Amylin (AMLN) Updates on BYDUREON, BYETTA, Other Drivers of Growth in FY12
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Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) today outlined its key strategic priorities for 2012, with a strong focus on driving the global commercial value of its diabetes franchise.
2012 Corporate Priorities
2012 Corporate Priorities
- Successfully launch BYDUREON in the United States. Amylin is prepared to leverage its commercial expertise in the glucagon-like peptide-1 (GLP-1) market and invest in the BYDUREON opportunity.
- Secure a partner outside the U.S. for exenatide. While Eli Lilly and Company continues to provide uninterrupted patient supply and support for BYETTA and BYDUREON in markets outside the U.S., Amylin is committed to ensuring a seamless transition of exenatide responsibilities in those markets to one or more new partners to maximize the global potential of these innovative products and future exenatide products.
- Maximize the value of BYETTA and SYMLIN. BYETTA is now the only short-acting GLP-1 agonist approved for use as an add-on therapy to insulin glargine in patients with type 2 diabetes, with or without metformin and/or a thiazolidinedione (TZD). For patients not at goal on insulin glargine, adding BYETTA can deliver a complementary approach to glycemic control. Amylin will support SYMLIN with a dedicated commercial organization in 2012. SYMLIN is indicated for patients with type 1 or type 2 diabetes using mealtime insulin and enables patients to achieve more time in the normal glycemic range.
- Advance the metreleptin development program. In the first half of 2012, Amylin plans to complete the rolling Biologics License Application (BLA) submission for the use of metreleptin to treat diabetes and/or hypertriglyceridemia in patients with rare forms of lipodystrophy, an ultra orphan indication with a dramatic unmet medical need. This program fits with the Company's overall diabetes strategy and can leverage existing commercial infrastructure.
- Advance exenatide once-weekly suspension and once-monthly suspension global development programs. Amylin plans to begin a Phase 3 program in mid 2012 for exenatide once-weekly suspension. The exenatide suspension formulations do not require reconstitution.
- Continue focused financial discipline. Building on its record of solid fiscal discipline, Amylin will focus on creation of shareholder value while making deliberate investments in value-driving opportunities including support for the commercialization of BYDUREON.
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