Submission of Marketing Authorisation Application

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, is pleased to announce that it has submitted a Marketing Authorisation Application and supporting dossier to the European Medicines Agency ("EMA") for its ECOVAXXIN® Mycoplasma synoviae ("MS") vaccine.

First poultry vaccine submission

The submission marks an important milestone in the development of ECO's vaccines portfolio and its broader R&D pipeline. The submission is marginally ahead of plan with the formal approval process expected to take approximately 18 months, aligning with our commercialisation strategy.

David Hallas, Chief Executive Officer of ECO Animal Health Group plc, commented: "This submission represents a pivotal moment for ECO; we are proud of the development work, the convincing trial work and the dossier quality. Mycoplasma synoviae is a significant poultry disease which is underserved by current preventative approaches, creating a significant market opportunity. Our commercialisation plan aligns well with the expected regulatory timetable and we look forward to accelerating this as we advance towards a planned launch."

"We continue to push forward in our work for US marketing approval of the MS vaccine as well as finalising our work in Europe and the USA for the sister vaccine for Mycoplasma gallisepticum in poultry."

Mycoplasma synoviae

MS causes significant economic loss through joint and respiratory infections in poultry. Recent studies indicate that MS infection can reduce egg production by 5-10% in layers and breeders, decrease hatchability by 5-10%, and increase broiler mortality by 1-4%1. Additionally, the disease negatively impacts feed conversion efficiency and performance, further reducing producer profitability.

Maintenance of Mycoplasma synoviae free status on farms is generally difficult and infected birds may require antibiotic treatment. By the time clinical signs are visible, mycoplasma infection may have spread to in-contact birds, likely sub-clinical damage has already occurred and egg production impacted. Medication costs combine with reduced feed efficiency and performance losses to negatively impact producer profits.

Other market activity

The Group is continuing to submit technical sections to the United States Department of Agriculture for both the ECOVAXXIN® Mycoplasma synoviae and the ECOVAXXIN® Mycoplasma gallisepticum vaccines and expects, subject to dossier review, to gain marketing approval for the MS vaccine in the United States at about the same time as Europe.

1 Yadav et al., "Insights on Mycoplasma gallisepticum and Mycoplasma synoviae infection in poultry: a systematic review, Animal Biotechnology", 2021.