Alkermes, Lilly To Develop Inhaled Hormone for Osteoporosis

Alkermes, Inc. and Lilly have signed an agreement to develop and commercialize inhaled formulations of parathyroid hormone (PTH). The development program will utilize the Alkermes AIR pulmonary drug delivery system. Lilly’s recombinant PTH, Forteo injection, was approved in 2002 by the FDA for the treatment of osteoporosis in postmenopausal women who are at high risk for bone fracture and to increase bone mass in men with primary or hypogonadal osteoporosis who are at high risk for fracture. The agreement was signed after completing extensive feasibility work.

Under the terms of the agreement, Alkermes will receive funding for product and process development activities and upfront and milestone payments. Lilly will have exclusive worldwide rights to products resulting from the collaboration and will pay Alkermes royalties based on product sales. Alkermes and Lilly will form a joint development team and will share responsibility for executing the overall development strategy for inhaled PTH. Alkermes will have responsibility for nonclinical development activities, primarily formulation testing and device development. Lilly will have responsibility for all other nonclinical development activities as well as all clinical development and regulatory activities.