New data from Boehringer Ingelheim and Lilly showcase strength of Diabetes Alliance at EASD Annual Meeting

Ingelheim, Germany and Indianapolis, US, 24. September 2012 - Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) will present data for three molecules, including two investigational compounds, from their Diabetes Alliance portfolio at the 48th European Association for the Study of Diabetes (EASD) Annual Meeting in Berlin, 1–5 October 2012. Now in its second year, the Boehringer-Lilly Alliance continues in its commitment to address patient needs arising from the growing global diabetes pandemic. Its portfolio of compounds represents several of the largest product classes for the treatment of diabetes.

New data for linagliptin, the dipeptidyl peptidase-4 (DPP-4) inhibitor approved in the U.S., E.U., Japan and other countries, will be presented at EASD. The Alliance has a robust, combined late-stage development programme in diabetes. Recent data are available for the investigational inhibitor of the sodium glucose co-transporter-2 (SGLT2), empagliflozin* as well as for the investigational novel basal insulin analogue LY2605541*, both of which are in late stage clinical development.

The abstracts to be presented at EASD include safety and efficacy data in various patient populations with T1D and T2D. Highlights of the data are:

• Linagliptin: Results from a large Phase III study evaluating the long-term safety and efficacy of linagliptin or placebo added on to basal insulin in patients inadequately controlled on basal insulin therapy** and three pooled analyses of Phase III data in T2D patient populations will be presented.
• Empagliflozin*: The Alliance will present Phase IIb safety and efficacy data, including effects on HbA1c, blood pressure and weight, for the SGLT2 inhibitor empagliflozin*.
• Novel basal insulin analogue, LY2605541*: Pre-clinical, Phase I and Phase II clinical trial data assessing the effects of the novel basal insulin analogue, LY2605541*, on glycaemic control and other measures in T1D and T2D patients will be presented.

Linagliptin Data
Clinical and pre-clinical abstracts on linagliptin will be presented at the meeting. Details of select presentations are as follows:

• Tuesday 2 October 2012, 10:45 AM - 12:15 PM, Oral Session: 01 Incretin based therapies
  • Long-term safety and efficacy of linagliptin as add-on therapy to basal insulin in patients with type 2 diabetes: a 52-week randomised, placebo controlled trial **
    (Lead Author: H Yki-Järvinen) [Presentation 6]
  • Effects of the DPP-4 inhibitor linagliptin on albuminuria in patients with type 2 diabetes and diabetic nephropathy 
    (Lead Author: P.-H. Groop) [Presentation 36]
• Tuesday 2 October 2012, 12:30 PM - 1:30 PM, General Poster Session: 067 DPP-4 inhibitors I
  • Safety and efficacy of linagliptin plus basal insulin combination therapy in a vulnerable population of elderly patients (aged ≥70 years) with type 2 diabetes**
    (Lead Author: HJ Woerle) [Poster No. 848]
  • Safety and efficacy of linagliptin in elderly patients with type 2 diabetes: evidence from 1331 individuals aged ≥65 years
    (Lead Author: S Patel) [Poster No. 850]
    

Linagliptin (5 mg, once daily) is marketed in Europe as Trajenta® (linagliptin), in the U.S. as Tradjenta™ (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.

Empagliflozin* Data
Pre-clinical and clinical data will be presented on empagliflozin*. Details on this presentation are as follows:

• Thursday 4 October 2012, 12:00 PM - 1:00 PM, General Poster Session 059 SGLT2 IV
  • The sodium glucose cotransporter-2 (SGLT2) inhibitor empagliflozin* lowers blood pressure independent of weight or HbA1c changes (Lead Author: T Hach) [Poster No. 770]

Novel Basal Insulin Analogue, LY2605541* Data
Details of select presentations for LY2605541* are as follows:

• Tuesday 2 October 2012,10:45 AM - 12:15 PM, Oral Session: 04 Insulin action in the liver
  • Novel PEGylated basal insulin LY2605541* has a preferential hepatic effect on glucose metabolism (Lead Author: MC Moore) [Presentation 24]
•   Tuesday 2 October 2012, 3:00 PM - 4:30 PM, General Poster Session: 07 What's new in insulin therapy?
  • LY2605541*: Leveraging hydrodynamic size to develop a novel basal insulin (Lead Author: JM Beals) [Presentation 42]
• Thursday 4 October 2012, 1:15 PM - 2:15 PM, General Poster Session: 078 Psychological aspects I
  • Novel long-acting basal insulin analogue LY2605541* significantly reduces nocturnal hypoglycaemia and fear of hypoglycaemia compared to insulin glargine in patients with type 2 diabetes mellitus (Lead Author: B Curtis) [Poster No. 954]

About Diabetes
An estimated 366 million people worldwide have diabetes.¹ T2D is the most common type, accounting for an estimated 90% of all diabetes cases.² Diabetes is a chronic condition 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 centres 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.

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.