European Commission Grants Marketing Authorisation to Simparica Trio™, a Once-Monthly Triple Combination Antiparasitic Medi...
September 20 2019 - 9:00AM
Business Wire
- Gives veterinarians a new choice for the treatment of mixed
external and internal parasitic infestations
- Treats and has persistent efficacy against ticks and fleas for
one month
- Treats gastrointestinal nematodes
- Prevents heartworm disease (Dirofilaria immitis) and lungworm
disease (angiostrongylosis)
Zoetis Inc. (NYSE:ZTS) today announced that the European
Commission has granted marketing authorisation for Simparica Trio™
(sarolaner/moxidectin/pyrantel) chewable tablets, a once-monthly
triple combination antiparasitic medication for dogs with, or at
risk from, mixed external and internal parasitic infestations. The
granting of the marketing authorisation follows a positive opinion
adopted by the Committee for Medicinal Products for Veterinary Use
on July 18, 2019.
“The approval of Simparica Trio™ provides veterinarians a safe
and effective option for the treatment of mixed external and
internal parasitic infestations in dogs in the form of a new oral
chewable,” said Dr. Domenico Otranto1, DVM, PhD, DipEVPC, Professor
in Veterinary Parasitology at the University of Bari (Italy).
“Simparica Trio has been shown to rapidly kill fleas and ticks with
concurrent efficacy for the prevention of heartworm disease and
angiostrongylosis (lungworm disease) and treatment of intestinal
round- and hookworms. The convenience of a once monthly chewable
tablet helps increase compliance with treatment, giving
veterinarians and dog owners confidence in continuous
protection.”
“We are excited to bring Simparica Trio to veterinarians in the
European Union as a new, effective triple combination parasiticide
for dogs,” said Dr. Catherine Knupp, Executive Vice President and
President, Research and Development at Zoetis. “This innovative
product 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. The addition of this new, broad spectrum parasiticide
to our sarolaner range of products helps to tailor the
antiparasitic treatment of pets to their individual needs.”
The global canine parasiticides market is more than $4 billion
US dollars2, and is the largest therapeutic category in medicines
for dogs.
Simparica Trio demonstrates Zoetis’ continued innovation in
parasiticides
The active ingredients of Simparica Trio are: sarolaner, which
is active against fleas and ticks; moxidectin, effective against
heartworm, lungworm and some intestinal worms; and pyrantel
embonate, effective against gastrointestinal nematodes (hookworms
and roundworms).
Simparica Trio was shown to provide immediate and persistent
killing activity for five weeks against two species of fleas
(Ctenocephalides felis and C. canis) and the ticks Ixodes
hexagonus, Ixodes ricinus and Rhipicephalus sanguineus and for four
weeks against Dermacentor reticulatus. 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. In addition, Simparica Trio is
indicated for the prevention of heartworm disease (Dirofilaria
immitis) and lungworm disease (Angiostrongylus vasorum) and the
treatment of gastrointestinal roundworm and hookworm infections of
Toxocara canis (immature adults (L5) and adults); Ancylostoma
caninum (L4 larvae, immature adults (L5) and adults); Toxascaris
leonina (adults); and Uncinaria stenocephala (adults). Simparica
Trio’s spectrum includes immature A. caninum and T. canis which is
important in controlling environmental contamination and minimizing
human exposure to these zoonotic parasites. The marketing
authorization for Simparica Trio was based on the results of
veterinary patient studies conducted in eight countries, involving
more than 1900 dogs of various breeds. The product is indicated for
dogs from at least eight weeks of age and 1.25 kg of
bodyweight.
Zoetis expects to launch Simparica Trio in the EU in the first
quarter of 2020. Simparica Trio chewable tablets will be available
in six tablet strengths for dogs of all sizes.
For more information about Simparica Trio and full prescribing
information, visit www.zoetis.com. For more information about the
European Commission’s marketing authorization click here.
About Zoetis
Zoetis is the leading animal health company, dedicated to
supporting its customers and their businesses. Building on more
than 65 years of experience in animal health, Zoetis discovers,
develops, manufactures and commercializes medicines, vaccines and
diagnostic products, which are complemented by biodevices, genetic
tests 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 2018, the company generated annual revenue of $5.8
billion with approximately 10,000 employees. For more information,
visit www.zoetis.com.
About internal and external parasites
Beyond being a burden by feeding off the blood of infested dogs,
fleas and ticks can be carriers of vector borne diseases to other
dogs which can be very debilitating and difficult to treat. Larvae
from certain gastrointestinal worms may be shed in the environment
and pose a threat of zoonotic disease to humans while both
heartworm (D.immitis) and lungworm (A.vasorum) disease can be fatal
to affected dogs. (ESCCAP)3
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, expectations regarding products, regulatory approvals
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, 2018, 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 Dr. Domenico Otranto, is a consultant to Zoetis Inc.
2 Based on internal estimates
3 European Scientific Council Companion Animal Parasites Website
(https://www.esccap.org/parasites/) Sept. 2019
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version on businesswire.com: https://www.businesswire.com/news/home/20190920005276/en/
Anne-France Quentric +33 6 85 53 95 87
anne-france.quentric@zoetis.com
Christina Lood 973-822-7249 christina.lood@zoetis.com
Steve Frank 973- 822-7141 steve.frank@zoetis.com
Marissa Patel 973-443-2996 marissa.patel@zoetis.com
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