GW plots path to new drug approvals as Epidiolex tops sales predictions

GW Pharma growing area for CBD Epidiolex
GW is planning an array of cannabinoidal products to follow Epidiolex, all based on cannabis plants, shown here in its growing fields. (GW Pharmaceuticals)

GW Pharmaceuticals is looking to blaze new trails in cannabinoid prescription meds, this time in multiple sclerosis. The company has launched a phase 3 trial of nabiximols, known as Sativex outside the U.S., to treat spasticity in MS.

Four additional phase 3 nabiximols studies will begin later this year and into 2021, but data from the first could come as soon as the middle of next year. Positive results from any one of the studies could enable an NDA submission, GW Pharmaceuticals CEO Justin Gover said.

The MS trial announcement for nabiximols coincided with third-quarter results reporting from GW that backed its cannabinoid game plan. Its first cannabinoid—Epidiolex, approved to treat severe epilepsy—beat Wall Street expectations with $137 million in sales, up from $121 million the previous quarter. U.S. sales accounted for 87% of overall sales.

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The Epidiolex performance led to a 25% stock price jump, but there's a lot more opportunity ahead for GW, SVB Leerink analysts pointed out. Nabiximols’ sales potential—especially if it earns a broad spasticity label—along with some early pipeline moves and the development of additional cannabis-based products are all underappreciated aspects of the GW story, they wrote in a note to clients.

Gover, meanwhile, stressed that “Everything starts with the plant,” adding that along with “epilepsy for Epidiolex and spasticity for nabiximols, we’re also looking at different products, all cannabinoid-based, in the fields of schizophrenia, autism and other neuro-psychiatric conditions as well.”

Nabiximols, if approved in the U.S., would get a new brand name, but more importantly, it would be able to leverage the hard-won path to market Epidiolex forged.

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“We’ve needed to ensure that regulators, government agencies like the DEA, physicians and payers are all reassured that a product derived from a cannabis plant carries all the hallmarks of any other medicine they would use,” Gover said. "That’s taken a lot of work and data and, frankly, also a reputation of trust and integrity as it relates to this field. All those things have allowed us to move on to nabiximols and other products.”