Boehringer Ingelheim and Eli Lilly and Company submit new drug application to FDA for empagliflozin, an investigational type 2

Boehringer Ingelheim and Eli Lilly and Company submit new drug application to
     FDA for empagliflozin, an investigational type 2 diabetes treatment

Marketing application for the sodium glucose co-transporter-2 inhibitor
follows completion of Phase III registration trials

PR Newswire

RIDGEFIELD, Conn. and INDIANAPOLIS, March 25, 2013

RIDGEFIELD, Conn. and INDIANAPOLIS, March 25, 2013 /PRNewswire/ --Boehringer
Ingelheim and Eli Lilly and Company (NYSE: LLY) today announced that a New
Drug Application (NDA) for the investigational sodium glucose co-transporter-2
(SGLT2) inhibitor empagliflozin* was recently submitted to the Food and Drug
Administration (FDA) in the United States for the treatment of type 2 diabetes
mellitus (T2D) in adults.
Empagliflozin is a member of the SGLT2 inhibitor class of drugs being
investigated for the reduction of blood glucose levels in adults with T2D. The
emerging SGLT2 inhibitor class removes excess glucose through the urine by
blocking glucose re-absorption in the kidney.

"We are excited to have submitted an application for a potential new treatment
option that may help patients better manage their type 2 diabetes mellitus,"
said Christophe Arbet-Engels, MD, PhD, MBA, vice president, metabolic-clinical
development and medical affairs, Boehringer Ingelheim. "Type 2 diabetes
mellitus is a critical health issue facing the world today, and through the
Boehringer Ingelheim and Lilly Diabetes Alliance, we are committed to
developing new treatments to address patients with this disease."

Empagliflozin is being investigated in adults with T2D in a Phase III clinical
trial program that plans to enroll more than 14,500 patients.[1] In total,
this program comprises 12 multinational clinical trials, including a large
cardiovascular outcome trial. Boehringer Ingelheim and Lilly plan to present
detailed data disclosures for many of these studies at scientific medical
meetings and in publications in 2013 and 2014.

About Diabetes
Approximately 25.8 million Americans[2] and an estimated 371 million people
worldwide[3] have type 1 or type 2 diabetes. T2D is the most common type,
accounting for an estimated 90 percent of all diabetes cases.[2] Diabetes is a
chronic disease that occurs when the body either does not properly produce, or
use, the hormone insulin.[4] Diabetes was estimated to cost the U.S. $245
billion in direct medical costs and reduced productivity in 2012.[5]

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 three 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
socially responsibly. 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 http://us.boehringer-ingelheim.com and
follow us on Twitter at http://twitter.com/boehringerus.

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 empagliflozin*
for 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 empagliflozin* will prove to 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
DIA548332PR

CONTACT:
Catherine London
Associate Director, Communications and Public Relations
Boehringer Ingelheim Pharmaceuticals, Inc.
Email: usnews@boehringer-ingelheim.com
Phone: (203) 798-4638

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

[1] Data on file, Boehringer Ingelheim Pharma GmbH &Co KG.

[2] Centers for Disease Control and Prevention. National Diabetes Fact Sheet:
National Estimates and General Information on Diabetes and Prediabetes in the
United States, 2011. Atlanta, GA: U.S. Department of Health and Human
Services, Centers for Disease Control and Prevention, 2011.

[3] International Diabetes Federation. IDF Diabetes Atlas Poster. 2012 Update.
2012 (5th Edition).

[4] International Diabetes Federation. IDF Diabetes Atlas, 5th Edition: What
is Diabetes?
http://www.idf.org/diabetesatlas/5e/what-is-diabetes. Accessed on: March 22,
2012.

[5] American Diabetes Association. Economic costs of diabetes in the U.S. in
2012. Diabetes Care. 2013. Mar 6. [Epub ahead of print]

*Empagliflozin is an investigational compound. Its safety and efficacy have
not yet been fully established.

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

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SOURCE Eli Lilly and Company; Boehringer Ingelheim

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