Boehringer Ingelheim and Eli Lilly company plans to conduct Jardiance® (empagliflozin) to be studied for the treatment of people with chronic heart failure

• New studies will evaluate the effect of JARDIANCE for the treatment of chronic heart failure
• There are approximately 26 million people worldwide, and 5.7 million people in the U.S., suffering from chronic heart failure
• The studies build on results from the landmark EMPA-REG OUTCOME® trial

World pharma today/Drug research/- Boehringer Ingelheim and Eli Lilly and Company announced plans to conduct two outcome trials investigating the diabetes medicine Jardiance®(empagliflozin) for the treatment of people with chronic heart failure. The trials are targeted to begin within the next 12 months and are planned to enroll people with chronic heart failure both with and without type 2 diabetes (T2D).

JARDIANCE was the first diabetes treatment to demonstrate a reduction in the risk of cardiovascular (CV) death in a dedicated CV outcomes trial. This was demonstrated on top of standard of care (including glucose-lowering agents and CV drugs) in people with T2D at high risk of CV events. In addition to reducing CV death by 38 percent, the EMPA-REG OUTCOME® trial also showed that JARDIANCE reduced the risk of hospitalization for heart failure in people with T2D at high risk of CV events. These results led to the planned trials.

Professor Hans-Juergen Woerle, global vice president medicine, Boehringer Ingelheim said that the EMPA-REG OUTCOME trial demonstrated that JARDIANCE reduces the risk of cardiovascular death in diabetes patients at high CV risk, and we now look forward to exploring whether JARDIANCE can also provide heart failure benefits.

One in two people with heart failure die within five years of diagnosis, so there is currently a compelling need for an effective therapy to treat those suffering from this condition.

Heart failure is when the heart cannot pump enough blood around the body. It is a debilitating condition and can be fatal. Heart failure is a prevalent disease; 26 million people around the world and 5.7 million people in the U.S. have chronic heart failure. Every 35 seconds, a new case of heart failure is diagnosed in the U.S. There is a high unmet need in the treatment of heart failure as there is significant morbidity and mortality associated with the condition. Heart failure is highly prevalent in patients with diabetes, however, approximately two-thirds of all heart failure patients do not have diabetes.

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 at high risk for CV events.

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 CV drugs (including for blood pressure and cholesterol). The primary endpoint was defined as time to first occurrence of CV death, non-fatal heart attack or non-fatal stroke.

Over a median of 3.1 years, JARDIANCE significantly reduced the risk of CV death, non-fatal heart attack or non-fatal stroke by 14 percent versus placebo. Risk of CV death was reduced by 38 percent, with no significant difference in the risk of non-fatal heart attack or non-fatal stroke. The overall safety profile of JARDIANCE was consistent with that of previous trials.

Approximately 29 million Americans and an estimated 415 million people worldwide have type 1 or type 2 diabetes, and nearly 28 percent of Americans with diabetes—totaling 8 million people—are undiagnosed. In the U.S., approximately 12 percent of those aged 20 and older have diabetes. Type 2 diabetes is the most common type, accounting for an estimated 90 to 95 percent of all diagnosed adult diabetes cases in the U.S. Diabetes is a chronic condition that occurs when the body either does not properly produce, or use, the hormone insulin.

JARDIANCE is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes. 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. The 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.

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 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, the company operates globally with 145 affiliates and more than 47,000 employees. Since its founding in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel treatments for human and veterinary medicine.

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

In 2015, Boehringer Ingelheim achieved net sales of about $16.74 billion dollars (14.8 billion euros). R&D expenditure corresponds to 20.3 percent of its net sales.For more information please visit www.us.boehringer-ingelheim.com, or follow us on Twitter @BoehringerUS.

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 broad and growing product portfolio 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

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 newsroom.lilly.com/social-channels.

Director, Public Relations

Boehringer Ingelheim Pharmaceuticals, Inc.

Email: jennifer.forsyth@boehringer-ingelheim.com

Phone: (203) 791-5889

Director of Communications

Lilly Diabetes

Email: kueterman_gregory_andrew@lilly.com

Phone: (317) 277-4021