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Boehringer Ingelheim and Eli Lilly and Company Alliance to Feature 34 Presentations on Type 1 and Type 2 Diabetes at the 73rd American Diabetes Association Scientific Sessions®

June 11, 2013

Alliance to feature research data for linagliptin and the investigational compound empagliflozin*

RIDGEFIELD, Conn. and INDIANAPOLIS, June 11, 2013 /PRNewswire/ — Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company (NYSE: LLY) are pleased to announce that the companies’ diabetes alliance will have a strong scientific and clinical presence at the 73rd American Diabetes Association (ADA) Scientific Sessions(®) in Chicago, June 21-25, with 34 posters, abstracts and an oral presentation.

Empagliflozin* Data
A total of 17 clinical and pre-clinical abstracts for the investigational agent empagliflozin will be presented, including three late-breaker abstracts. Empagliflozin is a member of the sodium glucose co-transporter 2 (SGLT2) inhibitor class of compounds and is being investigated for the reduction of blood glucose levels in adults with T2D. The emerging SGLT2 inhibitor class removes excess glucose through the urine by blocking glucose re-absorption by the kidney.

Details of clinical empagliflozin presentations and published abstracts are as follows:

  • Saturday, June 22, 11:30 a.m. – 1:30 p.m., General Poster Session[1]

    • Sodium Glucose Cotransport-2 Inhibition With Empagliflozin Attenuates Renal Hyperfiltration in Patients with Type 1 Diabetes (Presenting Author: D. Cherney) [Poster No. 1196-P]
  • Sunday, June 23, Noon – 2 p.m., General Poster Session[1]

    • Empagliflozin Improves Glycemic Parameters and Cardiovascular Risk Factors in Patients with Type 2 Diabetes (T2DM): Pooled Data from Four Pivotal Phase III Trials (Presenting Author: T. Hach) [Late-breaking poster - Poster No. 69-LB]
    • Metabolic Response to Sodium-Glucose Transporter 2 (SGLT2) Inhibition with Empagliflozin in Patients with Type 2 Diabetes (T2D) (Presenting Author: E. Ferrannini) [Late-breaking poster - Poster No. 71-LB]
    • Empagliflozin (EMPA) Increases Genital Infections but Not Urinary Tract Infections (UTIs) in Pooled Data from Four Pivotal Phase III Trials (Presenting Author: G. Kim) [Late-breaking poster - Poster No. 74-LB]
    • The Sodium Glucose Co-Transporter-2 (SGLT2) Inhibitor Empagliflozin Improves Glycemic Control in Patients with Type 1 Diabetes: A Single-Arm Clinical Trial (Presenting Author: B. Perkins) [Poster No. 1074-P]
    • Empagliflozin as Add-On to Metformin Plus Sulfonylurea (SU) for 24 Weeks Improves Glycemic Control in Patients with Type 2 Diabetes (T2DM) (Presenting Author: H. Haring) [Poster No. 1082-P]
    • Empagliflozin Monotherapy Improves Glucose Control in Drug-Naive Patients with Type 2 Diabetes (T2DM) (Presenting Author: M. Roden) [Poster No. 1085-P]
    • Empagliflozin as Add-On to Metformin for 24 Weeks Improves Glycemic Control in Patients with Type 2 Diabetes (T2DM) (Lead Author: L. Merker) [Poster No. 1092-P]
    • Empagliflozin as Add-On to Basal Insulin for 78 Weeks Improves Glycemic Control with Weight Loss in Insulin-Treated Type 2 Diabetes (T2DM) (Presenting Author: J. Rosenstock) [Poster No. 1102-P]
    • Empagliflozin in Patients with Type 2 Diabetes Mellitus (T2DM) and Renal Impairment (RI) (Presenting Author: H. Rattunde) [Poster No. 1104-P]
    • Empagliflozin as Add-On to Pioglitazone With or Without Metformin Improves Glycemic Control in Patients with Type 2 Diabetes (T2DM) (Presenting Author: C. Kovacs) [Poster No. 1120-P]
    • Empagliflozin Monotherapy for 12 Weeks Improves Glycemic Control in Japanese Patients with Type 2 Diabetes (T2DM) (Presenting Author: M. Haneda) [Poster No. 1144-P]
  • Publication Only

