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 insulin.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 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 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
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 a
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, 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.
P-LLY
DIA545051PR
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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. 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
Sessions®. 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? http://www.idf.org/diabetesatlas/5e/what-is-diabetes.
Accessed
on: December 18, 2012.
Press Release
For U.S. Media
January 7, 2013
