The company — whose first approved vaccine was for Covid-19 — reported initial data on antibody levels that suggested its vaccine could compete against GSK’s Fluarix. It is discussing the approval process with regulators. 

In another trial, the vaccine elicited a higher antibody response than French drugmaker Sanofi’s Fluzone high-dose, which is often used to vaccinate older people.

Stéphane Bancel, Moderna’s chief executive, said the results, coming after successful trials of vaccines for Covid-19 variants and the respiratory syncytial virus, showed the messengerRNA platform works. The technology, which uses genetic code to teach the body to recognise pathogens, was first used in Covid-19 jabs. 

Moderna plans to launch products in oncology, rare and latent diseases by 2028. In the five years after these launches, it expects $10bn-$15bn of annual sales from these treatments, on top of its previously announced $8bn-$15bn of expected sales from respiratory vaccines in 2027. It plans to invest about $25bn in research and development from 2024 to 2028.

Investors had hoped mRNA would be a good technology to improve flu vaccines, which are often only about 50 per cent effective, because they can be quickly adapted to new strains each winter.

But in February this year, shareholders were disappointed when a Moderna study reported that an earlier version of its flu vaccine was no better than current jabs for two of the four most common flu strains.

Moderna reformulated it, and the new version is better than Fluzone at tackling three of the strains. It is just as able to target the fourth strain, the company said.

Stephen Hoge, Moderna’s president, told the Financial Times that in the past year, Moderna had quickly learned how to improve the shot. “We didn’t disclose what that is for competitive reasons,” he added.

Pfizer and BioNTech are also trying to enter the flu market with an mRNA vaccine, which is in a phase 3 trial. Existing manufacturers are also adopting mRNA, including GSK, which is partnering with German biotech CureVac, on a phase 2 trial this winter, and CSL Seqirus, which has licensed a version of mRNA technology from San Diego-based Arcturus Therapeutics.

Sanofi said in June that its early efforts with using mRNA for flu had shown a similar pattern to Moderna’s previous trial results, missing the mark on two of the four strains. It is also working on updated versions.

Some analysts have been concerned that the flu market will not tolerate the same level of “reactogenicity”, short-term side effects such as swelling and fever that some people experienced after taking Covid-19 mRNA vaccines.

Moderna said the trial showed the vaccine had an “acceptable” safety profile. Hoge said the new flu shot’s reactogenicity was similar to that of existing higher-dose flu vaccines.

“We do not believe that it’s going to be a disadvantage,” he said, “but that’s really will be for others to decide.”

This story originally appeared on: Financial Times - Author:Hannah Kuchler

The pharmaceutical company had not yet launched Ozempic, the diabetes drug that would later become famous as celebrities took it off-label for weight loss, and was years from the approval of Wegovy, the version that targets obesity. The management team were debating whether to embark on an expensive trial that would prove whether or not Wegovy would cut the risk of heart attacks and strokes.

Mads Krogsgaard Thomsen, chief executive of the Novo Nordisk Foundation, which has the majority of voting rights in the company, described executives asking: “Why would we do such a trial with a high risk of maybe not showing anything? Maybe it’s just the anti-diabetic effect that is responsible for the benefits we’ve seen in diabetes. What if we don’t see anything in obesity, and the trial costs hundreds of millions of dollars?” 

But at the end of the day, it was up to Jørgensen. “His head was on the block. It is a lot of money,” he said. 

His gamble paid off: the initial trial data published last month showed that patients who took the Wegovy drug had a 20 per cent lower chance of suffering a cardiovascular event such as a heart attack or stroke than those who received a placebo.

Investors hope the data will prove to health systems and insurers that the medicine, which has made headlines as a rich person’s slimming tool, could actually save lives and costs. Shares soared 16 per cent that day, and continued rising until Novo Nordisk overtook French luxury conglomerate LVMH as the largest European company on Monday.