    • Design of the Empagliflozin Cardiovascular (CV) Outcome Event Trial in Type 2 Diabetes (T2D) (Published Author: B. Zinman) [Poster No. 2349-PO]

Linagliptin Data
A total of 17 clinical and pre-clinical abstracts regarding linagliptin will also be presented, including two late-breaker abstracts. Linagliptin is an inhibitor of DPP-4, which breaks down the incretin hormones glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) that are involved with regulating blood sugar.[2]

Details of all clinical presentations and published abstracts are as follows:[3]

  • Tuesday, June 25, 8 a.m. – 10 a.m., Oral Presentation – New Information on DPP-4 Inhibition

    • CV safety of linagliptin in patients with type 2 diabetes: a pooled comprehensive analysis of prospectively adjudicated CV events in phase 3 studies (Lead Author: O.E. Johansen) [Oral No: 376-OR] (Pooled data)
  • Sunday, June 23, Noon – 2 p.m., General Poster Session

    • Lower risk of hypoglycemia in elderly type 2 diabetes patients when linagliptin is added to basal insulin: an exploratory analysis (Presenting Author: M. von Eynatten) [Late-breaking poster - Poster No. 2-LB]
    • Regardless of the degree of glycemic control, linagliptin (LINA) has lower hypoglycemia risk than all doses of glimepiride (GLIM) at all time points over a 2-year trial (Presenting Author: B. Gallwitz) [Late-breaking poster - Poster No. 68-LB]
    • Linagliptin vs. placebo followed by glimepiride in type 2 diabetes patients with moderate to severe renal impairment (Presenting Author: S. Patel) [Poster No. 1090-P]
    • Linagliptin improved glycemic control without weight gain or hypoglycemia in patients with type 2 diabetes inadequately controlled by a combination of metformin and pioglitazone (Presenting Author: M. Bajaj) [Poster No. 1093-P]
    • The dipeptidyl peptidase (DPP)-4 inhibitor linagliptin improves beta cell function and postprandial glucose in patients with type 2 diabetes (Presenting Author: M. Larbig) [Poster No. 1138-P]
    • Efficacy and safety of linagliptin monotherapy in Asian patients with inadequately controlled type 2 diabetes mellitus: a 24-week, randomized, Phase III clinical trial (Presenting Author: Y. Chen) [Poster No. 1159-P]
    • Efficacy and safety of linagliptin in Asian patients with type 2 diabetes mellitus inadequately controlled on metformin: a 24-week, randomized, Phase III clinical trial (Presenting Author: W. Wang) [Poster No. 1177-P]
  • Publication Only

    • Baseline characteristics of patients enrolled in the cardiovascular outcome study of linagliptin versus glimepiride in patients with type 2 diabetes (CAROLINA) (Published Author: N. Marx) [Abstract book for the American Diabetes Association (ADA) 73rd Scientific Sessions]

Linagliptin, which is marketed as Tradjenta® (linagliptin) tablets in the U.S., is a once-daily 5mg tablet used along with diet and exercise to improve glycemic control in adults with type 2 diabetes. Linagliptin should not be used in patients with type 1 diabetes 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.

What are TRADJENTA (linagliptin) tablets?
TRADJENTA is a prescription medicine that is used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.

TRADJENTA is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).

Important Safety Information

Who should not take TRADJENTA?
Do not take TRADJENTA if you are allergic to linagliptin or any of the ingredients in TRADJENTA.

Symptoms of a serious allergic reaction to TRADJENTA are rash, raised red patches on your skin (hives), swelling of your face, lips, and throat that may cause difficulty breathing or swallowing. If you have any symptoms of a serious allergic reaction, stop taking TRADJENTA and call your doctor right away.

