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Elanco Enters Agreement with Medgene to Commercialize Highly Pathogenic Avian Influenza Vaccine in Dairy Cattle

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Elanco Animal Health (NYSE: ELAN) has entered an agreement with South Dakota-based Medgene to commercialize a highly pathogenic avian influenza (HPAI) vaccine for dairy cattle. Medgene reports the vaccine has met all USDA platform technology requirements and is in final stages of review for conditional license approval.

The current HPAI outbreak has entered its fourth year, with cross-species transmission affecting nearly 1,000 dairy herds across the U.S. since March 2024. The virus is predicted to persist, making a cattle vaccine critical to slow transmission between birds and cattle.

Jeff Simmons, President and CEO of Elanco, stated the partnership will provide options to fight this disease and believes the product will become part of routine vaccination protocols for U.S. dairy. Mark Luecke, CEO of Medgene, noted their company has existing vaccine manufacturing supply ready to deploy with capacity to support the U.S. dairy herd.

Elanco Animal Health (NYSE: ELAN) ha stipulato un accordo con Medgene, con sede nel Dakota del Sud, per commercializzare un vaccino contro l'influenza aviaria altamente patogena (HPAI) per il bestiame da latte. Medgene riporta che il vaccino ha soddisfatto tutti i requisiti tecnologici della piattaforma USDA ed è nelle fasi finali di revisione per l'approvazione della licenza condizionata.

Attualmente, l'epidemia di HPAI è entrata nel suo quarto anno, con trasmissioni interspecie che hanno colpito quasi 1.000 allevamenti di latte negli Stati Uniti dal marzo 2024. Si prevede che il virus persista, rendendo un vaccino per il bestiame fondamentale per rallentare la trasmissione tra uccelli e bovini.

Jeff Simmons, Presidente e CEO di Elanco, ha dichiarato che la partnership fornirà opzioni per combattere questa malattia e crede che il prodotto diventerà parte dei protocolli di vaccinazione di routine per il latte negli Stati Uniti. Mark Luecke, CEO di Medgene, ha sottolineato che la loro azienda ha già una fornitura di produzione di vaccini pronta per essere utilizzata, con capacità di supportare il bestiame da latte degli Stati Uniti.

Elanco Animal Health (NYSE: ELAN) ha firmado un acuerdo con Medgene, con sede en Dakota del Sur, para comercializar una vacuna contra la influenza aviar altamente patógena (HPAI) para el ganado lechero. Medgene informa que la vacuna ha cumplido con todos los requisitos de tecnología de plataforma del USDA y está en las etapas finales de revisión para la aprobación de licencia condicional.

El actual brote de HPAI ha entrado en su cuarto año, con la transmisión entre especies afectando a casi 1,000 hatos lecheros en los EE. UU. desde marzo de 2024. Se prevé que el virus persista, lo que hace que una vacuna para el ganado sea crítica para ralentizar la transmisión entre aves y ganado.

Jeff Simmons, Presidente y CEO de Elanco, declaró que la asociación proporcionará opciones para combatir esta enfermedad y cree que el producto se convertirá en parte de los protocolos de vacunación de rutina para la leche en EE. UU. Mark Luecke, CEO de Medgene, señaló que su empresa ya tiene una capacidad de producción de vacunas lista para desplegar, con capacidad para apoyar al ganado lechero de EE. UU.

엘란코 동물 건강 (NYSE: ELAN)은 남다코타에 본사를 둔 메드진과 유제품 소를 위한 고병원성 조류 인플루엔자(HPAI) 백신 상용화 계약을 체결했습니다. 메드진은 이 백신이 모든 USDA 플랫폼 기술 요구 사항을 충족했으며 조건부 라이센스 승인을 위한 최종 검토 단계에 있다고 보고했습니다.

현재 HPAI 발생은 4년 차에 접어들었으며, 2024년 3월 이후 미국 전역에서 거의 1,000개의 유제품 농장이 교차 종 전염의 영향을 받고 있습니다. 이 바이러스는 지속될 것으로 예상되며, 이는 조류와 소 사이의 전염을 늦추기 위해 소 백신이 중요하다는 것을 의미합니다.

엘란코의 회장 겸 CEO인 제프 시몬스는 이 파트너십이 이 질병과 싸울 수 있는 옵션을 제공할 것이며, 이 제품이 미국 유제품의 일반적인 백신 접종 프로토콜의 일부분이 될 것이라고 믿고 있습니다. 메드진의 CEO인 마크 루에케는 그들의 회사가 미국 유제품 농장을 지원할 수 있는 생산 능력을 갖춘 백신 제조 공급을 이미 준비하고 있다고 언급했습니다.

Elanco Animal Health (NYSE: ELAN) a conclu un accord avec Medgene, basé dans le Dakota du Sud, pour commercialiser un vaccin contre l'influenza aviaire hautement pathogène (HPAI) destiné aux vaches laitières. Medgene rapporte que le vaccin a satisfait à toutes les exigences technologiques de la plateforme USDA et est dans les dernières étapes de révision pour l'approbation d'une licence conditionnelle.

L'épidémie actuelle de HPAI est entrée dans sa quatrième année, avec une transmission inter-espèces affectant près de 1 000 troupeaux laitiers à travers les États-Unis depuis mars 2024. Le virus devrait persister, rendant un vaccin pour le bétail essentiel pour ralentir la transmission entre les oiseaux et les bovins.

Jeff Simmons, président et PDG d'Elanco, a déclaré que ce partenariat fournira des options pour lutter contre cette maladie et croit que le produit fera partie des protocoles de vaccination routiniers pour le lait aux États-Unis. Mark Luecke, PDG de Medgene, a noté que leur entreprise dispose déjà d'une capacité de production de vaccins prête à être déployée pour soutenir le cheptel laitier américain.

