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Merck Animal Health Announces FDA Approval Of BRAVECTO™ (fluralaner)



5/20/2014 7:48:21 AM

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Merck Animal Health Announces FDA Approval of BRAVECTO™ (fluralaner)

SUMMIT, N.J.
, May 20, 2014 /PRNewswire/ -- Merck Animal Health (known as MSD Animal Health outside the United States and Canada) today announced the U.S. Food and Drug Administration's approval of BRAVECTO (fluralaner) chewable tablets for dogs (112.5 mg, 250 mg, 500 mg, 1000 mg, 1400 mg). BRAVECTO is the first and only treatment that has been shown to quickly and effectively kill fleas and multiple tick species for 12 weeks in a single dose. BRAVECTO also is effective for eight weeks against Amblyomma americanum ticks.

"BRAVECTO is a breakthrough innovation that offers pet owners and veterinarians something that no other product does the longest-lasting oral flea and tick prevention currently available," said KJ Varma, Senior Vice President, Research and Development, Merck Animal Health. "The approval of BRAVECTO is truly a reflection of our 70-year history of innovation, research and commitment to helping shape the future of animal health, as well as our dedication to bringing novel products to market that meet the evolving needs of pet owners, customers and the industry."

BRAVECTO comes in a convenient, single-dose chewable tablet and offers:

  • Immediate and persistent flea (Ctenocephalides felis) killing activity for 12 weeks
  • Immediate and persistent tick killing activity for 12 weeks (Ixodes scapularis black-legged tick, Dermacentor variabilis American dog tick,and Rhipicephalus sanguineus brown dog tick)
  • Immediate and persistent tick killing activity for 8 weeks (Amblyomma americanum lone star tick)

"Effective flea and tick control used regularly is a crucial part of a pet's overall health regimen," said Kathleen Heaney, D.V.M., Director of Technical Services, companion animals, Merck Animal Health. "BRAVECTO offers pet owners an easy-to-administer chewable product that is fast-acting and lasts nearly three times longer* than conventional, monthly flea and tick products."

The active substance of BRAVECTO, fluralaner, a new ectoparasiticide belonging to the isoxazoline group, is systemically active against fleas and ticks. BRAVECTO is presented as a flavored chew that dogs accept readily. The product can be used as part of a treatment strategy for the control of Flea Allergy Dermatitis (FAD) as a direct result of eliminating flea infestations. The most common side effects are mild and transient gastrointestinal effects.

The most common adverse reactions recorded in clinical trials were vomiting, decreased appetite, diarrhea, lethargy, polydipsia, and flatulence. BRAVECTO has not been shown to be effective for 12-weeks' duration in puppies less than 6 months of age. BRAVECTO is not effective against lone star ticks beyond 8 weeks after dosing.

BRAVECTO is available only through licensed veterinarians.

*BRAVECTO is effective for eight weeks against Amblyomma americanum ticks.

About Merck Animal Health
Today's Merck is a global healthcare leader working to help the world be well. Merck Animal Health, known as MSD Animal Health outside the United States and Canada, is the global animal health business unit of Merck (NYSE: MRK). Through its commitment to the Science of Healthier Animals, Merck Animal Health offers veterinarians, farmers, pet owners and governments one of the widest range of veterinary pharmaceuticals, vaccines and health management solutions and services. Merck 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. Merck Animal Health is present in more than 50 countries, while its products are available in some 150 markets. For more information, visit www.merck-animal-health.com or connect with us on Twitter.

Merck 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 Merck'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; Merck'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 Merck patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

Merck 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 Merck's 2013 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).

Media

Contacts:

Kelly Goss

913 422 6846
kelly.goss@merck.com

Pam Eisele

267 305 3558

pamela_eisele@merck.com

Investor
Relations:

Justin Holko

908 423 5088

justin_holko@merck.com

Carol Ferguson

908 423 4465

carol_ferguson@merck.com





SOURCE Merck Animal Health



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