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U.S. biotechnology company was the last of three suitors standing in an auction for Horizon

Amgen Inc. AMGN -2.42% is in advanced talks to buy drug company Horizon Therapeutics HZNP 0.39% PLC, according to people familiar with the matter, in a takeover likely to be valued at well over $20 billion and mark the largest healthcare merger of the year.

The U.S. biotechnology company was the last of three suitors standing in an auction for Horizon, the people said, after French drugmaker Sanofi SA said Sunday it was out of the running.

A deal could be finalized by Monday assuming the talks with Amgen don’t fall apart, the people said.

Horizon develops medicines to treat rare autoimmune and severe inflammatory diseases that are currently sold mostly in the U.S. Its biggest drug, Tepezza, is used to treat thyroid eye disease, an affliction characterized by progressive inflammation and damage to tissues around the eyes.

The company is Nasdaq-listed, but based in Ireland and has operations in Dublin, Deerfield, Ill., and a new facility in Rockville, Md.

Horizon said last month it was fielding takeover interest from Amgen, Sanofi and Johnson & Johnson, a disclosure prompted by a Wall Street Journal report.

Johnson & Johnson later said it had dropped out.

Last year, revenue from Tepezza more than doubled, driving Horizon’s overall net sales 47% higher to $3.23 billion. Horizon has said that annual global net sales of the drug are targeted to eventually peak at more than $4 billion as the company aims to win approval to sell it in Europe and Japan.

That type of growth is attractive to big drug companies—with many sitting on big piles of cash—that rely on acquisitions as a key strategy to expand sales. Many big drugmakers are looking for new sources of revenue to offset losses when some of their main products lose patent protection.

Analysts expect Amgen will lose sales when patents begin expiring on its big-selling osteoporosis drugs Prolia and Xgeva later this decade. The pair of drugs accounted for nearly $5.3 billion of Amgen’s $26 billion in revenue last year.

In October, Amgen completed a $3.7 billion deal for ChemoCentryx and its drug to treat a rare immune-system disease.

Adding Horizon would provide more rare immune-disease drugs to Amgen’s lineup, which also includes the biotech’s Enbrel and Otezla immune-disease therapies. Amgen could help sell more of Horizon’s products overseas, according to analysts.

Acquiring Horizon could add about $4 billion in new revenue for Amgen by 2024, according to Jefferies & Co.

Other big life-sciences companies have been inking deals in recent months.

Johnson & Johnson recently struck a $16.6 billion deal to acquire heart device maker Abiomed Inc. to bolster sales of its medical-gear division, which had been lagging behind those of its pharmaceutical unit.

Merck & Co. followed with a deal of its own, agreeing to buy blood-cancer biotech Imago BioSciences Inc. for $1.35 billion, ahead of the patent expiration of its cancer immunotherapy Keytruda.

Pfizer Inc., meanwhile, agreed in August to buy Global Blood Therapeutics Inc. for $5.4 billion, in a deal that would give the big drugmaker a foothold in the treatment of sickle-cell disease.

A deal for Horizon would likely rank as the largest healthcare acquisition globally in 2022, ahead of the Johnson & Johnson-Abiomed tie-up. The selloff in stocks this year amid rising interest rates, while putting a damper on deal activity, has also made some companies more attractive targets. At the stock’s peak about a year ago, Horizon was valued at roughly $27 billion.

The shares, which fell sharply earlier this year, have surged since the possibility of a takeover surfaced, and the company now has a market value of about $22 billion.

Horizon’s other drugs include Krystexxa for treating gout, a form of inflammatory arthritis, and Ravicti for a rare, potentially life-threatening genetic disease known as urea cycle disorder that raises ammonia levels in the blood.

Drugs treating rare diseases have emerged as a large source of pharmaceutical sales because they can command high prices that health insurers have been willing to pay.

Negotiators are hoping to reach a deal on a full-year spending bill but they disagree on nondefense spending

WASHINGTON—Congressional leaders are set to return to the Capitol on Monday under pressure to negotiate a spending bill that would fund the federal government’s operations beyond Friday.

