Health

The Swedish scientist behind the cure for Alzheimer’s disease has big ambitions

The Swedish scientist behind the cure for Alzheimer’s disease has big ambitions

As Japanese drugmaker Eisai presented data this week confirming it has developed the first drug to slow cognitive decline in Alzheimer’s patients, the audience at a San Francisco conference erupted in applause.

Among those present was Lars Lannfelt, a little-known Swedish scientist who invented breakthrough drug, known as lekanemab, and will make a fortune if approved and successfully brought to market.

BioArctic, a company he co-founded in 2003 with Pär Gellerfors, entered into a monoclonal antibody therapy licensing agreement with Eisai in 2007, entitling it to hundreds of millions of dollars in milestone payments and royalties on sales of lekenemab.

About 55 million people worldwide live with dementia, and Alzheimer’s disease accounts for up to 70 percent 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 will transform BioArctic, as well as Eisai and its partner on the drug, US biotech Biogen.

“It’s nice to have money, but it’s not what drives me. It was a science and an opportunity to build a Swedish company,” the 73-year-old told the Financial Times.

“We wish [BioArctic] to be a full-fledged pharmaceutical company: that is our ambition.”

Brain scan in Alzheimer’s disease © BSIP SA/Alamy

Shares in BioArctic, which has just 75 employees, have more than tripled since Eisai revealed in September that lekanemab slowed the rate of cognitive decline in early-stage Alzheimer’s patients by 27 percent.

The Stockholm-based company is now worth nearly $2 billion and is hiring fast, with ambitions to sell the drug in the Nordic countries where it owns the rights to lekanemab in collaboration with Eisai.

Lecanemab could be approved in the US as early as January under the US Food and Drug Administration’s fast track approval process. But significant hurdles remain, including satisfying physicians’ concerns about its safety and whether the clinical benefit justifies the risks posed by side effects.

Investors also need to be reassured that Eisai will not repeat the mistakes of its partner Biogen, whose shares fell last year after the failed launch of a similar Alzheimer’s drug called aducanemab that the Japanese group also helped develop.

Biogen originally priced a one-year treatment with aducanemab at $56,000 despite concerns from some health experts who warned there was little convincing evidence of its benefits.

This week’s presentation of comprehensive data on lecanemab at the Alzheimer’s Clinical Trials Conference in San Francisco, along with the publication of a peer-reviewed article in the New England Journal of Medicine, was a positive development, analysts said.

“Is it a cure? No. Are we there? No. But the data set is clean and shows a clear benefit,” said Evan Seigerman, an analyst at BMO Capital Markets.

“Based on these data, we are very confident in the approval of lekanemab and eventual reimbursement by the Centers for Medicare and Medicaid Services (CMS),” he said.

BioArctic laboratory and office in Stockholm, Sweden
BioArctic’s laboratory and offices in Stockholm, Sweden, where early research into neurodegenerative diseases such as Alzheimer’s and Parkinson’s is carried out © BioArctic/Gustav Gräll

A decision by CMS, the US federal agency that administers the nation’s insurance schemes, to limit insurance coverage for aducanemab to people undergoing clinical trials has damaged the drug’s commercial prospects.

Despite the euphoria in San Francisco this week, some researchers and investors remain cautious about the prospects for lekanemab, a drug that targets sticky plaques called beta amyloid that build up in the brain. The therapy, they say, produces only a “moderate” clinical benefit compared to a placebo and can cause serious side effects, including bleeding in the brain.

The of death of two patients on lecanemab, who were also taking blood thinners, also raised the question of whether a large number of patients on anticoagulants may end up being excluded from treatment.

“I suspect that the lack of proven clinical efficacy will mean that lecanemab will not be widely accepted in health systems around the world,” said Robert Howard, professor of geriatric psychiatry at University College London.

Lannfelt disputes that estimate, arguing that the 27 percent reduction in the rate of cognitive decline is clinically meaningful and enough to get the drug approved and put on the market. He said the trial results also supported a controversial theory known as the amyloid hypothesis, which claims that Alzheimer’s disease is primarily caused by a build-up of plaque in the brain.

“Amyloid beta has been shown to cause Alzheimer’s disease as much as the HIV virus causes AIDS. I think the level of evidence is the same,” he claims.

Many researchers disagree that amyloid beta is now proven to be the “primary cause” of Alzheimer’s disease, saying instead that it is a complex disease with many contributing factors.

“Amyloid beta probably contributes to about 30 percent of the disease overall, but there are many other disease proteins and other conditions that can contribute to the rate of decline,” said Dr. Keith Vossell, a professor of neurology at the University of California, Los Angeles. Angeles.

It was Lannfelt’s discovery of a mutation in the gene responsible for amyloid beta in the early 1990s that helped establish the link between sticky plaques and Alzheimer’s disease. Almost a decade later, while working as a researcher at the Karolinska Institute – Sweden’s medical body – he discovered another genetic mutation linked to amyloid-beta aggregates called protofibrils, the rod-like structures that are a key target of lekanemab.

Called the “Arctic mutation,” it led to the discovery of the monoclonal antibody mAb158, which became lekanemab.

“We founded BioArctic in 2003 based on this idea and were able to get in touch with Eisai and convince them that targeting protofibrils was a very good idea,” said Lannfelt, who owns 33.5 percent of BioArctic’s stock but controls 49.3 percent biotechnology voting rights. In October, he sold a small portion of his stake.

If lekanemab turns into a commercial success, Lannfelt said BioArctic will use the proceeds to develop drugs that target Parkinson’s disease and other central nervous system disorders. Despite his age, he said he wants to continue working at BioArctic as long as he can contribute to research.

“You can’t change your lifestyle at this age,” Lannfelt said, adding that he would indulge himself by buying an electric car.



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