Boehringer Ingelheim and Lilly to Feature Type 2 Diabetes Research in More Than 25 Presentations at the 71st American Diabetes Association Scientific Sessions

RIDGEFIELD, Conn. and INDIANAPOLIS, June 20, 2011 /PRNewswire/ — Boehringer
Ingelheim and Eli Lilly and Company(NYSE: LLY) will present the latest data from
their diabetes portfolio at the 71st American Diabetes Association (ADA)
Scientific Sessions in San Diego on June 24-28. Study results evaluating the
dipeptidyl peptidase-4 (DPP-4) inhibitor linagliptin, as well as the
investigational sodium glucose cotransporter-2 (SGLT-2) inhibitor BI-10773, will
be featured among the 27 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.

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Two linagliptin abstracts were selected by ADA as President’s Posters, a
prestigious session showcasing 100 specially-selected posters on Sunday, June 26
and repeated on Monday, June 27. Two additional Phase III studies evaluating
cardiovascular events will be highlighted as late-breaking posters.

Among the presentations are the following:

Linagliptin Data

Presentation
Title Format Authors details
—– —— ——- ————
L Sloan, J Newman,
C Sauce, M von
Phase III President’s Eynatten, S Patel, President’s Poster
(12-week) Poster H-J Woerle Reception
——— ———— ——————- ——————-
Safety and
Efficacy of
Linagliptin
in Type 2
Diabetes
Patients
with Severe
Renal
Impairment 413-PP Date: Sun, June 26
———— —— ——————
Time: 6:45-8 p.m.
—————–
President’s Poster
Session
——————-
Date: Mon, June 27
——————
Time: 12-2 p.m.
—————
M Cooper, M von
Phase III Eynatten, A Emser,
(pooled S Patel, H-J
analysis) Poster Woerle Date: Sat, June 25
——— —— ——————- ——————
Efficacy and
Safety of
Linagliptin
in Patients
with Type 2
Diabetes
with or
without
Renal
Impairment:
Results
From a
Global
Phase III Time: 11:30
Program 1068-P a.m.-1:30 p.m.
———— —— —————
T Haak, T Meinicke,
R Jones, M von
Phase III Eynatten, H-J
(24-week) Oral Woerle Date: Mon, June 27
——— —- ——————– ——————
Combination
of
Linagliptin
and
Metformin
Improves
Glycemic
Control in
Type 2
Diabetes: A
Randomized
Trial with
an Open-
Label Arm
in Patients
with Poor
Glycemic
Control 279-OR Time: 8-10 a.m.
———— —— —————

B Gallwitz, B
Late- Uhlig-Laske, S
Phase III Breaking Battacharaya, S
(2-year) Poster Patel, H-J Woerle Date: Sun, June 26
——— ——— —————— ——————
Linagliptin
has
Improved
Safety and
Similar
Efficacy to
Glimepiride
over 2
Years in
Patients
with Type 2
Diabetes
Mellitus
Inadequately
Controlled
on
Metformin 39-LB Time: 12-2 p.m.
————- —– —————
O-E Johansen, D
Phase III Late- Neubacher, M von
(meta- Breaking Eynatten, S Patel,
analysis) Poster H-J Woerle Date: Sun, June 26
——— ——– —————— ——————
Cardiovascular
Risk with
Linagliptin
in Patients
with Type 2
Diabetes: A
Pre-
specified,
Prospective,
and
Adjudicated
Meta-
Analysis
from a
Large Phase
III Program 30-LB Time: 12-2 p.m.
————– —– —————

