Emyria leading the race to deliver Australia’s first over-the-counter cannabinoid medicine with Aspen deal

Emyria is leading the race to deliver one of the first successfully registered over-the-counter cannabinoid medicines in Australia, according to its boss, after the WA biotech company inked a new deal with pharmaceutical giant Aspen Australia.

Emyria on Tuesday announced it had entered an agreement with NSW-based Aspen Australia for the licensing and commercialisation of EMD-RX5, an ultra-pure CBD capsule aimed at treating symptoms of mild anxiety and stress in patients with a chronic condition.

“There is a little bit of a race on to try and bring forward one of the first over-the-counter cannabinoid medications,” Emyria managing director Michael Winlo said.

“The Therapeutic Goods Administration has allowed low-dose CBD to be registered as an over-the-counter medication but there is no product available yet.

“There have been at least three notable clinical failures from other groups pursuing this opportunity.”

Aspen Australia is a subsidiary of Aspen Holdings, listed on the Johannesburg Stock Exchange, and will provide funding and resources to support the development and TGA approvals of the product in Australia.

Aspen Australia will also have the exclusive right to market, sell and distribute EMD-RX5, which is in phase three clinical trials, across the country.

Emyria will be paid royalties of up to 10 per cent once annual sales of the product exceed $50 million.

Dr Winlo said Emyria could become one of the first companies to register a CBD treatment because it had a “great product that’s reliable”, “great data around where that product works effectively” and a “great partner that can get that product out.”

He said EMD-RX5 had a large potential market, with mild anxiety and stress affecting up to 15 per cent of the Australian adult population, and was more prevalent in patients with chronic disease, including chronic pain.

Chronic pain affects around 2.8 million adults in Australia.

“We know that people are spending somewhere between $200m to $400m a year on medicinal cannabis products for a range of problems,” Dr Winlo said.

“By making a treatment available through pharmacies, we suddenly improve dramatically the access that patients can have.”

Aspen chief executive Trevor Ziman said the company aimed to be leaders in every product category it operated in.

“We are excited to continue this tradition by partnering with Emyria and supporting the registration and commercialisation of their unique product with large potential in the Australian market,” he said.

Dr Winlo expects the product to be available in the market in mid-2024, pending successful clinical trials.

Investors appeared unmoved by the announcement, with Emyria shares closing down 7.9 per cent to 18¢ on Tuesday.

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