18/08/21 - Emyria is on track to deliver one of the first successfully registered, over-the-counter CBD medicines in Australia and has already completed much of the preliminary registration work.
Emyria is looking to register the new capsules with the Australia’s Therapeutic Goods Administration and the US Food and Drug Administration.
Emyria Ltd (ASX:EMD) has contracted a leading North American drug manufacturer to deliver a range of novel, synthetic cannabinoid-based (CBD) medicines for its Australian and US drug registration program.
Emyria is a data-backed drug development and care delivery company, with a leading drug registration program, EMD-003, which is focused on reducing symptoms of anxiety, depression and stress.
The company has engaged Altasciences, an award-winning contract drug manufacturer with more than 1,000 employees and seven locations across the US and Canada, to deliver a range of proprietary, synthetic cannabinoid-based capsules utilising a unique drug delivery approach.
Engagement with Altasciences comes just a week after, Emyria signed an exclusive agreement with the University of Western Australia (UWU) to develop a unique drug discovery pipeline of novel psychedelic therapies.
The capsules being developed in conjunction with Altasciences will form the foundation for Emyria’s cannabinoid drug development programs.
US registration opportunities
“We are excited to be contracting Altasciences to deliver a range of novel synthetic CBD medicines for our drug registration programs led by EMD-003," Emyria’s managing director Dr Michael Winlo said: Emyria is looking to register the new capsules with Australia’s Therapeutic Goods Administration (TGA) and the US Food and Drug Administration (FDA) and is working to both organisations’ quality standards.
“Emyria has been seeking a platform which can deliver a proprietary, cost-effective and FDA-compliant cannabinoid medicine for some time," Winlo said.
"We have always been committed to pursuing registration opportunities with the FDA in the USA in parallel to our Australian programs as the US is the world’s largest pharmaceutical market. The FDA is tightening rules on cannabinoid medicines and registration is required if reimbursement and product claims are targeted.”
The new capsules will be more cost-effective than previous supply options, which will enable Emyria to retain 100% ownership of all commercialisation rights and revenues.
Emyria shares have been as much as 13.2% higher this morning to A$0.215.
Synthetic CBD has range of benefits
There are development and cost savings benefits in using synthetic drug material, notably, the synthetic platform under development is expected to support multiple drug registration programs with the TGA and FDA.
The overall benefits of Emyria’s novel, pure CBD platform are:
Accelerated US FDA Registration. By using pure, synthetic cannabinoid Active Pharmaceutical Ingredients (APIs), Australian clinical development and trials can also support US/FDA registration efforts, greatly accelerating timelines for FDA registration;
Ownership. Emyria will retain 100% ownership, commercialisation rights and revenues for all Emyria-led cannabinoid programs; and
Cost-effective. Synthetic CBD currently has a significantly lower cost compared to plant-derived options, substantially improving affordability, patient access and providing Emyria with a cost-competitive advantage.
Winlo said: “The novel platform we are advancing with Altasciences has several key benefits for Emyria.
"First, all of our 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. This brings our US registration plans forward significantly.
“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.”
What is EMD-003?
EMD-003 is a drug registration platform that is aimed at delivering one of the first registered Schedule 3, over-the-counter cannabidiol (CBD) medicines.
This is a low-dose cannabidiol drug registration program that is aiming to be the first to make use of the new pure synthetic dose form.
EMD-003 is targeting the symptoms of psychological distress.
Emyria is on track to deliver one of the first successfully registered, over-the-counter CBD medicines in Australia and has already completed much of the preliminary registration work including:
Received feedback from the TGA regarding the target indication and the utility and importance of Emyria’s Real-World Evidence (RWE) for drug registration;
Filed patents supporting use of cannabinoids to treat the target indication;
Developed the pivotal trial protocols;
Secured independent clinical trial sites to support Emyria’s patient recruitment for the pivotal trial;
Engaged regulatory resources with prior, successful Schedule 3 registrations experience; and
Built an expert clinical advisory team to support the pivotal studies
Emyria and Cann Group end agreement
News of Emyria’s agreement with Altasciences comes as Emyria and Cann Group have mutually agreed to terminate their collaboration agreement in relation to the planned registration of a Schedule 3 (S3) medicine CBD product.
The plan was to progress the over-the-counter CBD medicine by utilising Emyria’s EMD-003 drug development program and Cann’s proprietary Gelpell microsphere technology.
However, following a detailed review, the companies have decided to independently pursue registration programs for an S3 CBD product.
