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Elanco Receives USDA Approval for TruCan� Ultra CIV H3N2/H3N8 (Canine Influenza Vaccine) Bringing to Market a High Standard of Respiratory Protection

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Elanco Animal Health (NYSE:ELAN) has received USDA approval for TruCanā„� Ultra CIV H3N2/H3N8, a groundbreaking canine influenza vaccine. The vaccine is the only ½ mL bivalent CIV vaccine offering protection against both H3N2 and H3N8 strains, achieving 100% virus neutralization against 33 current field isolates.

Key clinical achievements include zero lung lesions in vaccinated dogs post H3N2 challenge and proven reduction in viral shedding. The vaccine is particularly significant for high-risk breeds, including brachycephalic dogs, and completes Elanco's Tru Portfolio of vaccines featuring PureFil� Technology. The product is now available for pre-order with shipping expected within 30 business days.

Elanco Animal Health (NYSE:ELAN) ha ottenuto l'approvazione USDA per TruCanā„� Ultra CIV H3N2/H3N8, un vaccino innovativo contro l'influenza canina. Questo vaccino ĆØ l'unico bivalente da ½ mL che offre protezione contro i ceppi H3N2 e H3N8, garantendo una neutralizzazione virale del 100% su 33 isolati attualmente presenti in campo.

I principali risultati clinici includono l'assenza di lesioni polmonari nei cani vaccinati dopo la sfida con H3N2 e una dimostrata riduzione della diffusione virale. Il vaccino è particolarmente importante per le razze ad alto rischio, inclusi i cani brachicefali, e completa il Tru Portfolio di Elanco con la tecnologia PureFil�. Il prodotto è ora disponibile per il pre-ordine con spedizioni previste entro 30 giorni lavorativi.

Elanco Animal Health (NYSE:ELAN) ha recibido la aprobación del USDA para TruCanā„� Ultra CIV H3N2/H3N8, una vacuna innovadora contra la influenza canina. Esta vacuna es la Ćŗnica bivalente de ½ mL que ofrece protección contra las cepas H3N2 y H3N8, logrando una neutralización viral del 100% contra 33 aislados actuales en campo.

Los logros clĆ­nicos clave incluyen cero lesiones pulmonares en perros vacunados tras el desafĆ­o con H3N2 y una reducción comprobada en la eliminación viral. La vacuna es especialmente significativa para razas de alto riesgo, incluyendo perros braquicĆ©falos, y completa el Tru Portfolio de Elanco con la tecnologĆ­a PureFilā„�. El producto ya estĆ” disponible para pre-pedido y se espera su envĆ­o dentro de 30 dĆ­as hĆ”biles.

Elanco Animal Health (NYSE:ELAN)ź°€ USDA ģŠ¹ģøģ� ė°›ģ€ TruCanā„� Ultra CIV H3N2/H3N8ėŠ� ķ˜ģ‹ ģ ģø ź°� ģøķ”Œė£Øģ—”ģž� ė°±ģ‹ ģž…ė‹ˆė‹�. ģ� ė°±ģ‹ ģ€ H3N2와 H3N8 ė‘� 가지 균주ģ—� ėŒ€ķ•� ė³“ķ˜øķ•˜ėŠ” ģœ ģ¼ķ•� ½ mL ģ“ź°€ ė°±ģ‹ ģœ¼ė”œ, ķ˜„ģž¬ ķ˜„ģž„ 분리ģ£� 33종에 ėŒ€ķ•� 100% ė°”ģ“ėŸ¬ģŠ¤ 중화ė„� ė‹¬ģ„±ķ–ˆģŠµė‹ˆė‹¤.

