Much-Anticipated Alzheimer's Drug Scrapped After Study Fails
Pfizer Inc (NYSE:PFE) and Johnson & Johnson (NYSE:JNJ) said they were scrapping further studies of one of the most anticipated experimental Alzheimer's disease treatments after the drug failed to help patients with the memory-robbing condition in a second high-profile late stage clinical trial.
The companies said they would discontinue all other studies of the drug bapineuzumab, including two more late stage trials and follow-up extension studies, in patients with mild to moderate Alzheimer's.
The result marked the second such failure announced in recent weeks and was especially disappointing as bapineuzumab had been given a better chance of success in the patients studied in the second trial.
Bapineuzumab failed to improve cognitive or functional performance compared with placebo in patients who did not carry a variation of a gene called ApoE4, according to initial results of the Phase III study released on Monday.
Pfizer on July 23 announced the failure in the first of four high-stakes trials -- that in patients with the ApoE4 gene variation. That trial was considered more of a long-shot based on poor results in earlier trials, but hopes were high that the data would prove more encouraging in ApoE4 non-carriers.
"We are obviously very disappointed in the outcomes of this trial. We are also saddened by the lost opportunity to provide a meaningful advance for patients afflicted with mild-to-moderate Alzheimer's disease and their caregivers," Steven Romano, head of Pfizer's Medicines Development Group, said in a statement.
J&J said it would take a charge of between $300 million and$400 million against earnings in the third quarter related to discontinuation of the bapineuzumab Phase III clinical trial program.