Pharma, Advanced Labs Race to Find CBD/THC Synthetic CopyCats

by Lloyd Covens, Publisher, West420 NewsWeekly

More than 10 pharmaceutical or life science companies are all hoping to put their own imprint on creating a fully-effective suite of lab-created synthetic cannabinoids-- most proposed to build upon a base on bacteria, yeast, sugar or e-coli. The potential sources for a commercially-reliable source of non-plant products could come from long-time pharma research suppliers, or be produced from smaller labs now getting millions from MJ-related firms, many coming from Canada.

         “A synthetic route means that concerns around residual pesticides, heavy metals from the soil, and a myriad of related substances from extraction are not a concern,” said Bill Grubb, vice president for business development at Athens, GA based Noramco. His firm says it has already replicated about 30 cannabinoids, but the firm has not brought any commercial products to market. Founded in 1979, under the Johnson and Johnson umbrella, Noramco has been DEA-licensed to produce controlled substances such as codeine, morphine, and oxycodone in bulk for drug industry customers. It also makes amphetamines and nalowone, the active ingredient in opioid overdose antidotes. Noramco claims that lab-created cannabinoids-- and THC products-- will be reproducible at scale for much less than the cost of traditional plant and farming production.

With millions of indoor square feet-- and thousands of outdoor acres all pumping out legal cannabis in 10 RMJ states, plus another 21 MMJ state-based growers -- the risk for over-building demand-based on flower may become worrisome for many cannabis production planners. Even with all the press releases, the expectation for actual available synthetic cannabis may be 18 to 24 months away.

While Cronos Group, Organigram and Anandia Labs all made moves last year to increase their investments beyond cannabis growing to fund some new synthetic CBD/terpene research. New firms-- Librede, Teewinot Life Sciences, and San Diego-based Renew Biopharma-- have all signalled their intent to pursue creating all forms of cannabinoids in a test-tube.

But legality of general sales of future synthetic-CBD/THC products remains murky. "The 2018 Farm Bill removed hemp, and products derived from hemp like CBD, from the definition of marijuana. Similarly, tetrahydrocannabinols derived from hemp are excluded from the definition of marijuana under the 2018 farm bill," notes attorney David Wunderlich of Denver-based McAlister-Garfield law firm. Wunderlich adds "State laws vary on this topic. I’m not aware that any state specifically requires cannabinoids to be produced from “plant material” but rather from Cannabis Sativa L. in order to be regulated. " Wunderlich expects states will need to re-visit their interpretations on how THC may be licensed for synthetic distribution. Others guess that pharma approachs to THC as a bio-synthetic, may be aimed at widespread distribution after national legalization.

A stronger track record may be found at Vancouver-based pharma research group In-Med Pharmaceuticals (TSX: IMLFF) which was granted a $1/2million (CNDA) research grant from the Canadian government. Im-Med said the funding would " improve production of the different components of the terpenoid biosynthetic pathway, a pre-cursor of cannabinoid production, as well as research and development supporting up-stream and down-stream scale-up activities conducted by InMed's contract development and manufacture organizations." Also in Canada, Montreal-based Hyasynth is using $10Mil. investment from Canadian LP Organigram to conduct it bio-cannabinoid research. Likewise, another Canadian LP giant, Cronos Group, said it has committed up to $125Mil (in continuous milestones) to Boston-based Gingko Bioworks. Vancouver-based Anandia Labs has several years of basic cannabis research behind it, but a new outside investor might be expected to move the research firm closer to bio-synthetic development.

GW Pharmacueticals was granted its FDA approval for Epidiolex based upon its natural marijuana-derived isolate, reported to be delivering about 50 MG of CBD to initial patients with intractable epilepsy. No plans to produce synthetic CBDs are indicated from GW, and other pharma giants may be pursing other routes to entering the natural cannabis sector. For Tilray, it has a partnership with Sandoz Canada (a division of Swiss pharma giant Novartis) to develop non-flower delivery of THC/CBD medically-based consumer products. And beyond their roots in pharma and drug research and development, several other firms have signaled their entry into cannabis applications, but have foregone initial plans to depend upon lab-created synthetic approaches. Other smaller pharma startups-- including Zynerba, Cardiol and Corbus Pharma-- say they want to directly treat certain patient conditions with advanced formulations of cannabinoid combinations.

Noramco's CEO James Mish says GW's approach (with 98% CBD from cannabis derived plants) will be the exception to consumer options. Mish predicted to "PharmaTechnolgies" report that the recreational and nutraceutical markets will be served by CBD and THC extracted from plants, while the pharmaceutical market is served by synthetics. “In order to get the quality needed by regulatory bodies, the only way to do that is synthetically,” he said.

Last week, a California company, Amyris, claimed it had lined up $255Mil. in undisclosed investors to perfect lab-created cannabinoids, but the company was light on specifics. Amyris has been active in cosmetics, fragrances and malaria medicines in the past, but a harsh assessment by Motley Fool last week said " the most recent projections simply continue the company's tradition of grossly over-promising and under-delivering while changing the products central to the story line. A careful review of past projections and the actual results that followed demonstrates the dangers of believing the latest too-good-to-be-true numbers."

Please reach the author at [email protected]

See this related story from Alan Brochstein's New Cannabis Ventures.  February 24, 2019