Having expressed understandable apprehension due to recent political events in the U.S. and Britain (i.e. Trump’s election and Brexit), London-based GW Pharmaceuticals announced on Monday that they suffered a 62 percent revenue drop for 2016.
However, things turned around quickly.
GW’s stock jumped 5.5 percent on the first day of the new trading week, right after the company announced positive results for one of its flagship therapies, Epidiolex. This cannabidiol-based drug treats two of the most difficult-to-treat forms of epilepsy, especially in children: Dravet Syndrome and Lennox-Gastaut Syndrome.
“We are making very good progress toward a NDA [UK’s equivalent of the FDA] submission to the FDA, as well as preparations for commercial launch and look forward to the opportunity to make this important new medicine available to patients as quickly as possible,” said Justin Glover, GW’s Chief Executive Officer, on the company’s website.
“Our goal is to provide the children and their families suffering from these highly treatment-resistant forms of childhood-onset epilepsy with a much needed new prescription option as quickly as possible,” Glover continued.
Orrin Devinsky, M.D., of New York University Langone Medical Center’s Comprehensive Epilepsy Center and Principal Investigator of the Dravet Syndrome trial, said Epidiolex provides meaningful reductions in seizures for Dravet patients.
“The epilepsy community has been eagerly anticipating the presentation of this high quality scientific data from the Epidiolex program at the American Epilepsy Society,” Devinsky explained. “My colleagues and I are excited at the future prospect of prescribing an appropriately standardized and tested pharmaceutical formulation of cannabidiol.”
If Epidiolex gets full FDA approval, the DEA would need to reschedule cannabis in order for it to be prescribed to patients in the U.S.
GW Pharmaceuticals also speculated, in its year-end report, that the U.S. presidential results could negatively impact their future in terms of foreign trade, laws governing approval and importation of the cannabis-derived-medicine.
Dravet Syndrome is a rare, catastrophic, lifelong form of epilepsy that begins in the first year of life in an otherwise healthy infant and is characterized by frequent and/or prolonged seizures. Lennox-Gastaut Syndrome is a type of epilepsy with multiple different types of seizures, particularly tonic (stiffening) and atonic (drop) seizures. The cause of Lennox-Gastaut is unknown in 1-out-of-4 children.
With all the excitement being generated by the recent positive results for Epidiolex, medical professionals and families of children with Dravet and Lennox-Gastaut Syndromes are trying to be optimistic.
“Investors are genuinely excited about backing a company with such a compelling product,” said Glover. “It’s new hope for these children who have hundreds of seizures a day. This is real and it’s meaningful.”
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