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Johnson & Johnson and Pfizer announced on Monday that they were halting development of a closely watched Alzheimer’s drug after two clinical trials failed to show that it was effective in patients with mild to moderate forms of the disease.
Late last month, results of a large clinical trial of the drug, called bapineuzumab, failed to show that patients — all of whom carried a particular gene that raises the risk of getting Alzheimer’s — improved either cognition or daily functioning compared with a placebo. The companies announced Monday that the results of a second trial, which tested the drug on patients who did not carry the gene, also did not meet its goals.
Because the results of the earlier trial were already known, the decision to discontinue the drug was not altogether unexpected.
Bapineuzumab, like other Alzheimer’s drugs being developed, targets beta amyloid, a protein that has toxic effects on the brain and is believed to be a cause of the disease. Given the failure of the drug, some have called that theory into question.
But Dr. Husseini K. Manji, the global therapeutic area head for neuroscience at Janssen Research and Development, a unit of Johnson & Johnson, said the failed trials did not mean researchers should abandon the beta amyloid theory.
“While we are disappointed in the results of the two bapineuzumab IV studies, particularly in light of the urgent need for new advancements in Alzheimer’s disease, we believe that targeting and clearing beta amyloid remains a promising path to potential clinical benefits for people suffering from this disease,” he said in a news release.
Johnson & Johnson said it expected to record a charge of $300 million to $400 million in the third quarter of this year related to the discontinuation of the trials.
8 สิงหาคม 2555