S Del Prato, M-R
Taskinen, D Owens,
Phase III M von Eynatten, A
(pooled Emser, S Patel, H-
analysis) Poster J Woerle Date: Sat, June 25
——— —— ——————- ——————
Efficacy and
Safety of
Linagliptin
in Patients
with Type 2
Diabetes
and Poor
Glycemic Time: 11:30
Control 1067-P a.m.-1:30 p.m.
———— —— —————
Phase III C Friedrich, A
(pooled Emser, H-J
analysis) Poster Woerle, Date: Sat, June 25
——— —— ————— ——————
Renal
Impairment
has no
Relevant
Effect on
Long-Term
Exposure of
Linagliptin
in Patients
with Type 2 Time: 11:30
Diabetes 1105-P U Graefe-Mody a.m.-1:30 p.m.
———– —— ————- —————
J Rosenstock, N
Marx, SE Kahn, B
Zinman, J
Kastelein, J
Lachin, E Bluhmki,
A Schlosser, D
Neubacher, S
Patel, O-E
Johansen, H-J
Phase III Poster Woerle Date: Sat, June 25
——— —— ——————- ——————
The
Rationale
and Design
of the
CAROLINA
trial: An
Active
Comparator
CARdiOvascular
Outcome
Study of
the DPP-4
Inhibitor
Linagliptin
in Patients
with Type 2
Diabetes at
High
Cardiovascular Time: 11:30
Risk 1103-P a.m.-1:30 p.m.
————— —— —————
P-H Groop, M von
Phase III Eynatten, A
(pooled Publication Emser, S Patel, H-
analysis) only J Woerle N/A
——— ———– —————— —
Efficacy and
Safety of
Linagliptin
in Type 2
Diabetes
Patients at
High Risk
of Renal
Complications:
Results
From a
Large Phase
III Program 2274-PO
————— ——-
Phase III G Schernthaner, M
(pooled Publication von Eynatten, A
analysis) only Emser, H-J Woerle N/A
——— ———— —————— —
Safety and
Tolerability
of
Linagliptin:
A Pooled
Analysis of
Data from
3572
Patients
with Type 2
Diabetes 2327-PO
————- ——-
A-H Barnett, AA
Tahrani, M von
Phase III Eynatten, A Emser,
(pooled Publication S Patel, H-J
analysis) only Woerle N/A
——— ———– —————— —
The Novel
DPP-4
Inhibitor
Linagliptin
is
Associated
with a Very
Low Risk of
Hypoglycemia:
Results
from a
Large Phase
III Program 2346-PO
————– ——-
T Klein, R
Grempler, E
Mayoux, H Niessen,
President’s S Cheetham, D President’s Poster
Preclinical Poster Stiller, M Mark Reception
———– ———– —————— ——————
The DPP-4
Inhibitor
Linagliptin
Reduces
Intra-
myocellular
and Hepatic
Lipid
Accumulation
in a Diet-
induced
Obesity Rat
Model: An
MRS-based
Study in
Comparison
to
Sibutramine 415-PP Date: Sun, June 26
————- —— ——————
Time: 6:45-8 p.m.
—————–
President’s Poster
Session
——————-
Date: Mon, June 27
——————
Time: 12-2 p.m.
—————

BI-10773 Data

Presentation
Title Format Authors details
—– —— ——- ————
J
Rosenstock,
A
Jelaska,
L Seman,
S
Pinnetti,
S Hantel, General
Moderated H-J poster
Phase II poster Woerle session
——– ———- ———— ——–
Efficacy and
Safety of BI-
10773, a New
Sodium Glucose
Cotransporter-
2 (SGLT-2)
Inhibitor, in
Type 2 Diabetes
Inadequately
Controlled on Date: Sat,
Metformin 989-P June 25
—————- —– ———-
Time:
11:30
a.m.-1:30
p.m.
———-
Guided
audio
poster
tour
——-
Date: Sun,
June 26
———-
Time: 12-1
p.m.
———-
M Riggs, S
Macha, L
Seman, A
Staab, T
MacGregor,
H-J
Woerle, W
Gillispie,
M Date: Sat,
Phase I/II Poster Gastonguay June 25
———- —— ———- ———-
Evaluation of
Efficacy and
Tolerability
Using Exposure-
Response
Modeling for
BI-10773, a
Sodium Glucose
Cotransporter-
2 (SGLT-2) Time:
Inhibitor, in 11:30
Patients with a.m.-1:30
Type 2 Diabetes 1069-P p.m.
—————- —— ———-
C
Friedrich,
K
Metzmann,
P Rose, M
Mattheus,
S
Pinnetti,
Publication H-J
Phase I only Woerle N/A
——- ———– ———- —
Pharmacokinetics
and
Pharmacodynamics
of BI-10773, a
Sodium Glucose
Cotransporter-2
(SGLT-2)
Inhibitor, and
Linagliptin, a
Dipeptidyl
Peptidase-4
(DPP-4)
Inhibitor,
Following Co-
Administration
in Healthy
Volunteers 2318-PO
—————- ——-

Health Economics and Outcomes Research Data(HEOR)

Presentation
Title Format Authors details
—– —— ——- ————
Late- S-Y Chen, B
Breaking Kovacs, M Stokes,
Poster S Sander, K Siu, P
US – HEOR 52-LB Rao, L Boulanger Date: Sun, June 26
——— ——— —————— ——————
Clinical and
Economic
Outcomes of
Appropriate
Oral
Antidiabetic
Drug (OAD)
Treatment
Among Type 2
Diabetes
Mellitus
(T2DM)
Patients with
Chronic Kidney
Disease (CKD) Time: 12-2 p.m.
————— —————
J Burke, K Siu, B
Publication Kovacs, L Borton,
US – HEOR only S Sander N/A
——— ———– —————— —
Insulin Use,
its Associated
Costs,
Glycemic
Control and
Hypoglycemia
in Patients
with Type 2
Diabetes
Mellitus and
Renal
Impairment 2107-PO
————— ——-

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.

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.

Boehringer Ingelheim and Eli Lilly and Company

In January 2011, Boehringer Ingelheim and Eli Lilly and Companyannounced 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.

AboutEli 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.

This press release contains forward-looking statements about TRADJENTA or the
treatment of 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 or that TRADJENTA 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.

P-LLY

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