Negotiators have days to reach a deal on a full-year spending bill or pass a short-term measure delaying the deadline to avoid a partial government shutdown. To reach a longer-term deal, they will have to break the partisan deadlock between Republicans and Democrats, who are split over $26 billion in nondefense spending.

Republicans say that Democrats want big increases for entities such as the Internal Revenue Service that they say are already flush with cash. Democrats say their funding priorities, such as funding veterans’ healthcare, are critical.

Democrats in the U.S. Senate need to convince at least 10 Republicans to agree to advance a spending bill with the 60 votes needed. In the House of Representatives, a spending bill can be passed with a simple majority.

Few other items remain on the congressional agenda before new lawmakers take over for the next session, which begins on Jan. 3. Lawmakers who see the spending bill as the last major piece of legislation to pass are also lobbying hard for negotiators to include other measures they see as top priorities.

Some lawmakers want the spending bill to include the Electoral Count Act, which would change an 1887 law governing how Congress deals with presidential-election disputes. The bill has been pitched as a way to prevent a repeat of what happened following the 2020 election when then-President Donald Trump pressured his vice president, Mike Pence, to reject the Electoral College votes from some states. Mr. Pence declined to do so.

Other lawmakers are trying to include a measure that would extend a Dec. 27 deadline for Boeing Co. to secure federal safety approvals for two new versions of the 737 MAX airplane. The company would be required by law to install new cockpit-alerting systems to help pilots resolve emergencies in the wake of two deadly crashes.

The deadline was set by Congress two years ago, but Federal Aviation Administration approvals have taken longer than expected. Without an extension, Boeing said in a securities filing that it might cancel both planes, exposing it to financial losses. The company didn’t specify how much it could lose in the filing, but orders for the planes are valued at tens of billions of dollars in revenue.

Sen. Roger Wicker (R., Miss.), the top Republican on the Senate committee that oversees transportation issues, said he was hopeful that an extension would be included in a spending bill.

“I think it’s a reasonable ask,” he said last week.

Lawmakers could also include a provision that would shield banks from penalties if they handle marijuana-related transactions.

Banks that do business with the cannabis industry risk losing their federal banking charters because marijuana, despite being legal in some states, remains illegal on a federal level. As a result, some marijuana businesses are excluded from credit-card processing and rely heavily on cash to operate, making them targets for robberies.

Sen. Joe Manchin (D., W.Va.) could look toward the spending bill as a way to pass a measure that would speed up environmental reviews of major energy projects, including natural-gas pipelines, electricity transmission lines, wind farms and solar-power installations.

Sens. Martin Heinrich (D., N.M.) and Roy Blunt (R., Mo.) are pushing to include a measure that would steer federal money toward projects to restore habitats for struggling species.

The measure would fund state conservation plans, which are federally required strategies and wish lists that wildlife agency officials keep on struggling animal, fish and plant populations they monitor. Those plans say more than 12,000 species need conservation help because of extreme weather, habitat loss, invasive species and disease. Such plans received unstable funding in the past.

“Without enough resources, wildlife agencies have been forced to pick and choose which species are worth saving,” Mr. Heinrich said in a statement.

Senate lawmakers are expected this week to pass a defense policy bill that authorizes U.S. military leaders to purchase new weapons and increase pay for troops, and lifts a requirement for members of the military to get vaccinated against Covid-19.

The annual National Defense Authorization Act would increase America’s total national security budget for fiscal year 2023 to $857.9 billion. House lawmakers passed the NDAA bill on Thursday with 350 votes in favor and 80 votes against it.

Republicans had pushed for the bill to end the Defense Department’s Covid-19 vaccine rule, arguing that scrapping it would help recruitment and prevent the loss of additional troops whose departures have left the U.S. military weaker.

Katherine Kuzminski, a senior fellow and program director on military, veterans and society issues for the Center for a New American Security, a military think tank, said it is hard to assess whether vaccine-related discharges have hurt the U.S. military’s capability because it is unclear whether the people who left worked in high-profile, hard-to-fill specialized positions or whether they were easily replaceable.

