DMC: Novartis' drug safe but not effective in mid-study analysis

An independent data monitoring committee (DMC) has weighed in on Novartis and Nordic Biosciences' Phase III study of oral calcitonin for the treatment of osteoarthritis of the knee. After analyzing a year's worth of data from the two-year study, the DMC concluded that the drug is safe. But the DMC also said there is no reason to continue the study for efficacy. The group recommended continuation of a similar study in 2009.

Novartis and Nordic say they plan on to continue the clinical program of oral calcitonin in osteoarthritis, with data expected in the fourth quarter this year. The two companies are partnered with Emisphere and Unigene on the drug. This study uses Emisphere's Eligen Drug Delivery Technology for the improved oral absorption of salmon calcitonin, while Novartis licensed the right to produce recombinant calcitonin under Unigene's patented SecraPep E. coli manufacturing technology.

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