Jørgensen has a huge commercial opportunity: Novo Nordisk is one of two main companies, along with Eli Lilly, in a market that the Canadian investment bank BMO estimates could be worth up to $130bn to $140bn a year at its peak. 

But he also faces giant challenges: the company is still trying to scale up supply of the drug, some health insurers are reluctant to foot the bill, and Ozempic and Wegovy are being used as slimming jabs by people who are far from obese.

Jørgensen learnt to take responsibility at a young age, on the family farm in Jutland, Denmark.

Lars Green, chief financial officer of sister company Novozymes, has known Jørgensen since university. 

“His upbringing means he has always learned that things do not come by themselves. They require an investment, or an effort, and based on those efforts you harvest your returns,” he said.

After studying finance and business, Jørgensen joined Novo Nordisk on the graduate scheme in 1991 and has worked with the company in the US, Japan and the Netherlands, in functions from technology to business development. 

Jesper Brandgaard, former chief financial officer at Novo Nordisk, described Jørgensen when he became interim head of corporate finance at the company, aged just 33. “He is the type of person that very easily will be assigned responsibility, and then takes care of the responsibility, whether it’s needing to feed the pigs or whatever he needs to do,” he said. 

Jørgensen, 56, met his wife at Novo Nordisk and they now have two adult children. As well as responsibility, he stresses the importance of reflection in life, going kayaking on the lake near his house.

Novo Nordisk, which, while it turned 100 this year, is far from a household name, and Jørgensen does not want to become a ‘brand’, like some other chief executives of Big Pharma. Often described by his friends as a humble introvert who listens intently, he is eager to share the stage with his team. 

Emily Field, an analyst at Barclays, said he did not dominate his earnings calls like some better known pharmaceutical leaders. “He has not made himself the face of the company and people really like that. It is about Novo Nordisk, not about him,” she said. 

But one person familiar with the matter said while he liked the idea that the organisation was flat, he held the veto on everything. “At first you think he doesn’t have a lot of gravitas, but after half an hour in a room with him you see he is very calm, very poised, never gets angry. He can control the room by very quickly lifting his head,” he said.

Long before its obesity drugs hit the headlines, Novo Nordisk was under political pressure in the US for rising insulin prices. Recently, the company was suspended from the UK industry association for mismarketing a previous obesity drug. Jørgensen apologised and said the failure to disclose sponsorship of a training course was a “mistake”. 

Now Jørgensen faces scrutiny at home in Denmark, where Novo Nordisk is the largest taxpayer, and he is president of the industry’s European lobby group, battling the biggest EU reform in pharma legislation for 20 years. 

Jørgensen recently met one of his critics in the Danish parliament, Socialist People’s party member Lisbeth Bech-Nielsen, for lunch. She argued that now the company had a market cap and earnings that were “out of this world”, it should consider lowering prices. “Obviously, we didn’t agree, but I had a good impression of him,” she said. 

Nathalie Moll, director-general of the European Federation of Pharmaceutical Industries and Associations, believes Novo Nordisk is a poster child for European innovation. She said Jørgensen was the right person to lead the industry group because he knew how to make Europe better for a company “that grows, not a company that has already grown, or a tiny company, but one that has really evolved over the last 30 years”. 

Additional reporting by Euan Healy

This story originally appeared on: Financial Times - Author:Hannah Kuchler

Moderna said on Wednesday that a lab test showed its latest vaccine, which was designed to tackle the prevalent XBB.1.5 variant, also elicits antibodies to the more recently emerged strain BA.2.86. 

The Boston-based biotech’s announcement follows early research from scientists at Harvard and Sweden’s Karolinska Institute that suggested that people who had been infected with the XBB.1.5 variant could also make antibodies against BA.2.86. 

But there is less information available about whether people who had received previous boosters targeted at other strains, or had infections caused by other variants, are as well protected against BA.2.86. 

Stephen Hoge, president of Moderna, said its updated Covid-19 vaccine creates a “strong human immune response” against the variant, increasing existing antibodies that tackle the virus 8.7 fold. He added that it provides a similar response against other emerging variants, EG.5 and FL1.5.1.