On recruitment, she said that younger people who are weighing military service “are less likely to make decisions regarding military recruitment based on political debates.”

Health chiefs deny shortage of penicillin and amoxicillin following surge in infections

Pharmacies in the UK say they are being forced to dispense antibiotics to treat Strep A infection at a steep loss because of soaring wholesale prices, as health chiefs denied that there were shortages.

An unseasonably early surge in Group A Streptococcus, mainly among schoolchildren, has pushed up demand for penicillin and amoxicillin, the main antibiotic treatments, in recent days, heaping pressure on already stretched pharmacies.

A total of 851 Strep A cases were recorded by the UK Health Security Agency in the week ending November 20, compared with an average of 186 during the same period in recent years. The bacterial infection, which typically causes mild symptoms including a sore throat or skin rash, has led to the deaths of 16 children across the UK, according to UKHSA.

In response to the outbreak, health officials have lowered the prescription threshold for penicillin and amoxicillin, and even considered allowing preventive antibiotics to be given to close contacts of infected individuals, leading to an increase in demand.

Consequently, pharmacies have reported struggling to obtain supplies of the drugs from wholesalers and, on the occasions the antibiotics were available, said the wholesale price outstripped the compensation they received from the NHS, meaning they were losing money on each prescription.

“All these things that were taken as a given — that you press a button, order amoxicillin, it arrives the next day, the pharmacy makes a little bit of money, and the patient gets their medicine — that has all gone,” said Olivier Picard, managing director of Newdays Pharmacy and a board member of the National Pharmacy Association (NPA). He added that several parents had told him they had called more than a dozen pharmacies and failed to find antibiotics in stock.

Leyla Hannbeck, chief executive of the Association of Independent Multiple Pharmacies, said the situation was unsustainable. “We need better visibility on supply from the wholesalers and manufacturers, and we need pharmacists to be adequately reimbursed for these medicines as they can’t afford to give them out at a loss.”

Health officials and wholesalers insist that there are sufficient supplies of the antibiotics but acknowledged they were taking time to get to pharmacies.

“We have plenty of antibiotics,” Stephen Powis, NHS medical director, told the BBC. “Clearly, we’ve been asking people to prescribe them a little bit earlier. That means that pharmacies have needed extra supplies, so the government is working with wholesalers to make sure those supplies get out.”

Three pharmacies told the Financial Times that the minimum they had paid for amoxicillin or penicillin liquid solution from wholesalers, including Alliance Healthcare and AAH, in recent days was £5, which is more than double the amount they will receive in compensation under the NHS drug tariff scheme.

Martin Sawer, executive director at the Healthcare Distribution Association, which represents wholesalers, said the higher price directly reflected the amount wholesalers were having to pay manufacturers. He denied there was a shortage but said the supply chain was having to adjust to the “sudden huge demand surge”.

Sigma Pharmaceuticals apologised for setting its wholesale price at more than £19 for amoxicillin liquid solution, nearly 10 times the reimbursement cost paid by the NHS to pharmacies, blaming the mistake on an “IT glitch”.

Andrew Lane, NPA chair, urged the Department of Health and Social Care to update its concessionary price for amoxicillin and penicillin “as quickly as possible” so pharmacies don’t have to “foot the bill” for the Strep A outbreak.

If a medicine is added to the concessions list, pharmacies are reimbursed for any price increase.

A total of 158 medicines were on November’s concessions list. Janet Morrison, chief executive of the Pharmaceutical Services Negotiating Committee, which negotiates the concessions lists with the health department, said pharmacies were at “breaking point”.

She said they were “helpless against market forces that are working against them, and urgently need government assurance that all medicines will be available, and not at wildly inflated prices”.

The health department said there was “no supplier shortage”, explaining that “prices can fluctuate” because of surges in demand for certain antibiotics. “But no company should use this as an opportunity to exploit the NHS.”

