Value through Innovation25 October 2014
05 June 2012

Boehringer Ingelheim and Lilly to feature 30 presentations on type 1 and type 2 diabetes at the 72nd American Diabetes Association Scientific Sessions

Alliance to feature research for their investigational novel basal insulin analogue and SGLT-2 inhibitor

Ingelheim, Germany and Indianapolis, US, June 05, 2012 – Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) are pleased to announce that less than two years after forming a strategic alliance aimed at bringing new treatments to patients with diabetes, the companies will present 30 abstracts across three compounds and three classes of medicine at the 72nd American Diabetes Association (ADA) Scientific Sessions in Philadelphia, June 8-12.

Together, the Alliance will present data on a number of topics, including, but not limited to: efficacy and safety data in various populations of patients with diabetes, including patients on monotherapy and add on therapy, patients with comorbidities, patients with type 1 and type 2 diabetes (T1D and T2D), and efficacy and safety data in comparison to other diabetes medications. Highlights of this data, which demonstrates the Alliance's commitment to diabetes, includes:

  • Novel basal insulin*: The Alliance will present  pre-clinical, Phase I and Phase II clinical trial data for their investigational novel basal insulin analogue, LY2605541*. The Phase II data is further defined below.
  • Empagliflozin*: 78-weeks safety and efficacy results for the investigational sodium glucose co-transporter−2 (SGLT−2) inhibitor empagliflozin as monotherapy or add-on to metformin.
  • Linagliptin: Results from a randomised phase III clinical trial  with linagliptin alone or in combination with other diabetes therapies as well as a post-hoc analysis evaluating the clinical effect of the dipeptidyl peptidase-4 (DPP-4) inhibitor linagliptin on albuminuria in adults with T2D and high risk of declining renal function will be presented.
    • Linagliptin (5 mg, once daily) is marketed in the U.S. as Tradjenta™ (linagliptin), in Europe as Trajenta™ (linagliptin), and in other global markets as a once-daily tablet that is used along with diet and exercise either as monotherapy or in combination with other treatments, such as metformin or metformin + sulphonylurea, to improve glycaemic control in adults with T2D. Linagliptin should not be used in patients with T1D or for the treatment of diabetic ketoacidosis (increased ketones in the blood or urine). Linagliptin is a DPP-4 inhibitor that does not require dose adjustments, regardless of declining renal function or hepatic impairment.

Novel Basal Insulin Analog (LY2605541*) Data
Of the 10 abstracts to be presented for LY2605541, four are from two Phase II studies in people with T1D and T2D. These presentations are as follows:

  • Saturday, June 9, 11:30 AM - 1:30 PM, General Poster Session
    • Contrasting Weight Changes with LY2605541*, a Novel Long-Acting Insulin, and Insulin Glargine Despite Similar Improved Glycemic Control in T1D and T2D (Lead Author: S. Jacober) [Poster No. 1023-P]
    • Better Glycaemic Control and Weight Loss with the Novel Long-Acting Basal Insulin LY2605541* Compared with Insulin Glargine in Patients with Type 1 Diabetes (Lead Author: J. Rosenstock) [Poster No. 1026-P]
  • Monday, June 11, 4:30 – 6:30 PM, Oral Session: Insulin Analogs
    • The Novel Long-Acting Insulin LY2605541* Is Superior to Insulin Glargine in Lowering Intra-Day Glucose Variability and Hypoglycemia Event Rate from Continuous Glucose Monitoring (CGM) in Patients with Type 2 Diabetes (Lead Author: R. Bergenstal) [Presentation 346-OR]
    • Reduced Nocturnal Hypoglycemia and Weight Loss with Novel Long-Acting Basal Insulin LY2605541* Compared with Insulin Glargine in Patients with Type 2 Diabetes (Lead Author: R. Bergenstal) [Presentation 347-OR]

Empagliflozin* Data
Among the six abstracts for empagliflozin*, late breaking data from a trial investigating the safety and efficacy of empagliflozin* as monotherapy or in combination with metformin in T2D will be presented. Details on this and additional empagliflozin* presentations are as follows:

  • Saturday, June 9, 11:30 AM - 1:30 PM, General Poster Session
    • The effect of hepatic impairment on the pharmacokinetics, safety and tolerability of empagliflozin*, a potent sodium glucose co-transporter-2 inhibitor (Lead Author: S. Macha) [Poster No. 1067-P]
  • Sunday, June 10, 12:00 PM – 2:00 PM, General Poster Session
    • Safety and efficacy of empagliflozin* as monotherapy or add-on to metformin in a 78-week open-label extension study in patients with type 2 diabetes (Lead Author: HJ Woerle) [Poster No. 49-LB]

