The agreement allows for the joint development and licensing of early stage compounds from Lilly to Synthes for use within orthopedic trauma, spine, craniomaxillofacial and reconstructive areas.
The early stage compounds have pre-clinical and in some cases clinical data packages and have the potential to aid in the local treatment and regeneration of the skeleton.
The two companies will jointly develop site-specific osteoinductive (i.e. bone healing) products based on Synthes’ biomaterials combined with Lilly’s biologics or pharmaceuticals.
Within a second development program, Synthes and Lilly will jointly conduct and fund the evaluation of additional orthopedic uses for Lilly’s osteoporosis drug Forteo (teriparatide [rDNA origin] injection), marketed as Forsteo in some countries outside of the US.
Building upon a Phase II study that Lilly has already completed, Lilly and Synthes will collaborate on additional clinical studies to evaluate future indications for Forteo, including fracture healing.
In addition to the development component of the agreement, the collaboration also includes the US co-promotion of Forteo to orthopedic surgeons, an important segment of physicians who treat patients with a fracture due to osteoporosis.
Lilly Bio-Medicines Bone/Muscle/Joint global development platform leader Johnston Erwin said their collaboration will also explore ways to treat fractures with Forteo in older patients and/or those who have osteoporosis and, longer term, will look for new ways to deliver medicine locally to the fracture site.
Forteo, an FDA-approved osteoporosis therapy is used to treat postmenopausal women with osteoporosis who are at high risk for fracture and to increase bone mass in men with primary or hypogonadal osteoporosis who are at high risk for fracture.