“These data confirm that our updated Covid-19 vaccine will continue to be an important tool for protection as we head into the fall vaccination season,” he said. 

Pfizer and BioNTech have not yet published data on whether their updated vaccine is effective against BA.2.86. 

Shares in Moderna fell 0.7 per cent, while Pfizer was down 1.3 per cent and BioNTech down 0.4 per cent in early morning trading in New York.

The US is planning to start rolling out updated boosters targeting XBB.1.5 in the coming weeks after the Food and Drug Administration gives its approval. EU and UK regulators have approved new boosters, with the UK recommending them for the over-75s and the most vulnerable.

England has brought forward its Covid-19 vaccination campaign to start on September 11, rather than the start of October as originally planned, because of worries about the potential danger posed by BA.2.86. The UK health security agency said last week that it had “limited information” on the new variant. 

Research by the Barouch Laboratory at Harvard found that BA.2.86 elicited fewer antibodies than the variant BA.2, which was prevalent last year, but that an XBB.1.5 infection increased the antibody response, suggesting that the tweaked vaccines may offer more protection. 

Similarly, the Swedish team found that blood taken late last year before the XBB variant was circulating, contained antibodies that were less able to neutralise BA.2.86. But far more of the blood taken last week had antibodies against the strain. The researchers did not distinguish between people who had definitely had a Covid-19 infection caused by XBB.1.5 and those who had not.

Additional reporting by Jamie Smyth in New York

This story originally appeared on: Financial Times - Author:Hannah Kuchler

Researchers hunting for treatments that could benefit the millions of Long Covid patients, who currently have no approved drugs, have waited up to six months for the Medicines and Healthcare Products Regulatory Agency to approve adaptations that it is required to rule on within 35 days.

The Stimulate-ICP study is modelled on the UK’s flagship Recovery trial that found drugs to use against acute Covid-19. It has only enrolled 900 of the 4,200 participants that it aimed to recruit, and its funding from the UK’s National Institute for Health and Care Research runs out in March. 

But whereas the regulator moved quickly to enable trials during the pandemic, the Long Covid study has been stuck in a backlog at the agency, which has suffered significant staff cuts since Brexit. 

Amitava Banerjee, a professor at University College London who is co-leading the study, said it was “really frustrating” because the study was funded but had stalled because the MHRA did not have enough capacity to respond promptly to requests.

“We’re now in a situation where I’m struggling to see how we can get this over the line. And the worst-case scenario is that we have a job that’s unfinished,” he said. “If we’re unable to answer questions, that’s tragic for patients who don’t get answers and for taxpayers who had their money wasted.”

The UK government is promoting the NHS as the ideal location for clinical research. But the pharmaceutical industry has been warning that it is falling behind other countries because of delays at the regulator and an overwhelmed healthcare system. 

The chancellor gave the MHRA an extra £10mn in this year’s Budget to help speed up the approval process for “cutting-edge treatments”. 

The agency said that it had taken “urgent action” over the summer and the majority of delayed applications for clinical trial approval had now been processed. It added that from September 1, all new and fully compliant applications would be assessed within the statutory timelines. 

Scientists are also concerned that after March, the NIHR will have no more money set aside to research Long Covid. Daniel Altmann, a professor of immunology at Imperial College London, who is examining the biology of Long Covid in a separate study, said it was “pretty strange” because medical research takes time and is rarely finished within just two years. 

“Why on earth would you want to make the initial investment if you don’t follow through and deliver on it?” he asked. 

The NIHR said it had invested more than £50mn in Long Covid research projects and that project timelines could be extended if researchers and funders agreed. It added that scientists could submit proposals for further research through regular funding routes. 

Some 1.9mn people, about 2.9 per cent of the UK’s population, are living with self-reported Long Covid symptoms, according to data released in March by the Office for National Statistics. 

Emma Wall, an infectious disease consultant who leads the Stimulate-ICP trial with Professor Banerjee, warned that without robust research, many patients were turning to unproven and often expensive treatments.

