Extensive review and analysis of research data
completed
Final stage to focus on planned in-field use
studies
Best Management Practices and Certification
Program adopted
FDA approval of updates to Zilmax label,
including new feed delivery method
Merck Animal Health (known outside the United States and Canada
as MSD Animal Health) is pleased to announce significant progress
in the implementation of its Zilmax Five-Step Plan. With insights
from the company’s advisory board, an extensive assessment and
analysis of existing, as well as new product data, was conducted.
Additionally, Merck Animal Health obtained the input of industry
experts, business partners and customers about the product and its
use.
The totality of the comprehensive review supported that Zilmax®
(zilpaterol hydrochloride) is safe when used according to the
product label and in conjunction with sound animal husbandry
practices. The research results and industry data showed that
cattle weights, and thus feed consumption rates, have been steadily
increasing over time. This created the possibility that certain
cattle could consume feed quantities that result in ingestion of
Zilmax in an amount that exceeds the approved dose. The review also
noted that enhanced label language – coupled with the
implementation of comprehensive certification requirements and a
thorough best practices program – will ensure that usage of Zilmax
remains compliant with the label.
An updated Zilmax label, to include Component Feeding, which is
an alternative method of administering Zilmax using a targeted
lower dose, was submitted to and approved by the U.S. Food and Drug
Administration (FDA). Component Feeding provides cattle feeders
with an alternative option to deliver the appropriate dose of
Zilmax to cattle every day. The new convenient feed delivery method
allows cattle feeders to mix Zilmax in feed to deliver a lower
targeted dose of 60 mg/head/day of zilpaterol.
In addition, to help ensure that use of Zilmax is appropriate
and consistent with best practices, Merck Animal Health has taken
the following steps:
Certification
As previously noted, every feedyard team member, distributor,
feed manufacturer, nutritionist and veterinarian who uses Zilmax or
provides consultative services on feeding Zilmax to cattle, must
complete the Zilmax training program, as well as annual retraining,
addressing the proper use of the product. The training will focus
on best practices, product handling, mixing protocols, cattle
management, product inventory, record keeping and clean-out
procedures. Completion and adherence to the program will be a
prerequisite for the use of Zilmax. [Certification Program]
Best Management Practices
Merck Animal Health has worked with industry experts to develop
comprehensive Best Management Practices. These include best
regimens for the feeding of Zilmax, as well as a number of factors
that are critical to animal well-being, including animal handling,
proper nutrition/feeding protocols, environmental risk factors,
transportation, and cattle management and selection. [Best
Management Practices Program]
“Emphasizing best management practices illustrates our
commitment to our industry partners by helping set benchmarks for
animal mobility, mitigating risk factors, and reinforcing the
significant role of nutrition and handling in animal performance,”
said KJ Varma, BVSc, Ph.D., Diplomate ACVCP, Senior Vice President
Global R&D, Merck Animal Health. “We remain committed to
working closely with our customers to maintain the highest
standards of care for the health and well-being of cattle.”
Planned In-Field Use Studies
Merck Animal Health also maintains its commitment to sound
science – a cornerstone of the Five-Step Plan. The significant
advances noted have enabled the company to move forward with the
next step – the In-Field Use Studies, for which we will seek the
participation of industry partners. Given the addition of Component
Feeding to the label, the planned In-Field Use Study design and
protocols will be reviewed before the studies commence. As
previously noted, these studies will be overseen by an independent
third-party and will extend into the high heat months. The guiding
principles of the studies remain the same:
- Observing cattle throughout the system
– before and after receiving Zilmax – at the feedyard and at the
packing plant;
- Evaluating the mobility of cattle by
trained third-party experts utilizing an established mobility
scoring system; and
- Reviewing potential confounding
factors, such as nutrition, transportation, receiving facilities,
flooring surfaces and, cattle management and handling practices,
given that mobility issues can be the result of numerous issues or
even multifactorial in nature.
For the duration of the Planned In-Field Use Studies, Zilmax
will be made available only to cattle feeders that can meet and
maintain all conditions of the Best Management Practices initiative
and the Certification Program, as well as fully comply with all
protocols of the In-Field Use Studies. We believe the results of
the In-Field Use Studies will help support the return of Zilmax to
the market place in the future.
Additional Label Modifications
In addition to Component Feeding, the FDA has approved a
revision to the existing Complete Feed indication in the label. The
current Complete Feed label dose for zilpaterol is 6.8 grams/ton to
provide 60 to 90 mg/head/day. The label will now include an updated
caution statement that notes cattle should not be fed Zilmax in
excess of 90 mg/head/day. If pen consumption of complete feed
exceeds 26.5 lb/head/day (90% on a dry matter basis), zilpaterol
should not be fed in complete feed. This additional language will
further ensure that Zilmax use remains compliant with the label,
regardless of the delivery feed method chosen.
“We are pleased to announce the addition of Component Feeding to
the Zilmax label, and are equally excited to note we are moving
ahead with the Five-Step Plan,” said Dr. Varma. “The work
supporting Zilmax has been complex and time intensive, and we
appreciate the time and efforts of the Merck Animal Health Advisory
Board, the input and continued support of our customers, and the
FDA for its commitment to science and advancing animal
well-being.”
Merck Animal Health has recently filed a label update submission
in Canada. Click here to view the updated U.S. Zilmax label.
Zilmax has a withdrawal period of 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. Not to be fed to cattle in excess of 90 mg/head/day in
complete feed. If pen consumption of complete feed exceeds 26.5
lb/head/day (90 percent dry matter basis), zilpaterol should not be
fed in complete feed. For complete information, refer to the
product label.
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. 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 LinkedIn and
Twitter at @MerckAH.
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).
Merck Animal HealthMedia:Pam Eisele, 267-305-3558Kelly Goss,
913-422-6846orInvestor:Justin Holko, 908-423-5088
Merck (NYSE:MRK)
Historical Stock Chart
From Sep 2024 to Oct 2024
Merck (NYSE:MRK)
Historical Stock Chart
From Oct 2023 to Oct 2024