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Two Alzheimer’s drugs offer hope to patients after decades of waiting

In trials, the medications slowed the progress of a degenerative disease that affects 50mn worldwide

When Lori Weiss was diagnosed with mild cognitive impairment because of Alzheimer’s disease she thought it was a death sentence, given there were no approved treatments that could slow progress of the debilitating disease.

But after enrolling in a trial of an experimental therapy developed by Eli Lilly, the 65-year-old former teacher says her memory has improved and she is able to do things she previously found difficult.

“I’m able to drive again. I have freedom,” said Weiss, who was one of more than 1,700 participants in the late-stage trial of a drug called donanemab.

This week US drugmaker Lilly published positive results from the trial, raising hopes among patients and doctors for a new class of drugs being developed to treat Alzheimer’s. It also generated excitement across the pharmaceutical industry, which is enticed by the prospect of selling medicines to the more than 50mn people worldwide who suffer from the disease.

The trial showed donanemab slowed progression of the disease by 35 per cent compared with a placebo over an 18-month period. Although there is no evidence that the drug can reverse the symptoms of Alzheimer’s, the trial showed the decline in patients’ ability to perform daily tasks was 40 per cent lower for those on donanemab.

Lilly said it anticipates US regulators will approve the drug later this year based on the successful trial results.

The results mark the second significant breakthrough in a year for a class of drugs targeting a disease that is the most common cause of dementia and for which there is no cure. It comes as a new generation of blood tests for Alzheimer’s are being developed which offer the tantalising prospect of early detection and treatment of the condition for the first time.

In January the US Food and Drug Administration approved lecanemab, a drug co-developed by Japanese drugmaker Eisai and US biotech Biogen, under an accelerated process. In a late-stage trial the drug slowed the rate of cognitive decline in patients by 27 per cent when compared to placebo.

Both drugs work by reducing the build-up of sticky amyloid plaques in the brain known as beta-amyloid, which are at the centre of an acrimonious scientific debate about what causes Alzheimer’s.

Almost two dozen clinical trials on drugs seeking to treat Alzheimer’s by reducing these plaques have failed since 2003, prompting scepticism among some experts that removing amyloid can slow progression of the disease.

Lori Weiss, who has Alzheimer’s, has been encouraged by the effects of Eli Lilly’s trial drug donanemab © Alzheimer’s Association

The controversial approval by the FDA of another amyloid reducing drug called aducanumab in 2021, despite conflicting evidence that it slowed the rate of cognitive decline, further inflamed the debate.

Lilly told the Financial Times the results of the donanemab and lecanemab trials together prove the “amyloid hypothesis”, the theory holding that sticky amyloid plaques are the main cause of Alzheimer’s disease.

“As you look across the class you should be reassured about the ‘amyloid hypothesis’ because you can see in medicines, not just ours but in others that robustly remove plaque, you see clinical benefit,” said Anne White, president of Lilly Neuroscience.

Donanemab showed strong efficacy in removing the plaques in the trial, with just over half of trial participants able to complete their course of treatment within a year as they achieved the target for amyloid clearance.

The Alzheimer’s Association, an advocacy group, said the trial results were the “strongest” released to date for an amyloid-reducing drug and suggested an “inflection point” for treatment of the disease. Many experts welcomed the Lilly data as an important step forward but cautioned that donanemab was not a cure and the full results of the trial have not yet been published and need to be closely studied.

“While this result is greatly encouraging, it is clear we still have a lot more work to do,” said Dr Ian Musgrave, senior lecturer in pharmacology at University of Adelaide, Australia. “Despite near total removal of amyloid plaque, the disease still did progress, although at a much slower rate than without treatment.”

Scientists are pursuing other targets beyond sticky plaques in their pursuit of Alzheimer’s therapies, including inflammation in the brain. But none of these are as advanced as lecanemab and donanemab.

However, there are concerns over whether the slowdown in cognitive decline achieved by both drugs is clinically meaningful and worth the risks posed by potentially dangerous side effects.

Rob Howard, a professor of old-age psychiatry at University College London, said slowing the progression of the disease by 35 per cent sounded superficially impressive. However, the absolute differences between donanemab and placebo in cognition and function, apparent from the trial, were so tiny that they would be unnoticed by patients and their families.