“There’s a snake oil economy. People are making money out of these desperate patients because there is this vacuum of good research,” she said.

This story originally appeared on: Financial Times - Author:Hannah Kuchler

The pharmaceutical company’s market capitalisation narrowly exceeded $421bn for part of the trading day, taking it past LVMH, maker of Moët & Chandon champagne and Louis Vuitton designer goods. LVMH earlier this year became the first European company to cross the $500bn valuation barrier.

The Danish company is the only pharmaceutical producer on a list of Europe’s most valuable companies heavily skewed towards the luxury sector. Other luxury houses in the top 10 by market capitalisation are France’s L’Oréal, the cosmetics maker, and Hermès, the fashion house.

Novo’s success with Wegovy has increased the value of its shares more than fourfold since 2018. The company’s market capitalisation hit an even higher peak — of $423bn — in August after the company published trial data showing that Wegovy reduced the risk of serious cardiac events like heart attacks by 20 per cent. However, LVMH’s valuation at that point was higher.

Also in August, Novo raised its annual sales forecast partially thanks to increasing demand for Ozempic. The drug, which is designed for diabetics and contains the same active ingredient as Wegovy, has also been prescribed by clinicians to treat obesity.

Emily Field, an analyst at Barclays, said Novo Nordisk had been exciting pharmaceuticals specialists ever since Wegovy was approved in the US two years ago. It was now coming to the attention of a much wider group of investors, however.

The recent positive results from its study of the impact of Wegovy on heart conditions, which came on the same day as very strong earnings from its rival Eli Lilly, changed the game, she added. 

“It felt like it woke a lot of people up to the story,” she said. 

She said that, while Europe did not have as large a biotech sector as the US, there were some “amazing companies” with innovative scientists like those at Novo Nordisk.

The results led analysts to predict that Novo would be able to persuade more insurers and health systems to pay for the drug.

Novo is the largest producer by sales in a rapidly expanding market for diabetes and new weight-loss drugs that has been forecast by analysts to reach $130bn-$140bn in annual sales worldwide.

Indianapolis-based Eli Lilly is the Danish company’s largest competitor in the field. Eli Lilly has applied for regulatory approval to use its diabetes drug Mounjaro to treat obesity. 

The expansion of the market has also led Chinese companies to develop domestic copycat versions of Wegovy.

Novo has also announced plans to acquire Inversago Pharma, which specialises in drugs that target metabolic disorders like diabetes and can also be used to treat obesity, in a deal worth up to $1.1bn.

The Danish company’s significance for its home country has become such that its performance was the only factor in ensuring that Denmark’s economy expanded rather than contracted in the second quarter this year.

Additional reporting by Richard Milne

This story originally appeared on: Financial Times - Author:Hannah Kuchler

The UK Health Security Agency suggested speeding up the autumn programme, starting by giving the first shots to the most vulnerable on September 11, to give people greater protection from severe illness.

Subvariant BA. 2.86 has not been declared a variant of concern but it has a high number of mutations, leading some scientists to worry that it could evade protection from previous immunisation or infection. It was first detected in the UK on August 18.

This is a developing story

This story originally appeared on: Financial Times - Author:Hannah Kuchler

As workers return from holidays and children go back to school, governments, regulators and vaccine-makers are gearing up for an autumn Covid-19 booster season, tweaking shots to cope with the most prevalent variants and targeting the most vulnerable citizens at the same time as flu immunisation campaigns.

With hospitalisation rates low but rising, experts said Covid-19 cannot yet be treated as a seasonal virus like flu. The US Centers for Disease Control and Prevention warned last week that a new sub-variant, BA. 2.86, may be more able to cause infection in people who have previously had Covid-19 or been vaccinated against it, and urged the vulnerable to wear masks in public places.

Angela Rasmussen, a virologist at the University of Saskatchewan in Canada, said “all bets are off” if a variant that is more transmissible than Omicron, the dominant strain for nearly two years, emerges.

