European Commission Grants Marketing Authorisation to Humalog® 200 units/ml KwikPen™ Insulin

First 200 units/ml rapid-acting insulin product for the treatment of diabetes

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Oct 03, 2014, 04:00 ET

INDIANAPOLIS, Oct. 3, 2014 /PRNewswire/ -- Eli Lilly and Company today announced that the European Commission has granted marketing authorisation for Humalog^® 200 units/ml KwikPen^™ (insulin lispro 200 units/ml) for the treatment of diabetes in adults. Humalog 200 units/ml KwikPen is a prefilled pen that delivers the same amount of insulin in half the volume per injection as the currently marketed Humalog KwikPen (insulin lispro 100 units/ml).

The approval of Humalog 200 units/ml KwikPen provides patients and healthcare professionals with more options to meet their individual needs. It is intended for adults with diabetes who take more than 20 units of rapid-acting insulin per day. The prefilled pen contains 600 units of insulin – twice as many as Humalog KwikPen (insulin lispro 100 units/ml) – in the same 3 ml pen size, allowing people to use fewer pens.

"People with diabetes in the EU who require more than 20 units of mealtime insulin per day now have a new option to control their blood sugar levels," said David Kendall, M.D., vice president, Medical Affairs, Lilly Diabetes. "It represents an evolution in the mealtime insulin experience for patients who require such doses."

The Humalog 100 units/ml formulation has an established safety and efficacy profile. Approval of the Humalog 200 units/ml formulation was based on a demonstration of the bioequivalence of the Humalog 200 units/ml formulation to Humalog 100 units/ml formulation in a pharmacokinetic/pharmacodynamic clinical study.

Humalog 200 units/ml KwikPen received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency on July 24, 2014.

"Diabetes is a progressive disease that requires unique options for individual patients. We are proud to continue with our commitment to supporting people living with diabetes," said Enrique Conterno, president of Lilly Diabetes.

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 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.

Refer to: Julie Herrick Williams; (317) 698-3028; [email protected]

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SOURCE Eli Lilly and Company