Type 2 diabetes: CHMP recommends empagliflozin/metformin hydrochloride for approval in the European Union

Ingelheim, Germany and Indianapolis, US, 30 March, 2015 – Boehringer Ingelheim (BI) and Eli Lilly and Company (Lilly) today announced they have received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), recommending approval of a single-pill combination therapy with empagliflozin/metformin hydrochloride (HCl) for the treatment of adults with type 2 diabetes (T2D). If approved, the new therapy will be marketed under the name SYNJARDY^® in Europe.

Empagliflozin/metformin HCl combines within a single tablet the sodium glucose cotransporter 2 (SGLT2) inhibitor, empagliflozin (the active ingredient in Jardiance^® tablets, already approved in the European Union¹) and metformin HCl, which is commonly prescribed for the treatment of T2D. If approved, this will be the second single-pill combination therapy BI and Lilly will offer in Europe through their diabetes alliance.

The CHMP has recommended approval of the single-pill combination therapy for use alongside diet and exercise to improve blood glucose control in adults with T2D when they are:

• Inadequately controlled with metformin alone or in combination with other blood glucose-lowering drugs
• Already being treated with the combination of empagliflozin and metformin as separate tablets

About the Phase III Clinical Trials²
The positive opinion is based on the submission of robust clinical data from seven Phase III clinical trials that enrolled over 4,500 patients with T2D. These studies investigated the efficacy and safety data of empagliflozin plus metformin either alone or in combination with other blood glucose-lowering drugs (pioglitazone, sulfonylurea, DPP-4 inhibitors and insulin).

The results showed that treatment with empagliflozin (10mg and 25mg) when added to metformin, with or without other standard blood glucose-lowering drugs, led to statistically significant reductions in blood glucose, body weight and a clinically relevant reduction in blood pressure.

The most common side effect reported by patients in the clinical trials was hypoglycaemia (low blood glucose) in combination with insulin and/or sulphonylurea. In general, the adverse event profile of empagliflozin plus metformin HCl was in line with the known safety profile of the individual compounds empagliflozin and metformin.

About empagliflozin/metformin hydrochloride (HCl)²
Empagliflozin/metformin HCl is not intended to be used in patients with type 1 diabetes or for diabetic ketoacidosis.

Subject to approval, empagliflozin/metformin HCl is expected to be available in the following twice-daily doses in Europe:

• 5mg empagliflozin plus 850mg or 1000mg metformin HCl
• 12.5mg empagliflozin plus 850mg or 1000mg metformin HCl

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. Depending on geographies, the companies either co-promote or separately promote the respective molecules each contributed to the alliance.

About 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 142 affiliates and a total of more than 47,400 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.

Taking 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 2013, Boehringer Ingelheim achieved net sales of about €14.1 billion. R&D expenditure corresponds to 19.5 percent of its net sales.

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 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 about empagliflozin/metformin HCl for the treatment of type 2 diabetes along with diet and exercise. It reflects Lilly's current beliefs; however, as with any such undertaking, there are substantial risks and uncertainties in the process of drug development and commercialization. There is no guarantee that future study results and patient experience will be consistent with study findings to date, or that empagliflozin/metformin HCl will receive regulatory approvals or be commercially successful. For further discussion of these and other risks and uncertainties, please see Lilly's latest Forms 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.