Swedish scientist behind Alzheimer’s drug has big ambitions

As Japanese drugmaker Eisai this week introduced information confirming it had developed the primary drug to gradual cognitive decline in Alzheimer’s sufferers, the viewers at a convention in San Francisco burst into applause.

Amongst these in attendance was Lars Lannfelt, a little-known Swedish scientist who invented the groundbreaking drug, often called lecanemab, and can make a fortune whether it is permitted and efficiently marketed.

BioArctic, the corporate he co-founded in 2003 with Pär Gellerfors, struck a licensing deal on the monoclonal antibody remedy with Eisai in 2007, entitling it to a whole bunch of tens of millions of {dollars} in milestone funds and royalties on lecanemab gross sales.

About 55mn folks reside with dementia worldwide and Alzheimer’s illness accounts for as much as 70 per cent of those circumstances, based on the World Well being Group.

Analysts forecast the drug might generate gross sales value as much as $10bn a yr, a prospect that might rework BioArctic, in addition to Eisai and its accomplice on the drug, US biotech Biogen.

“It’s good to have cash however this isn’t what has been driving me. It has been the science and the chance to construct a Swedish firm,” the 73-year-old informed the Monetary Instances.

“We would like [BioArctic] to be a fully-fledged pharmaceutical firm: that’s our ambition.”

Shares in BioArctic, which has simply 75 workers, have greater than tripled in worth since Eisai disclosed in September that lecanemab slowed the speed of cognitive decline in early-stage Alzheimer’s sufferers by 27 per cent.

The Stockholm-listed firm is now value nearly $2bn and quickly recruiting workers, with the ambition of promoting the drug in Nordic international locations the place it owns the rights to lecanemab in co-operation with Eisai.

Lecanemab might be permitted within the US as early as January beneath the US Meals and Drug Administration’s accelerated approval pathway. However vital hurdles stay, together with satisfying physicians’ considerations about its security and whether or not the scientific advantages justify the dangers brought on by uncomfortable side effects.

Traders additionally want convincing that Eisai won’t repeat the errors of its accomplice Biogen, whose shares plunged final yr following the botched launch of an identical Alzheimer’s drug referred to as aducanemab that the Japanese group additionally helped develop.

Biogen initially priced a yr’s remedy of aducanemab at $56,000 regardless of considerations amongst some well being specialists who warned there was little conclusive proof of its advantages.

This week’s presentation of complete information on lecanemab on the Scientific Trials on Alzheimer’s Illness convention in San Francisco, together with publication of a peer reviewed article within the New England Journal of Drugs, was a optimistic growth, analysts stated.

“Is it a remedy? No. Are we there but? No. However the information set is clear and reveals a transparent profit,” stated Evan Seigerman, analyst at BMO Capital Markets.

“Primarily based on these information, we’re extremely assured in lecanemab’s approval and eventual Facilities for Medicare and Medicaid Companies (CMS) reimbursement,” he stated.

A choice by CMS, the US federal company administering nationwide insurance coverage schemes, to limit insurance coverage protection of aducanemab to folks present process the scientific trials broken that drug’s business prospects.

Regardless of the euphoria in San Francisco this week, some researchers and buyers stay cautious in regards to the prospects for lecanemab, a drug that targets sticky plaques referred to as beta amyloid that construct up within the mind. The remedy, they are saying, produces solely “average” scientific advantages in comparison with placebo and might trigger critical uncomfortable side effects together with mind bleeds.

The deaths of two sufferers on lecanemab, who have been additionally taking blood thinning medication, have additionally raised questions over whether or not massive numbers of sufferers on anticoagulants could finally be excluded from taking the remedy.

“I think that the shortage of demonstrable scientific effectiveness will imply that lecanemab won’t be taken up extensively inside healthcare methods around the globe,” stated Robert Howard, professor of outdated age psychiatry at College Faculty London.

Lannfelt takes concern with that evaluation, arguing {that a} 27 per cent discount within the fee of cognitive decline is clinically vital and sufficient to approve and launch the drug. He stated the trial outcomes additionally confirmed a contentious principle often called the amyloid speculation, which holds that Alzheimer’s is primarily brought on by the build-up of plaques within the mind.

“It’s properly confirmed that amyloid beta causes Alzheimer’s illness as a lot as HIV virus causes Aids. I believe it’s the identical degree of proof,” he claims.

Many researchers disagree that amyloid beta is now confirmed to be the “major trigger” of Alzheimer’s, saying reasonably that it’s a complicated illness with many contributory components.

“Amyloid beta most likely contributes roughly 30 per cent of the illness in totality, however there are numerous different illness proteins and different situations that may add to the speed of decline,” stated Dr Keith Vossell, a professor of neurology on the College of California Los Angeles.

It was Lannfelt’s discovery within the early Nineties of a mutation within the gene liable for amyloid beta that helped set up a hyperlink between sticky plaques and Alzheimer’s. Virtually a decade later whereas working as a researcher on the Karolinska Institute — a Swedish medical physique — he unearthed one other genetic mutation linked to amyloid-beta aggregates referred to as protofibrils, rod-like constructions which are a key goal of lecanemab.

Named the “Arctic mutation”, it led to the invention of the monoclonal antibody mAb158, which grew to become lecanemab.

“We based BioArctic in 2003 based mostly on this concept and we managed to get in touch with Eisai and persuade them that to focus on protofibrils is an excellent thought,” stated Lannfelt, who owns 33.5 per cent of BioArctic shares however controls 49.3 per cent of the biotech’s voting rights. He bought a small portion of his stake in October.

If lecanemab turns right into a business success, Lannfelt stated BioArctic would use the proceeds to develop medication focusing on Parkinson’s illness and different issues of the central nervous system. Regardless of his age, he stated he wished to proceed working at BioArctic so long as he might contribute with analysis.

 “You possibly can’t change your life-style at this age,” stated Lannfelt, including that he would indulge himself by shopping for an electrical automobile.