Novartis and Nordic Bioscience have decided to proceed with late-stage evaluations of oral calcitonin in osteoarthritis of the knee despite an independent Data Monitoring Committee (DMC) suggesting that there would be no significant benefit in terms of efficacy. The candidate is coupled with Emisphere's Eligen® drug-delivery technology for the improved oral absorption of salmon calcitonin.
DMC’s futility analysis was conducted on one year’s worth of data from the two-year Phase III study 2302. It concluded that although there is no reason to stop Study 2302 because of safety concerns, there is no reason to continue the study for efficacy. The DMC said that the final decision whether to continue study 2302 rests with Novartis and Nordic.
Besides going forward with study 2302, another two-year Phase III trial 2301 in osteoarthritis is also in progress. In December 2009, the DMC conducted a futility analysis of one-year data for patients enrolled in 2301 and recommended that it be continued. Final data of study 2301 is expected to be available in the fourth quarter of 2010.
Additionally, Novartis intends to continue the clinical program of oral calcitonin in osteoporosis. In its quarterly earnings report for the period ended June 30, 2010, Novartis stated that it plans to file for regulatory approval of oral calcitonin for the treatment of osteoporosis during 2011.