- 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.
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.
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.
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 [email protected]
Media Contact: Colleen Parr Dekker (317) 989-7011 [email protected]
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SOURCE Elanco Animal Health