Cann Group has entered into an exclusive evaluation & option agreement with GSK Consumer Healthcare in relation to the potential commercialisation of Satipharm CBD capsules for OTC (S3, Pharmacist-only) distribution in Australia. GSK also has potential interest in first rights to negotiate exclusivity periods to assess its interest in taking up commercialisation rights in other markets globally. Cann has granted GSK the exclusive right to evaluate Satipharm (excluding Cann’s Rx CBD products) for 60 days after the delivery of Cann’s final clinical study report.
In consideration of this, GSK will pay Cann £100,000 (US$130,437) as a non-refundable payment. Key terms of any definitive sales & marketing agreement will be contingent on factors including the results of the 4-week Phase 3 clinical trial and path to regulatory approval, as well as GSK’s marketing evaluation. Recruitment for the trial, which will examine the efficacy of Satipharm for the short-term treatment of sleep disturbances and quality of life outcomes, is in progress and the results are expected in H2 2022.
As highlighted in our recently published Innovation in CHC report, global launch activity for CBD products has dropped off substantially over the past two years since the pandemic. Regulatory uncertainty also still hovers over the status of CBD in the key US market, another factor in NPD dropping sharply there. In the near future, we expect there to be a greater emphasis on quality over quantity. Further clinical backing for CBD and other cannabinoids – in the way GSK is pursuing with this Cann partnership – will be crucial to this next phase in the maturity of the category.
Nicholas Hall Writes: “This is a very important story. As Peter Crock, the Cann CEO, says: “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.”
Alright, it’s not a done deal yet, but there is an expectation that it will be concluded for Australia, and possibly other markets. It is highly significant in many ways:
- It’s the first major move since Australia approved CBD for certain OTC indications in February 2021
- With all due deference to Nestlé, it’s the first instance of a major CHC company taking a direct interest in the CBD market
- There is some real science involved
- The sleep indication will be a sure-fire winner in a category that grew 13.2% in 2021 and still has massive unmet consumer demand
And finally, is it a sign of the greater freedom that the independent Haleon will have to enter “difficult” categories, which might not be possible for an affiliate of Big Pharma? All in all, this is a bold move, and one I hope will succeed.
We are pleased to announce that the latest edition of Innovation in CHC from CHC New Products Tracker is now published! This report showcases 100 major innovations from 2021, profiles best-in-class brands and highlights key ingredient and delivery format trends. To order your copy now, or for more information, please contact melissa.lee@NicholasHall.com.