U.S. Food and Drug Administration Issues Complete Response Letter for Empagliflozin

RIDGEFIELD, Conn. and INDIANAPOLIS, March 20, 2014 /PRNewswire/ — Boehringer
Ingelheim Pharmaceuticals, Inc. (BIPI) and Eli Lilly and Company (Lilly; NYSE:
LLY) today announced the U.S. Food and Drug Administration (FDA) has issued a
complete response letter for the New Drug Application (NDA) of the
investigational sodium glucose co-transporter-2 (SGLT2) inhibitor empagliflozin.

The complete response letter referenced previously observed deficiencies at a
Boehringer Ingelheim facility where empagliflozin will be manufactured. The FDA
stated these deficiencies need to be resolved before the approval of the
application. The FDA has not asked Boehringer Ingelheim to complete any new
clinical trials to support the approval of the application.

Boehringer Ingelheim and Lilly are committed to working with the FDA to make
empagliflozin available to adults with type 2 diabetes and submitting a response
to the complete response letter as soon as possible.

Empagliflozin is a member of the sodium glucose co-transporter-2 (SGLT2)
inhibitor class of compounds, and is 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 by
the kidney.

The U.S. NDA was based on results from one of the largest clinical registration
programs in its class, comprised of more than 10 multinational clinical trials
and more than 13,000 people with type 2 diabetes (T2D).

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.1

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 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

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 www.us.boehringer-ingelheim.com.

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 www.lilly.com and http://newsroom.lilly.com/social-channels.

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 empagliflozin, an
investigational compound that is being studied for 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 receive regulatory approvals or 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.



Emily Baier, Public Relations
Boehringer Ingelheim Pharmaceuticals, Inc.
Email: emily.baier@boehringer-ingelheim.com
Phone: (203) 791-5997

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


1. 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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