Pot Stocks: Emyria and Cann split, but who will win the race to register their CBD product first?
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The companies originally had an agreement for the planned registration of a schedule 3 (S3) over-the-counter cannabidiol (CBD) medicine product with Australia’s Therapeutic Goods Administration (TGA) using Emyria’s EMD-003 drug development program and Cann’s proprietary Gelpell microsphere technology.
But the companies have mutually agreed to terminate the collaboration, to pursue registration independently.
And now the race is on to see who can get their product over the line first.
Emyria has contracted leading North American drug manufacturer, Altasciences, to deliver a range of novel, synthetic cannabinoid-based medicines for its Australian and US drug registration program.
Altasciences will deliver a range of proprietary, synthetic cannabinoid-based capsules which are being developed to meet both TGA and FDA quality standards.
“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,” Managing director Dr. Michael Winlo said.
Plus, the company says synthetic CBD is more cost effective.
“As patients will have to pay out-of-pocket for an over-the-counter CBD, it is essential to register a product that is effective, affordable and reliable to achieve large-scale uptake and sales,” Dr. Winlo said.
“Currently, patients are required to spend more than $400 a month, out-of-pocket, which is not sustainable.
“For EMD-003, we believe our clinical data, drug development expertise and patent portfolio, when combined with a unique and low-cost dose form, will allow us to become one of the first successfully registered and affordable Schedule 3 cannabinoid medicines in Australia.”
The company says its on track to deliver its EMD-003 drug registration, with clinical trial material due to arrive in Q4, 2021.
Cann is proceeding with a registration program aimed at securing Australian approval for a S3 OTC CBD-only product based on its proprietary Gelpell microsphere technology which it secured on acquiring Satipharm earlier this year.
The company plans to build on clinical trials already undertaken by Satipharm to support product registration of the Satipharm CBD 50mg capsules as an S3 ‘Pharmacist Only Medicine’ in Australia – targeted for the end of calendar year 2022.
“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,” Cann Group CEO Peter Crock said.
“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.”
“The TGA assessment and approval process is rigorous and provides Australian consumers with a high degree of confidence around quality and safety.”
“Our recent institutional placement secured the funding necessary for Cann to independently pursue our registration plans and to seek to be first to market in Australia with a TGA approved product.”