MSD Animal Health Receives Marketing Authorization from European Commission for BRAVECTO™ (fluralaner)


February 17, 2014 3:00 am ET

First Chewable Tablet Approved for Fleas and Ticks in Dogs Effective for 12 Weeks (8 Weeks for Rhipicephalus sanguineus Ticks)

MSD Animal Health, known as Merck Animal Health in the United States and
Canada, announced today that following a positive opinion from the
Committee for Medicinal Products for Veterinary Use (CVMP), the European
Commission has granted marketing authorization for the veterinary
medicinal product BRAVECTO™ (fluralaner) chewable tablets for dogs
(112.5 mg, 250 mg, 500 mg, 1000 mg, 1400 mg). This is the first and only
treatment that has been shown to quickly and effectively kill fleas and
ticks for up to 12 weeks in a single dose.*

“BRAVECTO provides a powerful new weapon in the fight against these
dangerous parasites,” said KJ Varma, senior vice president, Research &
Development, MSD Animal Health. “We are incredibly proud to bring this
new innovative chewable tablet to dog owners, which we could not have
done without the partnership of the clinical veterinarians who worked
with us to bring this advancement to market.”

BRAVECTO is indicated for the treatment of tick and flea infestation on
dogs. It is a systemic insecticide and acaricide that provides*:

  • Immediate and persistent flea-killing activity for 12 weeks (Ctenocephalides
  • Immediate and persistent tick-killing activity for 12 weeks (Ixodes
    ricinus, Dermacentor reticulatus and Dermacentor variabilis
    ); and
  • Immediate and persistent tick-killing activity for 8 weeks (Rhipicephalus

“We are delighted with the CVMP’s decision to grant marketing
authorization for BRAVECTO,” said David Hallas, associate vice
president, MSD Animal Health. “Now veterinarians and pet owners have a
highly effective treatment option that works quickly and lasts longer
than the currently available once-monthly treatment options.”

The active substance of BRAVECTO, fluralaner, a new ectoparasiticide
belonging to the isoxazoline group, is systemically active against fleas
and ticks. The product can be used as part of a treatment strategy for
the control of Flea Allergy Dermatits (FAD). The most common side
effects are mild and transient gastrointestinal effects.

BRAVECTO will be launched in Germany, Spain, Italy, France, The
Netherlands and the United Kingdom in April 2014. It will be introduced
in additional European countries in the coming months.

About MSD Animal Health

Today’s MSD is a global healthcare leader working to help the world be
well. MSD Animal Health, known as Merck Animal Health in the United
States and Canada, is the global animal health business unit of MSD. MSD
Animal Health offers veterinarians, farmers, pet owners and governments
one of the widest range of veterinary pharmaceuticals, vaccines and
health management solutions and services. MSD Animal Health is dedicated
to preserving and improving the health, well-being and performance of
animals. It invests extensively in dynamic and comprehensive R&D
resources and a modern, global supply chain. MSD Animal Health is
present in more than 50 countries, while its products are available in
some 150 markets. For more information, visit

MSD Forward-Looking Statement

This news release includes “forward-looking statements” within the
meaning of the safe harbor provisions of the United States Private
Securities Litigation Reform Act of 1995. These statements are based
upon the current beliefs and expectations of MSD’s management and are
subject to significant risks and uncertainties. If underlying
assumptions prove inaccurate or risks or uncertainties materialize,
actual results may differ materially from those set forth in the
forward-looking statements.

Risks and uncertainties include but are not limited to, general industry
conditions and competition; general economic factors, including interest
rate and currency exchange rate fluctuations; the impact of
pharmaceutical industry regulation and health care legislation in the
United States and internationally; global trends toward health care cost
containment; technological advances, new products and patents attained
by competitors; challenges inherent in new product development,
including obtaining regulatory approval; MSD’s ability to accurately
predict future market conditions; manufacturing difficulties or delays;
financial instability of international economies and sovereign risk;
dependence on the effectiveness of MSD’s patents and other protections
for innovative products; and the exposure to litigation, including
patent litigation, and/or regulatory actions.

MSD undertakes no obligation to publicly update any forward-looking
statement, whether as a result of new information, future events or
otherwise. Additional factors that could cause results to differ
materially from those described in the forward-looking statements can be
found in MSD’s 2012 Annual Report on Form 10-K and the company’s other
filings with the Securities and Exchange Commission (SEC) available at
the SEC’s Internet site (

BRAVECTO™ is a registered trademark of MSD Animal Health, Summit

MSD Animal Health
Amy Firsching, +1 908-473-6357
Pam Eisele, +1 908-423-5042

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