29 March 2018
MSD Animal Health Receives Marketing Authorization from European Commission for Expanded Indication of PANACUR® AquaSol for Chickens
Addition of a new therapeutic indication to combat
the intestinal parasite, Capillaria spp. (L5 and adult stages)
MADISON, NJ, March 29, 2018 – MSD Animal Health, a division of Merck & Co., Inc., Kenilworth, N.J., USA, today announced that, following a positive opinion from the Committee for Medicinal Products for Veterinary Use (CVMP), the European Commission has granted an expanded indication of a marketing authorization for the veterinary medicinal product PANACUR® AquaSol (fenbendazole 200 mg/mL) for use in chickens. The addition of a new therapeutic indication to the product’s label in the European Union will combat the intestinal parasite, Capillaria spp. (L5 and adult stages).
PANACUR® AquaSol is a highly stable, farm-friendly, water-administered, oral suspension product produced with an innovative wet-milling technology. It is currently available in a number of countries around the world.
“At MSD Animal Health, we are committed to providing our customers with our commitment of always producing more for them in the areas of innovation, customer centricity and the knowledge and solutions they need to improve their business,” said Taylor Barbosa, DVM, Ph.D., ACPV, Executive Director, Global Poultry Marketing, MSD Animal Health. “We are pleased with the European Commission’s decision to approve an expanded indication for PANACUR® AquaSol for chickens. The product has a long history of proven results as a leading dewormer and we are excited to bring this additional indication to chicken farmers throughout the European Union.”
“Managing intestinal health results in better, overall performance for layers, breeders and broilers,” Dr. Barbosa said. “If not managed with proper parasite control, farmers could experience an economic impact when there is a drop in production or a loss due to worm infestation.”
The MSD Animal Health commitment extends to key products in our global poultry portfolio, which include INNOVAX®-ND-IBD, the first-ever, live vaccine made with biotechnology, which protects against three highly infectious diseases in poultry -- Newcastle Disease (ND), Infectious Bursal Disease (IBD), and Marek’s Disease (MD), and EXZOLT®, a breakthrough prescription product for treatment of Poultry Red Mite infestations.
PANACUR® AquaSol is indicated for the treatment of gastro-intestinal nematodes in chickens infected with:
- Ascaridia galli (L5 and adult stages)
- Heterakis gallinarum (L5 and adult stages)
- Capillaria spp.(L5 and adult stages)
Through the company’s proprietary wet-milling technology, PANACUR® AquaSol is a highly stable suspension which, as a result of smaller more uniform particle size, does not require frequent agitation and provides both a high level of efficacy and convenience. PANACUR® AquaSol has been proven safe for all types of chickens, including layers, breeders and broilers. It has a zero day withdrawal period for eggs and a six-day withdrawal period for meat and offal for 1mg/kg bodyweight dose (9-day for 2 mg/kg dose).
About MSD Animal Health
For more than a century, MSD, a leading global biopharmaceutical company, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases. MSD Animal Health, a division of Merck & Co., Inc., Kenilworth, N.J., USA, 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 www.msd-animal-health.com or connect with us on LinkedIn and Twitter.
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. 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 2017 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).
Please see Prescribing Information for PANACUR® AquaSol (fenbendazole) at [http://www.panacuraquasol.ca/].