Studies Show Investigational New Insulin Glargine Product from Lilly and Boehringer Ingelheim Similar in Safety and Effi

ELEMENT-1 was a 52-week Phase III, randomized, open-label study of 535 patients with type 1 diabetes. The primary objective was to evaluate whether LY2963016 insulin glargine was non-inferior to currently marketed insulin glargine in reducing average blood sugar levels (HbA1c) from baseline at 24 weeks. Patients in the study were also treated with mealtime insulin. Anti-insulin glargine antibodies were also measured to determine the immunogenicity profile of LY2963016 insulin glargine.(4,6 )

ELEMENT-2 was a 24-week Phase III, randomized, double-blind study of 756 patients with type 2 diabetes. The primary objective was to evaluate whether LY2963016 insulin glargine was non-inferior to currently marketed insulin glargine in reducing average blood sugar levels (HbA1c) from baseline at 24 weeks in patients inadequately controlled on two or more oral diabetes medicines. Anti-insulin glargine antibodies were also measured to determine the immunogenicity profile of LY2963016 insulin glargine.(5,6 )

About the Phase I Studies

The pharmacokinetics (PK) and pharmacodynamics (PD) of LY2963016 insulin glargine and the EU- and US-approved versions of insulin glargine were evaluated in three Phase I, randomized, double-blind, cross-over replicate euglycaemic clamp studies in healthy participants. There was a minimum washout period of one week to separate the doses. Blood samples were collected pre-dose and up to 24 hours post-dose to assess PK, and a euglycaemic clamp lasting up to 24 hours was used to assess PD after administration of study insulin at 0.5 U/kg.(1 )

The PK and PD of two other doses of LY2963016 insulin glargine and currently marketed insulin glargine (0.3 and 0.6 U/kg) were also assessed in a Phase I, randomized, subject- and investigator-blinded study. Twenty-four healthy participants randomly received one of four dosing sequences, receiving a total of two doses each of LY2963016 insulin glargine and currently marketed insulin glargine. There was a minimum washout period of six days to separate the doses. Blood samples were collected pre-dose and up to 24 hours post-dose to assess PK, and a euglycaemic clamp lasting up to 24 hours was used to assess PD.(2)

A Phase I randomized, double-blind, crossover glucose clamp study assessed the duration of action of LY2963016 insulin glargine and currently marketed insulin glargine in 20 fasted males with type 1 diabetes. Patients received single administered doses of 0.3 U/kg of both insulin treatments, with a minimum washout period of one week to separate the doses. Duration of action was assessed with a euglycaemic clamp lasting up to 42 hours post-dose.(3)

About Diabetes

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.(8)

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. Find out more about the alliance at www.boehringer-ingelheim.com [http://www.boehringer-ingelheim.com/] or www.lilly.com [http://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 142 affiliates and a total of more than 47,400 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.

Taking 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 2013, Boehringer Ingelheim achieved net sales of about 14.1 billion euros. R&D expenditure corresponds to 19.5% of its net sales.

For more information please visit www.boehringer-ingelheim.com [http://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 [http://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 [http://www.lilly.com/] and http://newsroom.lilly.com/social-channels [http://newsroom.lilly.com/social-channels].

This press release contains forward-looking statements about LY2963016 (new insulin glargine product) an investigational compound that is being studied for type 1 and type 2 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 commercialization. There is no guarantee that future study results and patient experience will be consistent with study findings to date or that new insulin glargine product will receive regulatory approvals 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[mailto:hullta@lilly.com] Phone: (317) 651-9116

Ralph Warsinsky Corporate Communications Boehringer Ingelheim GmbH Email: press@boehringer-ingelheim.com[mailto:press@boehringer-ingelheim.com] Phone: +49 178 290 8561

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