Failures halt Phase III trials of Alzheimer's drug

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Pfizer, Johnson & Johnson and Elan said all Phase III tests of Alzheimer's drug bapineuzumab are being halted after the drug failed to hit its goals for cognition and global function.

The Phase III tests involved the infusion form of the drug and were being conducted among patients with mild-to-severe forms of the neurological disease. Tuesday's announcement came just 15 days after the companies said the drug had also failed to hit endpoints in another Phase III trial.

With bapineuzumab, along with Eli Lilly's own Alzheimer's candidate solanezumab, considered long shots by many, the immediate fallout of the news has been little more than a shrug. Sanford Bernstein analyst Tim Anderson wrote in a research note that he never even bothered to front-load Pfizer forecasts with the possibility that bapineuzumab could become viable.

The drug is not completely dead, however. Pfizer said its Phase II studies with ACC-001 (active immunization) and a Phase II neuroimaging study, called SUMMIT (bapineuzumab delivered subcutaneously), remain up and running.

Anderson speculated that Pfizer's Phase II commitment may signal interest in using the drug as a preventative treatment among patients who are symptom free. Such a tack would put bapineuzumab into direct competition with an approach Genentech and AC Immune are pursuing to fight the disease, albeit via a different mechanism. Genentech's approach targets tau proteins, unlike bapineuzumab, which targets beta amyloid proteins, which are associated with brain plaques that are associated with the disease.

Moving forward, Lilly has yet to announce Phase III results on solanezumab. Leerink Swann's Seamus Fernandez wrote on Tuesday that he put the odds of a successful Phase III trial for solanezumab at less than 5%. He also wrote that Bapineuzumab's failure only enhanced his low expectations for the drug becoming any sort of contender.

Tuesday's setback for Pfizer highlighted additional pipeline concerns for Anderson who noted Eli Lilly will continue to tangle with significant patent losses through 2016, Anderson noted. In contrast he offered up, Pfizer, which is slated to deliver five product launches this year, could have an easier time weathering the Alzheimer's failure.

Anderson put J&J on similar footing. Like he did with Pfizer, the analyst avoided factoring in bapineuzumab's success into J&J consensus numbers. “JNJ has one of the more attractive near-term growth profiles in pharma," he wrote, "based on the fact that they are anniversarying their major patent expirations and have recently launched a set of priming new compounds.”

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