and its German partner
will delay plans to seek regulatory approval of their experimental colon cancer drug after it produced somewhat disappointing test results in a late-stage clinical trial.
The companies' announcement Monday drove down the price of their shares and gave a lift to the shares of
whose colon cancer drug Avastin is already on the market.
Shares of American Depositary Receipts for Novartis dropped $1.32, or 2.7%, to $47 while shares of Schering fell $11.12, or 14.3%, to $66.63. But shares of Genentech climbed $5.11, or 9.7%, to $57.62.
Novartis and Schering Monday offered mixed results for their drug PTK/ZK, which is designed to treat patients with advanced colon cancer that has spread to other parts of the body. The clinical trial compared patients who took PTK/ZK plus standard chemotherapy vs. patients who only received chemotherapy. In this trial, patients hadn't received previous treatments for colon cancer.
The companies said the drug failed to meet one test goal of prolonging life without the cancer becoming worse based on a radiological review. But they added that investigators said another measurement of prolonging life achieved statistical significance. The companies didn't provide details. Data will be submitted as an abstract at a major cancer care conference in May in Orlando, Fla.
The companies said an independent data monitoring board recommended that this phase III clinical trial, the last round of testing before a drug is submitted to regulators, be allowed to continue in measuring overall survival. The results are expected in mid-2006.
But that means the companies will seek both U.S. European regulatory approval sometime in early 2007, which had previously been expected sometime in 2005.
In addition, Novartis and Schering continue to pursue another phase III clinical trial of this drug in colon cancer patients who have shown some improvement after having received chemotherapy. This test compares patients taking the drug plus chemotherapy vs. patients receiving chemotherapy alone. An interim analysis is planned for mid-2005 and the final results are expected to be available in mid-2006.
PTK/ZK acts to thwart the development of blood vessels that provide nourishment for cancer tumors. It seeks to block vascular endothelial growth factor, or VEGF, a protein that plays a role in tumor growth. By interfering with VEGF, the drug thwarts the tumor's ability to stimulate the development of new blood vessels.
Novartis and Schering are hoping their drug will be an improvement on Genentech's Avastin, which acts in a similar way, because their drug is a pill and Avastin must be administered intravenously. Genentech recently reported
encouraging results from a clinical trial assessing Avastin's treatment of a certain type of lung cancer, and the company said it will seek approval from the Food and Drug Administration for this additional use.