“You would start to see [increased cases] wherever there was a nice susceptible population and not necessarily just in winter when conditions are very good for transmission,” she said. “We haven’t seen the end of this virus. It’s going to [continue to] acquire mutations and that has unpredictable results.”

Is Covid becoming a winter disease? 

Last winter Covid-19 infections in the northern hemisphere peaked around Christmas, before dropping in the spring and summer. But experts warn that it is premature to expect the disease to follow the pattern of other respiratory infections.

Adam Kucharski, professor of infectious disease epidemiology at the London School of Hygiene & Tropical Medicine, said there was a “surprisingly stable” pattern last year, but warned: “I don’t think that’s automatically a reason to expect Covid to peak in late December again. It is plausible there might be multiple smaller peaks going into winter.” 

Transmission increases as people mix indoors in winter, but in warmer climates like the southern US states it can also rise during the summer as people huddle indoors to avoid the heat. 

In 2020-21, before the widespread rollout of vaccines, if one variant looked “nasty here, it would be nasty [everywhere]”, Kucharski said. But now different populations have been exposed to varied strains, it is becoming harder to predict the severity of new variants as they cross into new regions, he added.

Will a powerful new variant emerge?

While politicians’ attention has shifted to the economic recovery from the pandemic, many scientists still believe there is a significant chance that a variant powerful enough to evade the population’s existing defences will emerge.

Eric Topol, director of San Diego’s Scripps Research Translational Institute, said it was not clear how transmissible BA. 2.86 is. Vaccine makers have not yet shown whether their tweaked shots can tackle the latest strain, but Topol warned the boosters might not help much because it had undergone 30 mutations.

Before the emergence of the latest sub-variants like BA. 2.86, EG.5.1 and FL. 1.5, Topol surveyed 10 experts about the likelihood of another “Omicron-like event” where the virus undergoes a “hyper-accelerated evolution”, most likely in an immunocompromised host.

The average probability of such an event happening by 2025 was put at 10-20 per cent, with one expert putting the chances at 38 per cent.

“The risk is too high to turn your back on,” Topol said.

Are new vaccines ready? 

The elderly and vulnerable will be offered Covid-19 boosters in many countries this autumn. Manufacturers followed advice from the US Food and Drug Administration to update the shots to protect against the prevalent XBB.1.5 Omicron sub-variant. Unlike last year, when some vaccines targeted two variants, the FDA recommended that they should focus on this one.

The EU’s drugs regulator said targeting XBB.1.5 would be a “reasonable choice” but is open to shots containing other XBB strains.

The campaigns will largely use the messenger RNA-based shots from BioNTech/Pfizer and Moderna. Pfizer aims to have its latest booster available at the same time as its updated flu shots — in late September or early October, delivering shots owed under existing contracts.

Moderna expects to sell 50mn-100mn shots in the US and will supply the UK at a similar time, but is still in negotiations with the EU. 

Work on pan-coronavirus vaccines continues but immunologists said it was hard to hold trials for a jab designed to tackle many sources of respiratory disease when Sars-Cov-2 is by far the most dominant virus in circulation.

How will we know if rates increase significantly? 

Governments have dismantled much of the Covid testing infrastructure that tracked infections. Topol at Scripps said health bodies would only know if there was a surge if a new variant caused severe Covid symptoms.

Increases in hospitalisations and deaths come weeks after infection rates have begun to rise. In the UK, hospital admission rates for Covid-19 increased in the week to August 17, from 1.97 to 3 per 100,000 people, while deaths rose 35 per cent in the seven days to August 24. In the US, the CDC reported a 19 per cent rise in hospitalisations and a 21.4 per cent increase in deaths in the week to August 19.

Epidemiologists are also looking at more passive forms of data collection, such as tracking the spread of the virus in wastewater. The CDC is collecting samples from aircraft toilets to boost early detection of new variants entering the country.

Have treatments for Covid-19 improved? 

