ECO Animal Health Submits First EU Vaccine Application for Poultry Mycoplasma Treatment

Key Insights

• ECO Animal Health has submitted its first Marketing Authorisation Application to the European Medicines Agency for ECOVAXXIN® Mycoplasma synoviae vaccine, marking a significant milestone in their vaccine portfolio development.
• The vaccine targets Mycoplasma synoviae infection, which causes substantial economic losses by reducing egg production by 5-10%, decreasing hatchability by 5-10%, and increasing broiler mortality by 1-4%.
• Parallel submissions are underway with the USDA for both Mycoplasma synoviae and Mycoplasma gallisepticum vaccines, with expected marketing approval timing aligned with European authorization.

ECO Animal Health Group plc has reached a significant milestone by submitting its first Marketing Authorisation Application to the European Medicines Agency (EMA) for ECOVAXXIN® Mycoplasma synoviae vaccine. The submission, completed ahead of schedule, represents the company's first entry into the European poultry vaccine market.

Disease Impact and Market Opportunity

Mycoplasma synoviae (MS) infection presents a significant challenge in poultry production, causing substantial economic losses through joint and respiratory infections. Recent research has documented the disease's considerable impact on commercial poultry operations:

• 5-10% reduction in egg production for layers and breeders
• 5-10% decrease in egg hatchability
• 1-4% increase in broiler mortality
• Significant negative effects on feed conversion efficiency

The disease's management currently poses significant challenges, as maintaining Mycoplasma synoviae-free status on farms proves difficult. By the time clinical signs become visible, the infection often has already spread to other birds, causing subclinical damage and impacting production.

Regulatory Timeline and Development Strategy

The approval process is expected to take approximately 18 months, aligning with the company's commercialization strategy. David Hallas, Chief Executive Officer of ECO Animal Health Group plc, emphasized the significance of this development: "This submission represents a pivotal moment for ECO; we are proud of the development work, the convincing trial work and the dossier quality."

Broader Development Pipeline

ECO Animal Health is simultaneously pursuing multiple regulatory approvals:

• U.S. marketing approval for the MS vaccine through the United States Department of Agriculture
• Development of ECOVAXXIN® Mycoplasma gallisepticum vaccine for both European and U.S. markets

The company anticipates receiving U.S. marketing approval for the MS vaccine concurrent with European authorization, demonstrating a coordinated global regulatory strategy.

Market Positioning and Prevention Strategy

The new vaccine addresses an underserved market in poultry disease prevention. Current preventative approaches have proven insufficient, creating a significant market opportunity. The vaccine offers a proactive solution to reduce reliance on antibiotic treatments, which are currently necessary when infection occurs.

The development represents a strategic expansion of ECO Animal Health's portfolio, building upon their existing success with products like Aivlosin® for respiratory and intestinal diseases in pigs and poultry.