Salmon Calcitonin for Osteoarthritis and Osteoporosis

Novartis Pharma AG and its partner Nordic Bioscience are currently in Phase III clinical development with an oral formulation of salmon calitonin with Emisphere's Eligen^® Technology for the treatment of osteoarthritis and osteoporosis. They are conducting two Phase III clinical studies for osteoarthritis and one Phase III clinical study for osteoporosis. The program is being conducted mainly in Europe and the US and both studies are expected to complete in the 2010/2011 timeframe.

Osteoarthritis ("OA") is a clinical syndrome caused by a wearing-away of cartilage that cushions the joints and a decrease in the important joint lubricant, synovial fluid , thereby resulting in low grade inflammation and pain. As OA progresses, joint pain can result when the patient bears weight in the course of walking or standing. It is the most common form of arthritis and affects nearly 21 million people in the United States.

Osteoporosis is a highly prevalent disease, but an ideal treatment with an optimal efficacy / safety / convenience profile is not available at present. The Eligen^® oral calcitonin product could provide an alternative to existing therapies, which currently include injectable or intranasal options. In addition, a meta-analysis that was recently published in Rheumatology Reports concluded that additional clinical studies should be conducted to confirm evidence of calcitonin's analgesic action and its promising potential role in managing musculoskeletal pain.