Amesh Adalja, an infectious disease specialist and senior scholar at Johns Hopkins University, said care of most Covid-19 inpatients had become so routine that it can be handled by general hospital departments. “It is infinitely more manageable than it once was,” he said.

But doctors would still welcome better drugs, in particular products that do not interact with other medication. Paxlovid, the antiviral from Pfizer, cannot be taken at the same time as many drugs, including those for cardiac conditions. A new antiviral from Japanese drugmaker Shionogi has been submitted to the US regulator.

Yet Pfizer has forecast a steep drop in Paxlovid sales this year. Many people with respiratory infections are not testing to see if they have Covid-19, so it is hard for them to access the drug within five days of getting symptoms, as required. 

Rasmussen at the University of Saskatchewan fears that people are “mentally done with Covid”, making tracking cases, treating patients and vaccinating the vulnerable more difficult. 

“Just like seasonal flu, Covid is still going to be killing a lot of people,” she said. “It’s going to be harming a lot of people long-term with long Covid, and people just aren’t going to care about it.”

This story originally appeared on: Financial Times - Author:Hannah Kuchler

The Royal Society examined hundreds of studies from around the world on the effectiveness of so-called non-pharmaceutical interventions, such as mask-wearing and border controls, that were used to try to stem the spread of the virus before the development of vaccines. 

In their report, researchers at the UK’s independent scientific academy found masks were highly effective at cutting transmission and that mask-wearing, border controls and shutdowns were most useful when introduced early, while case numbers were lower, and in combination.

Professor Sir Mark Walport, foreign secretary of the Royal Society and chief scientific adviser to the UK government between 2013 and 2017, said one of the main lessons to come out of the pandemic was to “be prepared”. 

“Governments on the whole are better prepared [than before Covid]. The last emergency was a major pandemic and so we should be better prepared for it next time. But viruses are dangerous things,” he said. 

The Covid inquiry is examining the UK’s response to the pandemic, including the decisions to lock down and introduce other social distancing measures, testing and contact tracing, and masking. It will last at least until 2026.

The Royal Society researchers concluded that lockdowns and social distancing measures were the most significant intervention, with some studies suggesting they could have reduced the reproduction number of the virus by more than 50 per cent.

In care homes, restricting visitor numbers, keeping residents apart and allocating individual staff to specific residents all reduced transmission.

The researchers pointed to Hong Kong, South Korea and New Zealand as examples of where stringently implemented lockdowns resulted in extremely low domestic transmission. 

But their report did not consider the broader impacts of lockdowns such as the effects on the economy, children’s education and people’s mental health. 

Chris Dye, professor of epidemiology at the University of Oxford, who examined the mask studies, said there was “surprisingly overwhelming evidence” that they cut transmission, especially N95 respirators.

He said they should be used by people working with vulnerable adults and children whenever rates of Covid or other respiratory illnesses were high.

In January 2023, a review by Cochrane, a non-profit organisation that issues medical guidance, of the randomised controlled trials found no clear link between encouraging people to wear masks and reducing infection.

But Dye said that since there were not many randomised controlled trials from which to draw conclusions, the Royal Society had looked at a broader range of studies and found they consistently reported that mask-wearing and mask mandates cut transmission. 

The researchers found that border controls were less consistently effective in preventing infection. While strict quarantine policies did significantly reduce the number of infected passengers entering a given country, measures such as symptom screening or taking travellers’ temperature failed to stop the virus crossing borders. 

Christl Donnelly, professor of statistical epidemiology at Imperial College London, who led the research into lockdowns, said the pandemic had been “unique” because so many countries implemented measures to curb viral spread.

“There’s absolutely no reason to think this only applies to Covid and wouldn’t apply to other respiratory diseases,” she said.

This story originally appeared on: Financial Times - Author:Hannah Kuchler

But his latest project, Colossal Biosciences, is his most outlandish yet. The Texas-based start-up is aiming to spin off businesses and license technologies to fund bringing the woolly mammoth, the Tasmanian tiger, and the dodo back from extinction. 