ģ£¼ģš” ģž„ģƒ ģ„±ź³¼ė”œėŠ” H3N2 ė„ģ „ ķ›� 백신 접종 ź°œģ—ģ„� ķ� 병변ģ� ģ „ķ˜€ ģ—†ģ—ˆģœ¼ė©° ė°”ģ“ėŸ¬ģŠ¤ 배출 ź°ģ†Œź°€ ģž…ģ¦ė˜ģ—ˆģŠµė‹ˆė‹�. ģ� ė°±ģ‹ ģ€ ķŠ¹ķžˆ ė‹Øė‘ģ¢…ģ„ ķ¬ķ•Øķ•� ź³ ģœ„ķ—� ķ’ˆģ¢…ģ—� ģ¤‘ģš”ķ•˜ė©°, Elancoģ� PureFilā„� 기술ģ� 적용ė� Tru ķ¬ķŠøķ“ė¦¬ģ˜¤ė„¼ ģ™„ģ„±ķ•©ė‹ˆė‹�. ģ œķ’ˆģ€ ķ˜„ģž¬ ģ˜ˆģ•½ 주문ģ� ź°€ėŠ„ķ•˜ė©�, 30ģ˜ģ—…ģ� ė‚� 배솔ģ� ģ˜ˆģƒė©ė‹ˆė‹�.

Elanco Animal Health (NYSE:ELAN) a obtenu l'approbation de l'USDA pour TruCanā„� Ultra CIV H3N2/H3N8, un vaccin rĆ©volutionnaire contre la grippe canine. Ce vaccin est le seul vaccin bivalent de ½ mL offrant une protection contre les souches H3N2 et H3N8, atteignant une neutralisation virale Ć  100% contre 33 isolats actuels sur le terrain.

Les principales réalisations cliniques incluent l'absence totale de lésions pulmonaires chez les chiens vaccinés après exposition au H3N2 et une réduction prouvée de la dissémination virale. Ce vaccin est particulièrement important pour les races à haut risque, y compris les chiens brachycéphales, et complète le Tru Portfolio d'Elanco avec la technologie PureFil�. Le produit est désormais disponible en précommande avec une expédition prévue sous 30 jours ouvrables.

Elanco Animal Health (NYSE:ELAN) hat die USDA-Zulassung für TruCanā„� Ultra CIV H3N2/H3N8 erhalten, einen bahnbrechenden Impfstoff gegen Hundeinfluenza. Der Impfstoff ist der einzige ½ ml bivalente CIV-Impfstoff, der Schutz gegen die StƤmme H3N2 und H3N8 bietet und eine 100%ige Virusneutralisation gegen 33 aktuelle Feldisolaten erreicht.

Wichtige klinische Erfolge umfassen keine LungenschƤden bei geimpften Hunden nach H3N2-Herausforderung sowie eine nachgewiesene Reduktion der Virusabgabe. Der Impfstoff ist besonders bedeutend für Hochrisikorassen, einschließlich brachyzephaler Hunde, und vervollstƤndigt Elancos Tru-Portfolio mit PureFilā„�-Technologie. Das Produkt ist jetzt vorbestellbar, der Versand erfolgt voraussichtlich innerhalb von 30 Werktagen.

Positive
  • 100% virus neutralization demonstrated against 33 current field isolates
  • Zero lung lesions in vaccinated dogs post H3N2 challenge
  • Proven reduction in viral shedding
  • Completes Elanco's extensive Tru Portfolio vaccine line
  • First vaccine line recommended by Fear FreeĀ® organization
Negative
  • Relatively low rate of CIV vaccination in the U.S. may impact market penetration
  • Product requires 30 business days before shipping begins

Insights

Elanco's new TruCan Ultra CIV vaccine offers superior canine influenza protection with strong efficacy data, completing their premium vaccine portfolio.

Elanco's newly USDA-approved TruCan Ultra CIV H3N2/H3N8 vaccine represents a significant advancement in canine respiratory disease protection. The product differentiates itself through three key clinical advantages: it's the only ½ mL bivalent vaccine targeting both major CIV strains, it demonstrated 100% virus neutralization against 33 current field isolates, and uniquely shows zero lung lesions in vaccinated dogs post-challenge ā€� a critical efficacy marker not matched by competitors.

The clinical data is particularly compelling for brachycephalic breeds (French Bulldogs, Pugs, etc.), which comprise 6 of the top 25 US dog breeds and face disproportionate respiratory disease risks. With respiratory disorders causing 17% of deaths in these breeds, this vaccine addresses a significant unmet need in veterinary medicine.

Strategically, this approval completes Elanco's premium "Tru Portfolio" of vaccines featuring their proprietary PureFil Technology, designed to minimize adverse reactions. The Fear FreeĀ® recommendation further enhances market positioning in the growing segment of pet owners concerned with minimizing veterinary stress.