Net energy gain indicates technology could provide an abundant zero-carbon alternative to fossil fuels

US government scientists have made a breakthrough in the pursuit of limitless, zero-carbon power by achieving a net energy gain in a fusion reaction for the first time, according to three people with knowledge of preliminary results from a recent experiment.

Physicists have since the 1950s sought to harness the fusion reaction that powers the sun, but no group had been able to produce more energy from the reaction than it consumes — a milestone known as net energy gain or target gain, which would help prove the process could provide a reliable, abundant alternative to fossil fuels and conventional nuclear energy.

The federal Lawrence Livermore National Laboratory in California, which uses a process called inertial confinement fusion that involves bombarding a tiny pellet of hydrogen plasma with the world’s biggest laser, had achieved net energy gain in a fusion experiment in the past two weeks, the people said.

Although many scientists believe fusion power stations are still decades away, the technology’s potential is hard to ignore. Fusion reactions emit no carbon, produce no long-lived radioactive waste and a small cup of the hydrogen fuel could theoretically power a house for hundreds of years.

The US breakthrough comes as the world wrestles with high energy prices and the need to rapidly move away from burning fossil fuels to stop average global temperatures reaching dangerous levels. Through the Inflation Reduction Act, the Biden administration is ploughing almost $370bn into new subsidies for low-carbon energy in an effort to slash emissions and win a global race for next-generation clean tech.

The fusion reaction at the US government facility produced about 2.5 megajoules of energy, which was about 120 per cent of the 2.1 megajoules of energy in the lasers, the people with knowledge of the results said, adding that the data was still being analysed.

The US department of energy has said energy secretary Jennifer Granholm and under-secretary for nuclear security Jill Hruby will announce “a major scientific breakthrough” at the Lawrence Livermore National Laboratory on Tuesday. The department declined to comment further.

The laboratory confirmed that a successful experiment had recently taken place at its National Ignition Facility but said analysis of the results was ongoing.

“Initial diagnostic data suggests another successful experiment at the National Ignition Facility. However, the exact yield is still being determined and we can’t confirm that it is over the threshold at this time,” it said. “That analysis is in process, so publishing the information . . . before that process is complete would be inaccurate.”

Two of the people with knowledge of the results said the energy output had been greater than expected, which had damaged some diagnostic equipment, complicating the analysis. The breakthrough was already being widely discussed by scientists, the people added.

“If this is confirmed, we are witnessing a moment of history,” said Dr Arthur Turrell, a plasma physicist whose book The Star Builders charts the effort to achieve fusion power. “Scientists have struggled to show that fusion can release more energy than is put in since the 1950s, and the researchers at Lawrence Livermore seem to have finally and absolutely smashed this decades-old goal.”

The $3.5bn National Ignition Facility was primarily designed to test nuclear weapons by simulating explosions but has since been used to advance fusion energy research. It came the closest in the world to net energy gain last year when it produced 1.37 megajoules from a fusion reaction, which was about 70 per cent of the energy in the lasers on that occasion.

At the launch of a new White House fusion power strategy this year, Congressman Don Beyer, chair of the bipartisan fusion energy caucus, described the technology as the “holy grail” of clean energy, adding: “Fusion has the potential to lift more citizens of the world out of poverty than anything since the invention of fire.”

Most fusion research is focused on a different approach known as magnetic confinement fusion, in which the hydrogen fuel is held in place by powerful magnets and heated to extreme temperatures so the atomic nuclei fuse.

Historically, that science has been done by large publicly funded laboratories, such as the Joint European Torus in Oxford, but in recent years investment has also flooded into private companies promising to deliver fusion power in the 2030s.

In the 12 months to the end of June, fusion companies raised $2.83bn in investment, according to the Fusion Industry Association, bringing total private sector investment to date to almost $4.9bn.

Nicholas Hawker, chief executive of Oxford-based start-up First Light Fusion, which is developing an approach similar to that used at NIF, described the potential breakthrough as “game-changing”.

“It couldn’t be more profound for fusion power,” he said.

