Schering AG shares fell by over 14% and Novartis’ shares dropped nearly 3% on the news. However, although the analysis of progression free survival as assessed by central radiology review did not achieve statistical significance, a separate pre-planned analysis of progression-free survival as assessed by the investigators did achieve statistical significance.
Based on a review of the CONFIRM 1 trial results, an independent data monitoring board recommended the phase III clinical trial program to continue to allow analysis of overall survival endpoints. This is expected in the second half of 2006.
Schering and Novartis now anticipate filing for approval with the FDA and the European Medicines Agency (EMEA) in early 2007. This represents a year’s delay, which could spell out bad news for the two companies as it will enable Roche and Genentech’s Avastin, which has already been launched in the US and Europe, to secure a stronger foothold in the market.