LILLY (ELI) & COMPANY: Additional Phase III Clinical Trials

Lilly Reassumes Sole Worldwide Development and Commercialization Rights for   
                      Novel Basal Insulin Analog                            
Announces it will begin remainder of pre-planned clinical trials for LY2605541  
INDIANAPOLIS and INGELHEIM, Germany, Jan. 7, 2013 /PRNewswire/ -- Eli Lilly and
Company (NYSE: LLY) and Boehringer Ingelheim International GmbH announced today
they will adjust the scope of their diabetes alliance with respect to LY2605541
*, Lilly's novel basal insulin analog, with Lilly reassuming sole worldwide
development and commercialization rights to LY2605541.  
Lilly and Boehringer Ingelheim formed their diabetes alliance in January 2011,
centering on four pipeline compounds representing several of the largest and
most promising product classes. It is one of the largest alliances among two
pharmaceuticals companies ever in a single therapeutic area and aims to provide
a broad portfolio of treatment options for patients with diabetes and their
healthcare professionals. 
While Lilly and Boehringer Ingelheim will continue to jointly develop and
commercialize the other assets in the alliance, Boehringer Ingelheim elected to
terminate the collaboration with Lilly with respect to LY2605541 given
independent strategic portfolio considerations. 
"There is an excellent spirit of collaboration in our alliance with Lilly, and
we are committed to the continued success in our partnership to develop and
commercialize the other molecules within the alliance, including Trajenta®
(linagliptin), empagliflozin and LY2963016, new insulin glargine product," said
Dr. Ulrich Drees, Corporate Senior Vice President, International Project
Management at Boehringer Ingelheim. 
Lilly also announced plans for the 2013 and 2014 initiation of the remainder of
the pre-planned clinical trials for LY2605541. In addition to supporting
regulatory submissions, these studies will be conducted to  evaluate safety,
efficacy and differentiation of this novel basal insulin analog. These studies
are in addition to the five ongoing IMAGINE clinical trials. 
"We're encouraged by the pre-clinical, Phase I and II data we've seen for our
novel basal insulin analog," said Gwen Krivi, Ph.D, vice president, Diabetes
Product Development, Lilly Diabetes.  "We look forward to sharing the Phase III
data results of our novel basal insulin therapy with the medical community as
early as 2014." 
"Boehringer Ingelheim is an important partner in our strategy to provide a
broad portfolio of diabetes medicines, and our diabetes alliance remains
strong," said Enrique Conterno, president of Lilly Diabetes. "There is no group
of patients with whom Lilly has a deeper history than those impacted by
diabetes. If approved, this basal insulin analog will be an important addition
to the Lilly portfolio as we work to provide a broad portfolio of diabetes
medicines to our customers." 
If the Phase III trials for LY2605541 are successful, Lilly could submit its
novel basal insulin analog to regulatory authorities as early as 2014, as
previously communicated. 
About Diabetes 
An estimated 371 million people1 worldwide have type 1 and type 2 diabetes.
Type 2 diabetes is the most common type, accounting for an estimated 90 to 95
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.2 
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 with
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 endeavours. 
In 2011, Boehringer Ingelheim achieved net sales of about 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 
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 better. 
For more information, visit 
This press release contains forward-looking statements about Lilly's basal
insulin LY2605541  in Phase III clinical trial development. 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 LY2605541
 will 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. 
*LY2605541 is an investigational agent.  Its efficacy and safety have not been
finally established. 
Tammy Hull
Communications Manager
Lilly Diabetes
Phone: +1 (317) 651-9116 
Ute E Schmidt
Boehringer Ingelheim GmbH
Phone: +49 (6132) 77 97296 
1.  International Diabetes Federation. Diabetes Atlas, 5th Edition: Fact Sheet.
2012 Update. 
2.  International Diabetes Federation. Diabetes Atlas, 5th Edition: What is
Diabetes? Accessed on:
August 2, 2012. 
*LY2605541 is an investigational agent. Its efficacy and safety have not been
finally established. 
Press Release 
*LY2605541 is an investigational agent. Its efficacy and safety have not been
finally established. 
-0- Jan/07/2013 14:06 GMT
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