Elanco Animal Health (NYSE: ELAN) hat eine Vereinbarung mit dem in South Dakota ansässigen Medgene getroffen, um einen hochpathogenen aviären Influenza (HPAI) Impfstoff für Milchkühe zu vermarkten. Medgene berichtet, dass der Impfstoff alle Anforderungen der USDA-Plattformtechnologie erfüllt hat und sich in den letzten Prüfungsphasen für die bedingte Lizenzgenehmigung befindet.

Der aktuelle HPAI-Ausbruch ist nun im vierten Jahr, wobei die Übertragung zwischen Arten seit März 2024 fast 1.000 Milchherden in den USA betroffen hat. Es wird prognostiziert, dass das Virus bestehen bleibt, was einen Impfstoff für Rinder entscheidend macht, um die Übertragung zwischen Vögeln und Rindern zu verlangsamen.

Jeff Simmons, Präsident und CEO von Elanco, erklärte, dass die Partnerschaft Optionen zur Bekämpfung dieser Krankheit bieten wird und er glaubt, dass das Produkt Teil der routinemäßigen Impfprotokolle für die Milchproduktion in den USA werden wird. Mark Luecke, CEO von Medgene, bemerkte, dass ihr Unternehmen bereits über eine bestehende Impfstoffproduktionskapazität verfügt, die bereit ist, die Rinderherde in den USA zu unterstützen.

Positive
  • Partnership to commercialize HPAI vaccine for dairy cattle
  • Vaccine in final stages of USDA conditional license approval
  • Medgene has manufacturing supply ready to deploy
  • Product expected to become part of routine vaccination protocols
  • Strengthens Elanco's dairy portfolio
Negative
  • HPAI outbreak entering fourth year with continued spread
  • Nearly 1,000 dairy herds affected since March 2024
  • Egg prices soaring and milk production declining in infected dairies

Insights

Elanco's agreement with Medgene to commercialize a highly pathogenic avian influenza (HPAI) vaccine for dairy cattle represents a timely market opportunity amid a persistent outbreak affecting nearly 1,000 dairy herds across the U.S. since March 2024. This partnership targets a critical unmet need in the $21 billion U.S. dairy industry, which has lacked effective tools against HPAI compared to the poultry sector.

The vaccine's advanced regulatory status—meeting USDA platform technology requirements and approaching conditional license approval—gives Elanco a potential first-mover advantage in this emerging segment. With Medgene's manufacturing capacity already in place to support the U.S. dairy herd of approximately 9 million cows, Elanco could begin capturing revenue relatively quickly upon approval, likely in H1 2025.

This agreement strategically enhances Elanco's dairy portfolio at a critical juncture when the animal health market is increasingly focused on preventative care rather than treatment. The company's decision to partner rather than develop in-house leverages Medgene's specialized platform technology while minimizing R&D investment and accelerating time-to-market.

The cross-species nature of HPAI creates a compelling value proposition beyond traditional animal vaccines. By potentially reducing virus transmission between birds and cattle, this vaccine addresses a One Health challenge with implications for poultry producers, dairy farmers, and public health. This multi-sector benefit could strengthen adoption rates and potentially support premium pricing.

While financial terms weren't disclosed, the recurring revenue potential is significant if the vaccine becomes part of routine protocols. Assuming a conservative $5-10 per dose price point and annual vaccination of even half the U.S. dairy herd, this could represent a $22-45 million annual revenue opportunity domestically, with additional upside from international markets experiencing similar HPAI challenges.

For investors, this partnership demonstrates Elanco's agility in addressing emerging market needs while diversifying revenue streams beyond its core portfolio. The company's ability to quickly secure this opportunity amid a public health crisis showcases management's market responsiveness—a positive indicator for navigating future industry challenges and opportunities.

GREENFIELD, Ind., Feb. 25, 2025 /PRNewswire/ -- 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.

Investor Contact: Tiffany Kanaga (765) 740-0314 tiffany.kanaga@elancoah.com
Media Contact: Colleen Dekker (317) 989-7011 colleen.dekker@elancoah.com    

 

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SOURCE Elanco Animal Health

FAQ

What is the purpose of Elanco's agreement with Medgene regarding HPAI?

Elanco (ELAN) has partnered with Medgene to commercialize a highly pathogenic avian influenza (HPAI) vaccine for dairy cattle, aiming to slow virus transmission between birds and cattle and protect dairy herds.

When might the HPAI vaccine for dairy cattle receive USDA approval?

According to the press release, Medgene's HPAI vaccine for dairy cattle has met all USDA platform technology requirements and is in the final stages of review for conditional license approval.

How many dairy herds have been affected by HPAI since March 2024?

Nearly 1,000 dairy herds across the U.S. have been affected by cross-species transmission of highly pathogenic avian influenza since March 2024.

How is Medgene prepared to supply the HPAI vaccine for dairy cattle?

Medgene has existing vaccine manufacturing supply ready to deploy with the ability to support the entire U.S. dairy herd once the HPAI vaccine receives approval.

What impact has HPAI had on dairy and poultry markets according to Elanco (ELAN)?

According to Elanco's CEO, egg prices have soared and milk production has waned in infected dairies due to HPAI, demonstrating the economic impact of the disease.

How long has the current HPAI outbreak been ongoing according to Elanco's press release?

The current highly pathogenic avian influenza outbreak is entering its fourth year, according to the information provided in Elanco's announcement.

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