Zoetis Announces FDA Approval of Solensia™ (frunevetmab injection) to Control Osteoarthritis Pain in Cats

• Solensia^™ is the first and only injectable monoclonal antibody (mAb) treatment for feline OA pain approved in the United States

• Monthly administration of Solensia controls OA pain by targeting Nerve Growth Factor (NGF), a key driver in OA pain

Zoetis Inc. (NYSE:ZTS) today announced that the U.S. Food and Drug Administration (FDA) has approved Solensia^™ to control the pain of osteoarthritis (OA) in cats, helping improve their mobility, comfort and overall well-being.¹ As a once-monthly injection administered in the veterinary clinic, Solensia keeps OA pain from disrupting the unique bond cats share with their humans.

Feline OA, a highly prevalent condition with nearly 40% of all cats showing signs of OA pain², occurs when the protective tissue in the joints (cartilage) is worn down, causing bones to rub together. This makes moving harder and causes severe pain. Without treatment, OA pain can worsen over time and seriously affect a cat’s long-term health and well-being.³

“Feline OA pain is typically undertreated because of a lack of effective solutions that are safe to use long-term, along with how difficult it can be for cat owners to administer oral medicines²,” said Mike McFarland, DVM, Chief Medical Officer at Zoetis. “The approval of Solensia is a significant step forward in the control of feline OA pain. Cat owners and veterinarians alike can feel confident that Solensia, with active substance frunevetmab, a monoclonal antibody (mAb) designed specifically for felines, has been studied and demonstrated to control OA pain and help cats get back to moving more freely again.”

Less OA pain for cats

Solensia works differently than other available treatments by targeting Nerve Growth Factor (NGF), a key driver of OA pain. NGF activates and perpetuates the pain signal by increasing the release of additional pain and inflammation mediators.⁴ By targeting NGF, Solensia reduces pain signals and effectively controls feline OA pain.

After a single treatment, Solensia noticeably reduced OA pain.⁵ In fact, 77% of cat owners experienced seeing improvement in signs of pain when their cats were treated monthly with Solensia in a 3-month study, while 67% of cat owners experienced improvement in signs of their cat’s pain in the placebo group. Solensia was found to be well-tolerated: the most common side effects were vomiting and injection site pain.⁶

“While feline osteoarthritis isn’t curable, the pain from osteoarthritis can be effectively managed¹,” said Margaret E. Gruen, DVM, MVPH, PhD, DACVB, Assistant Professor of Behavioral Medicine at North Carolina State University. “Pain is the primary experience of osteoarthritis, and when left untreated, it becomes its own disease state, in part due to the action of NGF, which makes anti-NGF therapy such a game-changing advancement in the management of OA pain. For cat owners, knowing your cat’s OA pain is well controlled with an easily administered monthly treatment can be a tremendous relief.^4,7”

Solensia is expected to be available to veterinarians in the second half of 2022. To learn more, please visit www.SolensiaVetTeam.com.

About Solensia^™ (frunevetmab injection)

Solensia is a monoclonal antibody therapy administered in the clinic that targets Nerve Growth Factor (NGF) to control feline OA pain. Solensia functions like naturally produced antibodies and is eliminated via normal protein degradation pathways in the same way with minimal involvement of the liver or kidneys.⁸

Solensia is approved in the European Union and has been available to veterinarians since May 2021.

IMPORTANT SAFETY INFORMATION ABOUT SOLENSIA™

For use in cats only. Women who are pregnant, trying to conceive or breastfeeding should take extreme care to avoid self-injection. Allergic reactions, including anaphylaxis, could potentially occur with self-injection. Solensia should not be used in breeding cats or in pregnant or lactating queens. Solensia should not be administered to cats with known allergy to frunevetmab. The most common adverse events reported in a clinical study were vomiting and injection site pain. See full Prescribing Information at SolensiaPI.com.

