Jardiance^® (empagliflozin) significantly reduced the risk of progressive kidney disease in adults with type 2 diabetes with established cardiovascular disease

Ingelheim, Germany, and Indianapolis, US, June 14, 2016 – New data showed Jardiance^® (empagliflozin) reduced the risk for new-onset or worsening kidney disease by 39 percent versus placebo when added to standard of care in people with type 2 diabetes with established cardiovascular disease. Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced today that the findings have been published in The New England Journal of Medicine and also presented at the American Diabetes Association (ADA) 76th Scientific Sessions^® in New Orleans.

“These findings are clinically important, given that one in two people with type 2 diabetes worldwide will develop kidney disease, which can lead to kidney failure and eventually the need for dialysis.” said Prof. Christoph Wanner, Chief of the Division of Nephrology and Hypertension at the University Hospital of Würzburg, Germany. “Since diabetes is the number one reason people require dialysis treatment, novel treatments that may have the potential to help address this crucial medical need are necessary.”

These findings were part of a pre-specified exploratory analysis plan of additional endpoints of the landmark EMPA-REG OUTCOME^® trial. New-onset or worsening kidney disease was a pre-specified composite endpoint that included the below clinical events. Compared with placebo, Jardiance^® led to the following statistically significant changes in outcomes:

• 55 percent reduction in the initiation of kidney replacement therapy (such as dialysis)
• 44 percent reduction in doubling of creatinine (a waste product usually filtered by the kidneys) in the blood
• 38 percent reduction in progression to macroalbuminuria (very high levels of a protein called albumin in the urine)

Jardiance^® also significantly slowed the decline in kidney function over time compared with placebo. Most patients in this trial were already taking the recommended standard treatment for kidney disease in type 2 diabetes, renin angiotensin aldosterone system blockade; the kidney effects of Jardiance^® were apparent on top of these agents.

Consistent risk reductions in kidney outcomes with Jardiance^® were seen in people who had impaired kidney function, or increased levels of albumin in the urine, at baseline and in those who did not, according to a post hoc sub-group analysis. Serious adverse events (AEs) and AEs leading to treatment discontinuation for Jardiance^® versus placebo were comparable for those with or without impaired kidney function at baseline. Death due to kidney disease was rare and occurred in three patients treated with Jardiance^® (0.1 percent) and none treated with placebo.

“With these new EMPA-REG OUTCOME data, Jardiance is the only SGLT2 inhibitor associated with evidence of slowing the progression of kidney disease in adults with type 2 diabetes and established cardiovascular disease in a cardiovascular outcome study,” said Prof. Hans-Juergen Woerle, Global Vice President Medicine, Boehringer Ingelheim.

About the EMPA-REG OUTCOME^® Trial
EMPA-REG OUTCOME^® was a long-term, multicentre, randomised, double-blind, placebo-controlled trial of more than 7,000 patients from 42 countries with type 2 diabetes and established cardiovascular (CV) disease.¹

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.¹

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.¹

The overall safety profile of Jardiance^® in the EMPA-REG OUTCOME^® trial was consistent with that of previous trials.¹

About Diabetes and Cardiovascular Disease
More than 415 million people worldwide have diabetes, of which 193 million are estimated to be undiagnosed.² By 2040, the number of people with diabetes is expected to rise to 642 million people worldwide.² Type 2 diabetes is the most common form of diabetes, responsible for up to 91 percent of diabetes cases in high-income countries.² Diabetes is a chronic condition that occurs when the body either does not properly produce, or use, the hormone insulin.²

Due to the complications associated with diabetes, such as high blood sugar, high blood pressure and obesity, cardiovascular (CV) disease is a major complication and the leading cause of death associated with diabetes.^3,4 People with diabetes are two to four times more likely to develop CV disease than people without diabetes.³ In 2015, diabetes caused 5 million deaths worldwide,²  with CV disease as the leading cause.³  Approximately 50 percent of deaths in people with type 2 diabetes worldwide are caused by CV disease.^5,6

About Diabetes and Kidney Disease
Kidney disease is much more common in people with diabetes than in those without diabetes, affecting about half of those with type 2 diabetes.⁷ In its final stages, kidney disease can lead to kidney failure, which typically necessitates either dialysis or a kidney transplant. Declining kidney function is associated with a lower than average life expectancy and also increases the risk of other diabetes-related complications such as hypoglycaemia and cardiovascular (CV) disease. Cardiovascular (CV) disease is the number one cause of death in people with type 2 diabetes.^8,9

About Jardiance^®
Jardiance^® (empagliflozin) is an oral, once daily, highly selective sodium glucose co-transporter 2 (SGLT2) inhibitor approved for use in Europe, the United States and other markets around the world for the treatment of adults with type 2 diabetes.

Jardiance^® works by blocking the reabsorption of glucose (blood sugar) by the kidney, leading to urinary glucose excretion, and lowering blood glucose levels in people with type 2 diabetes. SGLT2 inhibition targets glucose directly and works independently of β-cell function and the insulin pathway.

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

Intended audiences
This press release is issued from Boehringer Ingelheim Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where Boehringer Ingelheim and Eli Lilly and Company do business.

Boehringer Ingelheim and Eli Lilly and Company
In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an alliance in diabetes that centres 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.

Boehringer Ingelheim
Boehringer Ingelheim is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, Boehringer Ingelheim operates globally through 145 affiliates and a total of some 47,500 employees. The focus of the family-owned company, founded in 1885, is on researching, developing, manufacturing and marketing new medications of high therapeutic value for human and veterinary medicine.

Social responsibility is an important element of the corporate culture at Boehringer Ingelheim. This includes worldwide involvement in social projects through, for example, the initiative “Making More Health” while also caring for employees. Respect, equal opportunity and reconciling career and family form the foundation of mutual cooperation. The company also focuses on environmental protection and sustainability in everything it does.

In 2015, Boehringer Ingelheim achieved net sales of about 14.8 billion euros. R&D expenditure corresponds to 20.3 per cent of net sales.
For more information please visit www.boehringer-ingelheim.com

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 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 or follow @LillyDiabetes.

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 newsroom.lilly.com/social-channels.

This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about empagliflozin as a treatment for patients with type 2 diabetes along with diet and exercise and reflects Lilly's current belief. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of 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 empagliflozin will receive additional regulatory approvals. For further discussion of these and other risks and uncertainties, see Lilly's most recent Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.

CONTACT:

Dr Ralph Warsinsky
Executive Director Media & PR
Boehringer Ingelheim GmbH
Email: ralph.warsinsky@boehringer-ingelheim.com
Phone: +49 6132 77 7051

Molly McCully
Communications Manager
Lilly Diabetes
Email: mccully_molly@lilly.com
Phone: +1 (317) 478 5423