Pharmaceutical firm Aspen Australia has been granted exclusive rights to market, sell and distribute Emyria’s over-the-counter product should it successfully come through a clinical trial and be approved by the Therapeutic Goods Administration (TGA).

Under binding commercial terms struck between the companies, Emyria will be paid royalties of up to 10% once annual sales of the synthetic CBD hard capsule exceed A$50 million.

Emyria will also receive two payments of $200,000 once certain milestones have been reached.  

Aspen Australia, owned by South Africa-based Aspen Pharmacare Holdings, will provide “funding and resources” for the regulatory approval process, according to a statement to the ASX, and has first right of refusal to sell and distribute the product in New Zealand.

It will also “evaluate the opportunity” to manufacture the CBD product at its site in Dandenong, Victoria.

The announcement of the 10-year deal comes as Emyria continues its placebo-controlled clinical trial to study the effects of its schedule 3 candidate – EMD-RX5 – on symptoms of psychological distress.

The multi-site trial will see 300 patients suffering from mild stress and anxiety – and with a background of chronic pain – receive either 50mg of EMD-RX5, 150mg or a placebo.

While the agreement contains binding terms, there are a number of caveats, a successful trial key among them.

The agreement will terminate if the trial fails to generate sufficient data to support a TGA submission by July 1, 2024, while either party can walk away if the product is not registered within two years of a dossier being lodged with the regulator.

It is also subject to the parties striking a full licensing agreement before November 30, 2023, and Aspen entering supply agreements with the capsule manufacturer and API supplier by October 31, 2023.

Emyria chief executive Michael Winlo said Aspen has the necessary market power and skillset to sell, market and distribute the product.

Dr Michael Winlo
Emyria CEO Dr Michael Winlo

“We are excited to collaborate with Aspen, one of Australia’s largest and most successful pharmaceutical companies with an impressive track record in sales, marketing, manufacturing and distribution,” he said.

“Aspen’s extensive sales force is unique in that it can reach both pharmacies and prescribing doctors which will be instrumental in ensuring that Emyria’s product has strong brand awareness and gains widespread adoption after registration.”

Aspen chief executive Trevor Ziman added: “Aspen aims to be leaders in every product category we operate 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.”

Sydney-based Aspen Australia has around 140 brands and 500 products in the local market.

Its parent, Aspen Pharmacare, has a market capitalisation of A$6 billion, a presence in 50 markets and distributes medicine in 115 countries.      

Steve has reported for a number of consumer and B2B titles over a journalism career spanning more than three decades. He is a regulator contributor to health journal, The Medical Republic, writing on...

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