Oral Recombinant Parathyroid Hormone

Recombinant PTH, currently approved for the treatment of osteoporosis, is available only by injection. On December 1, 2004, Emisphere entered into a Research Option and License Agreement with Novartis whereby Novartis obtained an option to license Emisphere's existing technology to develop oral forms of PTH 1-34. On March 7, 2006, Novartis exercised its option to the license. Parathyroid hormone continues to be on a progressive clinical development path in collaboration with Novartis Pharma AG.

In July announced that Novartis Pharma AG has launched a Phase I study in postmenopausal women to determine the safety and tolerability of oral PTH134, a combination of human PTH-1-34 and the absorption enhancer 5-CNAC using Emisphere's proprietary Eligen^® Technology, for the treatment of postmenopausal osteoporosis. The study is designed to assess the bioavailability profile of increasing doses of PTH-1-34 combined with different amounts of 5-CNAC administered orally. The trial is being conducted in Switzerland and is estimated to yield first interpretable results by the end of the year.