Research into Alzheimer's disease has suffered a setback after Pfizer and Johnson & Johnson revealed that they will pull the plug on their development programme for bapineuzumab after another late-stage failure.
Last month, the companies presented disappointing data from the first of four trials looking at intravenous bapineuzumab in patients with mild-to-moderate AD who carry the ApoE4 (apolipoprotein E epsilon 4) genotype. Now they have posted a second set of poor results.
Specifically, the co-primary clinical endpoints, change in cognitive and functional performance compared to placebo, were not met in a J&J-led Phase III trial of bapineuzumab in patients with mild-to-moderate Alzheimer’s disease who do not carry the ApoE4 genotype. As a result, has decided to discontinue all other bapineuzumab studies.
Steven Romano, head of the medicines development group at Pfizer, said “we are obviously very disappointed in the outcomes of this trial", adding that "we are also saddened by the lost opportunity to provide a meaningful advance for patients afflicted with mild-to-moderate AD and their caregivers". However, he noted that these data, "and the subgroup and biomarker analyses underway, will further inform our understanding of this complex disease and advance research in this field".
J&J says it expects to record a net charge to third-quarter earnings of $300-$400 million relating to the discontinuation though Pfizer is not expected to make any specific provision. The bad news about bapineuzumab is also hitting Elan Corp hard. The Irish drugmaker, which discovered the drug, did a deal with J&J three years, giving the healthcare giant assets and rights related to itsAlzheimer's programme, centred around bapineuzumab.
Elan was set to benefit handsomely if the drug succeeded but now says it will record a non-cash charge of $117.3 million in the third quarter to write down the value of its 25% stake in the bapineuzumab programme. Shares in the Dublin-based firm are likely to take a major hit on the news.