CHMP Recommends Approval of Lilly's Humalog® 200 units/ml KwikPen®

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Positive opinion could lead to first 200 units/ml rapid-acting insulin in Europe for the treatment of type 1 and type 2 diabetes

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Eli Lilly and Company

Jul 30, 2014, 08:00 ET

INDIANAPOLIS, July 30, 2014 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that the Committee for Medicinal Products for Human Use (CHMP), a division of the European Medicines Agency, has recommended approval of insulin lispro 200 units/ml (proposed trade name: Humalog^® 200 units/ml KwikPen^®) for the treatment of type 1 and type 2 diabetes in adults.

Humalog 200 units/ml KwikPen is a pre-filled pen which, if approved, will deliver the same amount of insulin with half the volume per injection as the currently marketed Humalog^® (insulin lispro 100 units/ml) KwikPen. The device holds 600 units of insulin – twice as many as Humalog (insulin lispro 100 units/ml) KwikPen – in the same 3 ml pen size. Humalog 200 units/ml KwikPen is intended for people with diabetes who take more than 20 units of rapid-acting insulin per day.

"Diabetes is a progressive disease, often requiring increased doses of insulin over time to control a patient's blood sugar levels," said David Kendall, M.D., vice president, Medical Affairs, Lilly Diabetes. "Humalog 200 units/ml KwikPen is the first and only 200 units/ml mealtime insulin and represents an important advancement in the treatment of diabetes."

A pharmacokinetics/pharmacodynamics study comparing insulin lispro U-200 to Humalog U-100 met the criteria established for bioequivalency, providing support for the same efficacy and safety profile as Humalog U-100. Additionally, there were no adverse events related to study drug observed in the study.

The European Commission typically follows the committee's recommendation and is expected to make its final decision in approximately two months.

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 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.^{^[1]}

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 http://newsroom.lilly.com/social-channels.

This press release contains forward-looking statements about Humalog 200 units/ml KwikPen for use in the treatment of 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 Humalog 200 units/ml KwikPen 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.

^[1] International Diabetes Federation. Diabetes Atlas, 6th Edition: Fact Sheet. 2013.