Boehringer Ingelheim Pharmaceuticals, Inc.
Announces it will begin remainder of pre-planned clinical trials for LY2605541
INDIANAPOLIS, IN, USA, and INGELHEIM, GERMANY– January 7, 2013 – 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 investigational 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 pharmaceutical 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 TRADJENTA® (linagliptin) tablets, and investigational agents empagliflozin and LY2963016, a 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.
Linagliptin, marketed in the U.S. as Tradjenta®, is a once-daily tablet used along with diet and exercise to improve glycemic control in adults with type 2 diabetes. TRADJENTA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis (increased ketones in the blood or urine).
To learn more about TRADJENTA and for full prescribing information visit: http://bidocs.boehringer-ingelheim.com/BIWebAccess/ViewServlet.ser?docBase=renetnt&folderPath=/Prescribing+Information/PIs/Tradjenta/Tradjenta.pdf, or call Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800-542-6257.
What are TRADJENTA (linagliptin) tablets?
TRADJENTA is a prescription medicine that is used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.
TRADJENTA is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).
Important Safety Information
Who should not take TRADJENTA?
Do not take TRADJENTA if you are allergic to linagliptin or any of the ingredients in TRADJENTA.
Symptoms of a serious allergic reaction to TRADJENTA are rash, raised red patches on your skin (hives), swelling of your face, lips, and throat that may cause difficulty breathing or swallowing. If you have any symptoms of a serious allergic reaction, stop taking TRADJENTA and call your doctor right away.
What should I tell my doctor before taking TRADJENTA?
Tell your doctor if you take other medicines that can lower your blood sugar, such as a sulfonylurea or insulin.
TRADJENTA may cause serious side effects, including low blood sugar (hypoglycemia). If you take TRADJENTA with another medicine that can cause low blood sugar, such as sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea or insulin may need to be lowered while you take TRADJENTA.
Signs and symptoms of low blood sugar may include headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heartbeat, sweating, or feeling jittery.
Also tell your doctor if you take rifampin (Rifadin®, Rimactane®, Rifater®, Rifamate®), an antibiotic that is used to treat tuberculosis.
TRADJENTA may affect the way other medicines work, and other medicines may affect how TRADJENTA works.
Tell your doctor if you are pregnant or planning to become pregnant or are breastfeeding or plan to breastfeed.
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
What are the possible side effects of TRADJENTA?
The most common side effects of TRADJENTA include stuffy or runny nose and sore throat.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
For more safety information, please see Patient Information and full Prescribing Information.
TJ CONS ISI August 14 2012
To learn more about TRADJENTA visit: www.TRADJENTA.com. For full prescribing information visit: http://bidocs.boehringer-ingelheim.com/BIWebAccess/ViewServlet.ser?docBase=renetnt&folderPath=/Prescribing+Information/PIs/Tradjenta/Tradjenta.pdf or call Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800-542-6257.
Please report any unexpected effects or product problems to the Boehringer Ingelheim Drug Information Unit by calling 1-800-542-6257.
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 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.
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.
*LY2605541 is an investigational agent. Its efficacy and safety have not been finally established.
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.
1International Diabetes Federation. Diabetes Atlas, 5th Edition: Fact Sheet. 2012 Update.
2International Diabetes Federation. Diabetes Atlas, 5th Edition: What is Diabetes? http://www.idf.org/diabetesatlas/5e/what-is-diabetes. Accessed on: August 2, 2012.