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August 3, 2015

Zoetis Receives a Conditional License from USDA for Canine Atopic Dermatitis Immunotherapeutic*

Zoetis Receives a Conditional License from USDA for Canine Atopic Dermatitis Immunotherapeutic*

Zoetis announced on Aug. 3 that the U.S. Department of Agriculture (USDA) has granted the company a conditional license for Canine Atopic Dermatitis Immunotherapeutic,* a first-of-its-kind antibody therapy to help reduce clinical signs associated with atopic dermatitis in dogs. It represents another major innovation to emerge from the proprietary research and development platform Zoetis has built based on new scientific insights into the pathway of allergic skin conditions.

“The introduction of Canine Atopic Dermatitis Immunotherapeutic* will provide veterinarians an innovative new option to address this very challenging skin condition,” said Thomas Lewis II, DVM, DACVD, who participated in clinical studies of this antibody therapy and is a veterinary dermatologist at Dermatology for Animals in Gilbert, Ariz.** “By helping to relieve itching and the clinical signs associated with atopic dermatitis in affected dogs, it will also help restore quality of life for both atopic dogs and the people who love them.”

This novel therapy contains an antibody that specifically targets and neutralizes interleukin-31 (IL-31), a key protein that is responsible for sending the itch signal to the brain. It will be available in a ready-to-use, sterile liquid administered as a once-monthly subcutaneous injection and will help provide sustained relief from the itching associated with atopic dermatitis in dogs of any age.

“We have been active in building a research platform in monoclonal antibodies that will have a broad application across species and medical conditions,” said Catherine Knupp, executive vice president and president, Research and Development at Zoetis. “This first product from that platform builds on our knowledge base in the area of canine dermatology and further reinforces our dedication to developing innovative dermatology solutions.”

The USDA has communicated that all biological products for canine atopic dermatitis will be considered for conditional licensure only at this time. Zoetis is working with the USDA to obtain full licensure.

Zoetis will make Canine Atopic Dermatitis Immunotherapeutic* available primarily to veterinary dermatology specialists early in the fourth quarter of 2015 to gain more experience with this first antibody therapy in canine dermatology and acquire a deeper understanding of how veterinarians will use it in clinical practice. This will help the company prepare for full licensure. As the timing for full licensure becomes certain, the approach and timing for launch to veterinarians nationwide will be set.

About Atopic Dermatitis and Canine Atopic Dermatitis Immunotherapeutic*
Itching is among the most frequent complaints of pet owners, affecting roughly 1 in 6 dogs whose owners seek veterinary help.*** There are a number of factors that can trigger an itch reaction, such as infections, otitis and parasites—and approximately 15-20 percent of all itchy dogs will be diagnosed with atopic dermatitis.*** Canine Atopic Dermatitis Immunotherapeutic* works by mimicking the specific activity of natural antibodies by selectively binding and neutralizing IL-31 and interrupting the itch cycle.

Canine Atopic Dermatitis Immunotherapeutic* has been demonstrated to be safe and effective in helping decrease itching within one day and maintains efficacy for one month. Dosing can be repeated monthly as necessary, and reported adverse reactions to the product were similar to those of a placebo.

Innovation at Zoetis
Zoetis is focused on continuously innovating to develop animal health solutions that meet the needs of those who raise and care for animals. Research and Development is at the core of our efforts to provide innovation outcomes that anticipate the future needs of veterinarians and livestock producers in their local markets around the globe. For more information, visit www.zoetis.com/innovation

 

*This product license is conditional. Safety and efficacy studies are in progress. 

**Dr. Thomas Lewis II conducted clinical studies of Canine Atopic Dermatitis Immunotherapeutic and has a consulting relationship with Zoetis. 

***Data on file, IL-31 Positioning Research. IPSOS 2014. IL-31 Pricing Research. SKP. 2015, Zoetis Inc. 

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