Salmon Calcitonin for Osteoarthritis and Osteoporosis

Novartis Pharma AG and its development partner Nordic Bioscience are currently taking Emisphere's Eligen^® Technology into Phase III development with an oral salmon calcitonin product to treat osteoarthritis and osteoporosis. Enrollment in the first trial of Phase III clinical studies for osteoarthritis is expected to be completed by the third quarter of 2008, and enrollment for the second Phase III trial should be complete mid-2009. Osteoporosis Phase III trials are also ongoing, with enrollment completion expected in the first half of 2008. When these Phase III studies are completely enrolled under their current protocols, over 5,000 clinical study patients will be using the Eligen^® Technology.

Osteoporosis represents a large market, including 10 million managed patients and 34 million additional individuals at risk. An ideal treatment with an optimal efficacy/safety/convenience profile is not available, representing a clear need that could be addressed by Emisphere's oral calcitonin product. Oral calcitonin could provide a safe, effective, and convenient alternative to existing therapies, which currently include injectable or intranasal options.

The market for treatment of osteoarthritis is also substantial, represented by 21 million managed patients. Earlier research indicates that oral calcitonin could become the first global disease-modifying drug for osteoarthritis.