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Amylin to Advance Key Value-Driving Opportunities in 2011
Date:1/10/2011

SAN FRANCISCO, Jan. 10, 2011 /PRNewswire/ -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) today outlined its strategic corporate priorities for 2011, highlighting its continued focus on strong fiscal discipline while maximizing the value of the Company's diabetes franchise, notably through advancing the investigational compound BYDUREON™ (exenatide extended-release for injectable suspension) and other value-driving development programs. Daniel M. Bradbury, president and chief executive officer, provided an update on the Company's strategy at the 29th Annual JPMorgan Healthcare Conference in San Francisco.

"With evidence mounting daily about the incredible toll of the diabetes epidemic, we continue to work with a great sense of urgency to meet the needs of patients and secure approval for BYDUREON, which we believe is a potential game changer for the way people with type 2 diabetes manage their disease," said Bradbury. "In 2011, we will continue to pursue operating efficiencies within our business that will enable us to invest strategically in BYDUREON and other value-creating opportunities, including late-stage programs in obesity and lipodystrophy."

2011 Corporate Priorities

During his presentation, Bradbury highlighted the key corporate priorities for the year ahead, including:  

  • Maximize the value of Amylin's established diabetes franchise. Expand the use of BYETTA® (exenatide) injection, and develop the value of SYMLIN® (pramlintide acetate) injection;
  • Advance Amylin's metabolic pipeline. Key areas of focus will include:
    • Submit the reply to the U.S. Food and Drug Administration (FDA) regarding the second complete response letter for BYDUREON by the end of 2011;
    • Advance new forms and delivery options for exenatide;
    • Submit the remaining component of the rolling Biologics License Application (BLA) for metreleptin to treat rare forms of lipodystrophy;
    • Advance the obesity program, in partnership with Takeda; and
    • Submit the Investigational New Drug (IND) application and initiate the first clinical study of AC165198, a new fusion peptide, under the Company's collaboration with Biocon;
  • Manage expenses in line with expected revenue. The Company will continue to drive efficiencies to further build operating leverage and preserve cash to invest in high-value opportunities.

A recording of the presentation is accessible through the "Investors" section of Amylin's corporate website, located at www.amylin.com.

About Amylin Pharmaceuticals, Inc.

Amylin Pharmaceuticals is a biopharmaceutical company dedicated to improving lives of patients through the discovery, development and commercialization of innovative medicines. Amylin has developed and gained approval for two first-in-class medicines for diabetes, SYMLIN®(pramlintide acetate) injection and BYETTA® (exenatide) injection. Amylin's research and development activities leverage the Company's expertise in metabolism to develop potential therapies to treat diabetes and obesity. Amylin is headquartered in San Diego, California. Further information on 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 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 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 our response to the FDA's BYDUREON complete response letter may not be submitted in a timely manner and/or the information we provide in our response may not satisfy the FDA; risks that the FDA may request additional information prior to approving BYDUREON; risks that we will not be successful in our efforts to advance new forms and delivery options for exenatide; 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 submit the IND or initiate the clinical study mentioned in this press release for AC165198 in a timely manner; risks that our efforts to drive operational efficiencies and 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 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.


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SOURCE Amylin Pharmaceuticals, Inc.
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