To win approval for Epidiolex, the first cannabis-derived drug cleared by the U.S. Food & Drug Administration, GW Pharmaceuticals took no chances.
The active ingredient in Epidiolex is cannabidiol (CBD), a compound in cannabis that doesn’t produce a high, unlike tetrahydrocannabinol (THC), the plant’s psychoactive component. The U.S. government considers cannabis an illegal drug, so any pharmaceutical derived from it must be closely monitored for diversion and carefully manufactured for purity and chemical consistency.
Covering all its bases, GW set up giant greenhouses north of London where it raises cannabis plants under highly controlled conditions. It built facilities to extract CBD and crystallize purified CBD from the extract. Anticipating growing demand for Epidiolex, GW recently added extraction and purification capacity and is planning even more.
GW demonstrated that a drug extracted from cannabis can be approved in the U.S., despite the federal government’s hostility to cannabis. Today, more than 100 drug companies are furiously testing myriad new products, in dozens of therapeutic areas, based on CBD and other cannabinoids present in the cannabis plant.
Yet some pharmaceutical chemical companies consider GW an aberration in the emerging field of cannabinoid drugs. These firms are investing in R&D, analytical capabilities, and manufacturing facilities in the U.S. to support production of cannabinoids via organic chemistry rather than extraction from the cannabis plant. They are betting that the future of cannabinoid therapeutics will be synthetic.
Of these firms, Noramco is the most aggressive in its pursuit of the cannabinoid market. Founded in 1979, Noramco is licensed by the U.S. Drug Enforcement Administration to produce controlled substances such as codeine, morphine, and oxycodone in bulk for drug industry customers. It also makes amphetamines and naloxone, the active ingredient in opioid overdose antidotes.
Noramco was a unit of Johnson & Johnson until 2016, when the private equity firm SK Capital acquired it for a reported $800 million. Noramco added THC to its portfolio 10 years ago at the request of a customer, but under James Mish, who became CEO soon after the acquisition, cannabinoids are now front and center. “We have remodeled the entire organization to refocus around these products,” Mish said during a briefing at the CPhI Worldwide pharmaceutical chemical trade show in Madrid last month.
To complement the CBD and THC it gets from a manufacturing partner in Switzerland, Noramco began making clinical quantities of CBD last year at its own facility in Athens, Ga. Early next year, the firm said, it will begin larger-scale production of CBD in Wilmington, Del., and THC in Athens. Noramco will be the only company that uses chemical synthesis to make commercial quantities of pharmaceutical-grade CBD and THC, Mish said.
Mish made clear that those are not the only cannabinoids that Noramco is pursuing. “THC and CBD are just scratching the surface of the plant,” he said.
Bill Grubb, Noramco’s vice president of business development and innovation, explained that the cannabis plant contains 400 chemicals, of which about 60 are cannabinoids. Ten of those, he said, have been shown to have potential pharmaceutical benefits. Noramco stocks research quantities of all 10, Grubb said, plus 22 others.
Demand, Noramco executives said, is exploding. A year ago the firm had 10 customers working on eight therapeutic areas; today it has about 120 customers, including some big pharma firms, pursuing 80 therapeutic areas. At the briefing, Noramco disclosed three small customers: Axim Biotechnologies, which is developing a chewing-gum-released THC for nausea; Cardiol Therapeutics, which is working on a CBD-based heart failure drug; and RespireRx Pharmaceuticals, which is developing a THC-containing obstructive sleep apnea treatment.
The British firm Johnson Matthey is another veteran of the synthetic cannabinoid field. Like Noramco, JM is a longtime producer of opioids in possession of the Drug Enforcement Administration licenses needed to make cannabinoids.