Aspen Australia has secured exclusive rights to market, sell and distribute a synthetic CBD product developed by Emyria, contingent on the product clearing a clinical trial and receiving approval from the Therapeutic Goods Administration (TGA).
Under binding commercial terms agreed between the two companies, Emyria stands to collect royalties of up to 10% once annual sales of the synthetic CBD hard capsule surpass A$50 million.
Emyria will also receive two separate milestone payments of $200,000 each upon achieving specified targets.
Aspen Australia, a subsidiary of South Africa-headquartered Aspen Pharmacare Holdings, will contribute "funding and resources" toward the regulatory approval process, the company disclosed in an ASX statement. Aspen also holds first right of refusal to sell and distribute the product across New Zealand.
The company has additionally committed to assessing the feasibility of manufacturing the CBD product at its Dandenong, Victoria facility.
The 10-year agreement has been announced while Emyria presses ahead with a placebo-controlled clinical trial examining how its schedule 3 candidate — EMD-RX5 — affects symptoms of psychological distress.
The multi-site study will enrol 300 patients experiencing mild stress and anxiety alongside a history of chronic pain, with participants assigned to receive either 50mg of EMD-RX5, 150mg, or a placebo.
Although the agreement contains binding terms, it is subject to several conditions, with a successful trial outcome being the most critical.
The deal will be terminated if the trial does not produce sufficient data to support a TGA submission by July 1, 2024, and either party may exit if the product has not been registered within two years of a dossier being filed with the regulator.
The agreement is also conditional on the parties finalising a full licensing agreement before November 30, 2023, and on Aspen securing supply agreements with the capsule manufacturer and API supplier by October 31, 2023.
Emyria chief executive Michael Winlo said Aspen has the commercial strength and expertise needed to bring the product to market.
"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 carries around 140 brands and 500 products in the domestic market.
Its parent company, Aspen Pharmacare, holds a market capitalisation of A$6 billion, operates in 50 markets and distributes medicine across 115 countries.
