Lilly Reassumes Sole Worldwide Development and Commercialization Rights for Novel Basal Insulin Analog

Mon Jan 7, 2013 8:01am 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 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
pharmaceuticals 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 Trajenta
(linagliptin), empagliflozin and LY2963016, 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," 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
customers."

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.

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  www.boehringer-ingelheim.com  or  www.lilly.com.

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 with
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 endeavours.

In 2011, Boehringer Ingelheim achieved net sales of about  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  www.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 our 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 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.

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

CONTACT:

Tammy Hull
Communications Manager
Lilly Diabetes
Email:  hullta@lilly.com
Phone: +1 (317) 651-9116

Ute E Schmidt  
Boehringer Ingelheim GmbH
Email:press@boehringer-ingelheim.com
Phone: +49 (6132) 77 97296

REFERENCES

1.  International Diabetes Federation. Diabetes Atlas, 5th Edition: Fact Sheet.
2012 Update.

2.  International Diabetes Federation. Diabetes Atlas, 5th Edition: What is
Diabetes?  http://www.idf.org/diabetesatlas/5e/what-is-diabetes. Accessed on: 
August 2, 2012.

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SOURCE  Eli Lilly and Company; Boehringer Ingelheim
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