Tag Archives: Boehringer Ingelheim

EASD: Additional Evidence Showed ABASAGLAR® (insulin glargine) Provided Safety and Efficacy Similar to Lantus®

Secondary analyses evaluated ABASAGLAR® in patients previously treated with Lantus® insulin glargine

STOCKHOLM, Sept. 15, 2015 / PRNewswire — Data from secondary analyses of Phase III clinical trials showed that ABASAGLAR® (insulin glargine), Eli Lilly and Company and Boehringer Ingelheim’s biosimilar insulin glargine, demonstrated safety and efficacy outcomes similar to Lantus® insulin glargine in patients with type 1 and type 2 diabetes who received pre-study treatment with Lantus®. These data were presented today at the 51st European Association for the Study of Diabetes (EASD) Annual Meeting in Stockholm, Sweden.

The subgroup of patients previously treated with Lantus® had significant reductions in average blood glucose levels (HbA1c) from baseline when they were randomised to either ABASAGLAR® or Lantus®. Similar to the total study population, the analyses showed no significant differences in HbA1c reduction from baseline to 52 weeks in type 1 patients (-0.28 percent vs. -0.26 percent) and to 24 weeks in type 2 patients (-1.02 percent vs. -1.01 percent) with ABASAGLAR® and Lantus® treatment, respectively.

Eli Lilly and Company logo.

Results also showed no significant differences between the two treatments in key secondary efficacy and safety measures, including percentage of patients reaching target HbA1c levels, total and nocturnal hypoglycaemia rates and incidence of treatment-related adverse events. Statistical differences were seen in weight change, incidence of detectable antibodies and incidence of serious adverse events; however, these differences were not observed in the total study populations. Further, these results were not consistently observed across both studies and did not indicate any clinically meaningful treatment differences.

“These secondary analyses are important because they provide additional perspectives on how ABASAGLAR works in people with diabetes, regardless of prior insulin glargine treatment,” said David Kendall, MD, vice president, Medical Affairs, Lilly Diabetes. “These data provide important additional evidence for the similarity of ABASAGLAR to Lantus in people with type 1 and type 2 diabetes and provide physicians further information on this new treatment option.”

ABASAGLAR® was first granted approval by the European Commission in September 2014, marking the first biosimilar insulin approval in the European Union. As of September 2015, ABASAGLAR® has been commercially launched in several countries including Germany, United Kingdom, Estonia, the Czech Republic, Slovakia and Japan. It will launch in other markets throughout the remainder of 2015 and thereafter. Globally, Lilly and Boehringer Ingelheim refer to their insulin glargine product as Basaglar™, which will be the trade name in many regions across the world. In Europe, the product is referred to as ABASAGLAR®.

Manufacturing biological medicines is a complex process, and expertise is needed for consistent product quality. Lilly and Boehringer Ingelheim have extensive expertise, insights and knowledge, which enable them to provide high-quality medicines to help meet the needs of people with diabetes around the world.

About the Data
These secondary analyses evaluated the efficacy and safety of ABASAGLAR® compared to Lantus® insulin glargine in a subgroup of patients who reported pre-study treatment with Lantus® insulin glargine in two prospective, global, Phase III, parallel, randomised studies: ELEMENT-1, a 52-week open-label study in people with type 1 diabetes, and ELEMENT-2, a 24-week double-blind study in people with type 2 diabetes. The primary endpoint was defined as change in HbA1c from baseline to 24 weeks. Secondary measures included proportion of patients achieving endpoint HbA1c targets, insulin dose (basal insulin for type 1 and type 2 patients; mealtime insulin for type 1 patients only), change in body weight, hypoglycaemia, insulin antibodies and adverse events.

About ABASAGLAR®
ABASAGLAR® is indicated for the treatment of diabetes mellitus in adults, adolescents and children aged two years and above. ABASAGLAR® is available in cartridges and the pre-filled KwikPen™. It is designed to be taken once a day, at the same time each day, to lower blood glucose. ABASAGLAR® should not be used to treat diabetic ketoacidosis.

Boehringer Ingelheim and Eli Lilly and Company
In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an alliance in diabetes that centers on compounds representing several of the largest diabetes treatment classes. The alliance leverages the strengths of two of the world’s leading pharmaceutical companies. By joining forces, the companies demonstrate commitment in the care of patients with diabetes and stand together to focus on patient needs. Depending on geographies, the companies either co-promote or separately promote the respective molecules each contributed to the alliance. 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, Boehringer Ingelheim operates globally with 146 affiliates and a total of more than 47,700 employees. The focus of the family-owned company, founded in 1885, is researching, developing, manufacturing and marketing new medications of high therapeutic value for human and veterinary medicine.

Boehringer Ingelheim logo.

