Biogen to seek Alzheimer's drug approval
Biogen plans to apply for approval for an experimental Alzheimer's drug that could be the first to treat the devastating disease, reversing course after abandoning it earlier this year and sending shares up 35 per cent in early trade.
The biotech company said a new analysis of a larger data set from its trial for aducanumab showed the drug did have an impact on those suffering from the early stages of the neurological disease. Patients that received a high dose "experienced significant benefits on measures of cognition and function such as memory, orientation, and language", the company said.
The stock plummeted in March when Biogen and its Japanese partner Eisai said that it would stop the trial because an independent monitoring committee conducted a futility analysis which indicated the drug was not going to be effective.
The end of the trial was a blow to patients suffering from the debilitating disease, with 5.7m people affected in the US alone. It was also seen as a sign that it was time to ditch the so-called amyloid hypothesis that memory loss is caused by a build-up of sticky plaques in the brain.
Michel Vounatsos, Chief Executive Officer at Biogen, said the announcement was "truly heartening" in the fight against Alzheimers. The company will file its application in early 2020.
"This is the result of groundbreaking research and is a testament to Biogen's steadfast determination to follow the science and do the right thing for patients," he said. "We are hopeful about the prospect of offering patients the first therapy to reduce the clinical decline of Alzheimer's disease and the potential implication of these results for similar approaches targeting amyloid beta."
In the third quarter, non-gaap earnings per share were $91.7 beating the average analyst estimate of $8.27. Net income was $1.5bn, up 7 per cent year-on-year. Revenue was $3.6bn in the third quarter, higher than the consensus forecast for revenue of $3.5bn and up 5 per cent year-on-year.
Shares in Biogen rose 35 per cent to $301.12 in pre-market trading in New York.
n a shocking reversal, Biogen ( BIIB) on Tuesday said that it would resurrect an Alzheimer's drug that the company previously said had failed and will ask the Food and Drug Administration to approve it. The
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