Collaboration agreement aims to accelerate the registration of a Schedule 3, over-the-counter, cannabidiol (CBD) medicine in Australia
Emyria’s EMD-003 drug development program will incorporate Cann Group’s newly acquired GelpellTM microsphere formulation technology
Partnership provides potential significant cost and speed advantages to registration
Successful registration with the Australian Therapeutic Goods Administration (TGA) opens the path to registration opportunities overseas
Emyria and Cann Group will negotiate product commercialisation arrangements prior to a regulatory approval application being submitted
Emyria Limited (ASX: EMD) (Emyria) and Cann Group Limited (ASX: CAN) (Cann Group) are pleased to announce a collaboration agreement to seek accelerated registration of a unique, low-dose, CBD-only capsule with Australia’s Therapeutic Goods Administration (TGA).
Successful registration as a Schedule 3 medicine would 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. A joint project committee will be formed to oversee the allocation of registration costs and the development of commercialisation agreements.
Cann Group recently acquired the rights to the technology via the purchase of the Satipharm group of companies (as previously announced by Cann Group on 15 February 2021), which has commercialised a CBD product utilising the technology. Cann Group plans to incorporate manufacturing of the microsphere formulation in its new production facility currently under construction near Mildura.
Emyria’s Managing Director, Dr. Michael Winlo, said:
“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.
Satipharm CBD has already completed robust stability testing as well as Phase 1 clinical trials as required by the TGA. 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.
Further, at Emyria, we already have deep insights into how the Satipharm product performs clinically, having written over 400 Satipharm prescriptions to more than 170 patients. This de-risks the pivotal clinical outcomes trials required as an important first step towards registration with the TGA.”