– New outcome study to evaluate the effect of JARDIANCE for the treatment of people with chronic kidney disease
– Approximately 15 percent of adults in the U.S. are affected by chronic kidney disease
– The study is based on cardiovascular and renal insights from the landmark EMPA-REG OUTCOME® trial

RIDGEFIELD, CT and INDIANAPOLIS, IN, USA I June 12, 2017 I Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) today announced plans to conduct a new, large clinical outcomes trial investigating Jardiance® (empagliflozin) tablets for the treatment of people with chronic kidney disease. The trial will enroll people with chronic kidney disease both with and without type 2 diabetes.

“Our plans for this new trial are yet another example of our ongoing commitment to improving patient health, especially in areas where unmet needs exist,” said Prof. Hans-Juergen Woerle, global vice president medicine, Boehringer Ingelheim. “We look forward to exploring the potential that empagliflozin may offer for people with chronic kidney disease.”

JARDIANCE is the first and only type 2 diabetes medicine approved to reduce the risk of cardiovascular death in patients with type 2 diabetes and established cardiovascular disease. The landmark EMPA-REG OUTCOME® trial demonstrated that JARDIANCE reduced the risk of cardiovascular death by 38 percent versus placebo in people with type 2 diabetes and established cardiovascular disease when added to standard of care (including glucose-lowering agents and cardiovascular drugs). As one of the secondary endpoints, the trial also showed that JARDIANCE reduced the risk for new-onset or worsening of kidney disease by 39 percent versus placebo when added to standard of care in adults with type 2 diabetes and established cardiovascular disease. Based on these results, BI and Lilly decided to formally investigate the potential of JARDIANCE in people with chronic kidney disease. This and other ongoing mechanistic studies will allow the companies to further explore the potential mechanisms – including the reduction in glomerular pressure – by which empagliflozin may impact renal outcomes in those with chronic kidney disease.

“Based on the cardiovascular and renal results of the EMPA-REG OUTCOME trial, we, along with Boehringer Ingelheim, look forward to starting this new trial to gather evidence in support of a potential new indication for empagliflozin in people with chronic kidney disease,” said Jeff Emmick, M.D., Ph.D., vice president, Product Development, Lilly Diabetes.

About Chronic Kidney Disease
Chronic kidney disease is defined as a progressive decline of kidney function over time. About two thirds of chronic kidney disease cases are attributable to metabolic diseases such as diabetes, hypertension and obesity. Notably, chronic kidney disease is associated with increased morbidity and mortality. The majority of deaths among people with chronic kidney disease occur as a result of cardiovascular complications, often before reaching end stage renal disease. Chronic kidney disease affects approximately 15 percent of adults in the U.S. and treatment costs are estimated to exceed $48 billion annually. Since there are currently only few treatment options, the overarching unmet medical need for new treatment options in chronic kidney disease is evident.

About the EMPA-REG OUTCOME Trial (NCT01131676)
EMPA-REG OUTCOME was a long-term, multicenter, randomized, double-blind, placebo-controlled trial of more than 7,000 patients from 42 countries with type 2 diabetes and established cardiovascular disease.

The study assessed the effect of JARDIANCE (10 mg or 25 mg once daily) added to standard of care compared with placebo added to standard of care. Standard of care was comprised of glucose-lowering agents and cardiovascular drugs (including for blood pressure and cholesterol). The primary endpoint was defined as time to first occurrence of cardiovascular death, non-fatal heart attack or non-fatal stroke.

Although the EMPA-REG OUTCOME trial was not designed to assess the potential mechanisms behind the effect of empagliflozin on kidney outcomes, the kidney assessment was part of a pre-specified exploratory analysis plan of additional endpoints.

The overall safety profile of JARDIANCE was consistent with that of previous trials.

What is JARDIANCE? (www.jardiance.com)
JARDIANCE is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.

JARDIANCE is also used to reduce the risk of cardiovascular death in adults with type 2 diabetes who have known cardiovascular disease.

JARDIANCE is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).

Boehringer Ingelheim and Eli Lilly and Company
In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an alliance in diabetes that centers on compounds representing several of the largest diabetes treatment classes. This alliance leverages the strengths of two of the world’s leading pharmaceutical companies. By joining forces, the companies demonstrate commitment in the care of patients with diabetes and stand together to focus on patient needs. Find out more about the alliance at www.boehringer-ingelheim.com or www.lilly.com.

About Boehringer Ingelheim
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation.

Boehringer Ingelheim is one of the world’s top 20 pharmaceutical companies. Headquartered in Ingelheim, Germany, the company operates globally with approximately 50,000 employees. Since its founding in 1885, the company has remained family-owned and today creates value through innovation for three business areas including human pharmaceuticals, animal health and biopharmaceutical contract manufacturing.

Boehringer Ingelheim is committed to improving lives and providing valuable services and support to patients and their families.  Our employees create and engage in programs that strengthen our communities. Please visit our website to learn more about how we make more health for more people through our Corporate Social Responsibility initiatives.

In 2016, Boehringer Ingelheim achieved net sales of about $17.6 billion (15.9 billion euros). R&D expenditure corresponds to 19.6 percent of its net sales.

For more information please visit www.boehringer-ingelheim.us, or follow us on Twitter @BoehringerUS.

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 and collaboration, a wide range of therapies and a continued determination to provide real solutions—from medicines to support programs and more—we strive to make life better for all those affected by diabetes around the world. For more information, visit www.lillydiabetes.com.

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. To learn more about Lilly, please visit us at www.lilly.com and www.lilly.com/newsroom/social-channels.

SOURCE: Eli Lilly