Social responsibility is an important element of the corporate culture at Boehringer Ingelheim. This includes worldwide involvement in social projects, such as the initiative “Making more Health” and caring for the employees. Respect, equal opportunities and reconciling career and family form the foundation of the mutual cooperation. In everything it does, the company focuses on environmental protection and sustainability.

In 2014, Boehringer Ingelheim achieved net sales of about 13.3 billion euros. R&D expenditure corresponds to 19.9 percent of its net sales.

For more information please visit www.boehringer-ingelheim.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 are building upon this heritage by working to meet the diverse needs of people with diabetes and those who care for them. Through research and collaboration, a broad and growing product portfolio and a continued determination to provide real solutions—from medicines to support programs and more—we strive to make life better for all those affected by diabetes around the world. For more information, visit www.lillydiabetes.com.

About Eli Lilly and Company
Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com and newsroom.lilly.com/social-channels.

ABASAGLAR® is a registered trademark of Eli Lilly and Company.
Basaglarand KwikPen™ are trademarks of Eli Lilly and Company.
Lantus® is a registered trademark of Sanofi.

This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about ABASAGLAR® (insulin glargine) as a treatment for patients with diabetes mellitus in adults, adolescents and children aged two years and above and reflects Lilly’s current belief. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. Among other things, there can be no guarantee that future study results will be consistent with the results to date or that ABASAGLAR® will receive additional regulatory approvals. For further discussion of these and other risks and uncertainties, see Lilly’s most recent Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.

CONTACT:
Molly McCully
Communications Manager
Lilly Diabetes
Email: mccully_molly@lilly.com
Phone: +1-317-478-5423

Ralph Warsinsky
Corporate Communications
Boehringer Ingelheim GmbH
Email: press@boehringer-ingelheim.com
Phone: +49 (6132) 77-7051

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Eli Lilly and Company and Boehringer Ingelheim announce new drug application filing in the U.S. for new insulin glargine product

– New Drug Application follows submission of Marketing Authorisation Application to the European Medicines Agency

INDIANAPOLIS and INGELHEIM, Germany, Dec. 20, 2013 / PRNewswire – Eli Lilly and Company and Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) has accepted the filing of the New Drug Application (NDA) for LY2963016, an investigational basal (long-acting) insulin.

20131003121232ENPRN06 Eli Lilly and Company and Boehringer Ingelheim announce new drug application filing in the U.S. for new insulin glargine product

Eli Lilly and Company logo.

LY2963016 is a new insulin glargine product developed for the treatment of patients with type 1 and type 2 diabetes. The NDA was filed through the 505(b)(2) regulatory pathway, which allows the FDA to reference their previous findings of safety and efficacy data for an already-approved insulin glargine product, in addition to the studies of LY2963016.

Lilly and Boehringer Ingelheim designed the comprehensive development program for LY2963016 in order to meet the regulatory standards of clinical and nonclinical safety, efficacy and quality. In addition to comparative pharmacokinetic and pharmacodynamic studies, the NDA submission includes results from Phase III studies that were conducted in patients with type 1 and type 2 diabetes, using a currently marketed insulin glargine product as the active comparator.

“The U.S. regulatory submission for our new insulin glargine product demonstrates our progress in bringing another option to the millions of Americans with diabetes who require long-acting insulin as an integral part of their treatment plan,” said Gwen Krivi, Ph.D., vice president, Lilly Diabetes product development. “This submission of the NDA for this product helps us realize the goal of the Lilly-Boehringer Ingelheim Diabetes alliance, which is to leverage our combined expertise to develop important treatments for people with diabetes.”

In July 2013, the companies announced the marketing authorisation application (MAA) for LY2963016 was accepted for review by the European Medicines Agency (EMA).

About Diabetes
Approximately 24.4 million Americans and an estimated 382 million people worldwide have type 1 or type 2 diabetes. Type 2 diabetes is the most common type, accounting for an estimated 85 to 95 percent of all diabetes cases. Diabetes is a chronic condition that occurs when the body either does not properly produce, or use, the hormone insulin.(1)

20130924101116E Eli Lilly and Company and Boehringer Ingelheim announce new drug application filing in the U.S. for new insulin glargine product

Boehringer Ingelheim logo.

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 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 140 affiliates and more than 46,000 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.

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 Ingelheim’s endeavours.

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 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 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.

CONTACT:

Tammy Hull
Communications Manager
Lilly Diabetes
Email: hullta@lilly.com
Phone: +1 (317) 651-9116

Ralph Warsinsky
Launch and Established Products CVM
Boehringer Ingelheim GmbH
Email: press@boehringer-ingelheim.com
Phone:  +49 6132 777051

­­REFERENCES

  1. International Diabetes Federation. IDF Diabetes Atlas, 6th edn. Brussels, Belgium: International Diabetes Federation, 2013. http://www.idf.org/diabetesatlas. Accessed on December 18, 2013.

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