FONT-SIZE Plus   Neg

Pfizer And Janssen AI Discontinue Bapineuzumab IV Phase 3 Program

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

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
As Sony Corp. prepares to launch the new PlayStation 4 Pro gaming console on November 10, several new games that are compatible with the console have also been confirmed for launch. Game developers are readying to provide PlayStation 4 Pro support for many games on PS4. Shares of Advaxis Inc. dropped more than 13 percent in pre-market activity before paring losses to just more than 5 percent after the company said that it was not able to complete the second stage of the Phase 2 GOG-0265 trial as designed due to a clinical hold that affected its clinical development programs last year. Dicks Sporting Goods Inc., one of the major sporting good retailers in the U.S., is planning to acquire Golfsmith International Holdings Inc., a specialty retailer with stores in U.S. and Canada, through a bankruptcy auction, Reuters reported. The bid would be worth $70 million and needs approval by a U.S. bankruptcy court.
comments powered by Disqus
Follow RTT