Boehringer Ingelheim and Lilly to Feature Type 2 Diabetes Research in Presentations at the 47th Annual Meeting of the European Association for the Study of Diabetes

RIDGEFIELD, Conn. and INDIANAPOLIS, Sept. 7, 2011 /PRNewswire/ — Boehringer
Ingelheim and Eli Lilly and Company (NYSE: LLY) will present the latest data
from their diabetes portfolio at the 47th Annual Meeting of the European
Association for the Study of Diabetes (EASD) in Lisbon, Portugal, September
12-16. Study results evaluating the dipeptidyl peptidase-4 (DPP-4) inhibitor,
linagliptin, as well as the investigational sodium-dependent glucose
co-transporter-2 (SGLT-2) inhibitor, empagliflozin (BI-10773), will be featured
among the seven presentations. Linagliptin 5 mg is marketed under the trade name
Tradjenta(TM) (linagliptin) tablets in the U.S. and was approved by the U.S.
Food and Drug Administration (FDA) in May 2011 to be used along with diet and
exercise to lower blood sugar in adults with type 2 diabetes. TRADJENTA should
not be used in patients with type 1 diabetes or for the treatment of diabetic
ketoacidosis (increased ketones in the blood or urine). It has not been studied
in combination with insulin.

A long-term study evaluating the efficacy and safety of linagliptin in patients
with type 2 diabetes was selected by EASD as an oral presentation, taking place
on Friday, September 16.

The presentations are as follows:

Linagliptin Data

Title Format Authors Date/Time
—– —— ——- ———
L Chaykovska, K
von Websky, S
Heiden, J
Rahnenfuhrer, T Date: Tues, Sept.
Preclinical Poster Klein, B Hocher 13
———– —— —————- ——————
DPP-4
Inhibition -
A New
Approach for
the
Treatment of
Uraemic Time: 12:30-1:30
Cardiomyopathy 824-P p.m.
————— —– —————–
J Newman, J
McGill, S Patel,
C Friedrich, C
Phase III Sauce, H-J Date: Tues, Sept.
(52-week) Poster Woerle 13
——— —— —————– ——————
Long-term
Efficacy and
Safety of
Linagliptin
in Patients
with Type 2
Diabetes and
Severe Renal Time: 12:30-1:30
Impairment 821-P p.m.
————- —– —————–
Phase III
(pooled S Patel, S-A Date: Tues, Sept.
analysis) Poster Weber, A Emser, 13
M von Eynatten, H-
——— —— J Woerle ——————
Linagliptin
Improves
Glycemic
Control
Independently
of Diabetes
Duration and
Insulin
Resistance
in Patients
with Type 2 Time: 1:30-2:30
Diabetes 832-P ——————- p.m.
————– —– —————-
E Rafeiro, S Ross,
T Meinicke, R
Phase II Toorawa, H-J Date: Tues, Sept.
(12-week) Poster Woerle 13
———- —— ——————- ——————
Efficacy and
Safety of 5
mg Daily
Dosing
Regimens
with
Linagliptin
in Patients
with Type 2
Diabetes
Inadequately
Controlled Time: 1:30-2:30
on Metformin 831-P p.m.
———— —– —————-
T Pfab, Y
Sharkovska, M
Alter, K von
Websky, M Mark, T Date: Thurs,
Preclinical Poster Klein, B Hocher Sept. 15
———– —— —————— ————-
Effect of
Linagliptin
on
Infarction
Size and
Cardiac
Function in
Rats After
Myocardial
Ischaemia Time: 1:30-2:30
Reperfusion 811-P p.m.
———— —– —————-
A Schlosser, D
Owens, M-R
Taskinen, S Del
Prato, R Gomis, S
Patel, A
Phase III Oral Pivovarova, H-J Date: Fri, Sept.
(104 week) Presentation Woerle 16
———– ———— —————— —————–
Long-term
Efficacy and
Safety of
the DPP-4
Inhibitor
Linagliptin:
Data from a
Large Two-
year Study
in Patients
with Type 2
Diabetes Time: 11:45
Mellitus 242-OP a.m.-12:00 p.m.
————- —— —————-

Empagliflozin Data
——————
Title Format Authors Date/Time
—– —— ——- ———
L Seman, J
Rosenstock, A
Jelaska, S
Pinnetti, S
Phase II (12 Oral Hantel, H-J Date: Thurs,
week) Presentation Woerle Sept. 15
———— ————- ————– ————-
ENCORE:
Efficacy and
Safety of
BI-10773, a
new Sodium
Glucose Co-
transporter-
2 (SGLT-2)
Inhibitor,
in Type 2
Diabetes
Patients
Inadequately
Controlled Time: 11:15-11:30
on Metformin 147-OP a.m.
————- —— ——————

*All times in Western European Summer Time (WEST)

Indication and Important Limitations of Use

TRADJENTA is indicated as an adjunct to diet and exercise to improve glycemic
control in adults with type 2 diabetes mellitus.

