Cann Group, Emyria team up in bid to gain TGA approval for low-dose CBD gelcap
Health & Biotech
Health & Biotech
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Cannabis companies Cann Group (ASX:CAN) and Emryia (ASX:EMD) are joining forces in a bid to be the first companies to have a low-dose cannabinoid (CBD) product approved for sale in Australian pharmacies without a prescription.
They are hoping to have a gelcap CBD product approved for the treatment of psychological distress and the symptoms of anxiety, depression and stress.
New rules relaxing regulations on CBD products went into effect February 1, allowing companies to request approval for low-dose pills and oils to be dispensed in Australian pharmacies without a prescription.
Cann Group in response acquired Satipharm, a European business with “proprietary cannabinoid delivery technology” for up to $C4 million ($4.1 million).
“Satipharm CBD has already completed robust stability testing as well as Phase 1 clinical trials as required by the TGA,” said Emryia managing director Dr Michael Winlo.
“This allows us to move straight to pivotal clinical outcomes trials saving significant time and money. An experienced contract research organisation has already been engaged to manage these trials.”
Emyria has already written over 400 Satipharm prescriptions to move than 170 patients, Dr Winlo said.
Cann Group chief executive Peter Crock said the company was working to incorporate the microsphere gelcap formulation at its new production facility currently under construction near Mildura, Victoria.
Elsewhere in the ASX cannabis space, Althea Group (ASX:AGH) announced it had launched a new range of 20ml full-spectrum cannabis oil products, under the same trade names and formulations as its existing 50ml and 100ml products.
The new cheaper “flexi” oil range will give price-sensitive patients a lower entry point so they can trial Althea products, according to the company. Althea’s top-selling CBD100 product can cost as much as $299 for 100ml.
Althea had 12,273 Australian patients accessing its legal medical marijuana at the end of last year, more than triple than at the end of 2019.
At 11.33am AEDT, Althea shares were up 1.9 per cent to 53c; Emyria shares had gained 5.7 per cent to 18.5c; and Cann Group shares had dipped 1.8 per cent to 56c.