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

Mon Feb 17, 2014 3:00am EST

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

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 felis);
  • 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 sanguineus).

“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 www.msd-animal-health.com.

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 (www.sec.gov).

BRAVECTO™ is a registered trademark of MSD Animal Health, Summit N.J., USA

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