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European Commission (EC) Approves Boehringer Ingelheim Corporation-Eli Lilly and Company (LLY)'s Jardiance® Tablets



5/23/2014 6:32:47 AM

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Type 2 diabetes: European Commission approves Jardiance® (empagliflozin) tablets for use in adults in Europe

RIDGEFIELD, Conn.
and INDIANAPOLIS, May 23, 2014 /PRNewswire/ -- The European Commission granted marketing authorization for Jardiance® (empagliflozin) tablets, a sodium glucose co-transporter 2 (SGLT2) inhibitor, for the treatment of type 2 diabetes mellitus (T2D) to improve glycemic control in adults in Europe, Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company (NYSE: LLY) announced.1

The European Commission approved JARDIANCE 10 and 25 mg once daily tablets for use when diet and exercise alone do not provide adequate glycemic control. JARDIANCE may be used alone when metformin is not considered appropriate due to intolerance, or alongside other glucose-lowering medicines including insulin, when glucose control is inadequate.

JARDIANCE is a member of the sodium glucose co-transporter-2 (SGLT2) inhibitor class of compounds. The emerging SGLT2 inhibitor class removes excess glucose through the urine by blocking glucose re-absorption in the kidney.

"In Europe, the number of people with type 2 diabetes is growing and management of the condition increasingly requires a holistic approach for individuals and their needs," said Professor Klaus Dugi, chief medical officer, Boehringer Ingelheim. "We aim to bring the very latest therapy options to people living with type 2 diabetes and are delighted empagliflozin will become available in Europe."

The marketing authorization is based on results from a clinical program comprised of more than 10 multinational clinical trials and more than 13,000 adults with T2D. Phase III studies showed JARDIANCE 10 and 25 mg significantly reduced hemoglobin A1c (A1c, or average blood glucose) as well as body weight and blood pressure as a stand-alone treatment or in combination with a range of background treatments, including metformin, sulfonylureas, insulin and pioglitazone.1 The most frequently reported adverse reaction was hypoglycemia when used with sulfonylurea or insulin.1 Common side effects experienced with JARDIANCE were genital infection, urinary tract infection, pruritus and increased urination. Genital infection and urinary tract infection were more common in women than men.1 JARDIANCE is not indicated for weight loss or as antihypertensive therapy. Weight loss and blood pressure change were secondary or exploratory endpoints in clinical trials.

"The approval of empagliflozin marks the third diabetes product from the Boehringer Ingelheim and Lilly Diabetes alliance to be approved in Europe," said Enrique Conterno, president of Lilly Diabetes. "We are proud to continue with our commitment in supporting the varied treatment needs of people living with type 2 diabetes."

About Diabetes
Approximately 24.4 million Americans and an estimated 382 million people worldwide have type 1 or type 2 diabetes. T2D is the most common type, accounting for an estimated 85 to 95 percent of all diabetes cases. Diabetes is a chronic condition that occurs when the body either does not properly produce, or use, the hormone insulin. 2

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.

About Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.

The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 142 affiliates and more than 47,400 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine.

Social responsibility is a central element of Boehringer Ingelheim's culture. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim's endeavors.

In 2013, Boehringer Ingelheim achieved net sales of about $18.7 billion (14.1 billion euro). R&D expenditure in the Prescription Medicines business corresponds to 19.5% of its net sales.

For more information please visit http://www.us.boehringer-ingelheim.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 http://newsroom.lilly.com/social-channels.

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 solutionsfrom medicines to support programs and morewe strive to make life better for all those affected by diabetes around the world. For more information, visit www.lillydiabetes.com.

This press release contains forward-looking statements about empagliflozin, an investigational compound that is being studied for type 2 diabetes. 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 will receive regulatory approvals or prove to 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.

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CONTACT:

Shirley Johnson
Public Relations
Boehringer Ingelheim Pharmaceuticals, Inc.
Email: shirley.johnson@boehringer-ingelheim.com
Phone: (203) 448-1893
Cell: (203) 321-6537

Tammy Hull
Communications Manager
Lilly Diabetes
Email: hullta@lilly.com
Phone: (317) 651-9116
Cell: (317) 614-5132

References

1 Jardiance® (empagliflozin) tablets. EMA Summary of Product Characteristics. Approval May 2014.
2 International Diabetes Federation. Diabetes Atlas, 6th Edition. 2013. (http://www.idf.org/diabetesatlas). Accessed April 23, 2014.

Eli Lilly and Company logo.

Boehringer Ingelheim logo.

Logo - http://photos.prnewswire.com/prnh/20031219/LLYLOGO
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SOURCE Eli Lilly and Company; Boehringer Ingelheim



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