Novartis completes preclinical safety studies of oral calcitonin using Emisphere's technology

By Lisa Kerner

Erie, Pa., May 25 - Emisphere Technologies, Inc. said it has been notified by Novartis Pharma AG that the company 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, according to a company news release.

The carcinogenicity report will be submitted to the Food and Drug Administration in any New Drug Application submission on oral formulations of those molecules for which Novartis has obtained rights to use the Emisphere technology, including the calcitonin.

Calcitonin, a hormone secreted from the ultimobrachial glands, is marketed as a nasal spray and injectable product with 2005 sales of about $400 million.

Eligen, Emisphere's oral drug delivery technology platform, uses synthetic chemical compounds, or carriers, to deliver an unaltered therapeutic molecule.

"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," chairman and chief executive Michael M. Goldberg said in the release.

Emisphere and Novartis entered into license agreements for the development of oral calcitonin for the treatment of osteoporosis and for the development of oral human growth hormone.

Emisphere is a Tarrytown, N.Y., biopharmaceutical company specializing in the oral delivery of otherwise injectable drugs.

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