Eli Lilly and Company and Boehringer Ingelheim announce regulatory submission
for new insulin glargine biosimilar product
European Medicines Agency accepted companies' marketing authorisation
INDIANAPOLIS, and INGELHEIM, Germany, July 8, 2013
INDIANAPOLIS, and INGELHEIM, Germany, July 8, 2013 /PRNewswire/ -- Eli Lilly
and Company (NYSE: LLY) and Boehringer Ingelheim today announced that the
companies' marketing authorisation application (MAA) for LY2963016, an
investigational basal (long-acting) insulin for the treatment of type 1 and
type 2 diabetes, has been accepted for review by the European Medicines Agency
(EMA). LY2963016 is a new insulin glargine product and has been filed through
the EMA's biosimilar pathway.
Lilly and Boehringer Ingelheim have studied LY2963016 in a comprehensive
clinical development program in order to meet the highest standards of safety,
efficacy and quality. In addition to pharmacokinetic and pharmacodynamic
studies, Phase III studies in patients with type 1 and type 2 diabetes have
been conducted and results submitted, using currently marketed insulin
glargine as the active comparator.
"Long-acting insulin is a mainstay treatment for many people with diabetes,
and we anticipate that insulin glargine will continue to be widely used for
many years to come," said Gwen Krivi, Ph.D., vice president, Lilly Diabetes
product development. "We are pleased that the EMA's acceptance of our
application brings us closer to offering a new insulin glargine product to
clinicians and their patients, coupled with the expertise they expect from
Lilly and Boehringer Ingelheim."
An estimated 371 million people worldwide have type 1 and type 2 diabetes.^1
Type 2 diabetes 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
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 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
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 140
affiliates and more than 46,000employees. 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.
Social responsibility is a central element of Boehringer Ingelheim's culture.
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
In 2012, Boehringer Ingelheim achieved net sales of about €14.7 billion. R&D
expenditure in the business area Prescription Medicines corresponds to 22.5%
of its net sales.
For more information, please visit www.boehringer-ingelheim.com.
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
organisations. 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 www.lillydiabetes.com.
This press release contains forward-looking statements about LY2963016 for the
treatment of 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 commercialisation. There is no guarantee that
future study results and patient experience will be consistent with study
findings to date or that LY2963016 will receive regulatory approval 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.
Phone: +1 (317) 651-9116
Launch and Established Products CVM
Boehringer Ingelheim GmbH
Phone: +49 6132 77143880
1.International Diabetes Federation. IDF Diabetes Atlas Poster (2012 Update
- 5th Edition). 2012.
2.World Health Organization. 2009. Available from
www.who.int/mediacentre/factsheets/fs312/en/print.html Accessed February
3.International Diabetes Federation. What is Diabetes IDF Website - IDF
DIABETES ATLAS 5th edition. 2012.
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SOURCE Eli Lilly and Company; Boehringer Ingelheim
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