2014

Lilly to Present Data Across its Diabetes Portfolio at the 49th European Association for the Study of Diabetes Annual Meeting Company to showcase late-stage pipeline, including efficacy, safety and patient-reported health outcomes data for investigational GLP-1 receptor agonist

INDIANAPOLIS, Sept. 17, 2013 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that a total of 31 abstracts will be presented at the 49th European Association for the Study of Diabetes Annual Meeting in Barcelona, September 23-27. In seven presentations, Lilly will share Phase III data for dulaglutide, its investigational GLP-1 receptor agonist, and Phase II data for LY2605541, its investigational novel basal insulin analog.

Seventeen abstracts will be presented by Boehringer Ingelheim on behalf of the Alliance with Lilly.

Lilly will present an additional seven abstracts, including research from its early-stage pipeline. Lilly's pipeline comprises nearly 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.

Following are details on some of the presentations from Lilly's late-stage pipeline.

Dulaglutide Data  
Six dulaglutide abstracts will be presented, including efficacy, safety and health outcomes data from the Phase III programme. One of these abstracts will be given as an oral presentation. Details for the presentations are as follows:

  • Tuesday, 24 September 2013, 10:45-12:15 CEST, Oral Presentation
    • Efficacy and safety of dulaglutide vs metformin in type 2 diabetes (AWARD-3) (Santiago Tofe Povedano) [Presentation 4]

  • Tuesday, 24 September 2013, 13:45-14:45 CEST, General Poster Session
    • Dose-finding results in an adaptive trial of dulaglutide combined with metformin in type 2 diabetes (AWARD-5) (Zachary Skrivanek) [Poster No. 1003] 

  • Thursday, 26 September 2013, 13:45-14:45 CEST, General Poster Session
    • Efficacy and safety of dulaglutide versus placebo and exenatide in type 2 diabetes (AWARD-1) (Carol Wysham) [Poster No. 919]
    • Safety and efficacy of dulaglutide vs sitagliptin after 104 weeks in type 2 diabetes (AWARD-5) (Bruno Guerci) [Poster No. 920]
    • Efficacy and safety of dulaglutide vs sitagliptin after 52 weeks in type 2 diabetes (AWARD-5) (Michael Nauck) [Poster No. 921]
    • Patient-reported outcomes with dulaglutide, exenatide, or placebo (AWARD-1) (Kate Van Brunt) [Poster No. 985]

Novel Basal Insulin Analog (LY2605541) Data 
One Phase II abstract will be presented for LY2605541. Details for the presentation are as follows:

  • Thursday, 26 September 2013, 12:30-13:30 CEST, General Poster Session
    • LY2605541 exhibits a flatter glucodynamic profile than insulin glargine at steady state in subjects with type 1 diabetes (Linda Morrow) [Poster No. 1030]

About Diabetes
Approximately 25.8 million Americans1 and an estimated 371 million people2 worldwide have type 1 and type 2 diabetes. Type 2 diabetes is the most common type, accounting for an estimated 90 to 95 percent of all diabetes cases. Diabetes is a chronic disease that occurs when the body either does not properly produce, or use, the hormone insulin.3

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. National Diabetes Fact Sheet-2011. Available at: http://www.cdc.gov/diabetes/pubs/pdf/ndfs_2011.pdf. Accessed on: February 22, 2012. 
2 International Diabetes Federation. Diabetes Atlas, 5th Edition: Fact Sheet. 2012. 
3 International Diabetes Federation. Diabetes Atlas, 5th Edition: What is Diabetes? http://www.idf.org/diabetesatlas/5e/what-is-diabetes. Accessed on: February 22, 2012.

Refer to: Candace Johnson (for dulaglutide inquiries), +1-317-755-9143, johnson_candace_a@lilly.com  
Tamara Hull (for novel basal insulin inquiries), +1-317-651-9116, hull_tamara@lilly.com

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

SOURCE Eli Lilly and Company



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