This launch addresses the concerning low CIV vaccination rates in the US despite the risk of facility-shuttering outbreaks. For veterinary practices, having a comprehensive solution from a single manufacturer streamlines inventory and protocol management, likely driving adoption of Elanco's full vaccine line rather than just this individual product.

This USDA approval strengthens Elanco's competitive position in the companion animal vaccine market by completing their premium vaccine portfolio with a differentiated respiratory product. The approval timing (July 2025) allows Elanco to capitalize on the growing brachycephalic breed market, where 6 of the top 25 US dog breeds have heightened respiratory vulnerability.

The product's clinical advantages provide strong commercial differentiation: ½ mL dose (convenience factor), 100% neutralization against current field isolates, and the unique claim of zero lung lesions post-challenge. These features offer clear marketing advantages over existing products.

This launch aligns with Elanco's strategy to expand its pet health business, which typically generates higher margins than livestock segments. By completing their "Tru Portfolio" vaccine line, Elanco creates cross-selling opportunities and higher customer retention by offering veterinarians a comprehensive solution from a single manufacturer.

The Fear FreeĀ® endorsement provides additional market differentiation in the premium segment where pet owners are willing to pay more for products perceived as providing better experiences. The immediate availability for pre-order indicates confidence in manufacturing readiness and suggests potential revenue contribution beginning in Q3 2025.

While financial projections aren't provided, this approval represents a positive catalyst for Elanco's pet health segment by addressing a demonstrated clinical need with a differentiated product in a market with currently low vaccination rates but high disease impact.

  • TruCan Ultra CIV is the only ½ mL bivalent Canine Influenza Virus (CIV)Ģżvaccine offering broad protection against H3N2 and H3N8.
  • 100% virus neutralization against 33 current field isolates.1
  • Unlike currently available products, onlyĢżTruCan Ultra CIV demonstrates zero lung lesions in vaccinated dogs post H3N2 challenge.2,3,4
  • TruCan Ultra CIV completes Elanco's extensive line of Tru Portfolio vaccines.

GREENFIELD, Ind., July 9, 2025 /PRNewswire/ --ĢżElanco Animal Health Incorporated (NYSE: ELAN) today announced the U.S. Department of Agriculture (USDA) has approved TruCan Ultra CIV H3N2/H3N8, a canine influenza vaccine designed to provide broad respiratory disease protection. The approval of TruCan Ultra CIV completes Elanco's Tru Portfolio of comfortable and convenient combination vaccines made with PureFilā„� Technology, an exclusive process for creating highly purified vaccines designed to reduce adverse reactions and deliver better experiences.

In Canine Influenza Virus (CIV) studies, TruCan Ultra CIV was shown to be highly effective in protecting dogs' lungs and improving clinical signs:

  • Zero vaccinated dogs developed lung lesions post H3N2 challenge2
  • 100% neutralization of 33 currently circulating CIV field isolates1
  • Proven to reduce viral shedding2,5
  • Proven safe across multiple breed and ages in field safety study5

"With the recent USDA approval for TruCan Ultra CIV, Elanco continues to lead the charge in innovative animal health solutions," said Bobby Modi, Executive Vice President, U.S. Pet Health and Global Digital Transformation. "This vaccine not only offers broad protection against canine influenza but also integrates seamlessly into our Tru Portfolio. Our commitment to delivering safe, effective and advanced solutions reaffirms our position as a trusted partner in animal health, driving forward our mission to enrich lives through the health of animals."

Respiratory disease outbreaks can be devastating for patients, their families and veterinary clinics, sometimes leading to facility shutdowns and large financial impact. Canine Infectious Respiratory Disease Complex (CIRDC) is a collection of respiratory diseases of various causative agents, includingĢżCIV among others.

