MSD Animal Health Receives Positive Final Opinion from European Medicines Agency for BRAVECTO™ (fluralaner) Spot-On for Cats and Dogs


March 22, 2016 4:00 am ET

Only Spot-On Treatment for Fleas and Ticks Effective For 12 Weeks

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 final opinion, recommending the granting of a marketing
authorization for the veterinary medicinal product BRAVECTO™
(fluralaner) Spot-On for both cats and dogs.

In 2014, BRAVECTO was launched as a chew for dogs providing protection
with its active ingredient, fluralaner, against fleas and ticks for up
to 12 weeks with a single treatment. BRAVECTO Spot-On provides 12 weeks
of flea and tick protection for both cats and dogs with the same active
ingredient as BRAVECTO chew. More than 13 million doses of BRAVECTO have
been dispensed in 60 countries since its introduction.

BRAVECTO Spot-On will be the first product to provide immediate and
persistent systemic flea and tick protection for cats and gives
veterinarians and dog owners a choice in how to administer flea and tick
protection. BRAVECTO Spot-On can be used to treat Flea Allergy
Dermatitis (FAD) in dogs and also cats.

If adopted, BRAVECTO Spot-On will be indicated for the treatment of tick
and flea infestations on cats and dogs. It is a systemic insecticide and
acaricide that provides immediate and persistent flea (Ctenocephalides
) killing activity for 12 weeks in cats and dogs.

Fleas and ticks must attach to the treated animal and commence feeding
in order to be exposed to the active substance. The most common side
effects in dogs are mild and transient skin reactions such as erythema
or alopecia at the application site and, in cats, pruritus at the
application site.

BRAVECTO Spot-On is applied using the company’s unique “Twist’n’Use”™
pipette design for ease of application. 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

For 125 years, MSD has been a global health care 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. Through its commitment to the Science of Healthier Animals™,
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
or connect with us on LinkedIn.

Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA

This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the
“company”) includes “forward-looking statements” within the meaning of
the safe harbor provisions of the U.S. Private Securities Litigation
Reform Act of 1995. These statements are based upon the current beliefs
and expectations of the company’s management and are subject to
significant risks and uncertainties. There can be no guarantees with
respect to pipeline products that the products will receive the
necessary regulatory approvals or that they will prove to be
commercially successful. 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; the company’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 the company’s patents
and other protections for innovative products; and the exposure to
litigation, including patent litigation, and/or regulatory actions.

The company 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 the company’s 2015 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 (

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

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