Eli Lilly and Company and Boehringer Ingelheim announce regulatory submission for new insulin glargine biosimilar product

European Medicines Agency accepted companies' marketing authorisation application

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Eli Lilly and Company; Boehringer Ingelheim

Jul 08, 2013, 08:00 ET

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."

About Diabetes
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 insulin.³

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.

P-LLY

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: [email protected]
Phone: +1 (317) 651-9116

Ralph Warsinsky
Launch and Established Products CVM
Boehringer Ingelheim GmbH
Email: [email protected]
Phone: +49 6132 77143880

REFERENCES

International Diabetes Federation. IDF Diabetes Atlas Poster (2012 Update - 5th Edition). 2012.
World Health Organization. 2009. Available from www.who.int/mediacentre/factsheets/fs312/en/print.html Accessed February 2013
International Diabetes Federation. What is Diabetes IDF Website - IDF DIABETES ATLAS 5th edition. 2012.

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