Its plan is to use gene editing to change the embryos of familiar animals until they resemble the lost species and it wants to create its first version of a mammoth — a gene edited elephant embryo born to an elephant mother — by 2028. Church said the timeline was “ambitious” but “not impossible”. 

Since the business was co-founded by Church in 2021, it has raised $225mn from big name investors and celebrities including venture capitalist Peter Thiel, entrepreneur Thomas Tull and Paris Hilton. 

It has already spun off biotech software company Form Bio last year, raising $30mn and it hopes to capitalise on other technology developed along the way to help fund its mammoth project.

It is also anticipating revenue from media partnerships telling the story of a project that some have compared to Jurassic Park.

But according to Church: “The main business isn’t endangered species. We may even give a lot of that away just for conservation and goodwill. I think the main business is technology development.”

For years, Church said he did not think anyone would fund his pet project to resurrect the woolly mammoth. Then in 2015, Thiel, the co-founder of PayPal and Palantir, offered him $100,000 for the work over breakfast. 

“He just said, ‘What are your top three dreams?’ and I thought he would definitely bite on ageing reversal. But he didn’t. I didn’t think he would bite on mammoths, but he did,” Church said. 

In 2018, Church travelled to the Pleistocene Park experimental nature reserve in Siberia, where he was working with Russian scientist Sergey Zimov on a plan for the mammoths to eventually be released into the wild.

Colossal believes that bringing back mammoths could help restore the arctic tundra, preventing the thaw and release of stored greenhouse gases.

The project faces two huge challenges in particular. The first is to increase the number of gene edits that can be done at once, a process known as “multiplex editing”, to get as close as possible to creating a mammoth from an elephant embryo. 

The second is to create a system to incubate mammoths in artificial wombs. Matt James, chief animal officer at Colossal, who joined after a career in zoos where he specialised in looking after elephants, said the number of reproductive females in a population is always the limiting factor in scaling up endangered species populations. 

“If you have an artificial womb, then suddenly you can start to scale the population and help recover populations very quickly,” he said. 

Critics say the challenges make the project near impossible, or not ecologically sound.

Matthew Cobb, a professor of zoology at the University of Manchester, said the plans involve creating “a vaguely mammoth-ish elephant, or a vaguely dodo-ish pigeon”.

“They are not de-extincting any animal, they are using the power of genetic engineering, they claim, to create a weird hybrid,” he said. 

Colossal said it was not trying to make exact clones but to create a species that has specific traits that makes it unique. 

Cobb added it would also be hard to build a breeding population, which would require at least several hundred animals to ensure genetic diversity. 

Stuart Pimm, an ecologist at Duke University in North Carolina, who studies present day extinctions, said a single woolly mammoth would struggle to survive — and a sufficient herd would need a huge amount of space. 

“If you had a woolly mammoth, the only thing you could do is put it in a cage. That seems to be outrageous, you’ve done all this effort to create something for a peep show,” he said. “So how many woolly mammoths would you need? You’d need 50, maybe 100, and you’d need a thousand square kilometres in which to put them.” 

James agreed that the mammoths would be “highly social” and need a “strong herd structure”, so Colossal plans to create genetically diverse herds of mammoths to provide it. He said the company is working on identifying rewilding sites with sufficient space for a herd, including conversations with US state governments. 

Colossal said it was also working with governments on ideas for preserving endangered species.

Ben Lamm, the serial entrepreneur who is Colossal’s co-founder and chief executive, said Form Bio was just the first of the company’s spinout opportunities. 

Colossal created the software behind Form Bio to run its own labs, then sold it to other labs in biotech and academia. Lamm, who sits on its board, said Form Bio is working with other companies on projects such as using machine learning to design drugs, with the opportunity for it to create joint ventures and share revenues. 

Lamm thinks Colossal can partner with pharma and biotech on using new multiplex editing tools it is developing in humans. Treatments using gene editing techniques like Crispr are being developed for diseases such as sickle cell disease that are caused by a single faulty gene. Multiplex editing could allow the treatment of conditions caused by multiple genes. 

