The multinational pharmaceutical company GlaxoSmithKline has entered into an evaluation agreement with medical cannabis research company Cann Group which could lead to the marketing and distribution of a new CBD delivery system in Australia.
Australia’s Therapeutic Goods Administration (TGA) approved sale of CBD over the counter in the country’s pharmacies towards the beginning of 2021. However, no products have yet passed the TGA’s strict guidelines.
Cann Group Limited is one of the many Australian cannabis producers looking to become the first to sell over-the-counter CBD products in Australia and GSK Consumer Healthcare – a subsidiary of GlaxoSmithKline – has shown interest in supporting the company’s efforts.
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Cann has entered into an exclusive evaluation and option agreement with GSK which could lead to the commercialisation of Cann’s Satipharm CBD capsules for over-the-counter distribution in Australia and potentially other markets globally.
As part of the £100,000 agreement, Cann has granted GSK Consumer Healthcare the exclusive right to evaluate Cann’s Satipharm CBD capsules for 60 days following the completion of its final clinical study report.
Over the upcoming evaluation period, GSK will assess the commercial potential of the Satispharm capsules and review the results of Cann’s ongoing Phase 3 CBD clinical trial – a randomised, double blind, placebo-controlled study which is examining the efficacy of the CBD delivery system for short-term treatment of sleep disturbances and quality of life outcomes.
Cann’s CEO, Peter Crock, said GSK Consumer Healthcare’s interest in the product is a strong validation of the Satipharm delivery platform.
“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,” Crock said.
“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 currently in progress for Cann’s Phase 3 CBD clinical trial, which will involve patients being treated for a total of four weeks. The results of the trial are anticipated to be available during the second half of 2022.
The Satipharm capsules are being manufactured in Cann’s new state-of-the-art facility near Mildura, Victoria. While small-scale production is already underway, the evaluation process will scope the large-scale manufacturing requirements to support GSK Consumer Healthcare’s potential supply needs. This will initially be focused on Australia but Cann Group said there is potential for distributing the product in other markets across the world.
Cann has granted GSK the exclusive rights of first negotiation to obtain an exclusive licence to commercialise the product. Specifically, the licence would be for the product’s use as a consumer healthcare product for over-the-counter use in humans in Australia. Cann, however, will retain all rights to the product for other uses.
The evaluation is not a binding agreement so any definitive sales and marketing agreement will depend on factors such as the results of Cann’s Phase 3 clinical trial and path to regulatory approval, as well as GSK Consumer Healthcare’s marketing evaluation.
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