Shares fall 11% following two patient deaths in trials of lecanemab

Japan’s Eisai aims to silence critics over breakthrough Alzheimer’s drug


Just weeks ago at the company’s headquarters, Haruo Naito, the 74-year-old chief executive of Japan’s Eisai, was feeling vindicated after almost four decades of trying to develop an Alzheimer’s drug.
Ahead of the release of detailed information on Eisai’s new drug lecanemab, developed with Biogen, the company’s share price surged 60 per cent after results of a late-stage clinical trial showed that it slowed the progression rate of the memory-degenerating disease.
But on the eve of the presentation on Tuesday, news of a second death during trials emerged. That sent Eisai’s shares down 11 per cent, threatening to overshadow what Naito had hoped would be a convincing set of data to settle a debate among researchers about what causes the illness, which affects roughly 50mn people worldwide.

Under Naito, who took over as president in 1988, the company’s 11,000 employees have spent 1 per cent of their working hours — two and a half days a year — engaging with Alzheimer’s patients and their families. “It’s not by coincidence that our trial results were successful,” Naito said. “There has been a large amount of learning from our past failures.”
One of its biggest setbacks was the disastrous launch of aducanumab, which prompted the US Centers for Medicare & Medicaid Services to severely restrict reimbursement for all amyloid-reducing monoclonal antibody treatments. Eisai in March gave up its right to share the profits from that drug, whose benefits appear limited.
“The big lesson for us was to ensure transparency of data,” Naito said, referring to the controversy over whether the trial data of aducanumab provided enough evidence that the drug really worked.
“I don’t think there will be such a controversial debate this time since there is only one Clarity AD clinical trial for lecanemab so it is a very simple and easy to understand drug development.”
Regarding the potential price for lecanemab, Naito expressed confidence that US insurers will be willing to pay for the drug.
“There is no point unless the drug reaches the patients and is administered, so our biggest priority is to make sure the drug reaches the patients that need it,” Naito said. “The basis of our pricing policy will be that it will be at a level that is affordable.”
This story originally appeared on: Financial Times - Author:Kana Inagaki