Synthes, Inc. (SIX: SYST.VX) and Eli Lilly and Company (NYSE: LLY) today announced the signing of an exclusive worldwide collaboration agreement to address the needs of patients who are cared for by orthopedic surgeons, including those with osteoporosis and those with bone fractures.
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. These 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 United States). Building upon a Phase II study that Lilly has already completed, Lilly and Synthes will collaborate on additional clinical studies to evaluate potential future indications for Forteo, including fracture healing.
In addition to the development component of the agreement, the collaboration also includes the U.S. co-promotion of Forteo to orthopedic surgeons, an important segment of physicians who treat patients with a fracture due to osteoporosis. The companies will also co-promote Forteo in select countries and regions outside of the United States.
"I am very excited about this unique collaboration that will utilize the complementary clinical, development and operational strengths of each partner," said Michel Orsinger, president and CEO of Synthes. "Osteoporosis is one of the most significant unsolved clinical problems in orthopedics. Addressing the osteoporosis disease as well as the resulting fracture and bone defect is a significant strategic priority of both organizations," he continued. "Strategic collaborations between medtech and pharma companies represent a new and promising avenue to develop and market true innovations in a changing, dynamic market environment."
"We believe that patients worldwide will benefit from this collaboration because together we will be able to look for new ways to treat osteoporosis and bone fractures," said Bryce Carmine, executive vice president and president, Lilly Bio-Medicines, Eli Lilly and Company. "At Lilly, we are always exploring new opportunities to bring innovative medicines to people with unmet medical needs and improve outcomes for individual patients."
"Many orthopedic surgeons are in the position to diagnose and treat osteoporosis when their patients present with fractures, and we believe it is imperative to treat the underlying cause of the initial fracture," said Johnston Erwin, Bone/Muscle/Joint global development platform leader, Lilly Bio-Medicines, Eli Lilly and Company. "Our 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."