Company's broad spectrum parasiticide on-track
for October U.S. approval and first quarter 2025 launch
GREENFIELD, Ind., Aug. 20,
2024 /PRNewswire/ -- Elanco Animal Health
Incorporated (NYSE: ELAN) today announced the U.S. Food and Drug
Administration (FDA) has completed its review of all major and
minor technical sections for Credelio Quattro, and the final 60-day
administrative review is underway.
"This is an exciting time at Elanco as we deliver a robust
innovation portfolio that we believe will help transform animal
care with solutions that go beyond today's market leaders," said
Jeff Simmons, Elanco President and
CEO. "Elanco expects to launch a potential blockbuster each of the
next three quarters in large, fast-growing or new markets that are
largely accretive to Elanco. We continue to expect $600 million to $700
million of innovation sales in 2025."
The Company continues to expect Credelio Quattro to be
positively differentiated and is seeking approval for indications
that would give the broadest parasite coverage including fleas,
ticks, heartworms and other internal parasites, like tapeworm. In
addition to the regulatory process, the company is finalizing the
manufacturing scale-up to optimize launch, targeted for the first
quarter of 2025.
"We are very pleased with the continued progress of our
pipeline," said Dr. Ellen de
Brabander, Executive Vice President of Innovation and
Regulatory Affairs. "We completed the Bovaer review ahead of
schedule and now have two potential blockbusters – Zenrelia and
Credelio Quattro – in the final administrative review at FDA,
illustrating our R&D organization's high capacity and ability
to build capabilities to deliver a consistent flow of high impact
innovation. A significant thank you to the Elanco team for their
efforts to bring these differentiated innovations toward approval
while also refilling and advancing the early-stage pipeline for the
next era of innovation."
The FDA has the legal authority to approve and regulate drugs
for both people and animals. FDA's Center for Veterinary Medicine
(CVM) approves and regulates new animal drugs. The approval process
includes up to five major technical sections (Target Animal Safety;
Effectiveness; Chemistry, Manufacturing, and Controls; Human Food
Safety (farm animal products); and Environmental Impact (farm
animal products) and two minor technical sections (All Other
Information and Labeling)). Once all the major and minor technical
sections are complete, the drug sponsor submits the New Animal Drug
Application (NADA), for the final administrative review. For more
information about the FDA approval process, please visit:
https://www.fda.gov/animal-veterinary/animal-health-literacy/idea-marketplace-journey-animal-drug-through-approval-process.
ABOUT ELANCO
Elanco Animal Health Incorporated (NYSE: ELAN) is a global
leader in animal health dedicated to innovating and delivering
products and services to prevent and treat disease in farm animals
and pets, creating value for farmers, pet owners, veterinarians,
stakeholders and society as a whole. With nearly 70 years of animal
health heritage, we are committed to helping our customers improve
the health of animals in their care, while also making a meaningful
impact on our local and global communities. At Elanco, we are
driven by our vision of Food and Companionship Enriching Life and
our Elanco Healthy Purpose™ sustainability pillars – all to advance
the health of animals, people, the planet and our enterprise. Learn
more at www.elanco.com.
Cautionary Statement Regarding Forward-Looking
Statements
This press release contains forward-looking statements within
the meaning of the federal securities laws, including, without
limitation, statements concerning product approvals and launches
and revenue from such products
Forward-looking statements are based on our current expectations
and assumptions regarding our business, the economy and other
future conditions. Because forward-looking statements relate to the
future, by their nature, they are subject to inherent
uncertainties, risks and changes in circumstances that are
difficult to predict. As a result, our actual results may differ
materially from those contemplated by the forward-looking
statements. Important risk factors that could cause actual results
to differ materially from those in the forward-looking statements
include regional, national or global political, economic, business,
competitive, market and regulatory conditions, including but not
limited to operating in a highly competitive industry; the success
of our research and development (R&D) and licensing efforts;
the impact of disruptive innovations; competition from generic
products; an outbreak of infectious disease carried by farm
animals; risks related to the evaluation of animals; consolidation
of our customers and distributors; the impact of increased or
decreased sales into our distribution channels; our dependence on
the success of our top products; our ability to complete
acquisitions and divestitures and successfully integrate the
businesses we acquire; our ability to implement our business
strategies or achieve targeted cost efficiencies and gross margin
improvements; manufacturing problems and capacity imbalances;
fluctuations in inventory levels in our distribution channels; the
impact of weather conditions, including those related to climate
change, and the availability of natural resources; the effects of a
human disease outbreak, epidemic, pandemic or other widespread
public health concern; the loss of key personnel or highly skilled
employees; adverse effects of labor disputes, strikes and/or work
stoppages; the effect of our substantial indebtedness on our
business; changes in interest rates; risks related to the
write-down of goodwill or identifiable intangible assets; the lack
of availability or significant increases in the cost of raw
materials; risks related to our presence in foreign markets; risks
related to currency rate fluctuations; risks related to underfunded
pension plan liabilities; the potential impact that actions by
activist shareholders could have on the pursuit of our business
strategies; actions by regulatory bodies, including as a result of
their interpretation of studies on product safety; the possible
slowing or cessation of acceptance and/or adoption of our farm
animal sustainability initiatives; the impact of increased
regulation or decreased governmental financial support related to
the raising, processing or consumption of farm animals; the impact
of litigation, regulatory investigations, and other legal matters,
including the risk to our reputation; challenges to our
intellectual property rights or our alleged violation of rights of others; misuse,
off-label or counterfeiting use of our products; unanticipated
safety, quality or efficacy concerns and the impact of identified
concerns associated with our products. For additional
information about these and other factors that could cause actual
results to differ materially from forward-looking statements,
please see the Risk Factors in the company's latest Form 10-K and
Form 10-Qs filed with the Securities and Exchange Commission.
Although we have attempted to identify important risk factors,
there may be other risk factors not presently known to us or that
we presently believe are not material that could cause actual
results and developments to differ materially from those made in or
suggested by the forward-looking statements contained in this press
release. Any forward-looking statement made by us in this press
release speaks only as of the date thereof. We undertake no
obligation to publicly update or to revise any forward-looking
statement, whether as a result of new information, future
developments or otherwise, except as may be required by law.
Additional Information
We define innovation revenue as revenue from new products,
lifecycle management and certain geographic expansions and business
development transactions that is incremental in reference to
product revenue in 2020 and does not include the expected impact of
cannibalization on the base portfolio.
Investor Contact: Kathryn
Grissom, +1.317.273.9284, kathryn.grissom@elancoah.com
Media Contact: Colleen Parr
Dekker,
+1.317.989.7011, colleen.dekker@elancoah.com
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SOURCE Elanco Animal Health