacy group Canadians for Fair Access to Medical Marijuana to comment, “It’s actually more than a supply issue. Really, it’s something of a health crisis now.”
2019 looks to be a pivotal year for both the cannabis industry in general and for Cardiol Therapeutics in particular. Cannabinoid-based pharmaceutical development is flourishing with widespread legalization, and Cardiol is positioned firmly in the middle of this explosive trend. By mixing in the marketing and sale of pure, synthetic medical CBD, Cardiol is providing a near-term revenue opportunity to supplement the longer-term potential of successful drug development. For both pursuits, the company is aligned with major players in the pharmaceutical manufacturing world, assuring massive supply of pure CBD that meets regulatory requirements in all relevant countries. Now may be the optimal time to put Cardiol on your radar.
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