“This raises the question of whether taking the drug is worth the risks, given that three people died during the trials from side effects,” he said.

Both lecanemab and donanemab can cause severe side effects such as brain swelling and bleeding, which can be fatal. This will place a heavy burden on doctors when they recommend treatment, although the lack of alternatives suggests high patient demand for the drugs.

The high price of the drugs — lecanemab is priced at $26,500 per year — and tough restrictions imposed by the US government on reimbursement by publicly funded health schemes for amyloid-reducing treatments are other hurdles.

In the wake of the controversy over the FDA approval of Biogen’s aducanumab, the US Centers for Medicare and Medicaid Services said only patients taking part in a clinical trial would benefit from reimbursement. It was the first time CMS had imposed such restrictions on a drug approved by the FDA and it limits the number of patients on amyloid drugs to a few thousand, rather than the 6mn Alzheimer’s sufferers in the US.

“Unfortunately we are in uncharted territory,” said Robert Egge, chief public policy officer at the Alzheimer’s Association.

He said every day that reimbursement is denied about 2,000 Alzheimer’s sufferers in the US move past the window of eligibility for amyloid-reducing drugs, as they are only targeting early-stage patients.

Eisai said it is encouraged by “ongoing productive discussions” with CMS about lifting the restrictions. This could happen in July when lecanemab, which has been approved under an accelerated process, is expected to be granted full approval by the FDA.

For Alzheimer’s patients such as Weiss, a change of policy cannot come quick enough, even if concerns still exist about the safety and efficacy of the new drugs.

“These drugs give people a chance to get more years of their life back and live normal lives without having to face being in a nursing home,” said Weiss. “I’m still painting and going to parties with friends.”

Delays caused by software venture Cariad led to Oliver Blume’s anticipated move

BERLIN—Volkswagen VOW 1.16%increase; green up pointing triangle Chief Executive Officer Oliver Blume, in his first major restructuring move since becoming chief last year, is expected to replace the management of the company’s struggling software unit after it caused delays to new model launches, according to people familiar with the matter.

The decision to remove Dirk Hilgenberg, head of the unit called Cariad, finance chief Thomas Sedran, and Lynn Longo, a Michigan native who serves as Cariad’s chief technology officer, could be announced as early as this week, possibly before VW’s planned shareholder meeting on Wednesday, the people said.

Messrs. Hilgenberg and Sedran and Ms. Longo couldn’t be reached for comment. The changes at Cariad were earlier reported by the German-language Business Insider news site on Saturday.

While Mr. Blume is set to remove the executives from their current roles, one of the people familiar with the matter said they could be offered other jobs within the VW group in Europe or North America.

The expected decision to replace existing management comes after an intense analysis of Cariad conducted by VW that came to the conclusion that current management lacked strong tech experience and leadership skills in a restructuring situation, this person said.

VW executives have said publicly that VW remains committed to Cariad as a business unit. But the person said that the unit needed a new structure focused on fast, incremental software development in sync with the schedules of product launches at the brands.

Mr. Blume hasn’t settled on candidates for new management at Cariad, the person added.

Cariad was created by Mr. Blume’s predecessor, Herbert Diess, in a bid to produce advanced software including self-driving capabilities for the VW group’s brands by the middle of the decade.

The move to shun big tech software providers such as Google and Apple in favor of inhouse development was bold and risky. VW spent billions and had to recruit an army of software developers and coordinate efforts across its diverse brands. Despite the effort, Cariad got mired in the complexities of building advanced software, leading to a string of delays to model launches.

Instead of paving VW’s path toward overtaking electric-car market leader Tesla, Cariad held the company’s brands back from moving faster. The launch of VW’s first all-electric model built on in-house EV technology in 2019 was marred by glitchy software. Instead of delaying the launch again, VW decided to release the vehicle with an incomplete software package.

Mr. Diess hired Mr. Hilgenberg from BMW in 2020 to fix the group’s software organization. Although Mr. Hilgenberg made some progress, Cariad continued to stumble, causing the planned launches of breakthrough all-electric models—the Audi’s Q6 e-tron and a battery-electric version of Porsche’s popular Macan SUV—to be delayed.

