Novartis and Nordic Biosciences have begun a Phase III clinical program of oral salmon calcitonin (SMC021) for the treatment of osteoarthritis, a chronic, irreversible and degenerative condition. SMC021 is a new drug candidate with potential to be the first disease-modifying drug for osteoarthritis.

The salmon calcitonin is formulated in tablet form using a novel eligen delivery technology Emisphere Technologies. The delivery system creates the potential for salmon calcitonin to be available as a convenient oral medication for the first time.

"We are pleased to announce the initiation of Phase III trials for oral calcitonin, which may represent the first disease-modifying drug for the treatment of osteoarthritis," said Michael V. Novinski, president and chief executive officer of Emisphere. "Currently, there are no available treatment options for osteoarthritis that actually help prevent disease progression or joint damage, and we are excited to be at the leading edge of research in this area. An unmet need facing osteoarthritis patients and physicians today is the lack of any proven disease-modifying drug for osteoarthritis. Oral Calcitonin would help prevent structural damage in at-risk joints, or the progression of structural damage in joints already affected. Current treatment options for osteoarthritis provide only symptomatic relief."

The Phase III clinical program is being conducted by Nordic Bioscience both in the European Union and in the U.S., and is planned to include more than 2000 patients. In 2000, Emisphere and Novartis entered into a license agreement for the development of oral salmon calcitonin for the treatment of osteoarthritis and osteoporosis. A Phase III clinical trial of oral calcitonin for the treatment in osteoporosis started also early this year.

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