Novartis Pharma AG has notified Emisphere Technologies, Inc that Novartis Pharma AG has completed the planned preclinical safety studies for the oral calcitonin product using Emisphere's eligen delivery technology.
In a recently finalized report, 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 would be submitted to the US 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 including calcitonin.
"We are very pleased that Novartis has generated significant safety data on our technology for its various programmes," commented Michael M. Goldberg, chairman and CEO of Emisphere. "It is a major milestone for our technology that Novartis has now conducted all the necessary preclinical safety/toxicology studies over the past seven years required for the NDA submission on oral calcitonin, a chronically administered product," he added.
In 2000, Emisphere and Novartis entered into a license agreement for the development of oral calcitonin for the treatment of osteoporosis; in 2004, the two companies entered into a license agreement for the development of oral human growth hormone. In March 2006, the two companies entered into a license agreement for the development of an oral form of parathyroid hormone (PTH) fragment 1-34 following a January 2006 ruling by a US Federal Court that Eli Lilly had breached its agreements on PTH with Emisphere.