Genentech Gains on Novartis, Schering Setback
Switzerland-based
Novartis
(NVS) - Get Report
and its German partner
Schering
(SHR)
will delay plans to seek regulatory approval of their cancer drug after it produced somewhat disappointing test results.
The companies Monday said that the analysis of progression-free survival as assessed by central radiology review in their Confirm 1 clinical trial with the investigational drug PTK/ZK did not achieve statistical significance in treating metastatic colorectal cancer.
The companies, however, added that a separate preplanned analysis of progression-free survival as assessed by the investigators achieved statistical significance.
As a result, 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.
The companies will seek both U.S. European regulatory approval sometime in early 2007, which had previously been expected sometime in 2005.
Shares of both companies fell in European trading; both trade in the U.S. as American Depositary Receipts. Novartis ADRs closed at $48.32 Friday, while Schering's ended at $77.75.
The development boosted shares in U.S. rival
Genentech
(DNA)
, which makes the drug Avastin. Shares rose $4.61, or 8.7%, to $57.50 in the premarket.