European Medicines Agency accepts marketing authorization application for
Boehringer Ingelheim and Eli Lilly and Company's empagliflozin*, an
investigational type 2 diabetes treatment
Marketing application for the sodium glucose co-transporter-2 inhibitor
follows submission of New Drug Application to U.S. Food and Drug
RIDGEFIELD, Conn. and INDIANAPOLIS, March 26, 2013
RIDGEFIELD, Conn. and INDIANAPOLIS, March 26, 2013 /PRNewswire/ --Boehringer
Ingelheim and Eli Lilly and Company (NYSE: LLY) today announced the European
Medicines Agency (EMA) has accepted for review a marketing authorization
application (MAA) for the investigational sodium glucose co-transporter-2
(SGLT2) inhibitor empagliflozin*, for the treatment of type 2 diabetes
mellitus (T2D) in adults. The acceptance of the MAA marks the beginning of the
review process in the European Union for this potential oral diabetes
"We are pleased the EMA has accepted our marketing authorization application
for a potential new treatment option to help patients better manage their type
2 diabetes mellitus," said Prof.Klaus Dugi, Corporate Senior Vice President
Medicine,BoehringerIngelheim. "More than 300 million people worldwide live
with type 2 diabetes mellitus and varied approaches to treating this condition
are needed to help these patients better manage their condition."
A New Drug Application for empagliflozin was recently submitted to the Food
and Drug Administration (FDA) in the United States for the treatment of T2D in
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.
Approximately 25.8 million Americans and an estimated 371 million people
worldwide have type 1 or type 2 diabetes. T2D is the most common type,
accounting for an estimated 90 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. Diabetes was estimated to cost the U.S. $245
billion in direct medical costs and reduced productivity in 2012.
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
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
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
*Empagliflozin is an investigational compound. Its safety and efficacy have
not yet been fully established.
 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.
 International Diabetes Federation. IDF Diabetes Atlas Poster. 2012 Update.
2012 (5th Edition).
 International Diabetes Federation. IDF Diabetes Atlas, 5th Edition: What
is Diabetes? http://www.idf.org/diabetesatlas/5e/what-is-diabetes. Accessed
on: March 21, 2013
 American Diabetes Association. Economic costs of diabetes in the U.S. in
2012. Diabetes Care. 2013. Mar 6. [Epub ahead of print]
Associate Director, Communications and Public Relations
Boehringer Ingelheim Pharmaceuticals, Inc.
Phone: (203) 798-4638
Phone: (317) 651-9116
SOURCE Eli Lilly and Company; Boehringer Ingelheim
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