Investors Cheer As Biogen's BIIB037 Skips To Phase 3 For Alzheimer's
December 3, 2014
By Riley McDermid, BioSpace.com Breaking News Editor
News that Biogen Idec will be fast-tracking an experimental Alzheimer’s drug from Phase Ib trials to Phase III trials because of its enormously effective results on patients being studied has sent shares of the company up more than 9 percent in midday trading Wednesday.
The drug, dubbed BIIB037, binds to amyloid plaques in the brain as a way to slow the progress of Alzheimer's disease (AD). Biogen's head of research and development, Doug Williams, said Tuesday it had achieved those endpoints and more, reducing amyloid levels in “both a dose- and time-dependent fashion."
Williams said that BIIB037 improved cognition in patients with early signs of the disease 54 weeks after starting treatment, in a Phase 1 trial involving 200 patients. He added that Biogen will present full results of the trial at a medical meeting next year.
Because of those encouraging results at such an early stage of testing, the company will be leap-frogging BIIB037 into Phase III trials, said Biogen. It did not give a date for when the trials would start but analysts have projected the likely start will be mid-2015.
Wall Street analysts presented with the data at Deutsche Bank's BioFEST conference in Boston on Tuesday were literally speechless at the impact of the results in a field known for chronic failures.
"You've got me tongue-twisted with the Alzheimer's data," Deutsche Bank analyst Robyn Karnauskas told Williams during the presentation, reported CNBC.
The overwhelmingly encouraging results were a surprise to biotech watchers, because several large companies have tried and failed to develop similar Alzheimer’s therapies in recent year, including Johnson & Johnson , Eli Lilly and Pfizer .
The size of the market for patients with AD varies in estimates, but analyst Mark Schoenebaum with ISI Group said in a note Wednesday that he expects pricing to weigh in at around $25,000 per course.
“There are 600,000 mild AD patients in the U.S.,” he wrote. “At a net price of around $20,000 (below TNFs), 65 percent penetration would yield a potential sales opportunity of around $8 billion in the U.S. alone. The ex-U.S. patient opportunity is similar, but price will probably be lower.”