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Sarah Houlton, PhD, is Pharmaceutical Executive’s international correspondent.
Shares in Danish company Novo Nordisk took a hit after it suspended trials for one of its main pipeline candidates, the dual-acting insulin sensitizer, ragaglitazar.
Shares in Danish company Novo Nordisk took a hit after it suspended trials for one of its main pipeline candidates, the dual-acting insulin sensitizer, ragaglitazar. The Type II diabetes treatment was in Phase III trials with 2,500 patients when researchers found that it caused tumors in mice and rats.
Early clinical trials showed that ragaglitazar has significant potential as a blood glucose regulator. The company is now carrying out a renewed benefit-risk assessment, which it hopes to complete by the first quarter of 2003. If it determines that the tumors are rodent-specific, it will resume the trials, and filing for approval will likely be delayed by two years.
"We have, for patient safety reasons, decided to take a precautionary approach and stop the clinical trials while we investigate the preclinical findings in more detail," said Novo's chief science officer, Mads Krogsgaard Thomsen. "At this point in time, it is not, possible to say whether new clinical trials involving ragaglitazar will be initiated."
Novo in-licensed the compound from Dr. Reddy's Laboratories, which has also seen its share price dip as a result of the suspension.