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Zoetis Receives European Commission Marketing Authorization for Librela® (bedinvetmab)

11/12/2020
  • The first injectable monoclonal antibody authorized for alleviation of osteoarthritis pain in dogs
  • Librela works differently from other pain medications, combining one month of pain control and increased mobility, with a proven safety and efficacy profile
  • Librela has a unique mode of action, inhibiting Nerve Growth Factor—a key player in osteoarthritis pain

ZAVENTEM, Belgium--(BUSINESS WIRE)-- Zoetis Inc. (NYSE:ZTS) today announced that the European Commission has granted the company marketing authorization for Librela (bedinvetmab), the first injectable monoclonal antibody (mAb) therapy approved in the European Union for monthly alleviation of osteoarthritis (OA) pain in dogs. Librela provides veterinarians a new treatment option, which effectively controls OA pain for a month, while also offering a positive safety profile.

Librela is the first-of-its-kind veterinary medicine that contains bedinvetmab, a monoclonal antibody that binds to Nerve Growth Factor (NGF), a key player in OA pain1 and in doing so reduces pain. It functions like naturally occurring antibodies, with minimal involvement of the liver or kidneys in its metabolism and elimination from the body; bedinvetmab also produces minimal gastrointestinal (GI) impact.After one injection of Librela, dogs with osteoarthritis exhibited increased mobility and decreased pain.

Untreated OA Pain Can Limit a Dog’s Quality of Life

“My personal experience and clinical research has taught me that OA pain can affect many areas of a pet’s life, including sleep, cognitive function, affect (emotion) and social relationships, among several other factors,” said Dr. Duncan Lascelles, Professor of Surgery and Pain Management at North Carolina State University and Chair of the WSAVA Global Pain Council. “The potential for Anti-NGF therapy to control OA pain is an exciting new development, representing a new therapeutic class, an innovative tool for clinicians working to alleviate OA pain, and a new medicinal innovation. NGF is one of the key factors mediating pain, inducing the release of both proinflammatory mediators and more NGF contributing to a cycle of pain and inflammation. Anti-NGF therapy could be the most exciting therapeutic advance in more than 20 years in veterinary medicine to control osteoarthritis associated pain.”

“We are honored to be granted the first approval of a monoclonal antibody therapy for alleviation of pain for veterinary use,” said Dr. Catherine Knupp, Executive Vice President and President, Research and Development at Zoetis. “As a leader in innovation for Animal Health, we are once again using our science and understanding of customer needs to find solutions that can improve the health, well-being and quality of life for pets.”

According to Dr. Knupp, this innovation results from a deeper scientific understanding of the mechanisms of osteoarthritis pain. “Veterinarians have told us that OA remains one of the diseases that affects dogs’ quality of life the most. This first-in-class medicine gives veterinarians effective, safe options to alleviate pain for canine patients, and I am very proud of the breakthrough treatment our Zoetis team has developed,” said Dr. Knupp. “Librela joins Zoetis’ Trocoxil® and Rimadyl® as part of the company’s portfolio of treatment options for canine patients with osteoarthritis.”

Bedinvetmab administered as monthly injections during the pivotal field study (three-month placebo-controlled, followed by six months continuation therapy), demonstrated a reduction in osteoarthritis pain as compared to placebo-controlled dogs. Furthermore, this pain reduction was maintained throughout the six-month continuation study, demonstrating sustained efficacy of bedinvetmab for at least nine months. Mild reactions at the injection site (e.g. swelling and heat) may uncommonly be observed. In a subset of dogs included in a single-arm continuation study lasting up to nine months, no loss of efficacy or change in the safety profile were identified. Librela is generally well-tolerated at the recommended dose, and no additional side effects were observed at overdose.

About Librela® (bedinvetmab)

Bedinvetmab is a monoclonal antibody (mAb) designed for dogs. It neutralizes Nerve Growth Factor (NGF), a key player involved in osteoarthritis in dogs, and in doing so reduces pain. Since bedinvetmab is an antibody it is eliminated by the body similar to endogenous proteins, with minimal involvement of the liver or kidneys. Librela has demonstrated efficacy in lowering canine pain for up to nine months in clinical studies.

About Zoetis

Zoetis is the leading animal health company, dedicated to supporting its customers and their businesses. Building on more than 65 years of experience in animal health, Zoetis discovers, develops, manufactures and commercializes medicines, vaccines and diagnostic products, which are complemented by biodevices, genetic tests and precision livestock farming. Zoetis serves veterinarians, livestock producers and people who raise and care for farm and companion animals with sales of its products in more than 100 countries. In 2019, the company generated annual revenue of $6.3 billion with approximately 10,600 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, 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, 2019, 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. These filings and subsequent filings are available online at www.sec.gov, www.zoetis.com, or on request from Zoetis.

1 Schmelz, M., Mantyh, P., Malfait, A.M., Farrar, J., Yaksh, T., Tive, L. and Viktrup, L., 2019. Nerve growth factor antibody for the treatment of osteoarthritis pain and chronic low-back pain: mechanism of action in the context of efficacy and safety. Pain, 160(10), p.2210.

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Media Contact:
Anne-France Quentric
+32 227468311 (o)
anne-france.quentric@zoetis.com

Investor Contact:
Steve Frank
1-973-822-7141 (o)
steve.frank@zoetis.com

Source: Zoetis Inc.

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