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Amylin Pharmaceuticals and Eli Lilly and Company Statement on FDA's BYETTA(R) (Exenatide) Injection Update
Date:11/2/2009

pon existing language regarding use of BYETTA in patients with renal impairment, which Amylin and Lilly updated in September 2007 to include additional language regarding renal adverse events. It specifies that BYETTA should not be used in patients with severe renal impairment or end-stage renal disease and should be used with caution in patients with renal transplantation. It also specifies that because BYETTA may induce nausea and vomiting with transient hypovolemia (low blood volume), treatment may worsen renal function. This update was communicated to physicians via a "Dear Healthcare Professional" letter, which is available at www.BYETTA.com.

BYETTA has extensive post-marketing experience and a well-documented safety profile. BYETTA has been used by more than one million patients since market introduction in 2005. It has a proven history with more than 10 million prescriptions written and 6.5 years of clinical experience.

About Diabetes

Diabetes affects more than 24 million people in the United States and an estimated 246 million adults worldwide.(i, ii) Approximately 90-95 percent of those affected have type 2 diabetes. Diabetes is the fifth leading cause of death by disease in the United States and 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
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SOURCE Amylin Pharmaceuticals, Inc.
Copyright©2009 PR Newswire.
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