Novartis will begin Phase III trial for salmon calcitonin
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Novartis has finished recruitment for its multicenter Phase III study for salmon calcitonin, using Emisphere's proprietary oral delivery technology, in the treatment of vertebral fractures in postmenopausal women with osteoporosis. The 4,500-patient, three-year study will be conducted in North America, South America, Europe and Asia. A court ruled in January 2006 that Emisphere was free to license the Eligen delivery technology to Novartis for development of oral parathyroid hormone following termination of its licensing agreement with Lilly for a similar product. Lilly used an Emisphere carrier to bring Forteo, an injectable form of PTH, to market in 2002 for treatment of osteoporosis in postmenopausal women
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