The calcitonin to be used in the study was produced by Novartis using Unigene Laboratories’ patented manufacturing process, and Unigene will receive royalty payments if the product is successfully commercialized using this calcitonin.
This is the second pivotal study involving an oral calcitonin dosage form that Novartis and Nordic Bioscience have commenced this year, and the formulation is also being evaluated in a phase III trial for the treatment of osteoporosis.
Osteoarthritis is a progressively degenerative and often painful disease that affects approximately 20 million people in the US It is the most common form of arthritis and results in the destruction of cartilage, primarily in the weight-bearing joints.