MSD Animal Health Receives Positive Opinion from European Medicines Agency for BRAVECTO™ (fluralaner)


December 17, 2013 4:00 am ET

New Chewable Tablet Treatment 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) today announced that the Committee for Medicinal Products for
Veterinary Use (CVMP) of the European Medicines Agency has adopted a
positive opinion, recommending the granting of a marketing authorization
for the veterinary medicinal product BRAVECTO™ (fluralaner) chewable
tablets for dogs (112.5 mg, 250 mg, 500 mg, 1000 mg, 1400 mg).

The active substance of BRAVECTO, fluralaner, a new ectoparasiticide
belonging to the isoxazoline group, is systemically active against fleas
and ticks. The benefits of BRAVECTO are its efficacy in the treatment of
flea and tick infestations in dogs. The most common side effects are
mild and transient gastrointestinal effects.

If adopted, approved indication:

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

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

Fleas and ticks must attach to the host and commence feeding in order to
be exposed to the active substance. The onset of effect is within 8
hours of attachment for fleas (C. felis) and 12 hours of
attachment for ticks (I. ricinus). The product can be used as
part of a treatment strategy for the control of Flea Allergy Dermatits

Detailed conditions of the product will be described in the summary of
product characteristics (SPC), which will be published in the European
public assessment report (EPAR) and will be available after the
marketing authorization has been granted by the European Commission.

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 trademark of MSD Animal Health, Summit N.J., USA

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


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