Alkermes and Lilly Expand AIR Inhaled Insulin Collaboration

01-10-2007: Alkermes, Inc. and Eli Lilly and Company announced that they have signed a commercial manufacturing agreement for AIR® Inhaled Insulin (AIR® Insulin). As a result of the agreement, Alkermes will be the exclusive commercial manufacturer of AIR Insulin powder for the AIR® Inhaled Insulin System (AIR® Insulin System). The manufacturing agreement provides for an additional investment by Lilly for the construction and operation of a second manufacturing line at Alkermes' commercial-scale production facility for inhaled medications, expanding the facility's powder production capacity to meet post-launch requirements. The AIR Insulin System is currently in phase 3 clinical development by Lilly and Alkermes and is being studied as an innovative treatment for type 1 and type 2 diabetes.

Under the terms of the agreement, Alkermes is responsible for overseeing construction of the second manufacturing line, including process development, scale-up and validation, as well as for the manufacture and supply of inhaled insulin powder. Lilly is responsible for funding activities related to the construction, development and operation of the second manufacturing line as well as the facility expansion required to support the manufacturing line. Lilly is also responsible for all product packaging. If inhaled formulations of insulin are successfully developed and commercialized, Lilly will purchase product from the facility. Additional terms of the agreement were not disclosed.