Pfizer Inc. (NYSE: PFE; LSE: PFZ) and Johnson & Johnson (NYSE: JNJ) yesterday announced failure of a Phase III clinical trial of bapineuzumab for the treatment of Alzheimer disease, originally developed by Prof. Beka Solomon Tel Aviv University. Had the trial succeeded, the university could have been eligible for tens of millions of dollars in royalties.
Bapineuzumab failed to aid cognitive or functional ability of patients with the ApoE4 gene, which increases their risk of Alzheimer. This response of group of these patients in the Phase II clinical trial to test the efficacy of the drug, was also less than in patients without this gene. The current trial was first of four pivotal studies testing the drug, and Pfizer and Johnson & Johnson are continuing trials in patients without the higher genetic risk.
Bioassociate Ltd. CEO Dr. Ofir Levi said that the Alzheimer market did not have high hopes for the product, due to the complexity of the disease, and especially because the Phase II trial results were not great, achieving significant results only in sub-groups of patients and after retroactive statistical analysis.
In addition, the link between the beta amyloid protein that bapineuzumab targets and Alzheimer is not clear. Although the protein accumulates in Alzheimer patients, it is not yet clear if it causes the disease or is a consequence of it. Even before the announcement of failure, analysts covering the market gave the trial less than a 20% chance of success among the group of non-carriers of the ApoE4 gene.
Published by Globes [online], Israel business news - www.globes-online.com - on July 24, 2012
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