RIDGEFIELD - Findings from a new exploratory sub-analysis of the EMPEROR-Reduced phase III trial showed that Jardiance (empagliflozin) reduced the risk of adverse cardiovascular and kidney events in adults with heart failure with reduced ejection fraction with and without diabetes regardless of chronic kidney disease status at baseline.

These results were shared today as an oral presentation at the American Society of Nephrology Kidney Week 2020 and published in Circulation, Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced.

'On their own, heart failure and chronic kidney disease are each associated with an increased risk of hospitalizations and premature death from cardiovascular causes. The presence of one condition often accelerates the onset and progression of the other, further increasing this risk and leading to poorer prognoses,' said Faiez Zannad, M.D., Ph.D., EMPEROR Program clinical investigator and Emeritus Professor of Therapeutics at the University of Lorraine, France. 'In EMPEROR-Reduced, empagliflozin demonstrated a consistent reduction in the risk of the composite primary endpoint of cardiovascular death and heart failure hospitalizations, while slowing kidney function decline, in adults with heart failure with reduced ejection fraction, with and without chronic kidney disease. This is promising news for the growing population of adults suffering from both heart failure and chronic kidney disease.'

As previously reported, EMPEROR-Reduced showed Jardiance reduced the relative risk of the combined endpoint of cardiovascular death or hospitalization for heart failure by 25% and of first and recurrent hospitalizations for heart failure by 30%, and slowed the decline in eGFR, a measure of kidney function, in adults with heart failure with reduced ejection fraction with and without diabetes. An additional exploratory analysis showed that Jardiance decreased the relative risk of a composite kidney endpoint, including end stage kidney disease and a profound loss of kidney function, by 50%. In this new analysis of all endpoints, these benefits were consistently observed in subgroups of patients with and without chronic kidney disease at baseline, including patients with severe renal impairment. In all patient cohorts participating in the EMPEROR-Reduced trial, the safety profile was similar to the well-established safety profile of Jardiance.

'Over half of people with heart failure have moderate to severe chronic kidney disease, yet, there remains a need for new treatment options that address these interconnected conditions,' said Mohamed Eid, M.D., M.P.H, M.H.A, vice president, Clinical Development & Medical Affairs, Cardio-Metabolism & Respiratory Medicine, Boehringer Ingelheim Pharmaceuticals, Inc. 'These findings continue to show the potential of Jardiance to help improve the lives of adults living with cardio-renal-metabolic conditions, including heart failure and chronic kidney disease.'

'Heart failure and chronic kidney disease are common, life-threatening diseases that require improved treatment options. The EMPOWER clinical development program, including our ongoing EMPEROR-Preserved and EMPA-KIDNEY trials, explores the potential role Jardiance may play in improving outcomes for people with these conditions,' said Jeff Emmick, M.D., Ph.D., vice president, Product Development, Lilly. 'The new findings from EMPEROR-Reduced will help us achieve our goal of redefining how people living with these conditions are treated.'

In March 2020, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to Jardiance for the treatment of chronic kidney disease, demonstrating the urgent need for new treatment options for people living with the condition. This designation covers the ongoing EMPA-KIDNEY trial, which is investigating the effect of Jardiance on the progression of kidney disease and occurrence of cardiovascular death in adults with established chronic kidney disease, with and without diabetes. Results from EMPA-KIDNEY are expected in 2022.

The FDA also granted Fast Track designation in June 2019 to Jardiance for the reduction of the risk of cardiovascular death and hospitalization for heart failure in people with heart failure. This designation is for the EMPEROR program, which consists of the EMPEROR-Reduced and EMPEROR-Preserved trials. EMPEROR-Preserved is exploring the effect of Jardiance on cardiovascular death or hospitalization for heart failure in adults with heart failure with preserved ejection fraction, an area that currently has no approved treatment options. EMPEROR-Preserved results are expected in 2021. Jardiance is not indicated for the treatment of heart failure.

The EMPEROR and EMPA-KIDNEY studies are part of the EMPOWER clinical program, the broadest and most comprehensive of any SGLT2 inhibitor, exploring the impact of Jardiance on the lives of people across the spectrum of cardio-renal-metabolic conditions.

