(Bloomberg) -- Shares of Japanese drugmaker Eisai Co. and partner Biogen Inc. got a boost after the U.S. company said it plans to resume previous studies of their once-abandoned treatment for Alzheimer's disease.
Biogen rolled out detailed trial data at the Clinical Trials on Alzheimer's Disease conference in San Diego on Thursday, marking a climax in a months-long saga that has seen patients' hopes dashed and revived.
Eisai shares climbed as much as 5% in early trading in Tokyo on Friday. Biogen initially plummeted in New York trading Thursday, and then rebounded to close 3.4% higher.
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It was the first in-depth look at the experimental treatment, known as aducanumab, since the companies revived it in October. In March, Biogen and Eisai, who have been collaborating on the drug for several years, declared two studies of the medicine failures and abandoned the drug. Eisai lost $8 billion in market capitalization over two trading days following the news.
But executives said on Thursday that additional data showed the infusion, if given long enough and at high doses, could offer some benefit.
“This could represent the first treatment that targets a core pathology and open an era of precision medicine for Alzheimer's disease,” said Stephen Salloway, a Brown University professor who was part of a panel that discussed the results at the conference. “This is a milestone achievement for our field.”
What Bloomberg Intelligence Says:
Biogen's updated data for aducanumab Phase III trials at the CTAD conference doesn't convince us that they will be sufficient for regulatory approval. Rather, we believe the data are intriguing and suggestive of a need for a new Phase III trial at the higher 10mg dose. The drug's efficacy needs solid proof, given that its side-effect profile isn't benign.
-- Sam Fazeli, BI pharmaceuticals analyst
Read the report
Aducanumab's path is a reflection of the rollercoaster ride that researchers and drugmakers have been on for decades in trying to develop a way to combat Alzheimer's disease, the most common form of dementia in adults. They have tried and failed with more than 200 medications, at a cost of billions in research dollars.
“This is a pivotal time in the field, certainly with regard to the development of Alzheimer's therapeutics,” said Ronald Petersen, director of the Mayo Clinic Alzheimer's Disease Research Center in Rochester, Minnesota, who led the discussion of the study on behalf of the scientific organizers.
“Certainly there have been a lot of ups and downs in recent months and years, unfortunately more downs than ups,” said Petersen. “In many senses the aducanumab data that we are discussing today sort of characterizes -- is almost a caricature -- of the course we have had in the field.”
Read more: It's make or break for Alzheimer's drug in Biogen data reveal
The move comes as researchers debate whether another study will be needed to confirm the drug's benefits before it becomes widely available, a decision that will ultimately be the domain of the U.S. Food and Drug Administration and other regulators.
Shocking Move
Biogen and Eisai shocked researchers in March when they opted to shelve aducanumab, saying that trial results had suggested the drug was unlikely to work. The move caused investors to flee and disappointed scientists and patients who've hoped for decades to find a treatment for the harrowing incurable disease.
Then, in October, the companies reversed themselves, saying new data had come to light suggesting that aducanumab could be effective. The presentation on Thursday was the first detailed look at the data behind the dramatic decision to try to salvage the therapy.
As details of the trial unfurled, the most important audience was regulators who eventually will have to decide whether to allow aducanumab on the market. While the need for a medicine to slow the currently inexorable disease is enormous, the evidence of benefit will have to hold up.
“People are hoping of course, always hoping, that we will find something, but we aren't going to approve drugs that aren't effective,” said Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, speaking generally in an interview on Wednesday, ahead of the data release. “People won't send us applications if their trials fail; they will just terminate their programs. Obviously there is a tremendous need in Alzheimer's, and we'll just have to see about data.”
Biogen and Eisai plan to file for FDA approval in early 2020. Woodcock, in an interview about the agency's recent blistering pace for drug approvals, declined to comment specifically on Biogen's program.
To contact the reporters on this story: Michelle Fay Cortez in Minneapolis at mcortez@bloomberg.net;Robert Langreth in New York at rlangreth@bloomberg.net
To contact the editors responsible for this story: Drew Armstrong at darmstrong17@bloomberg.net, Timothy Annett, Mark Schoifet
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