g previous results, or not achieving the intended clinical endpoints; the DURATION-3 superiority study results potentially not being predictive of real world use including results relative to other diabetes medications; pre-clinical trials not predicting future results; label expansion requests or New Drug Application (NDA) filings, not being submitted in a timely manner; regulatory approval, including approval for exenatide once weekly, being delayed or not received; or manufacturing and supply issues. The potential for exenatide once weekly may also be affected by government and commercial reimbursement and pricing decisions, the pace of market acceptance, or scientific, regulatory and other issues and risks inherent in the development and commercialization of pharmaceutical products including those inherent in the collaboration with and dependence upon Amylin, Lilly and/or Alkermes. These and additional risks and uncertainties are described more fully in Amylin's, Lilly's and Alkermes' most recent SEC filings including their Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K. Amylin, Lilly and Alkermes undertake no duty to update these forward-looking statements.
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(i) "All About Diabetes." American Diabetes Association. Available at:http://www.diabetes.org/about-diabetes.jsp. Accessed July 13, 2009.
(ii) The International Diabetes Federation Diabetes Atlas. Available at:http://www.idf.org/home/index.cfm?unode=3B96906B-C026-2FD3-87B73F80BC22682A. Accessed July 13, 2009.
(iii) "Direct and Indirect Costs of Diabetes in the United States." American Diabetes Association. Available at:http://www.diabetes.org/diabe
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SOURCE Amylin Pharmaceuticals, Inc.; Eli Lilly and Company Copyright©2009 PR Newswire. All rights reserved | |
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One Year Study of Exenatide Treatment Showed Improved Beta-Cell Function2.
One Year Study of Exenatide Treatment Showed Improved Beta-Cell Function3.
Monotherapy BYETTA(R) (exenatide) Injection Study Results Presented at ADA 2008 Showed Adults with Type 2 Diabetes Experienced Improved Glycemic Control and Weight Loss4.
Type 2 Diabetes Patients Taking Exenatide Once Weekly, a Phase 3 Investigational Diabetes Therapy, Showed Improvements in Glycemic Control, Weight5.
After One Year, Type 2 Diabetes Patients Taking Exenatide Once Weekly Sustained Improvements in Glycemic Control and Weight; DURATION-1 Presented at ADA 20086.
Plans for Exenatide Once Weekly NDA Submission by End of First Half of 2009 Reaffirmed Following FDA Feedback7.
Exenatide Once Weekly Provided Superior Glucose Control With Weight Loss Compared to Sitagliptin or Pioglitazone in Head-to-Head DURATION-2 Study8.
Amylin and Lilly Announce Plans to Develop Pen Device for Exenatide Once Weekly9.
Exenatide Once Weekly Provided Sustained Improvements in Glycemic Control With Weight Loss Over Two Years: DURATION-1 Interim Long-Term Data Presented at ADA 200910.
Meta-Analysis of Clinical Data Showed No Increased Risk of Cardiovascular Events Associated With Exenatide Use: Data Presented at ADA 200911.
The Lancet Publishes Direct Comparison Study Between Liraglutide and Exenatide