Pfizer ($PFE) and Johnson & Johnson ($JNJ) have nixed development of one of the most closely watched drugs in their pipelines, bapineuzumab, after two Phase III clinical trials for the experimental Alzheimer's therapy ended in failure. The decision comes as no surprise as the program was given slim odds of success. But many are following bapi, one of the most advanced drugs for combating beta amyloid that builds up in the brain and is a suspected cause of the common memory-stealing disease.
Trouble for the program surfaced last month after bapi fell short in improving a key measure of cognition compared with placebo in a Phase III trial involving Alzheimer's patients who are ApoE4 gene carriers. On Monday, the companies reported that the second of four late-stage studies of the drug--this one involving patients with ApoE4 non-carriers--failed as well. And they have decided to end all trials for the drug from Irish drugmaking partner Elan ($ELN), ceasing development of their blockbuster hopeful.
Though the IV version of bapi has been scrapped, Reuters reports that a subcutaneous version is in mid-stage development. Eli Lilly ($LLY) takes center stage in the hunt for new Alzheimer's drugs, with its late-stage contender, solanezumab, expected to yield results this year. Like bapi had for its developers, solanezumab presents Lilly with multibillion-dollar sales potential, but lots of doubts about its potential efficacy against the disease. About 5 million Americans suffer from Alzheimer's, for which there are currently no drugs that address the suspected causes, as the biology of the disease remains poorly understood.
"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 Dr. Husseini Manji, head of neuroscience therapeutics for J&J's Janssen Research & Development, in a statement. J&J expects to take a $300 million to $400 million charge related to development of bapi in the third quarter, the healthcare giant said.
Elan is expected to take a $117.3 million charge in the third quarter related to the the bapi fiasco. Analysts have speculated that the the success of the program could influence a potential sale of the company, noting that its partner Biogen Idec ($BIIB) could swoop in at the right price.
As Reuters reported, experts had low expectations that bapi could benefit patients whose brains are already riddled with beta-amyloid plaques. Roche ($RHHBY) and others have begun work developing a drug intended to prevent the formation of the plaques, targeting patients at risk of developing Alzheimer's. Yet analysts want to disect the results of the late-stage data on bapi to understand the potential importance of beta amyloid in the disease. More details from the two failed Phase III studies of bapi are expected at the European Federation of Neurological Societies (EFNS) meeting in Stockholm next month.
"The probability of success in these trials was very low in the minds of most investors," said Anthony Butler, an analyst with Barclays Capital, as quoted by Reuters. "The overall impact financially is negligible. But it's a sentimental negative, for sure, and I think that's critical."
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Editor's note: Updated with additional details from Elan and Pfizer and to note information from Reuters that a subcutaneous version of bapi is in mid-stage development.
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