Oral Recombinant Parathyroid Hormone

In July 2008, Emisphere announced that its partner, Novartis Pharma AG, launched a Phase I study in postmenopausal women to determine the safety and tolerability of an oral formulation PTH1-34, a combination of human PTH1-34 and the absorption enhancer 5-CNAC using Emisphere's proprietary Eligen^® Technology, for the treatment of postmenopausal osteoporosis. The study was designed to assess the bioavailability profile of increasing doses of PTH-1-34 combined with different amounts of 5-CNAC administered orally. On October 19, 2009, Novartis reported results of this study which showed potentially relevant therapeutic exposure and safety profiles similar to those of the currently available injectable dosage form. These were presented at the 73rd Annual Scientific Meeting of the American College of Rheumatology in Philadelphia.

Recombinant PTH, has been approved for the treatment of osteoporosis, which is a disease associated with a gradual thinning and weakening of the bones that occurs most frequently in women after menopause.. PTH is produced by the parathyroid glands to regulate the amount of calcium and phosphorus in the body. When PTH is used therapeutically, it has been shown to increase bone strength and density, which in turn helps to prevent fractures. At this time, PTH is available only by injection.