Emisphere Technologies, Inc (CEDAR KNOLLS, New Jersey.), a biopharmaceutical company that focuses on improved delivery of therapeutic molecules, announced that Novartis Pharma AG has finished recruitment for a randomized, double-blind, placebo-controlled, multicenter study of oral salmon calcitonin in the treatment of osteoporosis in postmenopausal women taking calcium and vitamin D.

Novartis and its development partner Nordic Bioscience initiated the phase III clinical program of oral calcitonin for the treatment of osteoarthritis in mid-2007. Now, the last of >4500 patients has been recruited for the study that will evaluate the safety and efficacy of salmon calcitonin and Emisphere's proprietary Eligen^® technology in the treatment of vertebral fractures in postmenopausal women aged 60 to 80 with osteoporosis. The 3-year study is being conducted in North and South America, Europe, and Asia. Final data collection date for primary outcome measure is expected June 2011, and the estimated study completion date is September 2011.

The use of Emisphere's Eligen technology reflects the potential that for the first time salmon calcitonin may also be available as a convenient oral medication. Calcitonin is a polypeptide hormone secreted by the parafollicular cells of the thyroid gland. Calcitonin enables the bone to retain more of its mass and functionality by inhibiting the bone-tissue resorbing activity of osteoclasts, and is involved in the regulation of calcium. Calcitonin derived from salmon is estimated to be about 30 times more potent than the human version.

Synthetic salmon calcitonin, which is identical to the natural salmon calcitonin, is currently available only as a nasal spray or as an injectable therapy. Injectable calcitonin is used to treat osteoporosis and Paget’s disease. In women with osteoporosis, calcitonin has been shown to increase bone density and strength, while decreasing the rate of bone fractures. Calcitonin can decrease bone turnover and bone pain in patients with Paget's disease. Injectable calcitonin is also used to treat seriously elevated blood calcium levels.

Novartis Pharmaceuticals Corp markets synthetic salmon calcitonin in the US as Miacalcin^®, which is indicated for the treatment of women with osteoporosis who are >5 years postmenopausal, and should be reserved for those women who refuse or cannot tolerate estrogen, or for whom estrogens are contraindicated.

In February 2000, Emisphere entered into a licensing agreement with Novartis for the development and commercialization of a tablet dosage form of salmon calcitonin for the treatment of osteoporosis and its related indications. The Eligen technology can be applied to the oral route of administration as well other delivery pathways, such as buccal, rectal, inhalation, intravaginal, or transdermal.