Pfizer Inc. (PFE) announced that the co-primary clinical endpoints, change in cognitive and functional performance compared to placebo, were not met in the Janssen Alzheimer Immunotherapy R&D LLC-led Phase 3 trial of intravenous or IV bapineuzumab in patients with mild-to-moderate Alzheimer's disease who do not carry the ApoE4 (apolipoprotein E epsilon 4) genotype (Study 301).
Janssen Alzheimer Immunotherapy, a subsidiary of Johnson & Johnson (JNJ), is a partner with Pfizer in the Alzheimer's Immunotherapy Program or AIP.
Pfizer said that based on the topline results of this study, together with the topline results of a Janssen AI-led Phase 3 study in patients who carry the ApoE4 genotype (Study 302), the Janssen AI and Pfizer Joint Steering Committee for the AIP has decided to discontinue all other bapineuzumab IV studies in patients with mild-to-moderate Alzheimer's disease.
Pfizer stated that no new safety concerns were identified in Study 301. The most commonly observed serious adverse events which occurred in bapineuzumab-treated patients more commonly than in placebo-treated patients, and with an incidence of at least 1 percent in the combined 0.5 mg/kg and 1.0 mg/kg group, were pneumonia, ARIA-E (amyloid-related imaging abnormalities-edema or effusion), syncope, hip fracture and convulsion.
In a separate press release, Johnson & Johnson said it expects to record an after-tax, non-cash special item related to in-process research and development consisting of a net charge to earnings of between $300 and $400 million in the third quarter of 2012 related to the discontinuation of the phase 3 clinical development of bapineuzumab IV in mild-to-moderate Alzheimer's disease.
by RTT Staff Writer
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