16 August 2013
SUMMIT, N.J., Aug. 16, 2013 -- At Merck Animal Health, the health and well-being of animals is our first and foremost priority. We also take very seriously our commitment to providing safe, effective products that are developed based on comprehensive research, rigorous testing and sound science. We believe in the science that supports Zilmax and are confident in its safety and performance. Reinforcing this science and data-based approach, Merck Animal Health has announced it has strengthened its commitment to its Five-Step Approach to Ensuring Responsible Beef.
As previously announced, Merck Animal Health, in conjunction with independent experts, will conduct a scientific audit, which will monitor the process of feeding of Zilmax, and will follow identified cattle from the feedyard to the packing plant to determine potential causes of lameness and other mobility issues during feeding, transportation, offloading and staging at the processing facility. We also will do a thorough review of potential compounding factors—such as nutrition, transportation and receiving facilities.
In support of our customers and to ensure effective implementation of our five-step plan, Merck Animal Health has made the decision to temporarily suspend sales of Zilmax in the United States and Canada. This will allow sufficient time for the establishment of valid study protocols, identification of feeders and packers to participate in the audit, and creation of a third-party team to oversee this process and validate its results.
“We remain confident in the safety of the product, based on our own extensive research and that of regulators and academic institutions, and are committed to the well-being of the animals that receive it,” says KJ Varma, BVSc, Ph.D., Diplomate ACVCP, Senior Vice President Global R&D, Merck Animal Health. “This important step demonstrates our commitment to providing our industry partners with data that will reaffirm confidence in Zilmax. We sincerely regret that this situation creates business challenges for our customers but it is critical to ensure that this process is conducted appropriately and with rigorous scientific measures. After the five-step plan is completed, the results will be shared publicly.”
In addition, we are also accelerating the development of our Merck Animal Health Advisory Board, which will bring together industry experts, producers, academics and company leadership to promote an open dialogue on animal well-being and help shape and strengthen the company’s animal health and well-being program in the future.
Zilmax sales in the United States and Canada were $159 million in 2012. Visit the Zilmax Information Center at http://www.merck-animal-health.com/zilmaxinfocenter.aspx for more details and updates on Zilmax.
At Merck Animal Health, we constantly evaluate our processes and procedures across the entire company to ensure that we maintain the best science-based practices and procedures for not only the welfare of our animals but our business as a whole. We are proud of our animal well-being policies, as well as our role in providing quality products that meet the needs of a diverse consumer base around the world.
Zilmax has a withdrawal period 3 days prior to harvest. Not for use in animals intended for breeding. Do not allow horses or other equines access to feed containing zilpaterol. Do not use in veal calves. For complete safety information, refer to product label and Zilmax website.
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. 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.
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’s 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 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).
Zilmax® is a registered trademark of Merck Animal Health, Summit, N.J., USA