Alkermes, Inc. is a fully integrated biotechnology company committed to developing innovative medicines to improve patients' lives. Alkermes' robust pipeline includes extended-release injectable, pulmonary and oral products for the treatment of prevalent, chronic diseases, such as central nervous system disorders, addiction and diabetes. Headquartered in Cambridge, Massachusetts, Alkermes has research facilities in Massachusetts and a commercial manufacturing facility in Ohio.
This press release contains forward-looking statements about Amylin, Lilly and Alkermes and the investigational drug, exenatide once weekly. Actual results could differ materially from those discussed or implied in this press release due to a number of risks and uncertainties, including the risk that exenatide once weekly may be affected by unexpected new data; safety and technical issues; clinical trials not confirming previous results, or not achieving the intended clinical endpoints; the DURATION-5 superiority study results potentially not being predictive of real world use; 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 of 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.
BYETTA(R) is a registered trademark of Amylin Pharmaceuticals, Inc. and Medisorb(R) is a registered trademark of Alkermes, Inc.
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(4) The International Diabetes Federation Diabetes Atlas. Available at http://www.diabetesatlas.org/content/what-is-diabetes. Accessed on December 13, 2009.
(5) The International Diabetes Federation Diabetes Atlas. Available at http://www.diabetesatlas.org/content/what-is-diabetes. Accessed on December 13, 2009.
(6) The International Diabetes Federation Diabetes Atlas. Available at: http://www.diabetesatlas.org/content/eur.... Accessed on December 13, 2009.
(7) Kolterman, O, Buse J, Fineman M, Gaines E, Heintz S, Bicsak T, Taylor K, Kim D, Aisporna M, Wang Y, Baron A. Synthetic exendin-4 (exenatide) significantly reduces postprandial and fasting glucose in subjects with type 2 diabetes. Journal of Clinical Endocrinology & Metabolism. 2003; 88(7):3082-3089.
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Anne Erickson, Amylin, +1-858-754-4443, Cell: +1-858-349-3195, anne.erickson@amylin.com; or Tim Coulom, Lilly, +1-317-655-2998, Cell: +1-317-544-9757, coulom_timothy_d@lilly.com; or Rebecca Peterson, Alkermes, +1-617-583-6378, Cell: +1-617-899-2447, rebecca.peterson@alkermes.com