SAN DIEGO, Jan. 9, 2012 /PRNewswire/ -- 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.
In a presentation at the 30th Annual J.P. Morgan Healthcare Conference in San Francisco, Amylin President and Chief Executive Officer Daniel M. Bradbury highlighted steps the company is taking to prepare for the planned United States (U.S.) launch this quarter of the investigational medication BYDUREON™ (exenatide extended-release for injectable suspension), which is currently under review by the U.S. Food and Drug Administration (FDA) and has a Prescription Drug User Fee Action (PDUFA) date of January 28, 2012. In addition, Mr. Bradbury unveiled the Company's 2012 goals to realize the global value of its exenatide franchise, maximize the contribution from marketed products BYETTA® (exenatide) injection and SYMLIN® (pramlintide acetate) injection, and advance its late-stage product pipeline.
"We have a truly extraordinary opportunity at Amylin, as we embark on a year in which we are prepared to deliver the first ever once-weekly therapy in the U.S. for patients with type 2 diabetes – which we believe could change the way people with diabetes manage their disease," stated Mr. Bradbury. "With the addition of BYDUREON in the U.S., we will solidify our position as a driving force in the fight against this rising global epidemic. We have demonstrated strong fiscal discipline in recent years and are now very well positioned to drive shareholder value with the pending commercialization of BYDUREON."
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.
A recording of the presentation is accessible through the "Investors" section of Amylin's corporate website, located at www.amylin.com.
About Amylin Pharmaceuticals
Amylin Pharmaceuticals is a biopharmaceutical company dedicated to improving lives of patients through the discovery, development and commercialization of innovative medicines. Amylin is committed to delivering novel therapies that transform the way diabetes, obesity and related metabolic disorders are treated. Amylin is headquartered in San Diego, California and has a commercial manufacturing facility in Ohio. More information about Amylin Pharmaceuticals is available at www.amylin.com.
This press release contains forward-looking statements about Amylin, which involve risks and uncertainties. Our actual results could differ materially from those discussed herein due to a number of risks and uncertainties, including risks that BYETTA, BYDUREON or SYMLIN, and the revenues generated from these products, may be affected by competition, unexpected new data, safety and technical issues, or manufacturing and supply issues; risks that the strategic initiatives mentioned in this press release will not produce the results we expect; risks that our financial results may fluctuate significantly from period to period and may not meet market expectations; risks that any financial guidance we provide may not be accurate; risks that our clinical trials will not be completed when planned, may not replicate previous results, may not be predictive of real world use or may not achieve desired end-points; risks that our preclinical studies may not be predictive; risks that our NDAs for product candidates, such as the BYDUREON NDA, or sNDAs for label expansion requests may not be submitted timely or receive FDA approval; risks that the information we provided in our response to the FDA's BYDUREON complete response letter may not satisfy the FDA; risks that the FDA may request additional information prior to approving BYDUREON; risks that we will not launch BYDUREON, if approved, in a timely or successful manner; risks that our efforts to expand the reach of our sales force will not produce the results we expect; risks that we will not be successful in our efforts to advance new forms and delivery options for exenatide or in our efforts to secure an exenatide commercial partner outside the U.S.; risks that we will not submit the remaining components of the BLA mentioned in this press release in a timely manner; risks that we will not initiate the Phase 3 programs mentioned in this press release in a timely manner; risks that our efforts to drive operational efficiencies, reduce operating costs and/or preserve cash will not produce the results we expect and other risks inherent in the drug development and commercialization process. Commercial and government reimbursement and pricing decisions and the pace of market acceptance may also affect the potential for BYETTA, BYDUREON or SYMLIN. These and additional risks and uncertainties are described more fully in the Company's recently filed Form 10-Q. Amylin disclaims any obligation to update these forward-looking statements.
SOURCE Amylin Pharmaceuticals, Inc.
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