Last week, GW Pharmaceuticals made history. Epidiolex, an orphan drug developed by the company that treats two rare forms of epilepsy, became the first marijuana-derived medication approved by the U.S. Food and Drug Administration (FDA).
For the general public, this was perhaps less momentous than it initially seemed. Epidiolex is derived from cannabidiol (CBD), a chemical found in the cannabis plant that does not have psychoactive effects, and its approval does not mean that marijuana itself will be rescheduled.
But for the medical community, particularly those intrigued by the potential of cannabinoid science, it was a watershed moment. Following the FDA’s ruling, the Drug Enforcement Administration (DEA) will almost certainly reschedule CBD, which opens the door for additional drugs derived from the component to be studied and reviewed by the agency.
“This approval is historic in that it allows us, as a pharmaceutical company. to talk about this product in the way that pharmaceutical companies normally talk about their drugs,” says GW Pharmaceuticals CEO Justin Gover.
MM&M spoke to Gover about specific next steps, including pricing and marketing, as well as what he thinks Epidiolex’s approval means for the research of cannabinoids more generally.
This interview has been lightly edited for length and clarity.
MM&M: The DEA classifies CBD, along with the other components of marijuana, as a Schedule 1 substance, which means it has significant potential for abuse and no medical use. Given Epidiolex’s approval by the FDA, when do you expect the DEA to reclassify CBD? Is there any possibility it won’t?
Gover: The FDA approval is a determination of an accepted medical use. The DEA recognizes this, and so Epidiolex cannot stay in Schedule 1. The only question is, which schedule does it go into? In April, an FDA advisory committee said that Epidiolex had low abuse potential, which would signal a relatively low restriction in terms of scheduling. To us, that would mean Schedule 4 or Schedule 5.
MM&M: But until the DEA reschedules Epidiolex, you can’t launch or market it — does this leave you in a strange position?
Gover: This is exactly in line with our expectations; the DEA has up to 90 days [to reschedule the drug after it was approved by the FDA]. It’s been a week. Epidiolex is an orphan drug, and the way the legislation is written, the orphan exclusivity period only begins when the rescheduling takes place. From a commercial and launch preparation perspective, we are exactly where we expected to be at this point: Even if the DEA were to reschedule more rapidly than they are required to, we would still expect to launch in the fall.
MM&M: How will you convince doctors to embrace the drug, given its novel status?
Gover: I think it’s very straightforward: this is a well-characterized, highly-standardized product. For a certain proportion of patients with two difficult forms of epilepsy, it’s also a new treatment option. It’s not a solution that will work for every patient, but it’s a new advance and, per the FDA, it’s a new mechanism. It works differently than other anti-epileptic drugs, and we are dealing with patients for whom these existing medications have failed.
Whether a drug is derived from marijuana or any other substance, the same questions apply. What does the medicine do? How does it work? What is the evidence? Can you rely on the manufacturing? What is the label indication? Will insurance cover it? It’s a historic milestone because of the nature of the product, but when it comes to [marketing to] physicians, it’s about the efficacy and safety profile. We have two studies published in the New England Journal of Medicine and one study published in the Lancet. A physician will clearly recognize the importance of those medical journals, and the significance of their decision to publish our data. I think what it will come down to is, do they feel this product is appropriate for certain patients that they treat?
MM&M: So you’re saying that the CBD component is almost a side note. Your focus, when speaking to physicians, will be on the strength of the research and benefit it could provide patients.
Gover: I think that’s right. Not because I’m trying to hide from the source, but because there are very few medicines prescribed because of their origin as opposed to what they do.
MM&M: Any more details on how you plan to market the drug?
Gover: Epidiolex is an orphan drug for two extremely difficult to treat forms of epilepsy. We will be promoting this drug through our sales organization to specialist neurologists who prescribe epilepsy drugs and epileptologists. Our marketing strategy is very much focused on those disease states, and [GW’s U.S. subsidiary Greenwich Biosciences] will work with Relevant medical and patient organizations. This is not a product that would be appropriate for direct-to-consumer promotion.
MM&M: Do you have sales reps?
Gover: We are on track to complete the hiring of our sales organization over the week or two. In total, we expect to hire 68 sales representatives, plus national and regional sales leaders. The overall sales organization will be around 80 people or so.
MM&M: Are there any other marketing initiatives you are developing pre-launch?
Gover: We have a website called Cannabinoid Clinical. Targeted at healthcare professionals, patients, and caregivers, it’s a credible and accurate source for information on this area.
There is a lack of understanding in many quarters regarding, for example, the distinction between CBD and THC, the distinction between medical marijuana and cannabinoid medicines. There’s also a lack of understanding of the differences between Epidiolex and various CBD or hemp-derived oils. It’s important that when we talk about the topics of marijuana, cannabinoid science, CBD and so on that we have the opportunity to educate people on what we mean by each term. If you were to Google any of these terms, you’d end up in a variety of different places on the web, which are often contradictory and inaccurate.
MM&M: What would a successful launch look like?
Gover: Success means we continue to be seen as, and act as, a partner to the epilepsy community, and that patients have access to this medication in a timely fashion.
In that vein, we have had discussions with various payers over the last year or so, and expect to step up these discussions in the coming weeks. We would like to be in a position when we launch that patients who need access to this medication can get it under the appropriate insurance plans.
MM&M: Can you tell me what Epidiolex will cost?
Gover: No, we are finalizing that now.
MM&M: OK, more generally then: What are the factors you’re weighing when it comes to pricing?
Gover: I think it’s about access: we want to make sure that when a doctor wants to prescribe this medication, we do everything we can to allow those patients to get access through their regular insurance. We’ve developed this drug because we truly feel like we’ve responded to patient need. We care about this patient population and want to make sure those patients who need it can obtain it.
MM&M: There’s a lot of commentary and speculation about what Epidiolex’s approval means for marijuana-based medications more broadly. What do you hope it means?
Gover: That we will take the right approach to understanding whether there are therapeutic benefits to cannabinoids. That it paves the way for future medications derived from cannabis to be developed and approved by FDA, and that Epidiolex will be the first in a new class of medicine.
I’ve been at GW for 20 years, discussing the theory and prospect of how cannabinoids can be used as medicine. Epidiolex’s approval makes this conversation less theoretical.
This article has been updated to correct information about Greenwich Biosciences and GW’s work with the epilepsy community.