Biogen shares are up significantly following news the company plans to seek U.S. regulatory approval for an Alzheimer's drug.Brian Snyder/Reuters
Biogen Inc. revived plans on Tuesday to seek U.S. approval for Alzheimer’s treatment aducanumab, surprising investors and saying data from more patients in two discontinued studies showed the drug reduced the decline of patients suffering from the disease.
The drugmaker’s shares soared 27 per cent in response to the decision, recouping almost all of the US$18-billion lost from the company’s market value when it said in March it was abandoning the two studies.
The field of experimental Alzheimer’s treatments is littered with high-profile failures, with many major drugmakers abandoning the race to develop a medicine for a disease that makes up 60 per cent to 70 per cent of an estimated 50 million cases of dementia globally.
Any medicine that effectively treats the disease is likely to become one of the world’s top-selling drugs and could be transformative for Biogen, which is facing multiple challenges over its product pipeline.
Filing with U.S. regulators could “potentially bring back to life a drug that had been completely left for dead,” RBC Capital Markets analyst Brian Abrahams wrote in a note.
“The viability of such a filing is unknown, given the mixed results – in our view, Biogen is somewhat desperate for growth drivers ... so a change in narrative is badly needed.”
Biogen and partner Eisai Co. Ltd. decided to end the two late-stage trials of aducanumab based on a so-called “futility analysis” of data, which revealed the trials had little hope of succeeding.
The failure of the treatment spurred demands on Wall Street for the company to spend more on acquisitions as its mainstay multiple sclerosis franchise faced patent challenges and newer muscle wasting disorder treatment a competitor from Switzerland’s Novartis.
ADDITIONAL DATA SUPPORT
Biogen said on Tuesday more data had become available after the two studies were discontinued, resulting in a larger data set and new analysis that showed one of the trials met the main goal, while the other did not.
The company said that the results of patients in the failed second trial who had received high doses also supported the findings of the first.
Biogen also said patients who received aducanumab experienced significant benefits on measures of cognition and function such as memory, orientation and language.
Biogen said it had met with the Food and Drug Administration twice, once in June and again on Monday to discuss the data.
“They [FDA] thought it was reasonable for us to submit an application for approval,” said chief medical officer Alfred Sandrock, who earlier this month become the company’s R&D head.
Credit Suisse analyst Evan Seigerman said the agency was under no obligation to approve the drug even if it gave its blessing to the initial filing for approval.
The company said it plans to submit a marketing application for aducanumab in early 2020 based on the discussions.
Baird analyst Brian Skorney said he believed FDA approval for aducanumab was highly unlikely and predicted Biogen would have an uphill task to convince regulators that the results were nothing more than random chance.
The treatment, aducanumab, works on the hypothesis that removing deposits of amyloid, a type of plaque, from the brain of patients in the early stages of the disease could stave off its ravages, which include loss of memory and the inability to care for oneself.
Biogen executives on a conference call said the results from the new analysis were positive for another Alzheimer’s drug, BAN2401, which works on a similar principal and is also being jointly developed along with Eisai.
The company also reported a better-than-expected third-quarter profit, helped by higher demand for rare muscle disease drug, Spinraza.
Shares in the company, which had lost 25.7 per cent of its value this year as of Monday’s close, rose 27 per cent to US$284.
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