Alzheimer's, Dementia & Mental Health

Placebo Wins and Bapineuzumab Bites the Dust in Quest to Conquer Alzheimer’s

Pfizer, Johnson & Johnson call it quits on joint venture with antibody that targets beta-amyloid

Aug. 7, 2012 – The placebo wins again in the struggle to find drugs to prevent or treat Alzheimer’s disease. The latest victim is bapineuzumab in its intravenous form. Johnson & Johnson and Pfizer, partners in the clinical trials, announced yesterday that phase 3 clinical development of bapineuzumab intravenous (IV) in patients with mild-to-moderate Alzheimer's disease is being discontinued.

Bapineuzumab IV is an antibody that targets beta-amyloid (Aβ), a protein that can exert toxic effects in the brain and is believed to play a central role in the pathology of Alzheimer's disease.

Janssen Alzheimer Immunotherapy (Janssen AI), a subsidiary of Johnson & Johnson, is a partner with Pfizer in the Alzheimer's Immunotherapy Program (AIP). The Joint Steering Committee for the AIP has decided to discontinue the development of bapineuzumab IV in mild-to-moderate Alzheimer's disease based on the co-primary clinical endpoints not being met in the Janssen AI-led Studies 301 and 302.

"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," said Husseini K. Manji, M.D., Global Therapeutic Area Head for Neuroscience, Janssen Research & Development. Janssen Alzheimer Immunotherapy (Janssen AI), a subsidiary of Johnson & Johnson, is a partner with Pfizer in the Alzheimer's Immunotherapy Program (AIP)

Dr. Manji added, "Janssen remains strongly committed to tackling the enormous unmet medical needs in Alzheimer's disease. We believe the trial results will provide a rich data set that will advance our understanding of this complex disease and inform future research in this field. Studies with other compounds in earlier stages of development in the AIP portfolio are continuing and future development strategies will be discussed jointly by the alliance partners."

“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,” said Steven J. Romano, M.D., senior vice president, head, Medicines Development Group, Global Primary Care Business Unit, Pfizer Inc.

“Yet these data, and the subgroup and biomarker analyses underway, will further inform our understanding of this complex disease and advance research in this field.”

About the Bapineuzumab IV Phase 3 Studies

Four placebo-controlled Phase 3 studies comprised the bapineuzumab clinical development program. Janssen AI led the two completed 18-month, Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group, efficacy and safety studies of patients who are ApoE4 carriers (Study 302) and ApoE4 non-carriers (Study 301).

The two co-primary clinical endpoints are change in the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog), a validated measure of cognition, and the Disability Assessment for Dementia (DAD), a validated instrument to measure function.

In addition to the Janssen AI-led studies, Pfizer led two primarily ex-North America 18-month, Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group, efficacy and safety studies of patients with mild-to-moderate Alzheimer's disease who are ApoE4 non-carriers (Study 3000) and carriers (Study 3001).

About the Alzheimer's Immunotherapy Program (AIP)

The Alzheimer's Immunotherapy Program (AIP) of Janssen Alzheimer Immunotherapy and Pfizer Inc. is an equal collaboration committed to researching and developing selective products for the treatment and/or prevention of neurodegenerative conditions, including Alzheimer's disease.

We believe it may be possible to reduce the burden of disease through early intervention in the illness. The AIP is dedicated to delivering comprehensive and integrated solutions that help address the needs of people impacted by Alzheimer's disease.