- Easy-to-administer chewable tablet
delivers fast and persistent protection over 35 days from fleas and
ticks, without losing efficacy at the end of the month
- Innovation from Zoetis targets growing
demand for oral flea and tick medication
Zoetis Inc. (NYSE:ZTS) today announced that the U.S. Food and
Drug Administration (FDA) has approved SimparicaTM (sarolaner)
Chewables to kill adult fleas and prevent flea infestations, as
well as treat and control tick infestations due to the Lone Star
tick, the Gulf Coast tick, the American dog tick, and the brown dog
tick. Simparica is approved for use in dogs 6 months of age or
older and weighing 2.8 pounds or more. In a single-dose, tasty
chewable tablet, once-monthly Simparica offers fast and persistent
protection from fleas and ticks, with peak performance that lasts
for a full 35 days, without losing efficacy at the end of the
month.¹
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Simparica product packaging (Photo:
Zoetis)
“Simparica is exciting for two reasons: it acts fast to kill
fleas and ticks, and it maintains its efficacy all month long
providing veterinarians and dog owners with confidence in
continuous protection,” said Chris Adolph, DVM, DACVM
(Parasitology), Zoetis. “Simparica kills fleas before they can
reproduce and create a home infestation, and it kills ticks fast,
which may help to reduce the likelihood of transferring pathogens
that can cause tick-borne disease. Simparica continues to perform
well, even on the last day of the month, whereas some of the other
flea and tick products drop in efficacy at the end of their
treatment period.”
“Simparica is the result of the collaboration of Zoetis
scientists worldwide who share a commitment to develop innovative
medicines that help address the most pressing needs of our
veterinary customers and the animals in their care,” said Dr.
Catherine Knupp, executive vice president and president, Research
and Development at Zoetis. “We are excited to bring Simparica to
veterinarians and dog owners in the United States.”
The global market for antiparasitics in pets was over $4.2
billion 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: A New Ectoparasiticide from Zoetis
The active substance of Simparica is sarolaner, a new
ectoparasiticide in the isoxazoline class, discovered and developed
by Zoetis scientists. Simparica underwent extensive field safety
and efficacy testing involving more than 900 dogs over a two- or
three-month period. The dogs in these studies included both genders
and many different breeds.1
Clinical studies showed this isoxazoline started killing fleas
in three hours, virtually eliminated fleas within eight hours, and
it reduced the number of live fleas from ≥96.2% to 100% through day
35.1 Simparica’s rapid onset of action means that fleas are killed
before they have a chance to lay eggs,1 preventing home
infestations and providing relief to dogs suffering with flea
allergy dermatitis.1 Studies also showed that Simparica started
killing ticks in eight hours,5 remaining ≥96.9% effective for 35
days against weekly re-infestations.6-9
Simparica Killed Fleas Faster Than
NexGard®. In a comparative study, Simparica killed fleas
faster than NexGard® throughout the entire month. Simparica showed
almost 100% flea kill eight hours after infestation, even at day
35, while NexGard® started declining below 90% as early as day
21.4
Simparica Killed Ticks Faster Than
NexGard®. In a comparative study, Simparica killed ticks
faster than NexGard® throughout the entire month. Simparica
maintained more than 90% effectiveness against the brown dog tick
24 hours after infestation at day 35, while efficacy for NexGard®
decreased to less than 80% by day 14.10
Simparica comes in a highly palatable liver-flavored chewable
tablet. Zoetis expects to make Simparica available to veterinarians
and pet owners in March 2016. The tablets will be available in 5
mg, 10 mg, 20 mg, 40 mg, 80 mg, and 120 mg dosage strengths.
For more information about Simparica and full Prescribing
Information, visit: www.zoetisUS.com/Simparica.
IMPORTANT SAFETY INFORMATION
Simparica is for use only in dogs, 6 months of age and older.
Simparica may cause abnormal neurologic signs such as tremors,
decreased conscious proprioception, ataxia, decreased or absent
menace, and/or seizures. Simparica has not been evaluated in dogs
that are pregnant, breeding or lactating. Simparica has been safely
used in dogs treated with commonly prescribed vaccines,
parasiticides and other medications. The most frequently reported
adverse reactions were vomiting and diarrhea. See full Prescribing
Information at www.zoetisUS.com/SimparicaPI.
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. 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.
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, future guidance, future operating models, expectations
regarding products, future use of cash and dividend payments, tax
rate and tax regimes, changes in the tax regimes and
laws in other jurisdictions, 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 www.sec.gov, www.zoetis.com, or
on request from Zoetis.
References
1. Simparica (sarolaner) [package insert]. Kalamazoo, MI:
Zoetis, Inc.; 2015.
2. Vetnosis, Animal Health Service: Parasiticides Report (Sept.
2015).
3. Zoetis. Overview of Clinical Safety in Client-Owned Dogs.
2015.
4. Zoetis. Comparative Speed of Kill of Sarolaner Administered
Orally Against Induced Infestations of Ctenocephalides felis on
Dogs (A160RZA-13-343, 2015).
5. Zoetis. Knock-down and Speed of Kill of Sarolaner
Administered Orally Against Induced Infestations of Amblyomma
maculatum on Dogs (A166C-US-13-318, 2014).
6. Zoetis. Dose Confirmation of Sarolaner Administered Orally
Against Induced Infestations of Amblyomma maculatum on Dogs
(A166C-US-12-128, 2014; A166C-US-12-129, 2014).
7. Zoetis. Dose Confirmation of Sarolaner Administered Orally
Against Induced Infestations of Amblyomma americanum on Dogs
(A166C-US-12-130, 2014; A166C-US-12-131, 2014).
8. Zoetis. Dose Confirmation of Sarolaner Administered Orally
Against Induced Infestations of Dermacentor variabilis on Dogs
(A166C-US-12-132, 2013; A166C-US-12-133, 2013).
9. Zoetis. Dose Confirmation of Sarolaner Administered Orally
Against Induced Infestations of Rhipicephalus sanguineus on Dogs
(A166C-US-12-135, 2013; A166C-IE-13-160, 2014; A166C-US-13-303,
2014; A166-AU-14-419, 2015).
10. Zoetis. Comparative Speed of Kill of Sarolaner Administered
Orally Against Induced Infestations of Rhipicephalus sanguineus on
Dogs (A162R-US-15-539, 2015).
View source
version on businesswire.com: http://www.businesswire.com/news/home/20160225006649/en/
Media:Elinore White,
973-443-2835Elinore.y.white@zoetis.comColleen T. White,
973-822-7203colleen.white@zoetis.com
Investor:John O’Connor,
973-822-7088john.oconnor@zoetis.comSteve Frank,
973-822-7141steve.frank@zoetis.com
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