- The first monoclonal antibody
authorized for veterinary use in the European Union
- A single injection of Cytopoint treats
the clinical signs of atopic dermatitis in dogs, including itch and
inflammation, for up to one month
- Targets and neutralizes canine
interleukin-31 (cIL-31), a key cytokine involved in stimulating
itch in dogs with atopic dermatitis
- Joins Zoetis’ Apoquel® (oclacitinib
tablet), giving veterinarians two targeted treatment options for
canine patients with atopic dermatitis
Zoetis Inc. (NYSE:ZTS) today announced that the European
Commission has granted the company marketing authorization for
Cytopoint (lokivetmab), the first monoclonal antibody (mAb) therapy
approved in the European Union for veterinary use. Cytopoint is
indicated to treat the clinical signs, including itching and
inflammation, associated with atopic dermatitis in dogs of any age
weighing 3 kilograms or more. Cytopoint targets and neutralizes
canine interleukin-31 (cIL-31), a key protein involved in
triggering itch in dogs. Administered by injection once monthly,
Cytopoint provides fast, long-lasting relief of itching – the
hallmark sign of the allergic skin condition atopic dermatitis in
dogs – and the inflammation and lesions it causes. Cytopoint helps
improve the long-term health and quality of life for dogs suffering
from atopic dermatitis and eases the related frustration and
concern of their owners.
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Zoetis has received European Commission
marketing authorization for Cytopoint (lokivetmab), the first
monoclonal antibody (mAb) therapy approved in the European Union
for veterinary use. Photo: Zoetis
“My personal experience with Cytopoint showed impressive speed
of efficacy, significantly reducing itch in dogs from 24 hours
onwards,” said Dr. Emmanuel Bensignor, a specialist in veterinary
dermatology in Paris, France, who participated in field studies
conducted in Europe. “Atopic dermatitis is a very common
disease in dogs, and the owners I meet are desperate to find a
rapid, reliable and safe solution for their suffering dogs. With
its once monthly injection, I believe that Cytopoint has the
potential to meet pet owners’ needs for its convenience.
European veterinary dermatologists and veterinarians will now
have access to a new therapeutic class via this first
monoclonal antibody treatment for veterinary use. It is a very
exciting innovation which brings a notable improvement to the
health and quality of life of the dogs and happiness to their
families.”
“We are honored to be granted the first approval of a monoclonal
antibody therapy for veterinary use by the European Commission,”
said Dr. Catherine Knupp, Executive Vice President and President,
Research and Development at Zoetis. “As the first such therapy to
provide relief from atopic dermatitis, we are once again using our
science and focus on our customers’ most pressing challenges to
find solutions for an area of unmet need in animal health.”
According to Dr. Knupp, this innovation results from a deeper
scientific understanding of the causes of allergic skin conditions
in dogs at the molecular level and the development of novel,
targeted, effective treatments based on these new insights.
“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 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,” said Dr. Knupp.
Apoquel is the first Janus kinase inhibitor approved by the
European Commission 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 dermatitis.
About Cytopoint
Cytopoint is a ready-to-use, sterile solution for injection
containing the mAb lokivetmab. It is specifically designed to
target and neutralize cIL-31, a key cytokine (protein important in
cell to cell communication) involved in triggering itching
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 eight hours and delivers one
month of relief from the clinical signs of canine atopic
dermatitis, allowing damaged skin the chance to heal. In clinical
studies submitted to European Medicines Agency, treatment with
Cytopoint at a minimum dose of 1 mg/kg resulted in a clear benefit
in the reduction of pruritus (itching) and showed a beneficial
effect on the reduction of disease severity as evaluated by scoring
the skin lesions.
It is safe for dogs of any age, even those with concomitant
diseases, and can be used with many common medications, including
vaccines. Moreover, because of the precision and specificity with
which it acts to target and neutralize cIL-31, it has been
demonstrated not to interfere with the immune response, meaning
that it did not induce unintended immunosuppression or
enhancement.
Cytopoint functions like normally occurring antibodies and is
eliminated via normal protein degradation pathways in the same way,
with minimal involvement of the liver or kidneys.
Cytopoint Prescribing Information
The recommended minimum efficacious dose for the treatment of
clinical manifestations of atopic dermatitis in dogs is 1 mg/kg,
which can be repeated monthly. Cytopoint will be available in
single dose vials containing 10, 20, 30 or 40 mg/kg of
lokivetmab.
About Atopic Dermatitis
Itching is among the most frequent complaints of pet owners,
affecting roughly 1 in 6 dogs whose owners seek veterinary help.1
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.1
Cytopoint will be available beginning in July to veterinary
dermatology specialists through an early experience program and to
veterinarians in European Union countries in the fall. It brings
mAb therapy – a fast-growing area in human medicine – for the first
time to veterinarians for use to treat atopic dermatitis in canine
patients. For more information, click here.
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, genetic tests,
biodevices and 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 2016, the company generated annual revenue of $4.9
billion with approximately 9,000 employees. 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, 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, 2016, including in the sections thereof captioned
“Forward-Looking Statements 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.
1 Data on file, IL-31 Positioning Research. IPSOS 2014. IL-31
Pricing Research. SKP. 2015, Zoetis LLC.
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version on businesswire.com: http://www.businesswire.com/news/home/20170426006612/en/
Zoetis Inc.Media:Anne-France Quentric, +32
227468311 (o)anne-france.quentric@zoetis.comorElinore White,
1-973-443-2835
(o)elinore.y.white@zoetis.comorInvestor:Steve Frank,
1-973-822-7141 (o)steve.frank@zoetis.com
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