Certain breeds can be at a higher risk for severe symptoms associated with CIRDC, especially Brachycephalic dogs � dog breeds with short heads, flat faces and snub noses.6 These highly at-risk breeds, which includes French Bulldogs, Bulldogs, Pugs, Boston Terriers and more, continue to grow in popularity with six of the top 25 breeds in the U.S. being brachycephalic.7

Unfortunately, there is a relatively low rate of vaccination for CIV in the U.S. leaving these highly susceptible patients particularly at risk for developing infection when exposed to CIV.8 Patients with the highest risk factors include social dogs, dogs with pre-existing airway disease and those that are unvaccinated or incompletely vaccinated. Brachycephalics strongly benefit from added protection from respiratory disease as they can be life-threatening, with upper respiratory disorders being the cause of death in 17% of those breeds.6ĢżIt only takes one patient shedding CIV to spark an outbreak.

"With TruCan Ultra CIV, we are improving our ability to protect dogs from serious respiratory disease while remaining committed to helping provide a happier clinic experience for pets and their owners," said Dr. Jennifer Miller, technical veterinarian at Elanco. "This addition to our vaccine portfolio means our veterinarian customers can confidently offer a more complete set of immunizations tailored to the needs of all dogs, ensuring their long-term health and happiness."

Elanco's Tru Vaccine line is the first vaccine line recommended by Fear FreeĀ®, an organization whose mission is to prevent and alleviate fear, anxiety and stress in pets by inspiring and educating the people who care for them.

"Fear, anxiety and stress in pets can stem from many factors, including illness," said Dr. Marty Becker, Founder of Fear Free.Ģż"When veterinarians have effective tools to help protect pets from diseases like canine influenza, it can contribute to a smoother, less stressful experience for both pets and their people. Solutions like TruCan Ultra CIV support the goal of reducing fear, anxiety and stress by keeping pets healthier and more comfortable in the veterinary setting."

The approval of TruCan Ultra CIV is a key addition to completing Elanco's vaccine portfolio by addressing respiratory disease outbreaks. TruCan Ultra CIV is now available for pre-order and will ship within the next 30 business days.

Learn more about TruCan Ultra CIV at .

*Drs. Becker and Reinero are consultants for Elanco Animal Health.

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 purpose ā€� all to Go Beyond for Animals, Customers, Society and Our People. Learn more at Ģż

1,2 Elanco Animal Health. Data on File.
3 USDA APHIS. https://www.aphis.usda.gov/sites/default/files/2024-09/165a-15p5r0.pdf
4 USDA APHIS. https://www.aphis.usda.gov/sites/default/files/2023-10/190-15q520.pdf
5 Elanco Animal Health. Data on File.Ģż
6 The Humane Society of the United States.
7ĢżAmerican Kennel Club. Most Popular Dog Breeds of 2023 - American Kennel Club
8ĢżMalter et al. Vaccine 40 (2022) 1001-1009.ĢżĢż

Trucan, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates. Ā© 2025 Elanco or its affiliates. PM-US-25-0067(2)

Investor Contact: Tiffany Kanaga (765) 740-0314 [email protected]
Media Contact: Season Solorio (765) 316-0233 [email protected]ĢżĢż

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SOURCE Elanco Animal Health

FAQ

What are the key benefits of Elanco's new TruCan Ultra CIV H3N2/H3N8 vaccine?

The vaccine offers 100% virus neutralization against 33 field isolates, demonstrates zero lung lesions in vaccinated dogs post H3N2 challenge, and is the only ½ mL bivalent CIV vaccine protecting against both H3N2 and H3N8 strains.

When will Elanco's (NYSE:ELAN) TruCan Ultra CIV vaccine be available?

The vaccine is currently available for pre-order and will ship within the next 30 business days following the July 9, 2025 announcement.

Which dog breeds benefit most from Elanco's new canine influenza vaccine?

The vaccine is particularly beneficial for brachycephalic breeds (dogs with short heads and flat faces) such as French Bulldogs, Bulldogs, Pugs, and Boston Terriers, as they are at higher risk for severe respiratory symptoms.

What makes Elanco's TruCan Ultra CIV vaccine different from other canine influenza vaccines?

It's the only ½ mL bivalent vaccine for both H3N2 and H3N8 strains, features PureFilā„� Technology for reduced adverse reactions, and is the first vaccine line recommended by Fear FreeĀ®.

What is the clinical efficacy of Elanco's TruCan Ultra CIV vaccine?

Clinical studies show 100% neutralization of 33 current CIV field isolates, zero lung lesions in vaccinated dogs after H3N2 challenge, and proven reduction in viral shedding.
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