Cannabinoid-based medicine Epidiolex approved for sale in Canada

November 30, 2023 · mj-biz-daily

Canada’s federal health regulator has approved Jazz Pharmaceuticals Canada’s cannabinoid-based medicine Epidiolex as a supplementary therapy for certain rare and severe forms of epilepsy, allowing the company to bring to market a clinically tested drug with global sales that dwarf those of the nation’s entire medical cannabis industry.

Epidiolex is the top-selling clinically proven cannabinoid-based medicine in the world, with global sales through the first nine months of Jazz’s fiscal year totaling approximately $604.8 million (823 million Canadian dollars).

By comparison, in calendar year 2022, Canadian patients purchased CA$410 million dollars of cannabis products for medical use, 7.4% lower than in 2021, according to Statistics Canada.

Health Canada’s approval of Epidiolex makes Canada the 36th country to approve the cannabis-based drug, a prescription medicine that is administered as an oral solution.

Some others include the United States, the European Union and South Korea.

Epidiolex is produced by United Kingdom-based GW Pharma, which was acquired in 2001 by Jazz Pharmaceuticals, a global company, in a stock-and-cash deal initially valued at $7.2 billion.

The transaction remains by far the biggest M&A deal in the cannabis industry to date.

The Health Canada approval was based on results from five double-blind, randomized, placebo-controlled Phase 3 clinical trials, Jazz Pharmaceuticals said in a news release.

“The approval of Epidiolex is an important development for individuals living with specific rare epilepsies, their families, and clinicians across Canada, providing a new treatment option for those living with LGS (Lennox-Gastaut syndrome), Dravet syndrome or TSC (tuberous sclerosis complex),” said Paul Petrelli, general manager of Jazz Pharmaceuticals Canada.

“This decision affirms the potential of cannabinoid-based medicines for those living with epilepsy. It also reaffirms Jazz’s commitment to bringing forward new therapeutic options for Canadians living with rare and debilitating neurological conditions.”

Only a small number of cannabinoid-based medicines are authorized for sale by Health Canada and listed in the Drug Product Database.

In 2005, the cannabinoid-based medicine Sativex received approval in Canada under GW Pharmaceuticals.

Though GW was acquired by Jazz Pharmaceuticals in 2021, Sativex is marketed in Canada by pharma giant Bayer Canada.

The key difference between a cannabinoid-based medicine such as Epidiolex is that it underwent successful clinical trials and was approved to receive a Drug Identification Number (DIN); unapproved medical cannabis treatments do not have a DIN because their medical outcomes were not clinically proven.

Sales of medical cannabis products that are federally regulated but lack formal medical approval from Health Canada have been declining for years.

In the first half of calendar year 2023, spending on medical cannabis amounted to CA$185 million, according to the StatsCan data. That’s the lowest first-half total since 2016.

Some industry experts say the trend boils down to:

  • Canada prohibiting unapproved medical cannabis to be sold in pharmacies, unlike most other jurisdictions where medical cannabis distribution is allowed. Medical cannabis products are sold online and distributed through the mail in Canada.
  • Legalization of recreational marijuana in 2018, prompting cannabis patients to seek out their treatment from one of Canada’s 3,500 adult-use stores.

Canada still has the biggest federally regulated market in the world for unapproved medical cannabis, with Australia thought to be a close second. (The Australian government does not track legal, unapproved, sales of medical cannabis.)

GW shares trade on the Nasdaq as GWPH. (Full Story)

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