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.
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
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
SOURCE 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