REG - Eco Animal Health Gp - Submission of Marketing Authorisation Application

ECO Animal HealthAnnouncement

03/03/2025 07:15

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RNS Number : 0100Z  Eco Animal Health Group PLC  03 March 2025

3 March 2025

 

 

 

ECO Animal Health Group plc

("ECO" or the "Company")

 

Submission of Marketing Authorisation Application to EMA

First EU Vaccine Application submitted for regulatory 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, 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.

 

-Ends-

For further information please contact:

 ECO Animal Health Group plc                                    020 8447 8899

 David Hallas (CEO)

 Christopher Wilks (CFO)
 Singer Capital Markets (Nominated Adviser & Joint Broker)      020 7496 3000

 Phil Davies

 Sam Butcher
 Investec (Joint Broker)                                        020 7597 5970

 Gary Clarence

 Lydia Zychowska
 Equity Development                                             020 7065 2692

 Hannah Crowe

 Matt Evans
 ICR Healthcare (Financial PR)                                  020 3709 5700

 Mary-Jane Elliott                                              ecoanimalhealth@consilium-comms.com

 Jessica Hodgson

About ECO Animal Health

ECO Animal Health is a world leader in animal health, developing and marketing
branded veterinary pharmaceuticals globally, with expertise in antibiotics and
vaccines for pigs and poultry. We have a maturing proprietary R&D
pipeline.

Headquartered in the UK, with global offices including R&D and
manufacturing, we have marketing authorisations in over 70 countries and
employ over 200 people worldwide.

Our lead product, Aivlosin® is a proprietary, patented medication which is
effective against both respiratory and intestinal diseases in pigs and
poultry.

Click here for more information: https://ecoanimalhealth.com
(https://ecoanimalhealth.com)

 

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