• Foxconn Hon Hai Technology India Mega Development Private Limited, an electronics maker, received a $500 million investment.
• Singapore-based Lazada Group, an online shopping site, raised a $342.5 million corporate round.

The future is uncertain for AZ Factory, the fashion start-up backed by luxury goods giant Richemont and founded by the famed designer Alber Elbaz who died in April last year aged 59. Key members of the dream team Elbaz brought together in the months before his passing have decided to leave or have left the company, several sources close to the fashion brand have said.

Richemont, which derives most of its revenues from megabrand Cartier, can afford to stomach AZ Factory’s losses for some time. They represent only a few tens of millions of euros – small change for a group that made 2.1 billion euros in profit in its last fiscal year. Still, the story of the coming apart at the seams of AZ Factory serves as a microcosm of the problems with Richemont’s management of fashion. It also provides more ammunition to those investors who argue the group needs to narrow its focus to its watches and jewelry core businesses.

POINTY SNEAKERS

The story starts in January 2021, when Elbaz, a much-feted designer who had infused new life into Lanvin from 2001 to 2015, promised a fashion revolution with the launch of his new inclusive, technology-driven brand. AZ Factory would tell stories around products instead of collections. Elbaz wished to challenge the century-old tradition of dressing women only of a certain size and create a new business model better fit for the Internet age where trends are driven in real time by social media and algorithms, and by consumers of all shapes and sizes.

Highlights from AZ Factory’s launch included pointy sneakers that elongated silhouettes, dresses using figure-shaping technology and chic pajamas featuring prints of Elbaz’s drawings. “We are on a journey to design beautiful, purposeful, solutions-driven fashion that works for everyone,” Elbaz wrote on his brand’s website. “We are life, not just lifestyle, a place to experiment and try new things, our way. We believe in fashion that cares.”

Elbaz, who also designed for Yves Saint Laurent, was known for his short, ultra-feminine cocktail dresses and his passion for innovative, new fabrics that made his looks stand out. Suzy Menkes, the fashion critic, had described Albaz in his heyday when season after season he produced beautiful, simple and well-cut dresses as “every woman’s darling”. In early 2021, the fashion world applauded Elbaz’s return six years after his exit from Lanvin. He was sacked after disagreements with its Shaw-Lan Wang, the Taiwanese Chinese-born lady who owned the brand then.

Former clients and fashion critics were enthusiastic about his new project. Then, shockingly, in April 2021, just as Elbaz seemed on the cusp of realizing his dream, he died of complications from the coronavirus. The designer, who oozed charm and creative vigor despite being constantly anxious about his health, was publicly mourned by the fashion world. After his passing, AZ Factory staff spent their energy promoting his designs on the brand’s website, and at online retailers Farfetch and Net-A-Porter. They also worked tirelessly on putting together a spare no-expense homage show that closed Paris Fashion Week in October 2021.

That show proved to be the biggest ever organized to pay tribute to a designer. Everybody who was anybody in fashion was there and the French establishment too. French First Lady Brigitte Macron sat next to Richemont CEO Jérôme Lambert and other group executives and senior advisers such as Alain-Dominique Perrin. There was a notable absence though: Richemont Chairman Johann Rupert. Rupert never attends fashion shows. That detail speaks volumes about his lack of personal interest in fashion and Richemont’s struggle with other fashion brands such as Chloé and Dunhill.

In March this year, to keep Elbaz’s memory alive, dresses from the show were presented at an exhibition at Paris’ fashion museum Palais Galliera. However, two months earlier something happened at AZ Factory that would change the brand’s destiny.

Rupert decided he needed a new CEO to run his darling, lossmaking British luxury brand Dunhill and picked young Laurent Malecaze who had been chosen by Elbaz to lead AZ Factory. To replace Malecaze, Richemont chose Mauro Grimaldi who worked for Printemps and a few brands like Emilio Pucci and Elie Saab. On his LinkedIn account Grimaldi still describes himself as strategic adviser. Not a word about AZ Factory.

