In a statement released 29 March 2021, Emyria Limited and Cann Group Limited have announced a collaboration agreement to seek accelerated registration of a unique, low-dose, CBD-only capsule with Australia’s Therapeutic Goods Administration (TGA).
Reportedly, if successful the registration as a Schedule 3 medicine will result in an over-the-counter pharmacist-only CBD medicine.
Under the agreement, Emyria’s EMD-003 drug development program will use Cann Group’s proprietary Gelpell microsphere technology, as the basis for seeking a Schedule 3 registration for treating unmet needs in mental health, delivering a new, registered medicine for the treatment of psychological distress and symptoms of depression, anxiety and stress.
“This partnership greatly accelerates Emyria’s EMD-003 drug development program by combining Emyria’s unique clinical data and drug development expertise with Cann Group’s best-in-class CBD delivery technology,” says Emyria’s Managing Director, Dr Michael Winlo.
As announced by the Cann Group earlier this year, the company recently acquired the rights to the technology via the purchase of the Satipharm group of companies, which has commercialised a CBD product utilising the technology – Satipharm CBD, which is said to have 3.5 times greater bioavailability compared to oil preparations at 100mg.
“Satipharm CBD has already completed robust stability testing as well as Phase 1 clinical trials as required by the TGA,” says Dr Winlo.
“This allows us to move straight to pivotal clinical outcomes trials saving significant time and money.
“An experienced Regulatory Consultant has already been engaged to manage the TGA submission.”
According to the statement released by Emyria and the Cann Group, Emyria already has real-world data on more than 170 patients taking the Satipharm CBD capsule, with Dr Winlo adding that they “already have deep insights into how the Satipharm product performs clinically”.
“This de-risk’s the pivotal clinical outcomes trials required as an important first step towards registration with the TGA,” says Dr Winlo.
Welcoming the partnership, Cann Group’s CEO, Peter Crock says the “Cann Group is pleased to partner with Emyria to accelerate the registration of a Schedule 3 medicine”.
“We anticipate there will be a large patient demand for a TGA-registered CBD medicine that is convenient to patients and demonstrates the highest standards of quality, safety and efficacy,” says Mr Crock.
“We believe our microsphere technology – with improved bioavailability – fits well with Emyria’s drug development programs, which have the potential to accelerate registration with the TGA due to Emyria’s extensive real-world data, national clinical site network and previous drug development experience.
“We are also working to bring the Gelpell pharmaceutical GMP manufacturing line to Cann’s Mildura production facility, which, when commissioned at the end of this calendar year, will become the largest cannabinoid medicine production facility in Australia.”