As Japanese drugmaker Eisai this week presented data confirming it had developed the first drug to slow cognitive decline in Alzheimer’s patients, audiences at a conference in San Francisco erupted in applause.
Among those present was Lars Lannfelt, a little-known Swedish scientist who invented the breakthrough drug, known as lecanemab, and will make a fortune if approved and successfully marketed.
BioArctic, the company he co-founded in 2003 with Pär Gellerfors, entered into a monoclonal antibody therapy licensing agreement with Eisai in 2007, entitling him to hundreds of millions of dollars in milestone and royalty payments. on sales of lecanemab.
About 55 million people live with dementia worldwide and Alzheimer’s disease accounts for up to 70% of these cases, according to the World Health Organization.
Analysts predict the drug could generate sales worth up to $10 billion a year, a prospect that would transform BioArctic, as well as Eisai and its partner on the drug, US biotech Biogen.
“It’s nice to have money but that’s not what pushed me. It’s been the science and the opportunity to build a Swedish business,” the 73-year-old told the Financial Times.
“We want [BioArctic] to be a full-fledged pharmaceutical company: that is our ambition.
Shares of BioArctic, which has just 75 employees, have more than tripled since Eisai revealed in September that lecanemab slowed the rate of cognitive decline in patients with early-stage Alzheimer’s disease by 27%. .
The Stockholm-listed company is now worth nearly $2 billion and is rapidly recruiting staff, with ambitions to sell the drug in the Nordic countries where it owns the rights to lecanemab in cooperation with Eisai.
Lecanemab could be approved in the United States as early as January under the US Food and Drug Administration’s fast-track approval process. But significant hurdles remain, including addressing doctors’ concerns about its safety and whether the clinical benefits justify the risks caused by side effects.
Investors also need to be confident that Eisai won’t repeat the mistakes of its partner Biogen, whose shares plunged last year following the botched launch of a similar Alzheimer’s disease drug called aducanemab that the group Japanese also helped develop.
Biogen initially priced a year’s worth of aducanemab at $56,000 despite concerns from some health experts who warned there was little conclusive evidence of its benefits.
This week’s presentation of comprehensive data on lecanemab at the Alzheimer’s Disease Clinical Trials Conference in San Francisco, as well as the publication of a peer-reviewed article in the New England Journal of Medicine, were a positive development, analysts said.
“Is this a cure? No. Are we there already? No. But the data set is clean and shows a clear upside,” said Evan Seigerman, analyst at BMO Capital Markets.
“Based on these data, we are very confident in lecanemab’s approval and eventual reimbursement from the Centers for Medicare and Medicaid Services (CMS),” he said.
A decision by CMS, the US federal agency administering national insurance plans, to restrict insurance coverage for aducanemab to people undergoing clinical trials has hurt the drug’s market prospects.
Despite the euphoria in San Francisco this week, some researchers and investors remain cautious about the outlook for lecanemab, a drug that targets sticky plaques called amyloid beta that accumulate in the brain. The therapy, they say, produces only “moderate” clinical benefits over placebo and can cause serious side effects, including brain hemorrhages.
The deaths of two patients on lecanemab, who were also taking blood thinners, also raised questions about whether large numbers of patients on blood thinners could possibly be excluded from taking the treatment.
“I suspect the lack of demonstrable clinical efficacy will mean that lecanemab will not be widely used in healthcare systems around the world,” said Robert Howard, professor of old age psychiatry at University College London.
Lannfelt disputes this assessment, saying a 27% reduction in the rate of cognitive decline is clinically significant and sufficient to approve and launch the drug. He said the trial results also support a controversial theory known as the amyloid hypothesis, which says Alzheimer’s disease is primarily caused by the buildup of plaques in the brain.
“It is well proven that beta-amyloid causes Alzheimer’s disease as much as the HIV virus causes AIDS. I think it’s the same level of evidence,” he says.
Many researchers disagree that beta-amyloid is now proven to be the “root cause” of Alzheimer’s disease, instead saying it is a complex disease with many contributing factors.
“Beta amyloid probably contributes about 30% of total disease, but there are many other disease proteins and other conditions that can accelerate the rate of decline,” said Dr. Keith Vossell, professor of neurology at the University of California at Los Angeles. Angels.
It was Lannfelt’s discovery in the early 1990s of a mutation in the gene responsible for beta-amyloid that linked sticky plaques to Alzheimer’s disease. Almost a decade later, while working as a researcher at the Karolinska Institute – a Swedish medical organization – he discovered another genetic mutation linked to aggregates of beta-amyloid called protofibrils, rod-like structures which are a key target of lecanemab.
Baptized “Arctic mutation”, it led to the discovery of the mAb158 monoclonal antibody, which became lecanemab.
“We founded BioArctic in 2003 based on this idea and we were able to get in touch with Eisai and convince them that targeting protofibrils is a very good idea,” said Lannfelt, who owns 33.5% of the shares. of BioArctic but controls 49.3% of the biotech’s voting rights. He sold a small part of his stake in October.
If canemab becomes a commercial success, Lannfelt said BioArctic would use the proceeds to develop drugs targeting Parkinson’s disease and other central nervous system disorders. Despite his age, he said he wanted to continue working at BioArctic as long as he could contribute to research.
“You can’t change your lifestyle at this age,” Lannfelt said, adding that he would happily buy an electric car.
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