Novartis has received CHMP advice on the Phase III trial design and clearance from FDA to proceed with Phase III study under a special protocol assessment. The clinical trial is being conducted by Nordic Bioscience following a development agreement with Novartis.

Project Background
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.

Under the terms of this agreement, Emisphere received an up-front payment and could receive future milestone payments and equity investments. Emisphere could also receive royalties on potential product sales.

In 2003, Emisphere reported positive Phase IIa study results, conducted by Novartis, at the American Society for Bone and Mineral Research. The study demonstrated activity on bone markers over a three month dosing period when the peptide was delivered in combination with the Emisphere delivery agent. The data from the study demonstrated that in comparison to placebo, there was a significant reduction in bone resorption markers observed for one of these doses (1 mg/day; p = 0.0016).

Novartis and Nordic Bioscience have informed Emisphere that they have met with the Food and Drug Administration (FDA) to discuss their Phase III development plan. Based on the advice given by the FDA, Nordic Bioscience and Novartis are moving forward with planning their Phase III clinical studies with the oral formulation of salmon calcitonin for the treatment of osteoporosis using the Emisphere’s eligen^® technology. Novartis will also be pursuing an osteoarthritis indication for salmon calcitonin.

In May 2006, Novartis Pharma AG notified Emisphere that Novartis Pharma AG has completed the planned preclinical safety studies for the oral calcitonin product using Emisphere's eligen^® delivery technology. Novartis has concluded that oral administration of the eligen^® delivery agent administered by gavage to rats for 104 weeks is not considered carcinogenic at doses up to 750 mg per kilogram per day. The carcinogenicity report will be submitted to the FDA in any New Drug Application (NDA) submission on oral formulations of those molecules for which Novartis has obtained rights to use the Emisphere technology.