- Emyria (EMD) contracts AltaSciences to manufacture synthetic cannabinoid-based capsules for Emyria’s drug development programs
- The products are being developed to meet US Food and Drug Administration (FDA) and Australian Therapeutic Goods Administration (TGA) standards
- Compared to plant-derived options, synthetic (cannabidiol) CBD costs less to manufacture which improves affordability and access for patients
- Emyria’s EMD-003 program will use the pure CBD platform and is on track to deliver one of Australia’s first registered, over-the-counter CBD medicines
- Company shares are up 7.89 per cent to trade at 20.5 cents at 12:48 pm AEST
Emyria (EMD) has contracted AltaSciences to manufacture a range of synthetic cannabinoid-based capsules for Emyria’s drug development programs.
The capsules are being developed to meet both US Food and Drug Administration (FDA) and Australian Therapeutic Goods Administration (TGA) quality standards and are expected to be more cost effective than previous supply options.
It will also allow Emyria to retain a complete ownership of all commercialisation rights and revenues.
Synthetic CBD costs less than plant-derived options which improves affordability, and patient access as patients are currently required to spend more than $400 a month out of pocket. This option also provides Emyria with a cost competitive advantage.
Emyria’s Managing Director, Michael Winlo, is pleased to have contracted the North American drug manufacturer.
“The novel platform we are advancing with AltaSciences has several key benefits for Emyria,” Dr Winlo said.
“First, all of our good manufacturing practice (GMP) cannabinoid products will also meet FDA specifications for purity and quality. This means the clinical trials and investment required to obtain TGA registrations can also support our FDA registration plans.”
Emyria’s EMD-003 is a schedule three, low-dose CBD drug registration program and will be the first to use the new pure synthetic dose form.
Notably, EMD-003 is on track to deliver one of the first registered, over-the-counter CBD medicines in Australia.
Emyria expects to provide more information on its global registration plans in the coming weeks.
The announcement comes the same day as EMD and Cann Group said they had ended an agreement to progress an over-the-counter medicine with the TGA using Emyria’s EMD-003 drug development program and Cann’s proprietary Gelpell microsphere technology.
Company shares were up 7.89 per cent to trade at 20.5 cents at 12:48 pm AEST.