Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Indiana, Lilly provides answers - through medicines and information - for some of the world's most urgent medical needs.
Alkermes, Inc. is a fully integrated biotechnology company committed to developing innovative medicines to improve patients' lives. Alkermes' robust pipeline includes extended-release injectable and oral products for the treatment of prevalent, chronic diseases, such as central nervous system disorders, addiction and diabetes. Headquartered in Waltham, Massachusetts, Alkermes has a research facility in Massachusetts and a commercial manufacturing facility in Ohio.
This press release contains forward-looking statements about Amylin, Lilly and Alkermes. 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 not be approved by the FDA or in the EU in a timely manner or at all; the companies' response to the complete response letter may not satisfy the FDA; the FDA may request additional information prior to approval; exenatide and/or the approval of exenatide once weekly and the revenues generated from these products may be affected by competition; unexpected new data; safety and technical issues; clinical trials not being completed in a timely manner, not confirming previous results, not being predictive of real world use or not achieving the intended clinical endpoints; label expansion requests or NDA filings, such as the NDA filing for exenatide once weekly mentioned in this press release, not receiving regulatory approval; the commercial launch of exenatide once weekly being delayed; or manufacturing and supply issues. The potential for exenatide and/or 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.
BYDUREON(TM) and BYETTA(R) are trademarks of Amylin Pharmaceuticals, Inc., and Medisorb(R) is a registered trademark of Alkermes, Inc. All other marks are the marks of their respective owners.
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(iii) Turner RC, Cull CA, Frighi V, Holman RR. Glycemic control with diet, sulfonylurea, metformin, or insulin in patients with type 2 diabetes mellitus: progressive requirement for multiple therapies (UKPDS 49). JAMA. 1999; 281 (21):2005-2012.
(iv) The International Diabetes Federation Diabetes Atlas. Available at http://www.diabetesatlas.org/content/what-is-diabetes. Accessed on June 9, 2010.
(v) The International Diabetes Federation Diabetes Atlas. Available at http://www.diabetesatlas.org/content/what-is-diabetes. Accessed on June 9, 2010.
(vi) The International Diabetes Federation Diabetes Atlas. Available at: http://www.diabetesatlas.org/content/eur.... Accessed on June 9, 2010.
(vii) 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.
(Logo: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO )
Media: Anne Erickson, Amylin, +1-858-754-4443, Cell, +1-858-349-3195, anne.erickson@amylin.com; Tim Coulom, Lilly, +1-317-655-2998, Cell, +1-317-544-9757, coulomtd@lilly.com; Rebecca Peterson, Alkermes, +1-781-609-6378, Cell, +1-617-899-2447, rebecca.peterson@alkermes.com
