Aussie biotech enters agreement to commercialise its therapy for mental health disorder

Biotech News: A clinical stage ASX-listed biotech has entered an agreement for the licensing and commercialisation of its oral therapy for stress and anxiety, impacting up to 15% of the adult population.

EMD-RX5 is Emyria’s first cannabidiol (CBD) capsule targeting TGA registration as an over-the-counter (OTC) treatment for the symptoms of mild stress and anxiety for patients with a chronic health condition such as chronic pain. EMD-RX5 is currently in Phase 3 clinical trials and aiming to be the first to market.

Aspen Australia will provide funding and resources to support the development and regulatory approvals for EMD-RX5 in Australia. Additionally Aspen Australia will have the exclusive right to market, sell and distribute EMD-RX5 in Australia. The company has full GMP manufacturing capabilities at their site in Dandenong, Victoria and will retain the rights to evaluate the opportunity to manufacture EMD-RX5 locally. Both Aspen and Emyria will explore OTC market opportunities in other countries in which Aspen operates.

Currently, the market for registered CBD medicine is dominated by Jazz Pharmaceuticals’ Epidyolex oil, a prescription medication for rare seizure disorders that generates over AUD$1B in annual sales globally. While the TGA has allowed low dose CBD (<150mg/day) to be registered as an OTC medicine since December 2020, no CBD product has yet achieved this registration.

Aspen CEO, Trevor Ziman, said “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. We look forward to a long and successful partnership.”

Emyria’s Real World Data of over 8,000 patients prescribed pharmaceutical-grade cannabinoid medicines at their clinical service subsidiary, Emerald Clinics, suggests up to 50% of patients with Chronic Pain experience anxiety and stress symptoms. There is currently no OTC treatment for these symptoms and Emyria sees a significant opportunity for EMD-RX5 to address this unmet need in the OTC market.

Emyria Managing Director, Dr Michael Winlo said “Emyria expects to become one of the first companies to register a CBD product for the rapidly emerging Australian OTC market, thanks to our innovative product and registration strategy. 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. 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.”

Under the agreement, Emyria will generally be paid a royalty between 5% to 10% of net sales based on annual net sales and gross profit targets. The 10% royalty applies when annual sales exceed $50M. In addition, Emyria will earn a total milestone payment of A$400,000 upon the successful registration with the TGA and the successful launch of the product in market.

The initial term of the agreement is for 10 years and subject to Aspen entering into supply agreements with the capsules manufacturer and API supplier by 31 October 2023. The agreement will also terminate if the clinical trial fails to generate adequate data to support a TGA submission by 1 July 2024.

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