Expectations are High as Biogen Idec Prepares to Reveal Alzheimer's Data
March 17, 2015
By Riley McDermid, BioSpace.com Breaking News Sr. Editor
Investors and analysts are waiting with bated breath for Biogen Idec affiliated researchers to present detailed results on an early-stage study of the company's experimental drug BIIB037 in patients with the mildest forms of Alzheimer's disease, information that is expected Friday and which could revolutionize how the disease is treated.
Friday’s presentation will be closely watched because it will give new details from an initial announcement in December, when Biogen announced a statistically significant reduction in amyloid levels and improved cognition compared to a placebo.
News that Biogen Idec (BIIB) 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 the day it was announced Dec. 6.
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 at the time 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 In Dec. 6 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 Company and Pfizer Inc.
The size of the market for patients with AD varies in estimates, but analyst Mark Schoenebaum with ISI Group said in a note that week 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.”
That continues a consistent trend of anti-amyloid studies focusing on the mild patient subset, said Joshua Schimmer, a biotech analyst at Piper Jaffray, on Dec. 7.
“It is plausible to believe that early intervention on amyloid is a requisite for success, so while many companies and investors have given up hope on this indication, Biogen seems to have a viable shot on goal left for this massive commercial opportunity,” wrote Schimmer in a note to investors.
“Investors finally have an attractive pipeline program to focus on to help alleviate pressure from ongoing MS drug launches, patent and PML considerations for Tecfidera, and uncertainty on the anti-Lingo program,” said Schimmer.
The news is also good for Biogen’s market reputation, which has suffered from a Street perception that it’s drug pipeline has been fickle and inconsistent.
“We believe this will finally bring stability to Biogens multiple while the bottom line continues to grow at 25 percent or more per year. As such, Biogen moves up on our large cap conviction list as our second favorite pick,” wrote Schimmer.
“We believe that as investors pick over multiple datasets for crenezumab and solenezumab that show a benefit in the mild patient subsets, consider that the bapineuzumab studies included patients without amyloid accumulation and reflect on the BIiB037 data,” said Schimmer, “they will see an attractive risk reward profile that skews largely to the upside considering the multi-billion dollar potential Alzheimer's opportunity. We look forward to a formal data presentation, complete with press release.”
BioSpace Temperature Poll
After Amgen Inc. said last week that it will close its South San Francisco facility acquired during its $10 billion buyout of Onyx Pharmaceuticals and will lay off 300 of Oynx’s 750 workers, BioSpace is wondering—will the number of mergers and acquisitions completed in 2014 mean a “streamlining” of biotech jobs in the Bay Area? Tell us your thoughts.