The troubles at Cariad added to pressure on Mr. Diess, who was ousted last year. Mr. Blume, his successor, serves in a dual role as CEO of VW and Porsche.

One of Mr. Blume’s first decisions after taking control in September was to put development of Cariad’s most futuristic projects on ice and focus on getting the most current model launches back on schedule.

He scrapped plans for an ultramodern factory in Wolfsburg, Germany, to build a new high-end VW-branded EV with Cariad’s planned advanced software, instructing the unit instead to focus on getting the delayed Audi and Porsche models on the road.

Mr. Blume has also been more open to collaborating on software with outside developers, though he has stated publicly numerous times that automotive software controlling the car’s core operations shouldn’t be open to developers such as Google or Apple.

Mr. Blume has also spoken publicly about his talks with tech companies such as Apple and Google and his interest in having their apps in VW vehicles.

VW recently announced that it would build its own app store, accessible via the car’s display screens.

Adrian Hallmark points to poor incentives and energy prices that are putting off carmakers

The UK’s failure to attract investments from electric vehicle start-ups or large battery makers was “concerning”, the chief executive of luxury-car maker Bentley has warned.

The government needs to deal with energy costs to spur investment and compete with other countries whose incentives are “an order of magnitude more attractive than the UK”, Adrian Hallmark told the Financial Times.

The Bentley boss’s comments come as governments across the world vie to attract battery manufacturing plants in order to protect their own car industries as they gradually switch to making electric vehicles.

Companies such as Bentley’s owner Volkswagen are choosing “Canada, Spain, Poland, Belgium, even Germany — one of the highest-cost markets in Europe” to locate battery factories, he said.

In these countries “the incentives that are offered, which are all publicised, are an order of magnitude more attractive than the UK”, he added.

Speaking in a pre-recorded interview for the FT Future of the Car Summit this week, the Bentley chief said: “It’s surprising, if not a bit concerning that no [electric vehicle] manufacturer or battery manufacturer has chosen the UK over any other location as an investment destination.” 

He also pointed out that “no one has chosen so far to put any strategic investment in green mobility into the UK beyond the incumbents”.

The three-day event held in London from Tuesday will feature the chief executives or senior leaders from Ferrari, Geely, Renault, Nissan, Volkswagen, Stellantis, Ford and Aston Martin, as well as electric car start-ups Polestar and Fisker.

While the UK has previously held talks with start-ups including Rivian and Tesla, so far none of the new entrants have chosen to build factories in the UK. China’s BYD earlier this year said that it did not even consider a plant in the country because of its decision to leave the EU.

Chinese battery group Envision is building a larger battery plant for Nissan in Sunderland, and is expected to work with India’s Tata on a site to serve Jaguar Land Rover, which is choosing between the UK and Spain for the factory.

The government should offer “affordable energy prices and at least something approaching equivalent incentives to get the ball rolling in terms of inward investment,” Hallmark said, adding that UK energy costs are about a third higher than on mainland Europe.

Bentley has committed to making its future electric cars in the UK as part of a €3bn investment into its Crewe facility, but plans to use imported batteries.

The brand, which made about 15,000 cars last year, is not large enough to support a dedicated battery plant in the UK, Hallmark said. “To get a critical mass, to create a gigafactory and to make it work from an economic point of view is going to be a real challenge in the UK, unless a big player steps in to fulfil their own needs and has spare capacity”.

EU steps up efforts to clamp down on Russia sanctions evasion

Whack-a-mole

The EU’s 11th package of sanctions on Russia is meant to be an exercise in closing down loopholes. But that doesn’t mean it will be easy to land, write Sam Fleming and Andy Bounds.

Context: EU members want to further tighten the noose around key sectors of the Russian economy. But with little left to hit there, the discussions have focused on countering sanctions evasion through third countries.

Among the most radical ideas is a mechanism that would allow the EU to restrict sales of certain products to other third countries that then leak into Russia.

Critics, however, fear that targeting countries through which banned goods transit could alienate them. “We want to do this in such a way that we don’t push those third countries towards China or Russia,” an EU diplomat said.

According to the text, which will need to be unanimously approved by member states, the bloc would first try to counter circumvention through diplomatic means, using more restrictive measures for certain goods as last resort.

