Amylin buys Ohio facility, land for eventual manufacturing of exenatide LAR

By E. Janene Geiss

Philadelphia, Dec. 30 - Amylin Pharmaceuticals, Inc. said Friday that it has purchased a 150,000-square-foot building and 26 acres in West Chester, Ohio, for the eventual commercial manufacturing of a long-acting release (LAR) formulation of exenatide, a product candidate to treat type 2 diabetes.

Exenatide is the active ingredient in the commercial product Byetta (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 about $9 million, according to a company news release.

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, officials said.

The new facility is being designed to manufacture exenatide LAR in bulk form and finished drug product and also will include packaging capabilities.

The commercial use of this facility will depend upon successful clinical development, manufacturing scale up activities, validation and regulatory approval, officials said. Exenatide LAR has not been approved by the Food and Drug Administration for marketing in the United States.

Plans for the facility also include manufacturing of exenatide LAR for clinical studies at increasing scale prior to transitioning to commercial manufacturing.

The company said 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," Ginger L. Graham, president and chief executive officer of Amylin, said in the release.

Amylin, Eli Lilly and Co. and Alkermes 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 injectable long-acting release drug delivery technology, officials said.

Amylin is a San Diego biopharmaceutical company committed to development and commercialization of new medicines.

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