- The Drug Enforcement Agency has reclassified Epidiolex, the first-ever plant-derived cannabinoid medicine approved in the U.S., from Schedule I to Schedule V, removing the last major barrier keeping it from commercialization.
- Epidiolex gained an OK from the Food and Drug Administration in late June for treating seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients aged two years or older. GW Pharma, which manufactures Epidiolex, said recently it plans to set a list price of $32,500 for the drug.
- Cannabidiol, the active ingredient in Epidiolex, is a chemical found in cannabis plants. As such, cannabidiol-based drugs fall under the DEA's Schedule I classification, meaning they have no accepted medical use and a high potential for abuse. Schedule V drugs, conversely, are deemed to have lower potential for abuse and include Pfizer's epilepsy and pain treatment Lyrica and the diarrhea medication Motofen.
GW executives have underscored that, despite years of clinical testing and the eventual nod from the FDA, Epidiolex's market future depended on the DEA rescheduling it.
To that end, the company worked extensively to demonstrate the drug was safe and secure backing from regulators.
"With this approval and the positive comments from the FDA regarding our approach to developing cannabis-based medicines, our confidence has never been stronger that GW’s cannabinoid platform is one that is favored by the regulatory agencies and one that will serve to provide momentum for a number of important pipeline programs that have the potential to offer investors additional value," GW's CEO Justin Gover said during the company's most recent quarterly earnings call.
Wall Street has expected Epidiolex's approval and potential rescheduling to have wide-reaching implications for cannabis-based therapies.
Purely from a sales perspective, analysts predict GW's new product will be quite lucrative. Cowen & Co. foresees it becoming a blockbuster by 2021. Informa analysts were a bit more conservative, but still peg peak annual sales at $822 million in 2025.
With the scheduling issue taken care of, GW can now turn attention to marketing Epidiolex.
Executives noted on that quarterly earnings call in August they've been building commercial inventory and were ready to start shipping supply into the U.S. following the DEA's move.
As of early August, GW had a stateside sales team consisting of two national directors, eight regional managers and nearly 70 neurology account managers who would be targeting about 5,000 physicians who work with Lennox-Gastaut or Dravet syndrome patients.
There have also been "extensive" discussions with insurers, pharmacy benefit managers and the Centers for Medicare and Medicaid Services, leading GW to be optimistic about coverage.
"With that said, like almost all product launches, it may take time for physicians to learn how to use the new medicine and adopt it in their clinics and for payers to provide reimbursement coverage," Julian Gangolli, president of GW's North America business, said during the company's earnings call.
Company shares opened up more than 3% Thursday.