Type 2 diabetes: Synjardy^® (empagliflozin/metformin hydrochloride) approved in the European Union

Ingelheim, Germany and Indianapolis, US, 28 May, 2015 – Synjardy^® has been granted marketing authorisation by the European Commission for the treatment of adults with type 2 diabetes (T2D) in the European Union (EU). Synjardy^® is a new single-pill combination therapy from the Boehringer Ingelheim and Eli Lilly and Company diabetes alliance.

Synjardy^® combines empagliflozin, a sodium glucose cotransporter 2 (SGLT2) inhibitor, and metformin hydrochloride (HCl), commonly prescribed for the treatment of T2D. Empagliflozin was approved in the EU in May 2014 and is available in many countries as an oral, once-daily tablet, marketed
as Jardiance^®.¹

Synjardy^® is indicated for use alongside diet and exercise to improve blood glucose control in adults with T2D when they are:²

• Inadequately controlled on their maximally tolerated dose of metformin alone
• Inadequately controlled with metformin in combination with other glucose-lowering medicinal products, including insulin
• Already being treated with the combination of empagliflozin and metformin as separate tablets

“A single medicine is often not sufficient for patients to maintain blood glucose control in the long term, resulting in the need for combinations of blood glucose-lowering drugs,” said Professor Klaus Dugi, Chief Medical Officer, Boehringer Ingelheim. “We are delighted to offer this single-pill combination of two agents with different mechanisms. Synjardy^® may help adults with T2D achieve their blood glucose targets with the added benefit of a convenient treatment regimen.”

The marketing authorisation follows the positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency in March 2015.

About the Phase III Clinical Trials²

The marketing authorisation is based on the submission of robust clinical data from seven Phase III clinical trials evaluating the safety and efficacy of empagliflozin as add-on to metformin either alone or in combination with other blood glucose-lowering drugs (pioglitazone, sulphonylurea, DPP-4 inhibitors and insulin). More than 7,000 patients with T2D participated, of which over 4,700 were treated with empagliflozin as add-on to metformin.

The results showed that treatment with empagliflozin (10mg and 25mg) when added to metformin, with or without other blood glucose-lowering drugs, led to clinically relevant reductions in blood glucose, body weight and blood pressure compared to placebo as add-on to metformin.

The most common side effect reported by patients in the clinical trials was hypoglycaemia (low blood glucose) when empagliflozin and metformin were used in combination with insulin and/or sulphonylurea. In general, the adverse event profile of empagliflozin as add on to metformin was consistent with the known safety profile of the individual compounds empagliflozin and metformin.

The common side effects experienced with empagliflozin are urinary tract and genital infections, increased urination and itching. The common side effects experienced with metformin are gastrointestinal symptoms such as nausea, vomiting, diarrhoea, abdominal pain and loss of appetite as well as taste disturbance.

About empagliflozin/metformin hydrochloride (HCl)²
Empagliflozin/metformin HCl should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. For further information on contraindications, warnings and precautions for use please refer to the summary of product characteristics.

Empagliflozin/metformin HCl will be made available in the following twice-daily doses in the EU:

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

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 percent 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 about SYNJARDY^®. 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 SYNJARDY^® will be commercially successful, or that it will receive additional regulatory approvals. 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. Except as required by law, Lilly undertakes no duty to update forward-looking statements.