European Commission Approves Simparica™, a Once-Monthly Chewable Flea and Tick Medication for Dogs
November 17 2015 - 8:00AM
Business Wire
- Gives Veterinarians New Choice to Treat
Fleas, Ticks and Sarcoptic Mange in Dogs Aged Eight Weeks and
Older
- Innovation from Zoetis Targets Growing
Demand for Oral Flea and Tick Medication
Zoetis Inc. today announced that the European Commission has
granted marketing authorization for SimparicaTM (sarolaner)
chewable tablets, a once-monthly medication for the treatment of
fleas, ticks and sarcoptic mange in dogs beginning at eight weeks
of age. The approval follows a positive opinion adopted by the
Committee for Medicinal Products for Veterinary Use in September
2015.
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Simparica chewable tablets will be
available in 5 mg, 10 mg, 20 mg, 40 mg and 80 mg dosage strengths.
(Photo credit: Zoetis)
“The approval of Simparica gives veterinarians a new oral choice
in parasite control for dogs,” said Dr. Balázs Capári, veterinary
specialist, small animal medicine, in Sümeg, Hungary, who
participated in clinical trials of Simparica.1 “In my experience,
Simparica has been shown to rapidly kill fleas and ticks with
efficacy that persists for five weeks. Dog owners participating in
the trials also reported that Simparica is very palatable; the
chewable tablet was easily taken by their dogs. The convenience of
a once monthly chewable tablet helps increase compliance with
treatment, giving veterinarians and dog owners confidence in
continuous protection.”
“At Zoetis, we focus our innovation on the most pressing needs
of veterinarians, and that is what guided us to develop a new oral
choice to provide dogs with persistent protection from fleas and
ticks and treatment of mites that cause sarcoptic mange,” said Dr.
Catherine Knupp, executive vice president and president, Research
and Development at Zoetis. “Simparica is a result of the
collaboration of Zoetis scientists worldwide, who share a
determination to develop new medicines that deliver real value to
our veterinary customers and the animals in their care. We are
excited to bring this innovative medicine, Simparica, to
veterinarians and dog owners across Europe.”
The global market for antiparasitics in pets was over $4.2
billion dollars in 2014, with a compound annual growth rate of 5%
over the previous five years, driven largely by growth of new oral
products, according to Vetnosis.2
Simparica Results from Zoetis Innovation with New
Ectoparasiticide -- Sarolaner
The active substance of Simparica is sarolaner, a new
ectoparasiticide in the isoxazoline class, developed by Zoetis
scientists. The marketing authorization for Simparica was based on
the results of field studies conducted in seven countries,
involving more than 800 dogs of various breeds from at least eight
weeks of age and 1.3 kg of weight. Simparica was shown to provide
efficacy for at least five weeks against ticks and fleas. It
demonstrated a rapid onset of action, killing fleas before they
have a chance to lay eggs and can be used as part of a treatment
strategy for the control of Flea Allergy Dermatitis. It proved
effective in treating sarcoptic mange, a highly contagious skin
disease in dogs.
In studies, Simparica killed all four species of tick dominant
in Europe (Dermacentor reticulatus, Ixodes hexagonus, Ixodes
ricinus and Rhipicephalus sanguineus) and species of flea that most
frequently infect dogs in European countries (Ctenocephalides felis
and Ctenocephalides canis). Simparica was well tolerated with no
adverse events reported at the therapeutic dose.
Zoetis expects to launch Simparica in the EU in the first
quarter of 2016. Simparica chewable tablets will be available in 5
mg, 10 mg, 20 mg, 40 mg and 80 mg dosage strengths.
For more information about Simparica and full prescribing
information, visit
http://www.zoetis.com/products-services/companion-animals/dogs.
About Zoetis
Zoetis (zô-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 revenue 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.
1 Dr. Balázs Capári, is a clinical investigator of Simparica and
consultant to Zoetis Inc.
2 Vetnosis, Animal Health Service: Parasiticides Report (Sept.
2015)
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ZoetisMedia:Elinore White,
973-443-2835Elinore.y.white@zoetis.comorAnne-France Quentric,
+33.1.58.07.53.40Anne-france.quentric@zoetis.comorInvestors:John
O’Connor, 973-822-7088john.oconnor@zoetis.comorSteve Frank,
973-822-7141steve.frank@zoetis.com
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