What should I tell my doctor before taking TRADJENTA?
Tell your doctor if you take other medicines that can lower your blood sugar, such as a sulfonylurea or insulin.

TRADJENTA may cause serious side effects, including low blood sugar (hypoglycemia). If you take TRADJENTA with another medicine that can cause low blood sugar, such as sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea or insulin may need to be lowered while you take TRADJENTA.

Signs and symptoms of low blood sugar may include headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heartbeat, sweating, or feeling jittery.

Also tell your doctor if you take rifampin (Rifadin®, Rimactane®, Rifater®, Rifamate®), an antibiotic that is used to treat tuberculosis.

TRADJENTA may affect the way other medicines work, and other medicines may affect how TRADJENTA works.

Tell your doctor if you are pregnant or planning to become pregnant or are breastfeeding or plan to breastfeed.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

What are the possible side effects of TRADJENTA?
The most common side effects of TRADJENTA include stuffy or runny nose and sore throat.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For more safety information, please see Patient Information and full Prescribing Information

TJ CONS ISI August 14 2012

To learn more about TRADJENTA visit: www.TRADJENTA.com. For full prescribing information visit: http://bidocs.boehringer-ingelheim.com/BIWebAccess/ViewServlet.ser?docBase=renetnt&folderPath=/Prescribing+Information/PIs/Tradjenta/Tradjenta.pdf or call Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800-542-6257.

Please report any unexpected effects or product problems to the Boehringer Ingelheim Drug Information Unit by calling 1-800-542-6257.

About Diabetes
Approximately 25.8 million Americans[4] and an estimated 371 million people worldwide[5] have type 1 or type 2 diabetes. Type 2 diabetes is the most common type, accounting for an estimated 90 to 95 percent of all diabetes cases.[2] Diabetes is a chronic condition that occurs when the body does not properly produce, or use, the hormone insulin.[6]

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 three compounds representing several of the largest diabetes 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 Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.

The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 140 affiliates and more than 46,000 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 has a demonstrated commitment to corporate social responsibility. 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 2012, Boehringer Ingelheim achieved net sales of about $19.1 billion (14.7 billion euro). R&D expenditure in the business area Prescription Medicines corresponds to 22.5% of its net sales.

For more information please visit www.us.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 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.

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 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, a DPP-4 inhibitor, and empagliflozin, a potential future treatment for type 2 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, that empagliflozin will receive regulatory approvals or will prove to be commercially successful, or that linagliptin will 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.

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TJ550145PR

CONTACT:
Catherine London
Associate Director, Public Relations
Boehringer Ingelheim Pharmaceuticals, Inc.
Email: usnews@boehringer-ingelheim.com
Phone: (203) 798-4638

Tammy Hull
Communications Manager
Lilly Diabetes
Email: hullta@lilly.com
Phone: (317) 651-9116

*Empagliflozin is an investigational compound. Its safety and efficacy have not been established.

[1]Abstract book for the American Diabetes Association (ADA) 73rd Scientific Sessions.
[2]Tradjenta® (linagliptin) tablets.Highlights of Prescribing Information. Initial US Approval: 2011.
[3]Abstract book for the American Diabetes Association (ADA) 73rd Scientific Sessions.
[4]Centers for Disease Control and Prevention. National diabetes fact sheet: national estimates and general information on diabetes and pre-diabetes in the United States, 2011. Atlanta, GA: U.S. Department of Health and Human Services, Center for Disease Control and Prevention, 2011.
[5]International Diabetes Federation. Diabetes Atlas, 5th Edition: Fact Sheet. 2012.
[6]International Diabetes Federation. IDF Diabetes Atlas, 5th Edition: What is Diabetes? http://www.idf.org/diabetesatlas/5e/what-is-diabetes. Accessed on: April 4, 2013.

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SOURCE Eli Lilly and Company; Boehringer Ingelheim Pharmaceuticals, Inc.


Source: PR Newswire