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

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New Chewable Tablet Treatment for Fleas and Ticks in Dogs – Effective For 12 Weeks (8 weeks for Rhipicephalus sanguineus ticks)

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Tuesday, December 17, 2013 4:00 am EST

Public Company Information:

SUMMIT, N.J.--(BUSINESS WIRE)--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 provides:

  • 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 sanguineus)

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 (FAD).

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 www.merck-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).

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

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