Risk Profile Demonstrated for ECOVAXXIN MS

• Favourable internal risk assessment reviewed by the United States Department of Agriculture is key to US approval

ECO Animal Health Group plc (AIM: EAH), a rapidly growing global animal health company with a portfolio of marketed veterinary products and a maturing proprietary R&D pipeline, announces that ECOVAXXIN® MS, its new live vaccine against Mycoplasma synoviae in poultry, is a step closer to approval by the United States Department of Agriculture (USDA) after internal risk assessments demonstrated that the vaccine does not revert to virulence.

Mycoplasma synoviae is a bacterium that can cause respiratory disease and synovitis in chickens and may have deleterious effects on egg production.

Demonstrating that a vaccine strain does not regain virulence after passages through poultry is part of the risk assessment required to obtain a license for the vaccine in the US. These data demonstrating a lack of reversion to virulence have been reviewed by the USDA, which found the study methodology and data acceptable to support the safety of the vaccine strain.

The vaccine project is the result of a collaboration between ECO and Professor Naola Ferguson-Noel of the Poultry Diagnostic & Research Center, College of Veterinary Medicine at the University of Georgia (UGA), USA. The vaccine strain is a non-pathogenic Mycoplasma synoviae isolate and has been shown previously to be free of antimicrobial resistance (AMR) genes - a prerequisite for US registration.

ECO is working in close collaboration with the USDA for the licensure of its vaccine against Mycoplasma synoviae and to gain authorization to import and distribute the product in the US.

ECO is targeting a launch of ECOVAXXIN®MS in the US from late 2025.

David Hallas, CEO of ECO, commented: "ECO is focused on building a robust and long-lasting R&D pipeline, and providing the poultry industry with a safe and effective new vaccine against Mycoplasma synoviae is a key element of this. ECOVAXXIN® MS is the first step in strengthening ECO's ambition to launch multiple vaccine products in key territories."

"This risk assessment demonstrates that ECO can meet the robust safety threshold set out by the USDA and shows that we are taking the right steps towards obtaining a critical US license."