The sanctions would, if approved, also explicitly target a handful of companies in countries including China, because of claims they are selling equipment that could be used in weapons. Member state representatives will discuss the draft on Wednesday, and it could still change.

Other parts of the proposed package focus on ironing out wrinkles and listing dozens of new individuals and entities.

Brussels has, for example, proposed ending the temporary exemption from the Russian oil embargo for the north Druzhba pipeline to Poland and Germany.

The proposed sanctions also include ending the transit of certain goods through Russia and fresh export controls for newly identified dual-use goods.

More controversial proposals such as imposing sanctions on the Russian nuclear sector did not make it into the current text.

Still, expect lengthy discussions. “Experience has shown that these proposals need to be studied in detail,” one senior EU diplomat said.

Alessandro Michele, the architect of Gucci’s revamp who abruptly resigned in November, is preparing his comeback. The 50-year-old stylist is secretly working on reviving the Italian fashion name Walter Albini, according to several industry sources. Albini, widely considered the father of Italian ready-to-wear, is a designer Michele has always admired. Could it be a match made in fashion heaven?

Michele made his first appearance in public in months at the Met Gala in New York last week on the arm of Agnelli heiress and movie producer Ginevra Elkann. Michele dressed as a flamboyant, 1970s’ version of Karl Lagerfeld, at the event in the Kaiser’s honor.

In that flamboyancy, Michele also recalled Albini, a brilliant dandy designer who shot to fame in the late 1960s and 1970s. His explosive creativity and classy looks had him compared with both Lagerfeld and Yves Saint Laurent at the time.

But Albini did not live long enough for many people to remember him outside of Italy. Albini died of AIDS in 1983, at the height of his stardom, at the age of 42. For fashion insiders Albini is ripe for revival - and Michele is the ideal creative to do it.

GENDERLESS

Like Michele, Albini was considered a pioneer of genderless fashion, making suits for women and men alike. Albini too was known for his “total looks.” These involved not only entire silhouettes and accessories using the same theme, fabric or colors but also matching curtains and sofa.These produced striking images beloved by photographers and fashion magazine editors. Albini was known for working closely with fabric and clothes manufacturers. He helped industrialize and democratize fashion and contributed to the emergence of what would become known as Italian ready-to-wear.

In common with Albini, Michele’s baroque and eclectic universe is not only about clothes - it’s also about lifestyle and decoration. The long-haired and tattooed stylist loved designing for the Tuscan porcelain maker Ginori 1735 which Gucci saved from bankruptcy ten years ago. And like Albini, Michele is passionate about unisex clothes and accessories. Some fashion critics say Michele has influenced the rise of genderless as a major trend in fashion. The Italian stylist, who spent 20 years at Gucci and became creative director in 2015, admitted several times in interviews to being inspired by Albini’s legacy.

Some Italian media reported that Walter Albini is being relaunched by the Qatari fund Mayhoola that owns Valentino and Balmain. That’s incorrect, informed sources have told Miss Tweed.The Walter Albini brand and its archives were acquired last year by Bidayat, an investment company founded two years ago by Rachid Mohammed Rachid, several sources with first-hand knowledge of the matter told Miss Tweed on condition of anonymity. Rachid is also CEO of Mayhoola and chairman of fashion brands Balmain and Valentino.An Egyptian national, Rachid was previously Minister of Trade, Industry, and Investment of Egypt and president of Unilever North Africa.

BIDAYAT

Based in Switzerland, Bidayat is funded by Rachid’s family office Alsara Investment Group which has over $2 billion in assets under management and focuses primarily on markets in the Middle East, North Africa and Europe. The group has invested in many companies, including Japanese luxury eyewear maker Akoni which works for Valentino and Balmain.

Though Bidayat, Rachid invests in up-and-coming fashion, jewelry and accessories brands from around the Mediterranean Basin, putting in from $500,000 to $10 million. Bidayat has invested in the Egyptian accessories brand Okhtein and in the jeweler Azza Fahmy, a brand currently advised by former Kering watch and jewelry executive Albert Bensoussan.

