EMPA-REG OUTCOME^®: Top-line renal data to be presented during American Society of Nephrology (ASN) Kidney Week 2015

Ingelheim, Germany, and Indianapolis, US, 6 November, 2015 – Boehringer Ingelheim and Eli Lilly and Company today announced that top-line renal results from the EMPA-REG OUTCOME^® study (compound empagliflozin, marketed under the name Jardiance^®) will be presented during American Society of Nephrology (ASN) Kidney Week 2015 in San Diego.

The data will be presented during the oral abstract session:

High Impact Clinical Trials
Saturday 7 November, 10:30–10:45 a.m. PT, Oral Presentation: Empagliflozin and Cardiovascular Outcomes in Patients with Type 2 Diabetes and Chronic Kidney Disease
(Christoph Wanner)

Kidney disease (nephropathy) is far more common in people with diabetes than in people without diabetes; and diabetes is one of the leading causes of chronic kidney disease.¹

The full renal data set is currently being analysed and comprehensive study results on renal outcomes of patients in EMPA-REG OUTCOME^® are expected to be published in a peer-reviewed journal in due course.

About EMPA-REG OUTCOME^®
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 at high risk for cardiovascular (CV) events.²

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.²

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. Treatment with Jardiance^® also resulted in a 32 percent reduced risk of all-cause mortality and a 35 percent reduced risk of hospitalisation for heart failure.²

The overall safety profile of Jardiance^® was consistent with that of previous trials.

About Jardiance^®
Jardiance^® (empagliflozin) is an oral, once daily, highly selective 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. 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. Depending on geographies, the companies either co-promote or separately promote the respective molecules each contributed to the alliance.

Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, Boehringer Ingelheim operates globally with 146 affiliates and a total of more than 47,700 employees. The focus of the family-owned company, founded in 1885, is 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, such as the initiative “Making more Health” and caring for the employees. Respect, equal opportunities and reconciling career and family form the foundation of the mutual cooperation. In everything it does, the company focuses on environmental protection and sustainability.

In 2014, Boehringer Ingelheim achieved net sales of about 13.3 billion euros. R&D expenditure corresponds to 19.9 per cent of its 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.

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.