- Major technical sections complete for Zenrelia, with FDA
final approval on track for late in third quarter of 2024; updates
on differentiation and safety
- Final FDA approval for Credelio Quattro now expected in
the fourth quarter of 2024
- First Zenrelia approval received in Brazil
- 2024 Innovation sales guidance increased
GREENFIELD, Ind., June 27,
2024 /PRNewswire/ -- Elanco Animal Health
Incorporated (NYSE: ELAN) today announced updates to the expected
U.S. Food and Drug Administration (FDA) approval timelines for
Zenrelia and Credelio Quattro.
For Zenrelia, the company has received confirmation from FDA
that all major technical sections (Effectiveness, Safety and
Chemistry, Manufacturing, and Controls (CMC)) are complete as
of late June. For the Labeling minor technical section, earlier
this week the Company aligned with FDA on the language and expects
to receive the completion letter by mid-July. The 60-day final
administrative review will follow, placing expected approval late
in the third quarter of 2024. The company now anticipates a U.S.
launch for Zenrelia in the fourth quarter of 2024.
"Elanco continues to view Zenrelia as positively differentiated
for effectiveness and convenience, which we believe can address
unmet needs in the market. However, we expect the U.S. label will
include a boxed warning on safety based on the outcome of a trial
with unvaccinated dogs dosed at 3x the label dose," said
Bobby Modi, Elanco Executive Vice
President U.S. Pet Health and Global Digital Transformation. "While
we remain confident in Zenrelia's blockbuster potential, we believe
this warning will slow the product adoption curve in the U.S. and
initially limit the number of expected treatment days by
approximately 25%. We plan to conduct additional research to
support an improved label over time."
Zenrelia has also received its first approval in Brazil by the Brazilian Minister of
Agriculture, Livestock and Food Supply, with launch planned for the
fourth quarter of 2024. Additional reviews are ongoing in other
markets, including Canada,
Europe and Japan.
For Credelio Quattro, two of three major technical sections –
Effectiveness and Safety – are complete, however, in June, the
Company received an incomplete letter for the CMC major technical
section. Elanco has already submitted its response to the two
questions in the letter, which did not require any additional data
generation. The FDA has offered a shortened, 60-day review timeline
for Elanco's response. Following this, the minor technical section
reviews will be completed, including Labeling. The product is then
expected to go through the 60-day final administrative review,
placing the expected approval in the fourth quarter of 2024, with
U.S. launch expected in the first quarter of 2025. The Company
continues to expect positive differentiation related to
effectiveness.
"We have a robust innovation portfolio and continue to expect to
deliver $600 to $700 million of Innovation sales by the end of
2025," said Jeff Simmons, Elanco
President and CEO. "With the expected launches of Bovaer and
Zenrelia in the second half and the continued strong performance of
Experior and AdTab, we are increasing our expectations of
Innovation sales in 2024 from $375 to
$410 million to $400 to $450
million."
On the second quarter earnings call, the Company will update
2024 financial guidance for revenue, adjusted EBITDA, adjusted EPS
and other key metrics, including reflecting the sale of the aqua
business, with continued expectation of a close around
mid-year.
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, as well as the expected timing for
the sale of the aqua business.
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, including the proposed divestiture of our
aqua business; 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: Katy Grissom
(317) 273-9248 kathryn.grissom@elancoah.com
Media Contact: Colleen Parr Dekker
(317) 989-7011 colleen.dekker@elancoah.com
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SOURCE Elanco Animal Health