Biogen plans to seek approval for an experimental Alzheimer’s drug that could be the first to treat the devastating disease, reversing course after abandoning the treatment earlier this year and sending its shares up 35 per cent in early trade on Tuesday.
The US biotech company said new analysis of a larger data set from its trial for aducanumab showed the drug had an impact on those suffering from the early stages of the neurological disease when taken at a high dose.
Patients that received a high dose “experienced significant benefits on measures of cognition and function such as memory, orientation, and language”, the company said. They were better able to complete tasks such as cleaning and shopping, conducting personal finances and travelling independently.
“Today is about hope and opportunity for patients first but also for the shareholders,” said Michel Vounatsos, Biogen’s chief executive.
The share price rise added $15bn to Biogen’s market value.
The company’s stock had dropped in March when it and its Japanese partner Eisai said they would halt trials after a futility analysis by an independent monitoring committee indicated the drug was not going to be effective.
The end of two late-stage trials was a blow to patients suffering from the debilitating disease, which affects 5.7m people in the US alone. It was also seen as a sign that it was time to abandon the so-called amyloid hypothesis that memory loss is caused by a build-up of sticky plaques in the brain.
Mr Vounatsos said Tuesday’s announcement was “truly heartening” in the fight against Alzheimer’s.
“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.”
Since the studies were abandoned, more data have become available, with the data set now including 3,285 patients, more than 2,000 of whom took the drug for 18 months.
Dr Anton Porsteinsson, director of the University of Rochester Alzheimer’s Disease Care, research and education programme, and principal investigator, said the larger data set was the first time a phase III study — a trial used to win approval for a drug — demonstrated that clearance of the plaque known as amyloid beta can reduce Alzheimer’s patients’ clinical decline. Participants in the trials will now be able to go back on the drug.
The company will file for approval with the US Food and Drug Administration in early 2020 and is in talks with regulators in Europe and Japan.
The findings could also be positive for other potential drugs that Biogen has in development, including another that targets amyloid plaques and some which try to tackle a build-up of tau protein, which disrupts brain function. It could even affect research and development of drugs in different neurlogical conditions.
In third-quarter results released on Tuesday, Biogen’s adjusted earnings per share were $9.17, 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 quarter, higher than the consensus forecast of $3.5bn and up 5 per cent year on year.
Shares in Biogen were 30 per cent higher at $289.82 in New York in morning trade.
Sorry. No data so far.