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| Amylin Pharmaceuticals Acquires Facility in Ohio to Manufacture Exenatide LAR |
SAN DIEGO, Dec. 29 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) today announced that it has purchased an existing 150,000 square foot building and 26 acres of land in West Chester, Ohio. This acquisition completes previously announced facility expansion plans for the eventual commercial manufacturing of a long-acting release (LAR) formulation of exenatide, a product candidate in development for the treatment of type 2 diabetes. Exenatide is the active ingredient in the commercial product BYETTA(R) (exenatide) injection, which is used twice a day for the treatment of type 2 diabetes. The acquisition price and associated costs for the building and land were approximately $9 million. Facility and process design efforts are already underway and construction is set to begin in early 2006. The facility is expected to cost up to $150 million and will be completed in phases, allowing initial use of the facility before final aspects of construction are completed in 2008. Amylin's new facility is being designed to manufacture exenatide LAR in bulk form and finished drug product, and will also include packaging capabilities. The commercial use of this facility will depend upon successful clinical development, manufacturing scale up activities, validation and regulatory approval. The plans for the facility also include manufacturing of exenatide LAR for clinical studies at increasing scale prior to transitioning to commercial manufacturing. Alkermes, Inc. will continue to provide exenatide LAR for clinical studies. "This new facility is strategically located near our technology partner Alkermes, which will facilitate technology transfer and allow for additional support as we move forward," said Ginger L. Graham, President and CEO of Amylin Pharmaceuticals. "We are also very pleased with the cooperation and resources available to us in Ohio and Butler County, and look forward to building relationships within the community." About Exenatide LAR Amylin, Eli Lilly and Company, and Alkermes Inc. are working together to develop a once weekly sustained release, subcutaneous injection of exenatide for the treatment of type 2 diabetes based on Alkermes' proprietary Medisorb(R) injectable long-acting release drug delivery technology. Exenatide LAR has not been approved by the Food and Drug Administration (FDA) for marketing in the United States. About Amylin Amylin Pharmaceuticals is a biopharmaceutical company committed to improving lives through the discovery, development and commercialization of innovative medicines. Amylin has developed and gained approval for two first-in-class medicines for diabetes, SYMLIN(R) (pramlintide acetate) injection and BYETTA(R) (exenatide) injection. Amylin is located in San Diego, California with over 1000 employees nationwide. Further information on Amylin Pharmaceuticals and its pipeline in metabolism is available at www.amylin.com. This press release contains forward-looking statements about Amylin. The company's actual results could differ materially from those discussed in this press release due to a number of risks and uncertainties, including that BYETTA may not prove to be an important new therapeutic option or may be affected by unexpected new data or technical issues; risks and uncertainties that current or future exenatide LAR clinical trials may not confirm previous clinical trial results; risks and uncertainties inherent in the collaboration with and dependence upon Lilly and/or Alkermes; risks that exenatide LAR may not be successfully developed or receive regulatory approval; and risks and uncertainties that Amylin will be able to complete construction, manufacturing scale up, and validation of the manufacturing facility on a timely basis and/or within its budget projections, or at all. These and additional risks and uncertainties are described more fully in the Company's SEC filings, including its Form 10-Qs. Amylin undertakes no duty to update these forward-looking statements.
SOURCE Amylin Pharmaceuticals, Inc. |
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