European Commission Approves Simparica™, a Once-Monthly Chewable Flea and Tick Medication for Dogs

  • 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

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.

“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 —

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
and species of flea that most frequently infect
dogs in European countries (Ctenocephalides felis and Ctenocephalides
. 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,

About 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


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1 Dr. Balázs Capári, is a clinical investigator of Simparica
and consultant to Zoetis Inc.

2 Vetnosis, Animal Health Service: Parasiticides
Report (Sept. 2015)


Elinore White, 973-443-2835
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