Germany’s Schering AG saw its share price slide by more than 14% during morning trading in Frankfurt today, while Switzerland’s Novartis also took a knocking after the companies revealed that they would not be filing their new anti-cancer drug, PTK/ZK, for regulatory approval later this year as originally planned after the product failed to meet one of its goals in a late-stage clinical trial.
In a statement issued this morning, the firms said that the Phase III clinical trial, which had been investigating PTK/ZK in the treatment of metastatic colorectal cancer, had not met its primary endpoint of statistically significant progression-free survival. The full data from the Confirm 1 trial will be submitted to the American Society of Clinical Oncology meeting in Orlando, Florida, in May. The firms are now expecting regulatory submissions in both Europe and the US early in 2007. They had originally planned to file the drug with the regulators in the second half of 2005 [[25/01/05e]].
The news is particularly bad for Schering, as investors had been banking on PTK/ZK’s potential to compensate for slowing sales of its key multiple sclerosis offering, Betaferon/Betaseron (interferon beta-1b), which is facing heightened competition in the MS market [[09/02/05b]]. Chief executive, Hubertus Erlen, last year predicted that PTK/ZK could be a potential blockbuster earner for the firm, with annual sales in excess of one billion euros [[06/01/05d]].
PTK/ZK is an oral angiogenesis inhibitor, which is designed to target the tumour blood vessels and potentially lymphatic vessels, slowing tumour growth and spread. The companies will continue testing the drug to see if it does have a positive effect on survival, with results expected in the second half of 2006.