Zoetis Receives a Conditional License from USDA for Canine Atopic Dermatitis Immunotherapeutic*
First targeted antibody therapy approved for control of clinical signs of atopic dermatitis in dogs
Public Company Information:
FLORHAM PARK, N.J.--(BUSINESS WIRE)--Zoetis Inc. (NYSE:ZTS) today announced 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.
Zoetis (zō-EH-tis) is the leading animal health company, dedicated to supporting its customers and their businesses. Building on more than 60 years of experience in animal health, Zoetis discovers, develops, manufactures and markets veterinary vaccines and medicines, complemented by diagnostic products and genetic tests and supported by a range of services. In 2014, the company generated annual revenues of $4.8 billion. With approximately 10,000 employees worldwide at the beginning of 2015, Zoetis serves veterinarians, livestock producers and people who raise and care for farm and companion animals with sales of its products in 120 countries. For more information, visit www.zoetis.com.
Forward-Looking Statements: This press release contains forward-looking statements, which reflect the current views of Zoetis with respect to business plans or prospects, future operating or financial performance, expectations regarding products, future use of cash and dividend payments, 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, 2014, including in the sections thereof captioned “Forward-Looking Information 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.
* This product license is conditional. Efficacy and potency
test 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.