WEST CHESTER, Pa. and INDIANAPOLIS—Just weeksafter Johnson & Johnson acquired Synthes Inc. for $21.6 billion,Synthes is announcing a deal with Eli Lilly and Co. for an exclusive worldwidecollaboration agreement to address the needs of patients who are cared for byorthopedic surgeons, including those with osteoporosis and those with bonefractures.
The deal sets the stage for joint development andlicensing of early-stage compounds from Eli Lilly to Johnson and Johnson's Synthes for use in theorthopedic trauma, spine, craniomaxillofacial and reconstructive arenas. Thecompounds in question have preclinical data packages and, in some cases,clinical ones, as well as the potential to aid in the local treatment andregeneration of the skeleton.
According to the companies, they "will jointlydevelop site-specific osteoinductive (i.e. bone healing) products based onSynthes' biomaterials combined with Lilly's biologics or pharmaceuticals."
In addition, there exists under the deal a seconddevelopment program through which Synthes and Eli Lilly will jointly conductand fund the evaluation of additional orthopedic uses for Lilly's osteoporosisdrug Forteo (teriparatide [rDNA origin] injection), which is marketed asForsteo in some countries outside of the United States. This work will buildupon a Phase II study that Lilly has already completed, and one of the potentialfuture indications for Forteo is fracture healing.
In addition to the development component of theagreement, the collaboration also includes the co-promotion of Forteo toorthopedic surgeons in the United States and also co-promotion in selectcountries and regions outside of the United States.
Financial terms of the agreement have not beendisclosed.
"Osteoporosis is one of the most significantunsolved clinical problems in orthopedics. Addressing the osteoporosis diseaseas well as the resulting fracture and bone defect is a significant strategicpriority of both organizations," says Michel Orsinger, president and CEO ofSynthes. "Strategic collaborations between medtech and pharma companiesrepresent a new and promising avenue to develop and market true innovations ina changing, dynamic market environment."
"We believe that patients worldwide will benefitfrom this collaboration because together we will be able to look for new waysto treat osteoporosis and bone fractures," adds Bryce Carmine, executive vicepresident in Eli Lilly and Co. and president of Lilly Bio-Medicines. "At Lilly,we are always exploring new opportunities to bring innovative medicines topeople with unmet medical needs and improve outcomes for individual patients."
Furthermore, according to Johnston Erwin, thebone/muscle/joint global development platform leader for Lilly Bio-Medicines, "Manyorthopedic surgeons are in the position to diagnose and treat osteoporosis whentheir patients present with fractures, and we believe it is imperative to treatthe underlying cause of the initial fracture. Our collaboration will alsoexplore ways to treat fractures with Forteo in older patients and/or those whohave osteoporosis and, longer term, will look for new ways to deliver medicinelocally to the fracture site."
The only notable potential pall over the deal thusfar is that Synthes has had a brush with the law recently. U.S. prosecutors inPhiladelphia are looking to secure some prison time for various former Synthesexecutives that pled guilty to misdemeanors related to charges that companyrepresentatives were heavily marketing a bone-cement product for an unapproveduse. According to Lilly spokeswoman Tammy Hull, however, those executives areno longer with the company.
Forteo, an FDA-approved osteoporosis therapy tohelp build new bone, is a treatment for postmenopausal women with osteoporosiswho are at high risk for fracture and to increase bone mass in men with primaryor hypogonadal osteoporosis who are at high risk for fracture. Forteo is alsoapproved to treat men and women with osteoporosis associated with sustained,systemic glucocorticoid therapy at high risk for fracture.