LILLY (ELI) & COMPANY: Phase III data results for empagliflozin

Boehringer Ingelheim and Eli Lilly and Company announce             

      positive top-line pivotal Phase III data results for empagliflozin       

Ingelheim, Germany, January 7, 2013 - Boehringer Ingelheim and Eli Lilly and
Company (NYSE: LLY) today announced top-line results for four completed Phase
III clinical trials for empagliflozin, an investigational sodium glucose
co-transporter-2 (SGLT-2) inhibitor being studied for treatment of patients
with type 2 diabetes (T2D). In all four studies, the primary efficacy endpoint,
defined as significant change in HbA1c from baseline compared to placebo, was
met with empagliflozin (10 and 25 mg) taken once daily.

These four pivotal studies from the empagliflozin trial program are:

  * Study 1245.20 (n=986) evaluated 10 mg and 25 mg doses of empagliflozin as
    monotherapy versus placebo for 24 weeks.1
      * Study 1245.23 (n=1,504) compared 10 mg and 25 mg doses of empagliflozin as
    an add-on to metformin and metformin plus sulfonylurea versus placebo for
    24 weeks.1
      * Study 1245.19 (n=499) assessed 10 mg and 25 mg doses of empagliflozin as an
    add-on to pioglitazone and pioglitazone plus metformin versus placebo for
    24 weeks.1
      * Study 1245.36 (n=741) evaluated 25 mg dose of empagliflozin in patients
    with type 2 diabetes with mild, moderate or severe renal impairment, and 10
    mg dose in those with mild renal impairment versus placebo for 52 weeks.1

Incidence of adverse events was similar for placebo, empagliflozin 10mg and
25mg. Genital infections occurred more often with empagliflozin (both dosages)
compared with placebo. This safety information is consistent with findings
reported in the Phase II study results for empagliflozin.2 
Empagliflozin is part of a class of drugs being investigated for the reduction
of blood glucose levels in adults with T2D. In clinical trials to date, SGLT-2
inhibitors have been shown to reduce blood glucose. 
"Boehringer Ingelheim and Lilly are encouraged by the efficacy and safety
results for empagliflozin," said Prof. Klaus Dugi, Corporate Senior Vice
President Medicine, Boehringer Ingelheim. "Many patients with type 2 diabetes
are not meeting their blood sugar level goals, and alternative treatment
options are needed for them. We believe we are now one step closer to bringing
a new treatment option to these patients." 
"We are pleased with the results for these Phase III clinical trials for
empagliflozin," said Enrique Conterno, President, Lilly Diabetes.  "Diabetes is
growing at a tremendous rate across the world. Patients and their physicians
need more treatment options in order to help improve their blood sugar levels
and reach their treatment goals." 
Empagliflozin is being investigated in adults with T2D in a Phase III clinical
trial program that will enroll over 14,500 patients.1 In total, this program
comprises eight multinational clinical trials, including a large cardiovascular
outcome trial. 
The pivotal studies for empagliflozin completed in 2012, and Boehringer
Ingelheim and Lilly anticipate filing for regulatory review in the U.S., Europe
and Japan in 2013. Boehringer Ingelheim and Lilly plan to present detailed data
disclosures for many of these studies at scientific medical meetings and
publications in 2013 and 2014. 
About Diabetes 
Approximately 25.8 million Americans3 and an estimated 371 million people
worldwide4 have type diabetes. T2D is the most common type, accounting for an
estimated 90 percent of all diabetes cases.3 Diabetes is a chronic disease that
occurs when the body either does not properly produce, or use, the hormone
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
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 responsible. 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 and
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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 a continued commitment to providing real solutions - from
medicines to support programs and more - to make lives better. 
For more information, visit 
This press release contains forward-looking statements about empagliflozin, a
compound under investigation. 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
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. 



Catherine London

Associate Director, Communications and Public Relations

Boehringer Ingelheim Pharmaceuticals, Inc.


Phone: (203) 798-4638

Tammy Hull

Communications Manager

Lilly Diabetes


Phone: (317) 651-9116

 1. Data on file, Boehringer Ingelheim Pharma GmbH &Co KG.
     2. Woerle HJ, Ferrannini E, Berk A, et al. Safety and Efficacy of
    Empagliflozin as Monotherapy or Add-On to Metformin in a 78-Week Open-Label
    Extension Study in Patients with Type 2 Diabetes. Abstract #49-LB.
    Presented at the American Diabetes Association's (ADA's) 72nd Scientific
    SessionsĀ®. June 8-12, Philadelphia, PA.
     3. 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.
     4. International Diabetes Federation. IDF Diabetes Atlas Poster. 2012 Update.
    2012 (5th Edition).
     5. International Diabetes Federation. IDF Diabetes Atlas, 5th Edition: What is
    Diabetes? Accessed
    on: December 18, 2012.
    Press Release

For U.S. Media

January 7, 2013


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