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
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 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
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 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 our
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
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.
CONTACT:
Tammy Hull
Communications Manager
Lilly Diabetes
Email: hullta@lilly.com
Phone: +1 (317) 651-9116
Ute E Schmidt
Boehringer Ingelheim GmbH
Email:press@boehringer-ingelheim.com
Phone: +49 (6132) 77 97296
REFERENCES
1. International Diabetes Federation. Diabetes Atlas, 5th
Edition: Fact Sheet. 2012 Update.
2. International Diabetes Federation. Diabetes Atlas, 5th
Edition: What is Diabetes?
http://www.idf.org/diabetesatlas/5e/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.