Zoetis Receives USDA License for CYTOPOINT™

  • First monoclonal antibody licensed to help control the clinical
    signs associated with atopic dermatitis in dogs
  • Targets and neutralizes interleukin-31 (IL-31), a key itch-inducing
    cytokine (protein) in canine atopic dermatitis
  • Provides convenience and long-lasting relief from itch with one
    injection every four to eight weeks
  • Joins Zoetis’ APOQUEL® (oclacitinib
    tablet), giving the company two targeted treatment options to offer
    veterinarians for canine patients with atopic dermatitis

PARSIPPANY, N.J.–(BUSINESS WIRE)–$ZTS #animalhealthZoetis
. (NYSE:ZTS) today announced that the U.S. Department of
Agriculture (USDA) has granted the company a license for CYTOPOINT™, the
first monoclonal antibody (mAb) therapy approved to help provide
sustained control of the clinical signs associated with atopic
dermatitis in dogs. CYTOPOINT targets and neutralizes interleukin-31
(IL-31), a key protein involved in triggering itch in dogs. It provides
fast, effective relief of itching – the hallmark sign of the allergic
skin condition atopic dermatitis in dogs – and offers the sustained
efficacy and convenience of one injection every four to eight weeks.
CYTOPOINT helps improve the long-term quality of life for dogs suffering
from atopic dermatitis and eases the related frustration and concern of
their owners. It is now available to all veterinarians in the United

“As the owner of allergic pets, I understand the frustration that my
clients feel, and as a person with allergies myself, I understand what
my patients feel,” said Laura Stokking, PhD, DVM, DACVD, Veterinary
Specialty Hospital, San Diego, CA.* “With CYTOPOINT, in a
single injection we now have an excellent opportunity to help control
the itch without leading to any secondary signs that can be more
difficult to manage than the itch itself.”

“CYTOPOINT results from our acquiring a deeper scientific understanding
of the causes of allergic skin conditions in dogs at the molecular level
and developing novel, targeted, effective treatments based on these new
insights,” said Dr. Catherine Knupp, Executive Vice President and
President, Research and Development at Zoetis. “Veterinarians have told
us that allergic dogs and their owners have a variety of needs and we
are proud to offer them two innovative solutions with CYTOPOINT and with
our oral tablet therapy APOQUEL. These first-in-class medicines give
veterinarians effective, safe options to customize atopic dermatitis
treatment for canine patients, and I am very proud of the breakthrough
treatments our Zoetis team has developed.”

APOQUEL® (oclacitinib tablet) is the first Janus kinase
inhibitor approved by the U.S. Food and Drug Administration for
veterinary use to provide fast and safe itch relief for dogs at least 12
months of age that have symptoms associated with allergic dermatitis
triggered by food, fleas or contact allergens, as well as atopic


CYTOPOINT is a ready-to-use, sterile liquid injectable containing a mAb
specifically designed to target and neutralize cytokine interleukin-31
(IL-31), a key cytokine (protein important in cell-to-cell
communication) involved in triggering the itch associated with canine
atopic dermatitis. It works by mimicking the activity of natural
antibodies to selectively bind and neutralize IL-31, thus interrupting
the itch cycle in atopic dogs.

CYTOPOINT begins working within 1 day and delivers 4 to 8 weeks of
relief from the clinical signs of canine atopic dermatitis, allowing the
damaged skin the chance to heal. In clinical studies submitted to the
USDA and published in Veterinary Dermatology, treatment with
CYTOPOINT at a minimum dose of 2 mg/kg resulted in a significantly
(P≤0.05) greater percentage reduction from baseline in pruritus on days
1–49, and skin condition scores on days 7-561, when compared
to placebo.

It is safe for dogs of any age, even those with concomitant diseases,
and can be used with many common medications. Moreover, because of its
specificity in targeting IL-31, it has minimal impact on normal immune

The USDA granted Zoetis a conditional license for Canine Atopic
Dermatitis Immunotherapeutic (now branded as CYTOPOINT) in August 2015.
During the conditional licensing period, Zoetis collected valuable
feedback from dermatology specialists, a small group of general practice
veterinarians, and pet owners to prepare for full licensure.

About Atopic Dermatitis

Itching is among the most frequent complaints of pet owners, affecting
roughly 1 in 6 dogs whose owners seek veterinary help.2 There
are a number of factors that can trigger an itch reaction, such as
infections, allergies and parasites—and approximately 15-20 percent of
all itchy dogs will be diagnosed with atopic dermatitis.2

CYTOPOINT is now available for veterinarians throughout the United
States. It brings mAb therapy – a fast-growing area of human medicine –
for the first time to veterinarians for use to treat atopic dermatitis
in canine patients. For more information, visit www.cytopoint.com.


Do not use APOQUEL in dogs less than 12 months of age or those with
serious infections. APOQUEL may increase the chances of developing
serious infections, and may cause existing parasitic skin infestations
or pre-existing cancers to get worse. APOQUEL has not been tested in
dogs receiving some medications including some commonly used to treat
skin conditions such as corticosteroids and cyclosporines. Do not use in
breeding, pregnant, or lactating dogs. Most common side effects are
vomiting and diarrhea. APOQUEL has been used safely with many common
medications including parasiticides, antibiotics and vaccines. For full
Prescribing Information, go to ZoetisUS.com/ApoquelPI.

About Zoetis

Zoetis 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. Zoetis serves veterinarians, livestock producers and people
who raise and care for farm and companion animals with sales of its
products in more than 100 countries. In 2015, the company generated
annual revenue of $4.8 billion with approximately 9,000 employees. 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, future guidance, future
operating models, expectations regarding newly approved products and
other products 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, 2015, 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 
or on request from Zoetis.

* Dr. Laura Stokking has a consulting relationship with

1 Data on file, Study Report No. C863R-US-12-018, Zoetis LLC.

2 Data on file, IL-31 Positioning Research. IPSOS 2014. L-31
Pricing Research. SKP. 2015, Zoetis LLC.


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