GW Pharmaceuticals’ CEO talks Epidiolex, future of cannabidiol medicine

GW Pharmaceuticals’ CEO talks Epidiolex, future of cannabidiol medicine

UPDATE: GWs Epidiolex on April 19 received a unanimous recommendation from the Peripheral and Central Nervous System Drugs Advisory Committee of the U.S. Food and Drug Association. The following article has been updated to reflect that decision.

This is a make-or-break spring for GW Pharmaceuticals and its billion-dollar investment in a cannabidiol-based drug.

The London-based firm aims to develop the first FDA-approved medicine from plant-derived cannabis compounds.The U.S. Food and Drug Administration could decide as early as June 27 whether Epidiolex, a CBD oral solution, could be prescribed to patients with rare epilepsy conditions.

And as GW approaches that deadline, it appears the odds are in the companys favor.

Epidiolex this week received a positive review from FDA clinicians and on Thursday received a unanimous recommendation from an FDA advisory committee. The agency isnt obligated to follow recommendations from the clinical briefing or even the advisory committee, but positive reviews put Epiodiolex on good footing.

The Cannabist spoke with GW Pharmaceuticals CEO Justin Gover In advance of Thursdays hearing for an update on Epidiolexs progress, his perspective on the medicines potential, his views on the future for cannabinoid pharmaceuticals, and how an FDA-approved CBD drug could affect the booming business of cannabis extracts.

We consider ourselves to be world leaders, he said. Our job is to stay in that position as long as we can.

The fact that Epidolex is derived from the cannabis plant, adds a layer of interest that GW is prepared to address, Gover said.

Epidiolex would be a first-of-its-kind drug, so the scheduled committee hearing in this case the Peripheral and Central Nervous System Drugs Advisory Committee hearing was not unexpected, he said.

(Our) focus will be on the patient population and whether this meets the standard for a new treatment, he said.

GWs intended to show it appropriately characterized Epidolexs safety and efficacy; explain the level of unmet need; detail the rigor of the pre-clinical and clinical studies; and discuss the quality of the evidence, Gover said. Ultimately, GW wanted to convey its responsibility to patients 2 years of age and older who experience these rare and debilitating seizure syndromes, he said.

The coming days and weeks compose a transformative moment for the pharmaceutical company that has been toiling away at cannabinoid research since 1998, Gover said.

I think its fair to say that this product, it stands apart from the rest of our portfolio, he said. It is by far the most important product that we are developing today.

GW hasnt released pricing information for Epidiolex; however, analysts have estimated patients could pay between $30,000 to $60,000 per year if their insurance plans dont cover the costs.

The payout for GW could be significant: Some analyst forecasts have put Epidiolexs peak annual sales between $1 billion and $3 billion. During GWs last fiscal year, the company generated $11 billion in revenue, mostly attributed to sales of THC-CBD Multiple Sclerosis drug Sativex, which is approved for sale in more than a dozen countries outside the U.S.

The big break for GW would be entering the U.S. market with Epidiolex and following that up with a slew of other cannabinoid-centric medicines including Sativex, he said.

Were very much planning for success, Gover said.

GW has gone all in: Gover moved to California three years ago to head the infrastructure build-out and clinical development progression for Epidiolex. The company has invested roughly a $1 billion in the yet-to-be approved medicine.

We remain confident the drug will be approved, he said.

And if its not, he added, then the question becomes, Why is it not?

I find it very hard to envision a situation where we would not continue to plan on a basis of Epidiolex ultimately being approved, he said.

Questions have been raised as to whether GW will be able to successfully launch Epidiolex on its own.

A report in EP Vantage, the financial news site of biotech research firm Evaluate Group, noted that GW remains a rumored acquisition target.

The group has been busy building its ...

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