Schering AG, Novartis Delay Cancer Drug Development

Schering AG and Novartis have pushed back the development timetable for one of their most important pipeline candidates -- experimental colon-cancer drug PTK/ZK -- after it failed to stop the growth of tumors in a Phase III study, the companies said.

Based on the results of the CONFIRM 1 study, the companies said they are delaying their planned new drug application filing with the FDA by a year to early 2007. The decision comes after PTK failed to achieve the trial's primary endpoint of performing better than standard chemotherapy in preventing colorectal cancer from worsening, when administered in conjunction with chemotherapy. The companies said they will submit the full results of the CONFIRM 1 study at the American Society for Oncology meeting in mid-May.

PTK is widely considered one of German drugmaker Schering AG's most important drug candidates, as it is at the center of the company's previously announced strategy of building an oncology unit alongside its established gynecology/andrology, specialized therapeutics and diagnostics businesses.