First targeted antibody therapy approved for control of clinical signs of atopic dermatitis in dogs
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.
About Zoetis
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.
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,
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.
Zoetis Inc.
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