Swedish scientist behind Alzheimer’s drug has big ambitions

When Japanese pharmaceutical company Eisai this week presented data confirming that it had developed the first drug to slow cognitive decline in Alzheimer’s patients, the audience at a conference in San Francisco, in the United States, exploded in applause.

Among those in attendance was Lars Lannfelt, the little-known Swedish scientist who invented the breakthrough drug, called lecanemab, and will make a fortune if it is approved and successfully marketed.

BioArctic, the company he founded in 2003 with Pär Gellerfors, struck a licensing deal for monoclonal antibody therapy with Eisai in 2007, entitling it to hundreds of millions of dollars in one-off payments and royalties 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 of up to $10 billion a year, a prospect that would transform BioArctic, as well as Eisai and its partner in the drug, US biotechnology company Biogen.

“It’s nice to have money, but that wasn’t what drove me. It was the science and the opportunity to build a Swedish company,” the 73-year-old told the Financial Times.

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

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

The Stockholm-listed company (Sweden) 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 Food and Drug Administration’s (FDA) accelerated approval process. But significant hurdles remain, including satisfying physicians’ concerns about its safety and whether the clinical benefits justify the risks posed by side effects.

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

Biogen initially priced the year-long aducanemab treatment 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, 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 yet? No. But the data set is clear and shows a clear benefit,” said Evan Seigerman, analyst at BMO Capital Markets.

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

A decision by CMS, the US federal agency that administers national insurance schemes, to restrict aducanemab insurance coverage to people undergoing clinical trials has hurt the drug’s commercial prospects.

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

The death of two patients on lecanemab, who were also taking blood-thinning drugs, has raised questions about whether large numbers of patients on anticoagulants might eventually be excluded from treatment.

“I suspect that the lack of demonstrable clinical efficacy will mean that lecanemab will not be widely adopted in healthcare systems across the world,” said Robert Howard, professor of psychiatry for the elderly at University College London.

Lannfelt disagrees with that assessment, arguing that a 27% reduction in the rate of cognitive decline is clinically significant and sufficient to approve and launch the drug. He said the study results also confirmed a controversial theory known as the amyloid hypothesis, according to which Alzheimer’s disease is caused mainly by the accumulation of plaque in the brain.

“It’s 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 will ever prove to be the “primary cause” of Alzheimer’s disease, saying it is a complex disease with many contributing factors.

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

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

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

“We founded BioArctic in 2003 based on that idea, and we were able to reach out to Eisai and convince them that focusing on protofibrils is a very good idea,” said Lannfelt, who owns 33.5% of BioArctic’s shares but controls 49.3% of the biotech company’s voting rights. He sold a small portion of his stake in October.

If lecanemab becomes a commercial success, Lannfelt said BioArctic will use the proceeds to develop drugs against 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 cannot change your lifestyle at this age,” Lannfelt said, adding that he will buy himself an electric car as a gift.