J&J has rattled analysts with a new timeline for the Alzheimer's drug bapineuzumab, saying that full, late-stage results for the closely-watched therapy may not be available for two years.
"We are conducting some of the largest-scale trials ever in Alzheimer's disease," a J&J spokesperson told Bloomberg an e-mailed comment. "When they are complete, we expect to have a very comprehensive understanding of the clinical impact of bapineuzumab." The delay was attributed to the fact that J&J is still recruiting patients for the late-stage trials, and final results will have to wait until 18 months after the last patient is enrolled. Pfizer, which is partnered on the drug, has its own studies underway.
UBS analyst Gillaume van Renterghem quickly dubbed the delay "bad news," saying that analysts were eagerly expecting the data on the potential mega-blockbuster "as quickly as possible." J&J obtained the drug for its portfolio when it bought out Elan's rights to the Alzheimer's program last year.
Elan and Wyeth had started Phase III for bapineuzumab back in 2007. They launched a late-stage program even before the Phase II data was in, hoping that an aggressive development timeline would lead to a swifter approval. Van Renterghem estimates top potential worldwide sales at $8 billion, adding that there are a number of pitfalls for this program that would significantly cut that back.
- here's the article from Bloomberg
(Editor's Note: The original version of this story reported that J&J had acquired Elan's Alzheimer's portfolio last year. J&J acquired only the rights to this program.)