Lilly to Highlight Late-Stage Pipeline Molecules at the 73rd American Diabetes Association Scientific Sessions®

Company to showcase data for investigational GLP-1 receptor agonist and investigational novel basal insulin analog

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Jun 11, 2013, 09:00 ET

INDIANAPOLIS, June 11, 2013 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced it will present 13 abstracts on two late-stage investigational medicines from its diabetes pipeline at the 73^rd American Diabetes Association Scientific Sessions^® in Chicago June 21-25.

Lilly will share information including, but not limited to, efficacy and safety data for investigational compounds from two different classes of diabetes medicines. This research, which demonstrates the company's commitment to the everyday needs of people with diabetes, includes:

Dulaglutide: The company will disclose efficacy and safety results, as well as health outcomes findings, from three Phase III clinical trials for its investigational, long-acting glucagon-like peptide-1 (GLP-1) receptor agonist, dulaglutide.
Novel Basal Insulin: Additional analyses of Phase II data for patients with type 1 and type 2 diabetes will be presented for LY2605541, an investigational novel basal insulin analog.

These data are among the 71 presentations representing Lilly's research – thirty-four of which will be presented by Boehringer Ingelheim on behalf of the Boehringer Ingelheim-Lilly Diabetes alliance.

Lilly's pipeline comprises more than a dozen potential new medicines for the treatment of diabetes and its related conditions, encompassing both large and small molecules, and targeting a variety of mechanisms.

Dulaglutide Data

A total of seven dulaglutide abstracts will be presented at the meeting, three of which will be given as oral presentations. These presentations are as follows:

Saturday, June 22, 8 – 10 a.m. CDT, GLP-1 Agonists in Practice
- Efficacy and safety of dulaglutide vs. placebo and exenatide in type 2 diabetes (AWARD-1) (Lead author: C. Wysham) [Presentation 66-OR]
- Efficacy and safety of dulaglutide vs. metformin in type 2 diabetes (AWARD-3) (Lead author: G.E. Umpierrez) [Presentation 69-OR]
- Efficacy and safety of dulaglutide vs. sitagliptin after 52 weeks in type 2 diabetes (AWARD-5) (Lead author: M.A. Nauck) [Presentation 71-OR]

Novel Basal Insulin Analog (LY2605541) Data

The six abstracts to be presented for LY2605541 include additional analyses of data from Phase II clinical trials in people with type 1 and type 2 diabetes. Details for the presentations are as follows:

Saturday, June 22, 11:30 a.m. – 1:30 p.m. CDT, General Poster Session
- Basal insulin LY2605541 has hepato-preferential action across a range of delivery rates (Lead author: M.C. Moore) [Poster No. 912-P]
- Effects of a novel basal insulin, LY2605541, on hepatic glucose output and muscle glucose uptake: a physiologic based simulation analysis (Lead author B.G. Topp) [Poster No. 913-P]
- Improved glycemic control despite reductions in bolus insulin doses with basal insulin LY2605541 compared with basal insulin glargine in patients with type 1 diabetes (Lead author: J. Rosenstock) [Poster No. 915-P]
- LY2605541 (LY) exhibits a flatter glucodynamic profile than insulin glargine (GL) at steady state in subjects with type 1 diabetes (T1D) (Lead author: L.A. Morrow) [Poster No. 917-P]
- A clinical utility index for selecting an optimal insulin dosing algorithm for LY2605541 (Lead author D.H. Manner) [Poster No. 931-P]
Presentations 915-P and 917-P will also be featured in a guided audio poster tour on June 24, noon – 1 p.m. CDT, titled "Novel Agents for Diabetes Treatment."
Presentations 912-P and 913-P will also be featured in a guided audio poster tour on June 24, 1 – 2 p.m. CDT, titled "New Insulin Therapeutics."

Sunday, June 23, 12 – 2 p.m. CDT, General Poster Session
- Negative binomial regression analysis of hypoglycemia data from diabetes clinical trials: the effect of adjusting for baseline hypoglycemia rates (Lead author: J. Luo) [Poster No. 401-P]; these data will also be featured in a guided audio poster tour on June 24, 1 – 2 p.m. CDT, titled "Hypoglycemia–The Barrier."

About Diabetes

Approximately 25.8 million Americans[1] and an estimated 371 million people worldwide[2] have type 1 or type 2 diabetes. Type 2 diabetes is the most common type, and can account for more than 95 percent of all diabetes cases in some countries.[3] Diabetes is a chronic condition that occurs when the body either does not properly produce, or use, the hormone insulin.[4] Diabetes was estimated to cost the U.S. $245 billion in direct medical costs and reduced productivity in 2012.[5]

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 work to meet the diverse needs of people with diabetes through research and collaboration, a broad and growing product portfolio and our continued commitment to providing real solutions — from medicines to support programs and more — to make lives better. For more information, visit www.lillydiabetes.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 organizations. 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.

P-LLY

This press release contains forward-looking statements about two investigational compounds, dulaglutide 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 commercialization. There is no guarantee that future study results and patient experience will be consistent with study findings to date or that dulaglutide and/or novel basal insulin LY2605541 will receive required 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.

[1] Centers for Disease Control and 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. http://www.cdc.gov/diabetes/pubs/pdf/ndfs_2011.pdf. Accessed on: April 2, 2013.

[2] International Diabetes Federation. 2012 Update Poster. IDF Diabetes Atlas. 2012 (5th Edition). http://www.idf.org/sites/default/files/5E_IDFAtlasPoster_2012_EN.pdf. Accessed on: April 2, 2013.

[3] International Diabetes Federation. The Global Burden: Diabetes. IDF Diabetes Atlas. 2011. http://www.idf.org/diabetesatlas/5e/diabetes#footnote-1. Accessed on: April 3, 2013.

[4] International Diabetes Federation. What is Diabetes? IDF Diabetes Atlas. 2011 (5th Edition). http://www.idf.org/diabetesatlas/5e/what-is-diabetes. Accessed on: April 2, 2013.

[5] American Diabetes Association. Economic costs of diabetes in the U.S. in 2012. Diabetes Care. March 6, 2013 [Epub ahead of print].

(Logo: http://photos.prnewswire.com/prnh/20031219/LLYLOGO)

Refer to: Candace Johnson (for dulaglutide inquiries), +1-317-755-9143, [email protected]

Tamara Hull (for novel basal insulin inquiries), +1-317-651-9116, [email protected]

SOURCE Eli Lilly and Company