GW Pharmaceuticals (GWPH) a London UK-based biopharma company developing CBD therapies, announced that The Lancet, a leading health research journal, published results from its Phase 3 study of CBD-based Epidiolex in patients with Lennox-Gastaut syndrome epilepsy(LGS). In the study, Epidiolex reduced monthly seizure frequency in treatment-resistant patients when added to existing treatment.
Epidiolex is the potential first in a new category of anti-epileptic drugs (AEDs). It is based from cannabidiol (CBD), a cannabinoid without psychoactive effects. If approved, Epidiolex is expected to be available by prescription in the second half of 2018.
GW is a $3.8 billion (market cap) company with revenue of US$11 million in the previous year. It has no positive profit yet, but trades at roughly $138, over 300 times its revenue.
LGS is a rare, lifelong form of epilepsy that begins in childhood and is associated with high mortality and developmental delays. LGS patients suffer from severe seizures which cause falls and injuries. This is the only well-controlled clinical evaluation of a CBD medication for this condition.
GW has submitted a New Drug Application to the FDA for the treatment of LGS and Dravet syndrome. It currently has ongoing clinical trials in Tuberous Sclerosis Complex and Infantile Spasms.
GW commercialized the world’s first plant-derived CBD prescription drug, Sativex (nabiximols), approved for the treatment of spasticity due to multiple sclerosis in many countries outside the US. GW has a pipeline of CBD product candidates including compounds in Phase 1 and 2 trials for glioblastoma, schizophrenia and epilepsy.