Lilly to Present New Clinical Data from Diabetes Portfolio with 76 Abstracts at the 74th American Diabetes Association Scientific Sessions® Company to highlight late-stage pipeline molecules, including once-weekly dulaglutide and basal insulin peglispro

INDIANAPOLIS, June 9, 2014 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced 76 abstracts to be presented June 13-17 at the 74th American Diabetes Association Scientific Sessions® in San Francisco, highlighting the company's long-standing commitment to advancing scientific knowledge in the field of diabetes management. Forty-three of these abstracts will be presented as part of the Boehringer Ingelheim-Lilly Diabetes Alliance.

"These Scientific Sessions provide an important opportunity for both Lilly and our Alliance to share new data from our broad diabetes portfolio, including data on investigational treatments from our pipeline," said Gwen Krivi, Ph.D., vice president, Lilly Diabetes product development. "Lilly's commitment to serving the diverse needs of people with diabetes will be on full display next week in San Francisco." 

Lilly's pipeline consists of nearly a dozen potential medicines for the treatment of diabetes and its related conditions, including both large and small molecules and targeting a variety of mechanisms.

Among the data being presented at this year's Scientific Sessions are:

Dulaglutide Data 
Lilly is pleased to share new data for once-weekly dulaglutide, an investigational long-acting glucagon-like peptide-1 (GLP-1) receptor agonist being studied for the treatment of type 2 diabetes. Seven abstracts, including two late-breaking posters, will be presented:

  • Saturday, June 14, 11:30 a.m.1:30 p.m. PT, General Poster Session
    • Better Glycemic Control and Less Weight Gain with Once-Weekly Dulaglutide vs. Once-Daily Insulin Glargine, Both Combined with Premeal Insulin Lispro, in Type 2 Diabetes Patients (AWARD-4) (Lead author: J. Jendle) [Poster No. 962-P]
    • Patient-reported Outcomes with Once-Weekly Dulaglutide vs. Insulin Glargine (AWARD-2) (Lead author: M. Reaney) [Poster No. 979-P]
    • Pharmacokinetics of Once-Weekly Dulaglutide in Special Populations (Lead author: C. Loghin) [Poster No. 980-P]
    • Pharmacokinetics of Once-Weekly Dulaglutide in Patients with Type 2 Diabetes Mellitus (Lead author: A. de la Pena) [Poster No. 981-P]

Presentation 962-P will also be featured in a guided audio poster tour on June 15, noon – 12:50 p.m. PT, titled "GLP-1 Receptor Agonists."

  • Sunday, June 15, 12:00 – 2:00 p.m. PT, General Poster Session
    • Efficacy and Safety of Once-Weekly Dulaglutide Versus Once Daily Liraglutide in Type 2 Diabetes (AWARD-6) (Lead author: KM. Dungan) [Poster No.110-LB]
    • Safe and Effective Use of the Single-Use Pen (SUP) Intended for Injection of Dulaglutide in Injection-Naive Patients with Type 2 Diabetes (Lead author: G. Matfin) [Poster No. 122-LB] 

  • Monday, June 16, 3:15 p.m.3:30 p.m. PT, Oral Presentation: GLP-1 Agonists
    • Efficacy and Safety of Once-Weekly Dulaglutide vs. Insulin Glargine in Combination with Metformin and Glimepiride in Type 2 Diabetes Patients (AWARD-2) (Lead author: F. Giorgino) [Presentation 330-OR]

Basal Insulin Peglispro Data 
Lilly will also present six abstracts with pre-clinical and clinical data for its investigational basal insulin peglispro (BIL; previously LY2605541). Details for the presentations are as follows:

  • Saturday, June 14, 11:30 a.m.1:30 p.m. PST, General Poster Session
    • Basal Insulin Peglispro Demonstrates Preferential Hepatic versus Peripheral Action Relative to Insulin Glargine in Healthy Subjects (Lead author: RR. Henry) [Poster No.886-P]
    • Effect of Injection Site on the Pharmacokinetics (PK) and Glucodynamics (GD) of Single Subcutaneous (SC) Doses of Basal Insulin Peglispro in Healthy Subjects (Lead author: H. Linnenbjerg) [Poster No. 893-P]
    • Comprehensive Electronic Data Capture of Diabetes Management Information in a Diverse Population Across 25 Countries (Lead author: A.M. Chang) [Poster No. 897-P]
    • Pharmacokinetics and Elimination of Basal Insulin Peglispro (BIL) in Rats Following a Single Intravenous or Subcutaneous Dose (Lead author: M.P. Knadler) [Poster No. 899-P]
    • Internalization and Localization of Long-Acting Basal Insulin Peglispro (BIL) and Insulin Receptor in Cells (Lead author J.S. Moyers) [Poster No. 900-P]
    • Electronic Data Capture in Insulin Management for Patients (pts) with Type 1 (T1DM) and Type 2 (T2DM) Diabetes Mellitus in Global Clinical Trials (Lead author: E.J. Bastyr III) [Poster No. 913-P]

Presentation 886-P will also be featured in a guided audio poster tour on June 14 (12:30 – 1:20 p.m. PDT), titled "Insulin Therapeutic Tactics," and presentation 893-P will be featured in a guided audio poster tour on June 16 (1– 1:50 p.m. PDT) titled "Pharmacokinetic / Pharmacodynamic Insulin Studies."

About Diabetes
Approximately 24.4 million Americans and an estimated 382 million people 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.[1]

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.

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] International Diabetes Federation. IDF Diabetes Atlas, 6th edn. Brussels, Belgium: International Diabetes Federation, 2013. http://www.idf.org/diabetesatlas.

Refer to:
Candace Johnson (for dulaglutide inquiries), +1-317-755-9143, johnson_candace_a@lilly.com  
Molly McCully (for basal insulin peglispro inquiries), +1-317-478-5423, mccully_molly@lilly.com   

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SOURCE Eli Lilly and Company



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