Boehringer Ingelheim and Eli Lilly and Company Announce New Drug Application Filing in the U.S. for the Combination Tablet of Empagliflozin and Linagliptin

RIDGEFIELD, Conn. and INDIANAPOLIS, April 24, 2014 /PRNewswire/ — Boehringer
Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company (Lilly; NYSE: LLY)
today announced the U.S. Food and Drug Administration (FDA) accepted the filing
of the New Drug Application (NDA) for the investigational combination tablet of
empagliflozin and linagliptin for the treatment of adults with type 2 diabetes

If granted approval by the FDA, this combination will bring together, for the
first time into one tablet, the distinct mechanisms of action of a sodium
glucose co-transporter-2 (SGLT2) inhibitor and a dipeptidyl peptidase-4 (DPP-4)
inhibitor. SGLT2 inhibitors remove excess glucose through the urine by blocking
glucose re-absorption in the kidney. DPP-4 inhibitors work by increasing
hormones that stimulate the pancreas to produce more insulin and stimulate the
liver to produce less glucose.

“The FDA acceptance of our filing for the combination tablet of empagliflozin
and linagliptin brings us closer to providing patients with type 2 diabetes a
potential treatment option that lowers blood sugar through the dual mechanism of
action of a DPP-4 inhibitor and an SGLT2 inhibitor,” said Christophe
Arbet-Engels, MD, PhD, vice president, metabolic-clinical development and
medical affairs, Boehringer Ingelheim Pharmaceuticals, Inc. “Adults living with
type 2 diabetes often take more than one therapy to manage their condition, and
we hope the combination of these two products will help them improve control of
their blood sugar.”

The filing follows the completion of a phase III clinical registration trial
designed to evaluate the efficacy and safety of the empagliflozin/linagliptin
combination compared to the individual components in adults with T2D. The
Boehringer Ingelheim and Lilly Diabetes alliance plans to present data from this
study later this year.

Linagliptin, which is marketed as Tradjenta® (linagliptin) tablets in the U.S.,
is a once-daily, 5-mg tablet used along with diet and exercise to improve
glycemic control in adults with T2D. TRADJENTA should not be used in patients
with type 1 diabetes or for the treatment of diabetic ketoacidosis. TRADJENTA
has not been studied in patients with a history of pancreatitis.1

What are TRADJENTA 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).

If you have had inflammation of the pancreas (pancreatitis) in the past, it is
not known if you have a higher chance of getting pancreatitis while you take

Important Safety Information

What is the most important information I should know about TRADJENTA?
Serious side effects can happen to people taking TRADJENTA, including
inflammation of the pancreas (pancreatitis), which may be severe and lead to
death. Before you start taking TRADJENTA, tell your doctor if you have ever had
pancreatitis, gallstones, a history of alcoholism, or high triglyceride levels.

Stop taking TRADJENTA and call your doctor right away if you have pain in your
stomach area (abdomen) that is severe and will not go away. The pain may be felt
going from your abdomen through to your back. The pain may happen with or
without vomiting. These may be symptoms of pancreatitis.

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 may include rash, itching,
flaking or peeling; raised red patches on your skin (hives); swelling of your
face, lips, tongue 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 using TRADJENTA?
Tell your doctor about all the medicines you take, including prescription and
non-prescription medicines, vitamins, and herbal supplements. TRADJENTA may
affect the way other medicines work, and other medicines may affect how

Especially 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.

— rifampin (Rifadin®, Rimactane®, Rifater®, Rifamate®)^, an antibiotic
that is used to treat tuberculosis.
Tell your doctor if you are pregnant or planning to become pregnant or are
breastfeeding or plan to breastfeed.

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

You are encouraged to report negative side effects of prescription drugs to the
U.S. FDA. Visit or call 1-800-FDA-1088.

For more safety information, please see Medication Guide and full Prescribing


^The brands listed are trademarks of their respective owners and are not
trademarks of Boehringer Ingelheim Pharmaceuticals, Inc. The makers of these
brands are not affiliated with and do not endorse Boehringer Ingelheim
Pharmaceuticals, Inc., or its products.

To learn more about TRADJENTA visit: For full Prescribing
Information and Medication Guide visit:

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

About Diabetes
Approximately 24.4 million Americans and an estimated 382 million people
worldwide have type 1 or type 2 diabetes. Type 2 diabetes is the most common
type, accounting for an estimated 85 to 95 percent of all diabetes cases.
Diabetes is a chronic condition that occurs when the body either does not
properly produce, or use, the hormone insulin.2

Boehringer Ingelheim and Eli Lilly and Company
In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an
alliance in diabetes that centers on compounds representing several of the
largest diabetes treatment classes. The alliance leverages the strengths of two
of the world’s leading pharmaceutical companies. 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 or

About Boehringer Ingelheim
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 percent of its net sales.

For more information please visit

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 and

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

This press release contains forward looking statements about the investigational
fixed-dose combination of empagliflozin and linagliptin. Empagliflozin is an
investigational SGLT2 inhibitor being studied for the treatment of type 2
diabetes, and linagliptin, a DPP-4 inhibitor, is approved for the treatment of
type 2 diabetes along with diet and exercise. 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 the investigational fixed-dose combination
of empagliflozin and linagliptin will be commercially successful, or that it
will receive regulatory approvals. 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.


Emily Baier, Public Relations
Boehringer Ingelheim Pharmaceuticals, Inc.
Phone: (203) 791-5997

Tammy Hull
Communications Manager
Lilly Diabetes
Phone: (317) 651-9116


1. Tradjenta® (linagliptin) tablets. Highlights of Prescribing Information. June
2. International Diabetes Federation. Diabetes Atlas, 6th Edition. 2013.

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

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