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Amylin and Lilly Seek Expanded Use of BYETTA® Along with Basal Insulin
Date:12/22/2010

SAN DIEGO and INDIANAPOLIS, Dec. 22, 2010 /PRNewswire/ -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY) today announced that a supplemental New Drug Application (sNDA) has been submitted to the U.S. Food and Drug Administration (FDA) for the expanded use of BYETTA® (exenatide) injection as an add-on therapy to basal insulin, with or without metformin and/or a thiazolidinedione (TZD) in conjunction with diet and exercise for adults with type 2 diabetes who are not achieving adequate glycemic control.

BYETTA, the first marketed GLP-1 receptor agonist, was approved in the U.S. in April 2005 for the treatment of type 2 diabetes as add-on therapy to diet and exercise for adult patients not achieving adequate glycemic control using commonly prescribed oral diabetes medications. In October 2009, BYETTA was approved as monotherapy along with diet and exercise. BYETTA is available in more than 60 countries worldwide.

"Many patients using basal insulin with or without oral diabetes medications are unable to maintain adequate blood sugar control, particularly at mealtime," said Orville G. Kolterman, M.D., senior vice president, chief medical officer, Amylin Pharmaceuticals. "If approved for this expanded use, BYETTA may provide a complementary addition to basal insulin to improve overall blood sugar control with no weight gain and no increased risk of hypoglycemia. The combination may also offer a mealtime treatment option that is taken only twice a day and does not require dosing titration."

The sNDA is based on a double-blind, placebo-controlled clinical study evaluating BYETTA added to Lantus® (insulin glargine). The study showed many hard-to-treat patients with type 2 diabetes who were poorly controlled on basal insulin therapy w
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SOURCE Amylin Pharmaceuticals, Inc.; Eli Lilly and Company
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