Cann Group has entered into an exclusive agreement with GSK Consumer Healthcare to evaluate the distribution and marketing of its Satipharm CBD capsules as an over-the-counter (schedule 3) medicine in Australia.
During the exclusivity period (60 days after delivery of Cann’s final clinical study report), GSK will undertake an evaluation of Satipharm’s commercial potential and review the results of the trial.
In parallel, the parties will negotiate a definitive exclusive agreement for the marketing, sale and distribution of Satipharm in Australia and potentially other markets globally.
Cann CEO Peter Crock said: “Cann’s ability to produce a CBD capsule that presents as a regular pharmaceutical and has proven benefits in terms of stability and bioavailability has attracted interest from a number of potential distribution partners.
“We are delighted to have this opportunity to work with GSK Consumer Healthcare, which would bring industry-leading expertise and market access to our CBD product platform if we enter into a definitive exclusive agreement.”
Recruitment is underway for Cann’s Phase 3, randomised, double blind, placebo-controlled clinical trial examining the efficacy of Satipharm for the short-term treatment of sleep disturbances and quality of life outcomes.
The trial, part of the firm’s S3 registration program, will see patients treated for four weeks, with results expected during the second half of CY2022.
While small-scale production of Satipharm capsules is already underway at Cann’s new facility near Mildura, the evaluation process will scope the large-scale manufacturing requirements necessary to support GSK’s supply needs in Australia and other markets.