The AZ Factory story is revealing of how emotion, not reason, drive certain of Rupert’s business decisions. The 72-year-old South African billionaire still refuses to let go of Dunhill even though it is known as one of the UK luxury brands that has lost the most money in the past four decades. Rupert is emotionally attached to Dunhill because it was the first luxury fashion brand his father Anton bought in the 1980s. Like AZ Factory, he feels committed to it. And it seems that no one will make him change his mind.

EXODUS

People close to AZ Factory say the exodus of staff coincided with the arrival of Grimaldi at the brand. “No one can contradict him,” one person close to the brand said. Once the one-year homage work was done, some people left because they felt that the company was starting a new chapter post-Elbaz for which they did not sign up. They had joined to work with Elbaz and Malecaze not with Grimaldi.

“At least Laurent had a vision,” one person who worked for AZ Factory said. “Mauro does not. He is very much into “tick the box,” the box of inclusivity, the box of upcycling, etc… Fashion does not work like that. And he thinks and talks about price all the time. But how can you build a collection just around price. He does not understand fashion.” Richemont declined to comment for this report. Grimaldi spontaneously declined an interview request by Miss Tweed at the Hyères fashion festival last October.

Departures started in May, June of this year, according to accounts reported to Miss Tweed by several people inside and outside the company. AZ Factory’s head of marketing and communication – a key member of staff - Charles-Henry Paradis, a former close associate of Elbaz who worked for Christian Louboutin, is on sick leave since the summer. Bastide Rey, who was studio director and had left Dior to join Elbaz with whom he worked before, left to join Alaïa.

The influential French fashion PR company Lucien Pages chosen by Elbaz no longer wants to represent AZ Factory, an industry source said. It stopped working for the brand after its last Paris Fashion Week show by guest designer Lutz Huelle. The catwalk was held at Richemont’s Fondation Cartier for Contemporary Art in Paris, a place considered ill-suited for such events due to its layout. That said, being already part of the Richemont stable, it allowed the group to save money.

Making matters worse, the film of the show was poorly produced. Strutting models were filmed from one angle only. It was obvious the brand could only afford one cameraman. At times other cameras would appear on the film and in the background, you could see computers and metallic boxes on the first floor. Somebody who understands fashion and knows how important such films are for a brand’s image – as it is posted everywhere on social media and on the website of the Federation de la Haute Couture et de la mode - would never allow such a thing to happen, critics say.

“It is never good when it becomes pretty evident that a brand is trying to cut costs and save money,” one former AZ Factory associate said. “Remember this is a business about image, so when you start doing things that affect image, it’s bad news.”

NEW BUSINESS MODEL

After the one-year homage period was over, around January this year, AZ Factory decided to become something else: a platform for young designers. Since no one could replace Elbaz, it chose to invite young designers to tell their story and use AZ Factory’s infrastructure to help promote their work. Only it never quite made this strategy clear both internally or externally.

To this day, the brand continues to sell Elbaz-designed clothes while selling capsule collections by guest designers. If AZ Factory has turned itself into an incubator of young designers, it should describe itself as such, industry insiders say. Only on the brand’s website, customers still read that invited designers are asked to reinterpret Elbaz’s vision. Yet, this attempt at homage confuses the brand’s message, another signal of the lack of strategic focus on fashion from the very top management at Richemont, senior fashion executives say.

The first guest designer was South Africa’s Thebe Magugu, who won the LVMH prize in 2019 and is known for his authentic voice and natural sense of elegance. His dress for the homage collection was one of the most beautiful and featured on posters advertising the Palais Galliera exhibition.

And then came other designers such as Lutz Huelle, known for his denim looks and mix of fabrics. Huelle is also working with Charles de Vilmorin who designs for Rochas and for his own brand. And then there was Ester Manas, whose designs and vision Miss Tweed highlighted last year as among Belgium’s most promising. Manas is known for ruched stretch-mesh dress that fit every body types. Then there was Cyril Bourez, a little-known designer who produced a collection with upcycled products and offered customers made-to-order items.

