GW Pharmaceuticals and the Government of New South Wales Report a Strategic Agreement to Study Epidiolex and CBDV in a Clinical Trial and Research Program for Children With Epilepsy

— GW Pharmaceuticals plc (Nasdaq: GWPH) (AIM:GWP) (“GW,” “the Company” or “the Group”), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, today 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 this research program for cannabinoid-based medicines in children with treatment resistant epilepsy,” stated Justin Gover, GW’s Chief Executive Officer. “As part of this research partnership, GW expects to advance clinical trials in Australia for both Epidiolex and our earlier stage pipeline product CBDV.”

“This confirms NSW’s position as a world leader in cannabinoid research and demonstrates the determination of our Government to ensure we secure these groundbreaking trials,” stated NSW Premier Mike Baird. “Our research and development is driven by compassion for those suffering so we hope that these initiatives will bring relief to many children and their loved ones.”

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
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.

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.