Zoetis Receives a Conditional License from USDA for Canine Atopic Dermatitis Immunotherapeutic*
August 03 2015 - 4:30PM
Business Wire
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.
This Smart News Release features multimedia.
View the full release here:
http://www.businesswire.com/news/home/20150803006322/en/
Dog with veterinarian. Source: Zoetis
Inc.
“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.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20150803006322/en/
Zoetis Inc.Media:Colleen White,
973-822-7203colleen.white@zoetis.comorElinore White,
973-443-2835elinore.y.white@zoetis.comorInvestors:John O’Connor,
973-822-7088john.oconnor@zoetis.comorSteve Frank,
973-822-7141steve.frank@zoetis.com
Zoetis (NYSE:ZTS)
Historical Stock Chart
From Jun 2024 to Jul 2024
Zoetis (NYSE:ZTS)
Historical Stock Chart
From Jul 2023 to Jul 2024