United States

STUDY SHOWS APOQUEL® EFFECTIVE AND SAFE IN CONTROLLING ITCHING ASSOCIATED WITH ALLERGIC SKIN DISEASE IN DOGS

Pivotal Data Published in Veterinary Dermatology Online

Florham Park, N.J. – August 13, 2013 – Results of a new pivotal study show that APOQUEL® (oclacitinib tablet) provides effective and safe control of pruritus associated with allergic dermatitis in dogs with a rapid onset of efficacy within 24 hours and without the commonly reported side effects of steroids. The study was published in the July issue of Veterinary Dermatology online. APOQUEL is the first Janus kinase (JAK) 1 inhibitor approved for veterinary use. Its novel mode of action specifically targets and inhibits the cytokines involved in itch and inflammation with minimal activity against cytokines involved in hematopoiesis or innate immune function.

“These results are significant because they illustrate that APOQUEL quickly and substantially improves pruritus, affording the damaged skin an opportunity to heal,” said Candace Sousa, DVM, DABVP, DACVD, and associate director of Veterinary Operations at Zoetis. “This, in turn, allows the veterinarian time to correctly diagnose and treat the underlying cause, without the side effects of steroids.”

According to the study results, both owners and veterinarians noted statistically superior improvements in pruritus and dermatitis VAS (visual analog scale) scores when compared to placebo-treated dogs. APOQUEL produced rapid onset of efficacy within 24 hours - within the first day of treatment, pruritus scores were reduced by at least 2 cm on a 10 cm VAS scale in 44% of the APOQUEL-treated dogs compared with 19% of the placebo- treated dogs. By day seven, 86.4% of the APOQUEL-treated dogs compared with 42.5% of the placebo-treated dogs achieved a 2 cm reduction in Owner Pruritus VAS scores (based on a 10cm VAS to measure severity of pruritus). In this study, treatment success was defined as a reduction of 2cm or greater in the Owner Pruritus VAS score on 5 of the first 7 days of treatment. In dogs with allergic dermatitis associated with conditions such as flea allergy dermatitis, food allergy, contact allergy and atopic dermatitis, treatment success was achieved in 67% of dogs treated with APOQUEL vs. 29% of dogs treated with placebo

Atopic dermatitis is one of the most common allergies of dogs, affecting approximately 10% of the dog population. Itching caused by an allergic skin disease can be an acute, short-term condition or can be recurrent or chronic—all which can impact the quality of life for both the dog and its owner unless it is controlled with effective management.

About the Study

The study, “Efficacy and safety of oclacitinib for the control of pruritus and associated skin lesions in dogs with canine allergic dermatitis,” was conducted as a double-masked, placebo-controlled clinical trial aimed to evaluate the safety and efficacy of APOQUEL compared with placebo. Over the course of seven days, 436 client-owned dogs at least 6 months of age treated at 26 veterinary clinics were given twice-daily oral doses of either APOQUEL or identical placebo caplets. Dogs could remain on the study for 28 days if they responded well to APOQUEL. There were no serious or abnormal health events that necessitated hospitalization. In previously reported laboratory studies, APOQUEL inhibited IL-31-induced pruritus in dogs faster than oral prednisolone and dexamethasone. It also controlled pruritus and improved skin condition in flea-allergic dogs comparable to steroids.

The most common side effects observed in dogs treated with APOQUEL were vomiting (2.3% in APOQUEL-treated dogs compared to 1.8% in placebo treated dogs) and diarrhea (2.3% in APOQUEL-treated dogs compared to 0.9% in placebo treated dogs). APOQUEL can be safely used in combination with other common medications including antibiotics, parasiticides and vaccines. APOQUEL may increase the susceptibility to infection and demodicosis and may exacerbate neoplastic conditions. The study can be accessed online at http://onlinelibrary.wiley.com/doi/10.1111/vde.12047/abstract.

About APOQUEL

APOQUEL is a targeted new approach to rapidly and safely stop the cycle of itch and inflammation associated with allergic skin disease in dogs. Zoetis announced the U.S. Food and Drug Administration approval of APOQUEL on May 16, 2013. APOQUEL is the only animal health product approved for the control of pruritus associated with allergic dermatitis and the control of atopic dermatitis in dogs over 12 months of age. APOQUEL is proven to effectively reduce itch within 24 hours and provide long-term relief with minimal side effects.

Zoetis plans to make APOQUEL available to veterinarians by the First Quarter 2014. During the coming months, Zoetis will be educating veterinarians on the new science associated with canine allergic diseases to lay the groundwork for a successful launch. For more information, please visit www.apoquel.com. As the latest addition to the company’s diverse portfolio of companion animal medicines, this approval signifies an important milestone for this leading animal health company.

About Zoetis

Zoetis (zō-EH-tis) is the leading animal health company, dedicated to supporting its customers and their businesses. Building on a 60-year history as the animal health business of Pfizer, Zoetis discovers, develops, manufactures and markets veterinary vaccines and medicines, with a focus on both farm and companion animals. In 2012, the company generated annual revenues of $4.3 billion. With approximately 9,300 employees worldwide at the beginning of 2013, Zoetis has a local presence in approximately 70 countries, including 29 manufacturing facilities in 11 countries. Its products serve veterinarians, livestock producers and people who raise and care for farm and companion animals in 120 countries. For more information on the company, visit www.zoetis.com.

Zoetis is the proud sponsor with the Smithsonian Institution Traveling Exhibitions and the American Veterinary Medical Association of the mobile educational exhibit Animal Connections: Our Journey Together. Families visiting the exhibit will explore the vast bonds between people and animals and learn about the important role veterinarians play in protecting animal and human health.

Important Safety Information

APOQUEL® should not be used in dogs less than 12 months of age or in dogs with serious infections. APOQUEL may increase the susceptibility to infection and demodicosis and may exacerbate neoplastic conditions. APOQUEL has not been evaluated in combination with systemic immunosuppressive agents such as glucocorticoids or cyclosporine. APOQUEL should not be used in breeding dogs, or pregnant or lactating dogs. The most common side effects seen in dogs administered APOQUEL were vomiting and diarrhea. APOQUEL has been safely used in conjunction with other common medications including antibiotics and parasiticides and with vaccinations. For Full Prescribing Information visit www.apoquel.com.

For further information, Contact:

Deron Johnson
Zoetis
973-822-7203
Deron.Johnson@zoetis.com

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