Other designers are scheduled to come present their work on AZ Factory in the next few months. “If AZ Factory has become an incubator for young designers, it should present itself as such,” one industry insider said. “But for the moment it is still presenting itself as the offspring of Elbaz, paying homage to him while at the same time turning itself into a platform for young designers.”

The company describes itself thus on its website: “Now, AZ Factory welcomes Amigos, guest creatives, to co-create stories and products. We provide them with a platform to develop and share their visions of what fashion means today and to them, by appropriating and reinterpreting the codes that have made AZ Factory unique from day one. With this new approach, AZ Factory offers a new perspective on today’s fashion, driven by the perspectives of uniquely positioned individuals, rather than heritage houses exclusively.”

The business model of promoting the work of young designers cannot be profitable, industry specialists say. When a brand changes designer every two months, customers do not have the time to get accustomed to his or her work and build loyalty to it. AZ Factory is not like Moncler or other well-established brands that invite designers to offer something new every other month. The company is just two years old.

Department stores do not want to work with AZ Factory because they do not want to commit to designers whose work remains untested in terms of demand, fashion retail experts say. AZ Factory is bound to end up with unsold stock which it will have to sell at a discount – the kiss of death in terms of image. Currently, on the AZ Factory website, several previous collections, from Elbaz’s work to that of Magugu, are sold at a discount even though now is the time to sell at full price before Christmas. “Private sale,” the website calls it.

LET IT GO

Industry analysts predict Richemont will keep AZ Factory going for some time but eventually, it will have to let it go, unless it turns it into a foundation that sponsors young designers. But that would not make that much sense either. Unlike LVMH, Richemont does not have dozens of fashion brands for which it needs to build a pool of promising designers.

Some investors argue that Rupert should have closed down AZ Factory right after Elbaz passed away. Back then, it was already clear that it was going to be an impossible mission to make the brand take off and flourish without its founding designer. If Rupert ended AZ Factory, fans would have called it cruel. Rupert, who highly regarded Elbaz and believed in his vision, chose to remain true to his word and fund Elbaz’s newborn baby no matter what. It is still the case now, when it seems evident that the company’s new business model post-Elbaz will struggle to turn a profit.

• Lacutamab demonstrated encouraging efficacy and a favorable safety profile in heavily pretreated, post-mogamulizumab patients with advanced Sézary syndrome
• In addition, Innate’s ANKETTM (Antibody-based NK cell Engager Therapeutics) platform on display at ASH via oral presentation and posters

Presented data from a preliminary analysis of the TELLOMAK Phase 2 trial demonstrating clinical activity and a favorable safety profile for lacutamab, a first-in-class anti-KIR3DL2 humanized cytotoxicity-inducing antibody, in patients with advanced Sézary syndrome, a form of T cell lymphoma. The data were presented during the 2022 ASH (American Society Hematology) Annual Meeting, in New Orleans (United States).

At the time of data cut off (April 29, 2022), the Intention To Treat (ITT1) population included 37 post mogamulizumab patients with advanced, highly refractory Sézary syndrome, and 35 patients were Evaluable for Efficacy (EES2). The patient population was heavily pre-treated with a median of 6 prior lines of therapy. The median follow-up was 10.9 months.

In the ITT population, the global objective response rate (ORR) was 21.6% (8/37). ORR in the blood was 37.8% (95% confidence interval (CI): 24.1-53.9), with 21.6% (8/37) achieving complete response (CR). ORR in the skin was 35.1% (95% CI: 21.8-51.2). In the EES population, global objective response rate (ORR) was 22.9% (8/35). ORR in the blood was 40.0% (95% CI: 25.6-56.4) and ORR in the skin was 37.1% (95% CI: 23.2-53.7).

Within the subgroup of patients that achieved a global response, median duration of global response was 10.8 months (95% CI: 6.2-12.3) with median time to global response of 4 months (range: 1.0-6.5); median time to blood response was 1.0 month (range: 1.0-6.5) and median time to skin response was 2.8 months (range: 0.9-10.2).

