Biogen's shelved drug for Alzheimer's found to work
Biogen will ask US drug regulators to approve the company's experimental Alzheimer's therapy, reviving the nearly abandoned treatment after a new analysis of data from two failed clinical trials showed promising results.
The move by Biogen, if successful, would be the drug industry's most dramatic reversal of fortune in history.
The company said it made the decision after talking with the US Food and Drug Administration (FDA) and reviewing data that showed the therapy helped Alzheimer's patients' cognitive function and their ability to perform basic tasks.
In March, the company said a major trial of the drug, Aducanumab had been a failure. That announcement sent Biogen's shares down by more than 25pc and raised questions about the firm's future.
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Investors erased those losses in the minutes after the new announcement Tuesday, boosting Biogen shares by 35pc to about $300 (€269) in early trading - almost back to where the stock traded before the March plunge.
The Massachusetts-based drugmaker said in a statement that it plans to send its application to the FDA early next year.
It is developing the treatment in partnership with Japan's Eisai.
Biogen CEO Michel Vounatsos said the company met with the FDA Monday and got the agency's blessing to move ahead.
"We got clear support from the FDA," he said in a telephone interview.
The company does not believe it needs to conduct additional trials of the drug before moving ahead.
The company also reported third-quarter financial results on Tuesday, though last quarter's numbers will almost certainly be overwhelmed by investors' review of a drug that, if it reaches the market, would upend the industry and reset Biogen's future.
Adjusted earnings were $9.17 per share, topping the $8.27 per share average of analysts' estimates.
The Alzheimer's results are certain to receive closer-than-usual scrutiny from regulators and investors, as well as rival drugmakers who have abandoned other related treatments after similar, earlier setbacks.
In the new analysis, Biogen looked at data from the two final-stage trials of more than 3,000 patients.
A subset of patients treated with the highest dose of aducanumab had what the company said was a statistically significant slowing of decline of cognitive ability and basic activities of daily living.