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The first company to create and patent a CBD compound will have a serious edge in this fast-growing industry.
Most cannabis producers are busy growing plants, but scientists at biotech companies are actively developing what they believe could be the future of the industry: It’s “synthetic” CBD, created in the lab.
Because the synthetic cannabinoid could cut the massive costs of cultivating the crop and quicken the FDA approval process, the quest has taken hold especially among medical marijuana pharmaceutical companies focused on developing new drugs. Already, researchers, universities, and a handful of startups are in the early stages of synthesizing cannabis’s CBD. But the first company to actually patent a compound (or the process to make it) in a way that’s both therapeutic and scalable would command a serious edge in this fast-growing industry.
What exactly is synthetic CBD?
We’re not talking about so-called synthetic marijuana, a misnomer with street names like K2 and Spice, which was turning New Yorkers into zombies a few years back. K2 is an illegal mind-altering chemical sprayed on potpourri that’s often smoked like weed. Underground manufacturers keep tweaking the chemistry to stay one step ahead of the law.
The compounds entrepreneurs are so excited about are purified analogs of CBD, which has a relatively simple molecular structure that makes it easy to produce through organic chemistry in a pharmaceutical setting. CBD is one of dozens of known compounds in the marijuana plant. It’s the nonpsychoactive cousin of THC, the more famous cannabinoid that gets you high. And it has fanned huge interest for its potential in treating all kinds of health issues. With sales tripling to $367 million from 2014 to 2017, the CBD market is projected to reach more than $1.3 billion by 2022, according to New Frontier Data. Even big, publicly traded retailers like CVS and Walgreens are getting into the act with plans to add CBD products to their shelves.
How close to lab cannabis are we?
Unlike CBD, THC has already been synthesized for pharmaceutical use in a few very specific cases. There are two drugs on the market, Marinol and Syndros, that contain lab-made THC. The compound, called dronabinol, was approved by the FDA back in 1985. The drugs are used to treat wasting in AIDS and nausea caused by chemotherapy. A third drug, Cesamet, also prescribed for chemo patients, contains a different synthetic active ingredient that has a similar structure to THC.
With CBD, the pace has been slower. But last June, the FDA approved the first-ever drug made with it, Epidiolex, to treat children with severe forms of epilepsy. The CBD in Epidiolex is plant-derived, according to Stephen Schultz, vice president of investor relations for GW Pharmaceuticals, which developed the drug. “We’re a cannabinoid company, so we’re open to all methods,” he says. “If synthesizing a compound makes sense to our strategy, then certainly it’s an option for us.”
Looking at the history of other drugs, synthesizing would seem to make sense. Nobody chews on the bark of willow trees to relieve pain — they take aspirin. Nor do they eat mold when they’ve got pneumonia; they get a scrip for penicillin, which was synthesized and mass-produced during World War II.
In the case of CBD, early experiments are promising. Scientists at the University of California, Berkeley, announced this year that they had created CBD compounds in a lab by engineering brewer’s yeast. The process they used is called biosynthesis, and their research was published in the journal Nature. For both medical and economic reasons, news like this is exciting. Today, says Jeff Chen, M.D., executive director at the UCLA Cannabis Research Initiative in Los Angeles, CBD compounds can be replicated in a lab with “99 percent the same effectiveness as the plant, or more.” And while you can’t patent that plant, “these novel compounds are able to be patented, and [scientists] are able to modify the molecules for different ailments.”
Where the opportunity is
Biotech and pharma companies are seeing billion-dollar signs. Some companies like Hyasynth in Canada and CB Therapeutics in California are already engineering CBD using yeast. Last year, Ginkgo Bioworks signed a $122 million deal with the Canadian cannabis company Cronos to create cannabinoid compounds — again via yeast — with methods aimed to scale. And biotechs like CannBioRex and Katexco Pharmaceuticals are working on making their own synthetic versions of medical-grade CBD, hoping to harness its properties in conjunction with other compounds to create drugs for treating multiple sclerosis, rheumatoid arthritis, and various inflammatory diseases.
The drugs would be put through clinical trials and eventually submitted to the FDA, just like any other traditional pharmaceutical that’s synthesized in a lab from chemical compounds. There are not only opportunities to patent new compounds, points out Katexco’s CEO, Jonathan Rothbard, Ph.D.; you can also patent the methods used to produce them, “particularly the biosynthesis of the molecule.”
Throughout the industry, CBD made in the lab could be cheaper, more consistent, and easier to mass-produce than CBD extracted from the plant. “You don’t have to deal with growing or the genetics of the plants shifting over time,” says Chen. The other advantage for those in the pharmaceutical realm is that because natural CBD still has a murky legal status, products made with its synthetic cousin would presumably have an easier time getting through regulatory hurdles.
Looking ahead, synthetic CBD could also, at long last, enable the kind of large-scale clinical trials that are desperately needed to lay the groundwork for the next phase of the medical cannabis industry. Because if the visionaries are right, patients will eventually no longer be smoking pot. Future generations of medical cannabis will come in the form of a patented pill, not from a plant firmly rooted in the public domain.
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