Elanco Enters Agreement With Medgene To Commercialize Highly Pathogenic Avian Influenza Vaccine in Dairy Cattle

GREENFIELD, Ind., February 25, 2025 /3BL/ - Elanco Animal Health Incorporated (NYSE: ELAN) today announced it has entered into an agreement with South Dakota-based Medgene to leverage the company’s innovative vaccine platform technology. The agreement includes commercialization of a highly pathogenic avian influenza (HPAI) vaccine for use in dairy cattle. Medgene reports the vaccine has met all requirements of the U.S. Department of Agriculture’s (USDA) platform technology guidelines and is in the final stages of review for conditional license approval.

While the poultry industry has developed interventions and processes to reduce the spread or eradicate HPAI, those efforts have continued to be challenging as the current outbreak enters its fourth year. Dairy producers have worked quickly to protect their herds without the same tools and biosecurity options to tackle this devastating disease. The cross-species transmission of the disease into nearly 1,000 dairy herds across the U.S. since March 2024, along with zoonotic transmission to people, shows that more interventions are quickly needed. This virus is prevalent and predicted to persist over time, thus a cattle vaccine will be critical to slow virus spread between birds and cattle.

“As egg prices soar and milk production wanes in infected dairies, the need for new solutions to curb disease spread is evident,” says Jeff Simmons, President and CEO of Elanco Animal Health. “Elanco is pleased to partner with Medgene to bring customers options to fight this devastating disease and believes this product will become part of a routine vaccination protocol for the U.S. dairy industry. This partnership further strengthens our diverse dairy portfolio and advances our One Health platform of animal health solutions, not only benefitting our dairy customers, but helping curb disease spread for our poultry customers, and working to improve egg prices for consumers.”

“Medgene has an established reputation of supporting animal owners and their veterinarians with our USDA-licensed platform technology and bioinformatics software to design transformational vaccines. With our critically important H5N1 vaccine for dairy cattle in the final stages of approval, we’re excited to partner with Elanco to quickly bring this much needed solution to U.S. dairies,” said Mark Luecke, CEO of Medgene.

The USDA previously approved Medgene’s vaccine platform technology in cattle, allowing the company to accelerate H5N1 vaccine development. Medgene has existing vaccine manufacturing supply ready to deploy with the ability to support the U.S. dairy herd.

ABOUT ELANCO

Elanco Animal Health Incorporated (NYSE: ELAN) is a global leader in animal health dedicated to innovating and delivering products and services to prevent and treat disease in farm animals and pets, creating value for farmers, pet owners, veterinarians, stakeholders and society as a whole. With 70 years of animal health heritage, we are committed to breaking boundaries and going beyond to help our customers improve the health of animals in their care, while also making a meaningful impact on our local and global communities. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our Elanco Healthy Purpose™ sustainability pillars – all to advance the health of animals, people, the planet and our enterprise. Learn more at www.elanco.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the federal securities laws, including, without limitation, statements concerning product approvals and launches and expectations for contractual relationships. Forward-looking statements are based on our current expectations and assumptions regarding our business, the economy and other future conditions. Because forward-looking statements relate to the future, by their nature, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. As a result, our actual results may differ materially from those contemplated by the forward-looking statements. Important risk factors that could cause actual results to differ materially from those in the forward-looking statements include regional, national or global political, economic, business, competitive, market and regulatory conditions, including whether and when the USDA completes its review, the USDA’s determination about any conditional approval, market acceptance of the vaccine, our ability to market and sell the vaccine, competition with other solutions to address highly pathogenic avian influenza and additional factors that could cause actual results to differ materially from forward-looking statements described in the company’s latest Form 10-K and Form 10-Qs filed with the Securities and Exchange Commission. We caution you against relying on any forward-looking statements, which should also be read in conjunction with the other cautionary statements that are included elsewhere in this press release. Any forward-looking statement made by us in this press release speaks only as of the date thereof. We undertake no obligation to publicly update or to revise any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

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