Date: 2015-10-27
Type of information: Clinical research agreement
Compound: Epidiolex® (cannabidiol (2-[(1R,6R)-3-Methyl-6-(1-methylethenyl)-2-cyclohexen-1-yl]-5-pentyl-1,3-benzenediol) and GWP42006 (cannabidivarin)
Company: GW Pharmaceuticals (UK) Government of New South Wales (Australia)
Therapeutic area: CNS diseases
Type agreement: clinical research
Action mechanism: cannabinol derivative/endocannabinoid modulator. GWP42006 is the non-psychoactive cannabinoid cannabidivarin (CBDV) extracted from the cannabis plant.
Disease: children with epilepsy
Details: *On October 27, 2015, GW Pharmaceuticals announced that a Memorandum of Understanding (MOU) has been signed with the Government of New South Wales (NSW) in Australia to progress a research program for Epidiolex® (cannabidiol or CBD) and cannabidivarin (CBDV) in children with severe, drug resistant childhood epilepsy.
“GW is pleased to have been able to respond to the needs of the New South Wales government and its citizens by establishing
The MOU will facilitate:
A world first, Phase 2 clinical trial in children for GW’s novel product containing the cannabinoid cannabidivarin (CBDV)
A compassionate access program for Epidiolex which is currently in Phase 3 clinical trials with the U.S. Food and Drug Administration for Dravet syndrome and Lennox-Gastaut syndrome, two rare, extremely debilitating epilepsy syndromes that begin in infancy or early childhood.
Provision for NSW to host additional Phase 3 clinical trials of Epidiolex in children with treatment-resistant epilepsy
A Phase 4 clinical trial of Epidiolex based on Phase 3 studies
The agreement also delivers a compassionate access program for Epidiolex for a small number of children who are too sick to participate in a clinical trial, due to the unrelenting nature of their epilepsy. To date, Australian children have had great difficulty accessing this drug. The partnership between the NSW Government and GW Pharmaceuticals also means NSW could host additional clinical trials in the future, including an international Phase 3 trial for children with Tuberous Sclerosis Complex. The agreement also includes a future Phase 4 clinical trial of Epidiolex for children with severe, drug resistant epilepsy which will be led by clinicians at the Sydney Children’s Hospitals Network and which would take place following completion of the ongoing Phase 3 trials. The goal will be to gather local medication safety data which will support an application to the Australian Therapeutic Goods Administration to make the product more widely available, if proven safe and effective.
The MOU, between the NSW Government and GW Pharmaceuticals, comes as part of the NSW Government’s $21 million commitment to support medicinal cannabis reforms.
Financial terms: As part of this agreement,the NSW Government is providing $3.5 million to the Sydney Children\'s Hospitals Network to lead this world first, Phase 2 clinical trial of CBDV in children, which is expected to commence in 2016. Like CBD, CBDV does not produce the psychoactive effects associated with herbal cannabis.
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