TRADJENTA should not be used in patients with type 1 diabetes or for the
treatment of diabetic ketoacidosis.

TRADJENTA has not been studied in combination with insulin.

Important Safety Information

CONTRAINDICATIONS

TRADJENTA is contraindicated in patients with a history of hypersensitivity
reaction to linagliptin, such as urticaria, angioedema or bronchial
hyperreactivity.

WARNINGS AND PRECAUTIONS

Use with Medications Known to Cause Hypoglycemia

Insulin secretagogues (e.g., sulfonylurea) are known to cause hypoglycemia.
Therefore, a lower dose of the insulin secretagogue may be required to reduce
the risk of hypoglycemia when used in combination with TRADJENTA.

Macrovascular Outcomes

There have been no clinical studies establishing conclusive evidence of
macrovascular risk reduction with TRADJENTA or any other antidiabetic drug.

ADVERSE REACTIONS

Adverse reactions reported in >/=5% of patients treated with TRADJENTA and more
commonly than in patients treated with placebo included nasopharyngitis.

Hypoglycemia was more commonly reported in patients treated with the combination
of TRADJENTA and sulfonylurea compared with those treated with the combination
of placebo and sulfonylurea. Pancreatitis was reported more often in patients
randomized to linagliptin (1 per 538 person-years versus zero in 433
person-years for comparator).

DRUG INTERACTIONS

The efficacy of TRADJENTA may be reduced when administered in combination with a
strong P-glycoprotein or CYP3A4 inducer (e.g., rifampin). Therefore, use of
alternative treatments is strongly recommended.

USE IN SPECIFIC POPULATIONS

There are no adequate and well-controlled studies in pregnant women. Therefore,
TRADJENTA should be used during pregnancy only if clearly needed. It is not
known whether linagliptin is excreted in human milk. Because many drugs are
excreted in human milk, caution should be exercised when TRADJENTA is
administered to a nursing woman. Safety and effectiveness of TRADJENTA in
patients below the age of 18 have not been established.

To learn more about TRADJENTA and for full prescribing information visit:
www.TRADJENTA.com 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.

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

About Diabetes

Approximately 25.8 million Americans(1) and an estimated 220 million people(2)
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.(1)
Diabetes is a chronic disease 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 centers 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 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 145
affiliates and more than 42,000 employees. Since it was founded in 1885, the
family-owned company has been committed to researching, developing,
manufacturing and marketing novel products 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 2010, Boehringer Ingelheim posted net sales of approximately $16.7 billion
(about 12.6 billion euro) while spending almost 24 percent of net sales in its
largest business segment, Prescription Medicines, on research and development.

For more information, please visit http://us.boehringer-ingelheim.com and follow
us on Twitter at http://twitter.com/boehringerus.

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

For more than 85 years, Lilly has been a worldwide leader in pioneering
industry-leading solutions to support people living with and treating diabetes.
Lilly introduced the world’s first commercial insulin in 1923, and remains at
the forefront of medical and delivery device innovation to manage diabetes.
Lilly is also committed to providing solutions beyond therapy – practical tools,
education, and support programs to help overcome barriers to success along the
diabetes journey. At Lilly, the journeys of each person living with or treating
diabetes inspire ours. For more information, visit www.lillydiabetes.com.

P-LLY

TJ110803 PR

(1) Centers for Disease Control. National Diabetes Fact Sheet-2011. Available
at: http://www.cdc.gov/diabetes/pubs/pdf/ndfs_2011.pdf. Accessed on: August 5,
2011.

(2) World Health Organization. Fact Sheet No. 312: What is Diabetes? Available
at: http://www.who.int/mediacentre/factsheets/fs312/en/. Accessed on: August 5,
2011.

(3) International Diabetes Federation. Diabetes Atlas. 3rd edn. Brussels:
International Diabetes Federation, 2006.

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SOURCE Eli Lilly and Company