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Amylin, Lilly and Alkermes Announce Receipt of Complete Response Letter from FDA for BYDUREON™
Date:10/19/2010

228-4970 (international), conference access code 7487145. A replay of the call will also be available by phone beginning approximately two hours after the close of the call and can be accessed at (866) 375-1047 (U.S./Canada) or (203) 369-0288 (international).

About Diabetes

Diabetes affects more than 24 million people in the U.S. and an estimated 285 million adults worldwide.(i),(ii) Approximately 90-95 percent of those affected have type 2 diabetes. Diabetes costs approximately $174 billion per year in direct and indirect medical expenses.(iii)

According to the Centers for Disease Control and Prevention's National Health and Nutrition Examination Survey, approximately 60 percent of people with diabetes do not achieve their target blood sugar levels with their current treatment regimen.(iv) In addition, 85 percent of type 2 diabetes patients are overweight and 55 percent are considered obese.(v) Data indicate that weight loss (even a modest amount) supports patients in their efforts to achieve and sustain glycemic control.(vi),(vii)

About BYETTA® (exenatide) injection

BYETTA is the first FDA-approved GLP-1 receptor agonist for the treatment of type 2 diabetes. BYETTA exhibits many of the same effects as the human incretin hormone glucagon-like peptide-1 (GLP-1). GLP-1 improves blood sugar after food intake through multiple effects that work in concert on the stomach, liver, pancreas and brain.

BYETTA is an injectable prescription medicine that may improve blood sugar (glucose) control in adults with type 2 diabetes mellitus, when used with a diet and exercise program. BYETTA is not insulin and should not be taken instead of insulin. BYETTA is not recommended to be taken with insulin. BYETTA is not for people with type 1 diabetes or people with diabetic ketoacidosis.

BYETTA provides sustained A1C control and low incidence of hypoglycemia when used alone or in combination with metformin or a thia
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SOURCE Amylin Pharmaceuticals, Inc.; Eli Lilly and Company; Alkermes, Inc.
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Storage temperature: 2 - 8C, linearity: 0 - 25 mg/dL, expected value: male: 3.5 - 7.0 mg/dL and female: 2.5 - 6.0 mg/dL. Available with calibrator and number of test 500....
Storage temperature: 15 - 30C, linearity: 0 - 20 mg/dL, expected value: male: 3.0 - 7.0 mg/dL and female: 2.2 - 6.2 mg/dL. Available with calibrator and number of tests 125....
The assay kit is for determination of uric acid in serum or urine. Wavelength: 600 nm. Linear range: up to 80 mg/dL....
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