Lilly reassumes sole worldwide development and commercialization rights for novel basal insulin analog

Mon Jan 7, 2013 8:00am EST

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Announces it will begin remainder of pre-planned clinical trials for LY2605541
INDIANAPOLIS  and INGELHEIM,  Germany,  Jan. 7, 2013  /PRNewswire/ -- Eli Lilly
and Company (NYSE: LLY) and Boehringer Ingelheim International GmbH announced
today they will adjust the scope of their diabetes alliance with respect to
LY2605541*, Lilly's investigational novel basal insulin analog, with Lilly
reassuming sole worldwide development and commercialization rights to LY2605541.

Lilly and Boehringer Ingelheim formed their diabetes alliance in  January 2011,
centering on four pipeline compounds representing several of the largest and
most promising product classes. It is one of the largest alliances among two
pharmaceutical companies ever in a single therapeutic area and aims to provide a
broad portfolio of treatment options for patients with diabetes and their
healthcare professionals.  

While Lilly and Boehringer Ingelheim will continue to jointly develop and
commercialize the other assets in the alliance, Boehringer Ingelheim elected to
terminate the collaboration with Lilly with respect to LY2605541 given
independent strategic portfolio considerations.

"There is an excellent spirit of collaboration in our alliance with Lilly, and
we are committed to the continued success in our partnership to develop and
commercialize the other molecules within the alliance, including TRADJENTA
(linagliptin) tablets, and investigational agents empagliflozin and LY2963016, a
new insulin glargine product," said Dr.  Ulrich Drees, Corporate Senior Vice
President, International Project Management at Boehringer Ingelheim.

Lilly also announced plans for the 2013 and 2014 initiation of the remainder of
the pre-planned clinical trials for LY2605541. In addition to supporting
regulatory submissions, these studies will be conducted to evaluate safety,
efficacy and differentiation of this novel basal insulin analog. These studies
are in addition to the five ongoing IMAGINE clinical trials.

"We're encouraged by the pre-clinical, Phase I and II data we've seen for our
novel basal insulin analog," said  Gwen Krivi, Ph.D, vice president, Diabetes
Product Development, Lilly Diabetes. "We look forward to sharing the Phase III
data results of our novel basal insulin therapy with the medical community as
early as 2014."

"Boehringer Ingelheim is an important partner in our strategy to provide a broad
portfolio of diabetes medicines, and our diabetes alliance remains strong," said
 Enrique Conterno, president of Lilly Diabetes. "There is no group of patients
with whom Lilly has a deeper history than those impacted by diabetes. If
approved, this basal insulin analog will be an important addition to the Lilly
portfolio as we work to provide a broad portfolio of diabetes medicines to our

If the Phase III trials for LY2605541 are successful, Lilly could submit its
novel basal insulin analog to regulatory authorities as early as 2014, as
previously communicated.

*LY2605541 is an investigational agent. Its efficacy and safety have not been
finally established.

Linagliptin, marketed in the U.S. as Tradjenta®, is a once-daily tablet used
along with diet and exercise to improve glycemic control 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

To learn more about TRADJENTA and for full prescribing information visit:,
or call Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800-542-6257.

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

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

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

TJ CONS ISI  August 14  2012

To learn more about TRADJENTA visit: For full prescribing
information visit:
 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
An estimated 371 million people1  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.2

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 or

About Boehringer Ingelheim  
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 44,000 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 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 2011, Boehringer Ingelheim achieved net sales of about  $17.1 billion  (13.2
billion euro). R&D expenditure in the business area Prescription Medicines
corresponds to 23.5% of its net sales.

For more information, please visit  and
follow us on Twitter at  

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

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 our continued commitment to providing real solutions -
from medicines to support programs and more - to make lives better.  

For more information, visit


This press release contains forward-looking statements about Lilly's basal
insulin LY2605541 in Phase III clinical trial development. 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 LY2605541 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.


Tammy Hull
Communications Manager
Lilly Diabetes
Phone: +1 (317) 651-9116

Catherine London
Associate Director, Communications and Public Relations
Boehringer Ingelheim Pharmaceuticals, Inc.
Phone: (203) 798-4638

(Logo:  )

(Logo:  )


1International Diabetes Federation. Diabetes Atlas, 5th Edition: Fact Sheet.
2012 Update. 2International Diabetes Federation. Diabetes Atlas, 5th Edition:
What is Diabetes? Accessed
on: August 2, 2012.

SOURCE  Eli Lilly and Company; Boehringer Ingelheim
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