NOVARTIS BEGINS TRIAL OF ORAL SALMON CALCITONIN

Emisphere Technologies announced that Novartis and its development partner Nordic Bioscience have begun a Phase III clinical trial of an oral form of salmon calcitonin, which uses Emisphere's eligen delivery technology, for the treatment of osteoporosis. The eligen technology may make salmon calcitonin available as an oral medication, rather than the currently available injectable or intranasal options. Emisphere will receive a milestone payment from Novartis.

The Phase III trial, which will include more than 4,500 osteoporosis patients in Europe, the U.S., China and Latin America, is a three-year, randomized, multicenter, placebo-controlled study to evaluate the safety and efficacy of oral calcitonin.

Novartis has previously conducted extensive safety testing on both the oral calcitonin product and Emisphere's technology, including a Phase II study, several Phase I clinical trials and extensive preclinical safety studies.

Novartis has received advice from European regulators on the Phase III trial design, as well as clearance from the FDA to proceed with the study under a special protocol assessment.

Calcitonin is a polypeptide hormone secreted by the parafollicular cells of the thyroid gland, according to Emisphere. It enables the bone to retain more of its mass and functionality by inhibiting the bone-tissue resorbing activity of specialized bone cells called osteoclasts.