Cann Group and Emyria have ditched plans to collaborate on the registration of an over-the-counter (Schedule 3) CBD product, opting to go their own ways instead.
In plans announced to the ASX in March, the companies said Emyria’s EMD-003 drug-development program would use Cann’s Gelpell microsphere technology as the basis for a Schedule 3 registration to treat unmet needs in mental health.
However, this morning they told the ASX in a joint statement that they had mutually agreed to end the arrangement.
It said: “Following a detailed review, both companies have agreed to formally terminate those arrangements and mutually release each other from the obligations of the collaboration agreement. Both Emyria and Cann plan to independently pursue registration programs for a Schedule 3 CBD product.”
In separate statements, the companies unveiled their new plans.
Cann confirmed it is proceeding with a Schedule 3 registration program based on the Gelpell technology it acquired the rights to as part of its Satipharm acquisition in March.
It added: “Cann will now resume an internal development program building on clinical trials already undertaken by Satipharm.”
The company expects to make announcements in the near future regarding the proposed indication and clinical program to support the registration process.
The protocol design for the next clinical trial will be for a pivotal Phase III study, to produce data that supports regulatory approval by the Therapeutic Goods Administration (TGA).
Cann CEO Peter Crock said the company remains focused on submitting a registration application for the Satipharm S3 CBD product as soon as possible, with the aim of securing an approval by the end of CY22.
He added: “Cann’s unique formulation and delivery platform enables us to develop a CBD-only product that has superior stability and bioavailability properties and a medicine presentation that will be familiar to consumers and pharmacists.
“Satipharm CBD capsules were one of the first medicinal cannabis products available to approved patients in Australia (under the Special Access Scheme) and have been successfully used in a variety of medical conditions since 2017.
“Satipharm CBD products are currently sold over-the-counter at major pharmacies and health food retailers in the UK and Cann is in discussions with major healthcare companies in relation to global distribution rights to the product.
“Our international expansion plans for the Satipharm CBD products prioritise Australia as a key market, where consumer interest and demand for CBD-only products continues to grow.”
Meanwhile, Emyria has teamed up with AltaSciences to “deliver a range of proprietary, synthetic cannabinoid-based capsules utilising a unique drug-delivery approach”.
The capsules will become the foundation for the firm’s cannabinoid drug-development programs targeting registration with the TGA and US Food and Drug Administration (FDA).
The company said the new capsules are being developed to meet both TGA and FDA quality standards, are “likely to be much more cost effective than the previous supply options considered”, and will allow Emyria to retain 100% ownership of all commercialisation rights and revenues.
It added: “By selecting synthetic CBD, Emyria has ensured that its drug-development programs, and Australian-based clinical trials, can also support the pursuit of FDA registration following
Managing Director Dr Michael Winlo said: “Emyria will also have complete ownership over our Australian and US drug-development programs, reducing our reliance on third-parties and allowing us to move rapidly towards TGA registration and sales in pharmacies where there is already a great deal of patient and commercial interest.”