Alkermes, Lilly to collaborate on inhaled treatment for osteoporosis

By Lisa Kerner

Erie, Pa., Jan. 9 - Alkermes, Inc. and Eli Lilly and Co. signed an agreement to develop inhaled formulations of parathyroid hormone.

The development program will use the Alkermes AIR pulmonary drug delivery system and Lilly's recombinant parathyroid hormone, Forteo, approved by the Food and Drug Administration for the treatment of osteoporosis in postmenopausal women.

Under the terms of the agreement, Alkermes will receive funding for product and process development activities. The company will also receive upfront and milestone payments.

The agreement calls for Lilly to maintain exclusive worldwide rights to products resulting from the collaboration. Lilly will pay Alkermes royalties based on product sales.

Alkermes will have responsibility for nonclinical development activities, primarily formulation testing and device development. Lilly will have responsibility for all other nonclinical development activities and all clinical development and regulatory activities.

The partnership to commercialize parathyroid hormone marks the third collaboration between Alkermes and Lilly to develop medicines based on Alkermes' AIR pulmonary drug delivery technology.

In 2000, the companies established an alliance for the development of an inhaled formulation of human growth hormone, currently in phase 1 of clinical development.

The companies entered an agreement in 2001 to develop an inhaled insulin system that delivers human insulin inhalation powder, which began phase 3 clinical studies in July.

Alkermes, with headquarters in Cambridge, Mass., develops extended-release injectable products and pulmonary drug products.

Headquartered in Indianapolis, Ind., Lilly is developing a portfolio of pharmaceutical products using research from its worldwide laboratories and through collaborations with other organizations.

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