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BYDUREON™ RECEIVES MARKETING AUTHORIZATION IN EUROPE
Date:6/21/2011

ubmission builds upon six years of market experience with BYETTA® (exenatide) injection, the twice-daily form of exenatide that is available in more than 70 countries worldwide. The most common side effect with BYDUREON in clinical trials was mild-to-moderate nausea, which affected approximately 20 percent of patients and decreased over time in most patients. Other common side effects were vomiting, diarrhea and constipation.

In the U.S., the New Drug Application for BYDUREON (exenatide extended-release for injectable suspension) was submitted to the U.S. Food and Drug Administration (FDA) in 2009. The FDA issued a complete response letter and requested further data in late 2010. The companies plan to submit a response in the second half of 2011. BYDUREON is the proposed trade name.

BYDUREON is delivered using a biodegradable microsphere technology developed by Alkermes. The medicine offers a continuous release of exenatide with just one weekly dose.  

About Diabetes

Diabetes affects an estimated 285 million adults worldwide and nearly 26 million people in the U.S.(1),(2)  Approximately 90-95 percent of those affected have type 2 diabetes. Diabetes costs exceed $174 billion per year in direct and indirect medical expenses.(3)

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.(4) In addition, 85 percent of type 2 diabetes patients are overweight and 55 percent are considered obese.(5) Data indicate that weight loss (even a modest amount) supports patients in their efforts to achieve and sustain glycemic control.(6),(7)

About BYETTA® (exenatide) injection

BYETTA was the first glucagon-like peptide-1 (GLP-1) receptor agonist to be approved by the FDA for the treatment of type 2 diabetes. BYETT
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SOURCE Amylin Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

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1. BYDUREON™ Recommended for Approval in Europe
2. Amylin, Lilly and Alkermes Announce Receipt of Complete Response Letter from FDA for BYDUREON™
3. BYETTA® and BYDUREON™ to be Featured in More Than a Dozen Study Presentations at EASD 2010
4. Access Pharmaceuticals Receives Letter of Acceptance For MuGard Filing From SFDA of China
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