About Feline Osteoarthritis

Feline osteoarthritis (OA) is a highly prevalent condition. Nearly 40% of cats show signs of OA pain²: in clinical studies, osteoarthritis was detected in 60% of cats older than 6 years of age⁹, and 90% of cats older than 12 years of age.¹⁰ Feline OA pain is undertreated due to the lack of safe and efficacious treatments approved for long-term treatment, and to the administration challenges for pet owners with oral medicines.²

About Zoetis

As the world’s leading animal health company, Zoetis is driven by a singular purpose: to nurture our world and humankind by advancing care for animals. After nearly 70 years innovating ways to predict, prevent, detect, and treat animal illness, Zoetis continues to stand by those raising and caring for animals worldwide -- from livestock farmers to veterinarians and pet owners. The company’s leading portfolio and pipeline of medicines, vaccines, diagnostics and technologies make a difference in over 100 countries. A Fortune 500 company, Zoetis generated revenue of $6.7 billion in 2020 with approximately 11,300 employees. For more information, visit www.zoetis.com.

DISCLOSURE NOTICES

Forward-Looking Statements: This press release contains forward-looking statements, which reflect the current views of Zoetis with respect to business plans or prospects, expectations regarding products including timing of shipments, and other future events. These statements are not guarantees of future performance or actions. Forward-looking statements are subject to risks and uncertainties. If one or more of these risks or uncertainties materialize, or if management's underlying assumptions prove to be incorrect, actual results may differ materially from those contemplated by a forward-looking statement. Forward-looking statements speak only as of the date on which they are made. Zoetis expressly disclaims any obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise. A further list and description of risks, uncertainties and other matters can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2020, including in the sections thereof captioned “Forward-Looking Statements and Factors That May Affect Future Results” and “Item 1A. Risk Factors,” in our Quarterly Reports on Form 10-Q and in our Current Reports on Form 8-K. Such risks and uncertainties may be amplified by the COVID-19 pandemic and its potential impact on the global economy and our business. These filings and subsequent filings are available online at www.sec.gov, www.zoetis.com, or on request from Zoetis.

References

1. Gruen ME, Myers JAE, Lascelles BDX. Efficacy and Safety of an Anti-nerve Growth Factor Antibody (Frunevetmab) for the Treatment of Degenerative Joint Disease-Associated Chronic Pain in Cats: A Multisite Pilot Field Study. Front. Vet. Sci. 2021.
2. Zoetis Market Research: KG MarketSense 2018.
3. Lascelles BDX, Brown DC, Conzemius MG, Gill M, Oshinsky ML, Sharkey M. Measurement of chronic pain in companion animals: discussions from the Pain in Animals Workshop (PAW) 2017. Vet J. 2019:250(8):71-78. (2) Mantyh PW, Koltzenburg M, Mendell LM, et al. Antagonsim of nerve growth factor-TrkA signaling and the relief of pain. Anesthesiology. 2011;115:189-204.
4. Isola M, Ferrari V, Miolo A, et al. Nerve growth factor concentrations in the synovial fluid from healthy dogs and dogs with secondary osteoarthritis. Vet Comp Orthop Traumatol. 2011;24:279-284. (2) Mantyh PW, Koltzenburg M, Mendell LM, et al. Antagonsim of nerve growth factor-TrkA signaling and the relief of pain. Anesthesiology. 2011;115:189-204.
5. Gearing DP, Heubner M, Virtue ER, et al. In vitro and in vivo characterization of fully felinized therapeutic anti-nerve growth factor monoclonal antibody for the treatment of pain in cats. J Vet Inern Med. 2016; 30(4):1129-1137. doi:10.1111/jvim.13985.
6. Solensia Prescribing Information.
7. Mantyh PW, Koltzenburg M, Mendell LM, et al. Antagonsim of nerve growth factor-TrkA signaling and the relief of pain. Anesthesiology. 2011;115:189-204.
8. Keizer RJ, Huitema AD, Schellens JH, Beijnen JH. Clinical pharmacokinetics of therapeutic monoclonal antibodies. Clin Pharmacokinet. 2010;49(8):493-507.
9. Slingerland L, Hazewinkel H, Meif B, Picavet P, Voorhout G. Cross-sectional study of the prevalence and clinical features of osteoarthritis in 100 cats. Vet J. 2011;187:304-309.
10. Hardie EM, Roe SC, Martin FR. Radiographic evidence of degenerative joint disease in geriatric cats: 100 cases (1994-1997). J Am Vet Med Assoc. 2002;220:628-632.

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