GW Pharmaceuticals signs MOU to research Epudiolex with New South Wales (Australia)

GW Pharmaceuticals plc, a Nasdaq and AIM listed biopharmaceutical company announced Tuesday that it had signed a Memorandum of Understanding (MOU) 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.”

NSW Premier Mike Baird said:

“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.”

“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.”

According to GW, 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, GW says that 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.

urthermore, 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, GW says, 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.

According to GW, 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, GW adds.

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, GW concludes.

Sativex results

In a separate press release on Tuesday, the company and Otsuka Pharmaceutical Development & Commercialization, Inc., reported top-line results from the remaining two Phase 3 trials for the investigational product Sativex in the treatment of pain in patients with advanced cancer who experience inadequate analgesia during optimized chronic opioid therapy.

According to the company, consistent with the previously reported Phase 3 trial, Sativex did not meet the primary endpoint in these trials. However, a pre-specified pooled analysis of patients across the two Phase 3 trials which involved clinical sites in the U.S. showed a statistically significant improvement for Sativex compared with placebo (p=0.024), with several secondary efficacy endpoints exhibiting p-values of less than 0.05.

GW and Otsuka have submitted a request to meet with the U.S. Food and Drug Administration (FDA) to discuss the clinical relevance of these data and to determine potential paths forward.