About the EMPEROR Heart Failure Studies

The EMPEROR (EMPagliflozin outcomE tRial in patients with chrOnic heaRt failure) heart failure studies are two phase III, randomized, double-blind trials investigating once-daily Jardiance compared with placebo in adults with heart failure with preserved or reduced ejection fraction, both with and without diabetes, who are receiving current standard of care:

EMPEROR-Reduced [NCT03057977] investigated the safety and efficacy of Jardiance in patients with heart failure with reduced ejection fraction (HFrEF).

About the EMPOWER Program

The Alliance has developed the EMPOWER program to explore the impact of Jardiance on major clinical cardiovascular and renal outcomes in a spectrum of cardio-renal-metabolic conditions. Cardio-renal-metabolic conditions are the leading cause of mortality worldwide and account for up to 20 million deaths annually. Through the EMPOWER program, Boehringer Ingelheim and Lilly are working to advance knowledge of these interconnected systems and create care which offers integrated, multi-organ benefits. Comprised of nine clinical trials and two real-world evidence studies, EMPOWER reinforces the long-term commitment of the Alliance to improve outcomes for people living with cardio-renal-metabolic conditions. With 377,000 adults estimated to have enrolled worldwide upon completion of the studies, it is one of the broadest and most comprehensive clinical programs for an SGLT2 inhibitor to date.

About Cardio-Renal-Metabolic Conditions

Boehringer Ingelheim and Lilly are driven to transform care for people with cardio-renal-metabolic conditions, a group of interconnected disorders that affect more than one billion people worldwide and are a leading cause of death.

The cardiovascular, renal and metabolic systems are interconnected, and share many of the same risk factors and pathological pathways along the disease continuum. Dysfunction in one system may accelerate the onset of others, resulting in progression of interconnected diseases such as type 2 diabetes, cardiovascular disease, heart failure, and kidney disease, which in turn leads to an increased risk of cardiovascular death. Conversely, improving the health of one system can lead to positive effects throughout the others.

Through our research and treatments, our goal is to support people's health, restoring the harmony between the interconnected cardio-renal-metabolic systems and reducing their risk of serious complications. As part of our commitment to those whose health is jeopardized by cardio-renal-metabolic conditions, we will continue embracing a multidisciplinary approach towards care and focusing our resources on filling treatment gaps.

Boehringer Ingelheim and Eli Lilly and Company

In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an alliance that centers on compounds representing several of the largest diabetes treatment classes. Depending on geographies, the companies either co-promote or separately promote the respective molecules each contributing to the alliance. The alliance leverages the strengths of two of the world's leading pharmaceutical companies to focus on patient needs. By joining forces, the companies demonstrate their commitment, not only to the care of people with diabetes, but also to investigating the potential to address areas of unmet medical need. Clinical trials have been initiated to evaluate the impact of Jardiance on people living with heart failure or chronic kidney disease.

About Boehringer Ingelheim

Making new and better medicines for humans and animals is at the heart of what we do. Our mission is to create breakthrough therapies that change lives. Since its founding in 1885, Boehringer Ingelheim is independent and family-owned. We have the freedom to pursue our long-term vision, looking ahead to identify the health challenges of the future and targeting those areas of need where we can do the most good.

As a world-leading, research-driven pharmaceutical company, more than 51,000 employees create value through innovation daily for our three business areas: Human Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing. In 2019, Boehringer Ingelheim achieved net sales of around $21.3 billion (19 billion euros). Our significant investment of over $3.9 billion (3.5 billion euros) in R&D drives innovation, enabling the next generation of medicines that save lives and improve quality of life.

We realize more scientific opportunities by embracing the power of partnership and diversity of experts across the life-science community. By working together, we accelerate the delivery of the next medical breakthrough that will transform the lives of patients now, and in generations to come.

About Lilly Diabetes

Lilly has been a global leader in diabetes care since 1923, when we introduced the world's first commercial insulin. Today we are building upon this heritage by working to meet the diverse needs of people with diabetes and those who care for them. Through research, collaboration and quality manufacturing we strive to make life better for people affected by diabetes and related conditions. We work to deliver breakthrough outcomes through innovative solutions-from medicines and technologies to support programs and more.

About Eli Lilly and Company

Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism.

This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Jardiance and reflects Lilly's current belief. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug development and commercialization. Among other things, there can be no guarantee that future study results will be consistent with the results to date or that Jardiance will receive additional regulatory approvals.

Contact:

Jennifer Forsyth

Tel: (203) 791-5889

Email: jennifer.forsyth@boehringer-ingelheim.com

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