Amylin Pharmaceuticals Acquires Facility in Ohio to Manufacture Exenatide LAR
December 29 2005 - 4:29PM
PR Newswire (US)
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 http://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. DATASOURCE: Amylin
Pharmaceuticals, Inc. CONTACT: Alice Bahner, Executive Director,
Investor Relations of Amylin Pharmaceuticals, Inc.,
+1-858-552-2200, ext. 7272 Web site: http://www.amylin.com/
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