Linagliptin Data
A total of 14 clinical and preclinical abstracts regarding linagliptin will be presented at the meeting. Details of select presentations are as follows:

  • Saturday, June 9, 11:30 AM - 13:30 PM, General Poster Session
    • Linagliptin lowers albuminuria on top of recommended standard treatment for diabetic nephropathy (Lead Author: P-H. Groop) [Poster No. 953-P] Also Guided Audio Tour: 13:00 – 14:00, Monday, 11 June
    • Efficacy and safety of linagliptin as add-on therapy to basal insulin in patients with type 2 diabetes (Lead Author: H. Yki-Jarvinen) [Poster No. 999-P]
    • Linagliptin is more effective than glimepiride at achieving a composite outcome of A1C target with no hypoglycemia and no weight gain over 2 years in mildly hyperglycaemic type 2 diabetes patients on metformin (Lead Author: B. Gallwitz) [Poster No. 1044-P]


About Diabetes
An estimated 366 million people worldwide have T1D and T2D.1 T2D is the most common type, accounting for an estimated 90 to 95% of all diabetes cases.2 Diabetes is a chronic disease that occurs when the body either does not properly produce, or use, the hormone insulin.3

Boehringer Ingelheim and Eli Lilly and Company
In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an alliance in the field of diabetes that centers on four pipeline compounds representing several of the largest treatment classes. This alliance leverages the companies' strengths as two of the world's leading pharmaceutical companies, combining Boehringer Ingelheim's solid track record of research-driven innovation and Lilly's innovative research, experience, and pioneering history in diabetes. 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
The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 145 affiliates and more than 44,000 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.

As a central element of its culture, Boehringer Ingelheim pledges to act socially responsible. 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 2011, Boehringer Ingelheim achieved net sales of about 13.2 billion euro. R&D expenditure in the business area Prescription Medicines corresponds to 23.5% of its net sales.

For more information please visit www.boehringer-ingelheim.com

About Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organisations. Headquartered in Indianapolis, IN, Lilly provides answers – through medicines and information – for some of the world's most urgent medical needs. Additional information about Lilly is available at www.lilly.com.

About Lilly Diabetes
Lilly has been a global leader in diabetes care since 1923, when Lilly introduced the world's first commercial insulin. Today Lilly work to meet the diverse needs of people with diabetes through research and collaboration, a broad and growing product portfolio and a continued commitment to providing real solutions - from medicines to support programs and more - to make lives better.

For more information, visit www.lillydiabetes.com.

This press release contains forward-looking statements about linagliptin tablets for the treatment of type 2 diabetes and two investigational compounds, empagliflozin* and novel basal insulin LY2605541*, which are currently in development for the treatment of 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 commercialisation. There is no guarantee that future study results and patient experience will be consistent with study findings to date, that empagliflozin* and novel basal insulin LY2605541* will receive required regulatory approvals,or that linagliptin 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
1International Diabetes Federation. IDF Diabetes Atlas, 5th Edition: The Global Burden. 2011. http://www.idf.org/diabetesatlas/5e/the-global-burden. Accessed on: April 11, 2012.
2Centers for Disease Control and Prevention.Prevention. National diabetes fact sheet:
national estimates and general information on diabetes and prediabetes in the
United States, 2011. Atlanta, GA: U.S. Department of Health and Human. Services, Centers for Disease Control and Prevention, 2011.
3International Diabetes Federation. IDF Diabetes Atlas, 5th Edition: What is Diabetes? http://www.idf.org/diabetesatlas/5e/what-is-diabetes. Accessed on: April 11, 2012.

*Novel basal insulin LY2605541 and empagliflozin are investigational compounds. Their safety and efficacy have not yet been fully established.

Media contact

  • Ute Schmidt
    Boehringer Ingelheim

    Media & PR
    Ute E. Schmidt
    Binger Strasse 173
    55216 Ingelheim am Rhein
    GERMANY

Media contact

  • Eli Lilly and Company

    Communications Manager
    Lilly Diabetes
    Tammy Hull

    • Phone +1 (317) 651-9116

Media contact

  • Ute Schmidt
    Boehringer Ingelheim

    Media & PR
    Ute E. Schmidt
    Binger Strasse 173
    55216 Ingelheim am Rhein
    GERMANY

Media contact

  • Eli Lilly and Company

    Communications Manager
    Lilly Diabetes
    Tammy Hull

    • Phone +1 (317) 651-9116