Johnson & Johnson (JNJ) and Pfizer Inc. (PFE) Monday indicated halting a phase 3 clinical development of bapineuzumab intravenous in Alzheimer's disease, as the drug did not meet primary end points pertaining to change in cognitive and functional performance in a second latestage study.
Janssen Alzheimer Immunotherapy, or Janssen AI - a part of Johnson & Johnson - is a partner with Pfizer in the Alzheimer's Immunotherapy Program, or AIP.
Johnson & Johnson said 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.
Johnson & Johnson expects to record an after-tax, non-cash special charge of $300 million to $400 million in the third quarter 2012 due to the discontinuation of the trial.
Meanwhile, Elan Corp. (ELN), which has a 49.9 percent interest in Janssen AI, said it will record a non-cash impairment charge of $117.3 million on its equity method investment in Janssen AI in the third quarter 2012. Elan owns 25 percent of the AIP asset on a global basis plus certain royalty streams should any therapy from AIP be commercialized in the future.
The bapineuzumab clinical development program comprised four placebo-controlled Phase 3 studies. Janssen AI led the two completed 18-month, Phase 3 randomized, double-blind, placebo-controlled studies in Alzheimer's patients who are ApoE4 carriers (Study 302) and ApoE4 non-carriers (Study 301). Pfizer led the other two Phase 3 studies.
Based on the topline results, 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.
JNJ closed Monday at $68.84, down 0.41%, on a volume of 8.7 million shares on the NYSE. In after hours, the stock fell 1.22%.
PFE closed at $24.26, down 0.08%, on a volume of 25.8 million shares. In after hours, the stock slid 2.60%.
ELN closed at $11.25, down 0.88%, on a volume of 2.9 million shares. In after hours, the stock dropped 11.91%.
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