“Mr Rachid is passionate about entrepreneurship and Bidayat is a way for him to support talents and take risks,” a source close to Mayhoola told Miss Tweed declining to be named. “This is a very serious project for Bidayat,” the source explained. “A lot of work and resources are being invested in it,” the person said, adding that the relaunch of the Walter Albini brand was due to take place a few months from now. Rachid may have found the designer to relaunch the label but he is still looking for a CEO and a Chief Merchandising Officer, the source said. Building teams takes time and is no easy task.

Still, the prospect of Michele reviving Albini is tantalizing. Michele, may have left Gucci because owner Francois-Henri Pinault wanted a change of mood at the Italian mega brand, but Michele still remains a creative juggernaut whose maximalist style has millions of followers. During his seven-year tenure, Gucci’s annual revenues went from €3.9 billion to more than €10 billion.

“He’s a great match for Albini,” one senior industry source said about the choice of Michele for resuscitating the name of the late Italian designer. Some creatives are better at telling others’ stories than their own. Michele’s run at Gucci suggests he is a master at this skill. Will he be able to do the same at Albini? The superlative example of this was Karl Lagerfeld, who worked for Krizia alongside Albini in the late 1960s, and who was always more successful designing for Fendi and for Chanel than he was for his own eponymous brand, fashion critics say. Some designers are not comfortable telling their own personal story. It forces them to reveal their inner selves and makes them feel vulnerable. They much prefer hiding their sensibility behind the mask of another person. That way, they feel protected and more at ease to create.

SLEEPING BEAUTIES

The fashion industry is full of success stories of designers who resuscitated sleeping beauties. The advantage of that business model is that when the brand parts ways with a designer for whatever reason, it still has a chance to survive and even thrive under another creative director. Balenciaga, Schiaparelli and Yves Saint Laurent are good examples. And then are some prestigious historic names in fashion such as early 20th century Madeleine Vionnet and Paul Poiret who never found the right designer and business partner to help them really take off. Under the ownership of Korean retailer Shinsegae International, Paul Poiret’s fashion debut flopped and now it’s mainly a cosmetics brands sold in Asia.

Even though Michele built a huge fan base with his colorful, romantic and geek chic looks and is now actually much better known today than Albini, it makes more sense for him to bring back a historic name on the fashion map and make it relevant again than launching his own label, fashion industry analysts say. “Michele is currently working on a start-up but he’s keeping that project very secret,” a senior industry source told Miss Tweed.

ILLUSTRATOR

Born in Busto Arsizio, outside of Milan, in 1941, Albini was the only male attending the all-girls Institute of Art, design and fashion at Turin University. At 17, he started as an illustrator, producing ads for fashion magazines and rapidly applied his talent to drawing clothes and accessories.

Albini broke with the tradition of showcasing in Florence’s historic Palazzo Pitti, by hosting catwalks in Milan. And many other brands would follow him. Today, Milan is Italy’s fashion capital. The designer drew inspiration from all kinds of artistic movements from Gustav Klimt and Art Deco to films from the Inter-War period. He was also very impressed by the rigor and vision of Coco Chanel whom he met in Paris in the early 1960s.

In the meantime, there are plenty of signs a relaunch is underway, although it remains behind-the-scenes. TheWalter Albini website that showcased the late designer’s work and told the designer’s story was shut down this week. It now only features a logo with “W” sitting above an “A” on a white page with an email contact. That email contact never replied to a request for an explanation as to why the website was pulled down.

Hired by Bidayat, students at Italy’s Bocconi University, have been interviewing specialists on how to best revive dormant heritage brands in preparation for this project, one senior industry source said.Official documents from the European Union Intellectual Property Office show that the owner of the brand changed address in Milan last month.

What’s more, Stefano Tonchi, an Italian fashion industry veteran is understood to be advising Rachid and the Bidayat teams on how to best bring back the spirit of the legendary designer. Maria Luisa Frisa co-authored with Tonchi, former editor of W fashion magazine, a book called Walter Albini and his times: All power to the imagination, published in 2010 by Marsilio Editori.

Bidayat, Rachid and Tonchi did not reply to requests for comment.

Even though speculation is growing about Michele’s comeback and his involvement with this revival, the project is kept under wraps for now. The plan is to say something only when the teams and the strategy are in place. This may not happen as fast at Rachid would like.

Still, the stage is being set for an enticing revival not only of Albini, but also Michele.

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