In line with previous observations, lacutamab demonstrated a favorable safety profile for patients with advanced Sézary syndrome in the TELLOMAK Phase 2 preliminary analysis. Grade = 3 Treatment-related (TR) Treatment-Emergent Adverse events (TEAEs) were observed in 6/37 (16.2%) patients. Most common TR TEAEs were general disorders and administration site conditions (N=6, 16.2%), skin and subcutaneous tissue disorders (N=5, 13.5%), and gastrointestinal disorders (N=3, 8.1%).

CMO: “This encouraging preliminary analysis in Sézary syndrome adds to the encouraging cutaneous T-cell lymphoma data we previously shared within the Phase 1 study, and Phase 2 mycosis fungoides cohort. The data continues to support our fast to market strategy for lacutamab in the niche setting of Sézary syndrome where lacutamab was granted U.S. Fast Track designation and EU Prime designation. We look forward to final data in 2023 while we continue investigate the role of lacutamab in other T-cell lymphomas including the monotherapy and combination trials for peripheral T-cell lymphoma.”

- Pr. Vivier, DVM, PhD, Chief Scientific Officer: “Progress continues toward investigational new drug (IND) filing in 2023 for our latest innovation, Innate’s CD20 targeted tetra-specific ANKETTM, IPH6501.”

Traders rush for exits alarmed at safety of their assets after FTX filed for bankruptcy

Investors are pulling record levels of bitcoin from crypto exchanges as the collapse of Sam Bankman-Fried’s FTX stirs fears over the safety of their assets.

FTX, once the darling of the crypto industry, filed for bankruptcy protection in mid-November after an $8bn hole emerged in its balance sheet.

New chief executive John Ray described a lack of basic risk management and Bankman-Fried has admitted to poor internal controls. Its rapid descent has alarmed investors who keep and trade their assets on other centralised crypto exchanges, leading to record levels of withdrawals of bitcoin, the most widely-traded crypto token. FTX failed last month with potentially more than 1mn creditors, including many who had left assets on the exchange.

Last month investors pulled 91,363 bitcoin, worth a total of close to $1.5bn based on the November average price of around $16,400, from centralised exchanges including Binance, Kraken and Coinbase. That marked the largest bitcoin outflow on record, according to data from CryptoCompare.

It is unclear whether the coins are being sold or moved to private wallets.

The rush for the exit comes as the price of bitcoin has plunged 64 per cent this year and is currently trading around $17,000.

Withdrawals in October were also high, at 75,294 bitcoin, as crypto traders pulled their funds following a crisis-laden summer which included the collapse of digital asset lenders Celsius and Voyager Digital.

Rival exchanges have rushed to distance themselves and their practices from the chaos inside FTX in an effort to ease customers’ nerves and limit potential market contagion.

However, the record outflows highlight investors’ wariness of bitcoin as the digital asset industry faces increased scrutiny from global regulators.

In the first seven days of December, 4,545 bitcoin were withdrawn from centralised exchanges, compared with inflows of 3,846 bitcoin in the same period last year, according to CryptoCompare.

In a sign of the detrimental impact of FTX’s collapse on its once-rival exchanges, credit rating agency Moody’s placed US-listed Coinbase’s bond rating on review for downgrade in late November, citing “the increasing likelihood of sustained declines in trading volumes and client engagement, two essential revenue drivers”.

“Falling crypto asset prices will restrict businesses’ ability to raise funds and depress customer demand,” Moody’s analysts wrote this week. They added that markedly lower crypto prices “will deteriorate the credit quality of centralised finance companies”.

“While the bitcoin sell-off decelerates, the damage has been done,” wrote Eric Robertsen, global head of research at Asia-focused bank Standard Chartered, this week.

He predicted that the pain for crypto investors will continue well into 2023. “More and more crypto firms and exchanges find themselves with insufficient liquidity, leading to further bankruptcies and a collapse in investor confidence in digital assets,” he added.