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

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

Announces it will begin remainder of pre-planned clinical trials for LY2605541

PR Newswire

INDIANAPOLIS and INGELHEIM, Germany, Jan. 7, 2013

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 people^1 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.

(Logo: http://photos.prnewswire.com/prnh/20031219/LLYLOGO )
(Logo: http://photos.prnewswire.com/prnh/20110825/DE57898LOGO )

SOURCE Eli Lilly and Company; Boehringer Ingelheim

Website: http://www.lilly.com
Website: http://www.boehringer-ingelheim.com
 
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