Type 2 Diabetes: European Commission approves Jardiance® (empagliflozin)

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• Empagliflozin once daily tablets approved in EU for adults with Type 2 Diabetes
• Third approved product from the Boehringer Ingelheim and Lilly Diabetes alliance

For Non-U.S. and Non-U.K. Media

Ingelheim, Germany and Indianapolis, US, 23 May 2014 - The European Commission has granted Marketing Authorisation for empagliflozin, a sodium glucose cotransporter 2 (SGLT2) inhibitor from Boehringer Ingelheim and Eli Lilly and Company. Empagliflozin has been approved for the treatment of Type 2 Diabetes (T2D) to improve glycaemic control in adults and will be marketed in Europe as Jardiance®.

The European Commission approved empagliflozin 10 and 25 mg once daily tablets for use when diet and exercise alone do not provide adequate glycaemic control:

  • alone when metformin is not considered appropriate due to intolerance
  • alongside other glucose-lowering medicines including insulin when glucose control is inadequate.1

Professor Klaus Dugi, Chief Medical Officer, Boehringer Ingelheim

Professor Klaus Dugi, Chief Medical Officer, Boehringer Ingelheim

"In Europe, the number of people with Type 2 Diabetes is growing and management of the condition increasingly requires a holistic approach to 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 Phase III clinical trial programme that supported empagliflozin’s Marketing Authorisation enrolled over 13,000 patients. Results from the programme showed empagliflozin 10 and 25 mg provided a significant reduction in blood sugar from baseline values. Both empagliflozin groups also demonstrated clinically relevant reductions from baseline values in body weight and blood pressure.1 When used as monotherapy, most adults did not experience side effects such as weight gain, low blood sugar and gastrointestinal issues.2 Common side effects experienced with empagliflozin were genital infection, urinary tract infection and increased urination. Genital infection and urinary tract infection were more common in women than men.3

"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 Empagliflozin
Empagliflozin, marketed in Europe as Jardiance® is an oral, once daily tablet for the treatment of adults with Type 2 Diabetes and is part of the SGLT2 inhibitor class. SGLT2 are proteins fundamental to the kidney’s role in filtering blood sugar and are responsible for about 90 percent of the reabsorption of glucose back into the bloodstream.4 In people with T2D, there is an overexpression of SGLT2, contributing to elevated blood glucose levels.5 Empagliflozin reduces the kidneys’ ability to reabsorb glucose into the bloodstream, leading to urinary glucose excretion. Unlike most classes of existing oral T2D treatments, SGLT2 inhibitors like empagliflozin work independently of β-cell function and insulin pathway.

Boehringer Ingelheim and Eli Lilly and Company
In January 2011, Boehringer Ingelheim and Eli Lilly and Company entered into 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.

Jardiance®

Jardiance®

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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% 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 http://newsroom.lilly.com/social-channels.

This press release contains forward-looking statements about empagliflozin for the treatment of 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 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.

References

1. Jardiance® (empagliflozin) tablets. EMA Summary of Product Characteristics. Approval 22 May 2014.
2. Hach T, et al. Empagliflozin improves glycaemic parameters and cardiovascular risk factors in patients with Type 2 Diabetes mellitus (T2DM): Pooled data from four pivotal Phase III studies. Poster 943 on 23-27 September 2014 at the European Association for the Study of Diabetes (EASD) 2013, Barcelona, Spain.
3. Kim G, et al. Urinary tract infections (UTIs) and genital infections: Pooled data from four empagliflozin (EMPA) pivotal Phase III trials Poster 74-LB on 21–25 June 2013 at the 73rd Scientific Sessions of the American Diabetes Association (ADA) 2013, Chicago, USA.
4. Bays H. From victim to ally: the kidney as an emerging target for the treatment of diabetes mellitus. Curr Med Res Opin. 2009;25(3):671-81.
5. Poudel RR. Renal glucose handling in diabetes and sodium glucose cotransporter 2 inhibition. Indian J Endocrinol Metab. 2013;17(4):588-93.

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