Eriona Hysolli, head of biological sciences at Colossal, listed some of the possibilities of gene editing: “With multiplex editing, can you actually target the diseased cells or tissue? Can you target multiple genes at the same time, not just monogenic diseases, but multigenic diseases like diabetes or Alzheimer’s?”

Lamm hopes the 17-person team working on artificial wombs will create technology that could be licensed or spun out into another company to help human reproduction. “It is kind of like Mars. Lots of people are working on Mars and think they will eventually get there. I feel very similar on the ex-utero development side.”

In the meantime, Colossal is working on ways to publicise the project further and earn revenue from media partnerships. 

Lamm said every large entertainment studio had contacted Colossal to express interest in filming their work. Several of Colossal’s investors have a background in media, including Tull, who is the former chair and chief executive of Legendary Entertainment.

“We want to educate and inspire by creating mammoths or dodos,” Lamm said.

There may be opportunities to go and look at animals created by Colossal, but James said the company had not decided how much access to give to the public. 

He resisted comparisons to Jurassic Park. “That association isn’t my favourite because I think we’re doing this for purposes other than vanity. And also I think we’re probably taking a few more ethical considerations along the way,” he said. 

Church, however, thinks the film did scientists a favour by encouraging people to think about what can go wrong. “It vaccinates us against particular scenarios. It is unlikely we’re going to make the exact mistakes they made in Jurassic Park,” he said. “First of all, I’m not in a big rush to do hyper carnivores.”

This story originally appeared on: Financial Times - Author:Hannah Kuchler

The UK’s former deputy chief medical officer, who gained celebrity status among the British public during the pandemic and was affectionately known as “JVT”, took up the role as part-time adviser to Moderna in May, according to official filings.

As part of his duties during the pandemic, Van-Tam was a member of the Vaccine Taskforce, which the government said made decisions on “all vaccine supply contracts and major investments in manufacturing and clinical opportunities”. He stepped down from his government role in March 2022.

Widely praised for his communication skills, Van-Tam often deployed elaborate sporting analogies to portray various stages of the pandemic. Describing the vaccine rollout in December 2020, he said: “It’s clear in the first half, the away team gave us an absolute battering . . . In the 70th minute we’ve now got an equaliser. OK, we’ve got to hold our nerve now, see if we can get another goal and nick it.”

Van-Tam’s move follows controversy over previous “revolving door” moves between government and business.

In 2020 there was an outcry after former UK chancellor Sajid Javid took a high-paying role at JPMorgan. A scandal erupted the following year when it emerged that former prime minister David Cameron lobbied members of the government on behalf of Greensill Capital.

Nearly a third of all new jobs taken by former ministers and senior officials had a significant overlap with their previous brief, according to research conducted earlier this year by civil society group Transparency International.

Rose Whiffen, senior research officer at Transparency International UK, said the government should prohibit ex-senior civil servants and ministers from taking up positions where they have had substantial responsibility for policy that is relevant to the hiring company.

“Currently, there are only threadbare safeguards against abuse of the revolving door between the public and private sector,” she said, adding this created a “risk of privileged information being misused for commercial benefit”. 

Moderna said the appointment was in accordance with the health department’s rules for officials who take up jobs in industry. Paul Burton, Moderna’s chief medical officer, said the professor’s “significant experience and expertise as a specialist in influenza” will be a “vital asset” to the company. The part-time consulting role is for the whole global business, not focused on the UK.

Moderna’s Covid-19 vaccine was approved for use in the UK in January 2021. The government initially bought 17mn of the Moderna vaccine, compared with 100mn doses of the Oxford-AstraZeneca jab, and 40mn of the Pfizer jab. However, in late December it agreed to buy a further 60mn Moderna doses, alongside 54mn from Pfizer, to last through 2022 and 2023.

Last year the government signed a 10-year partnership with the US pharmaceutical company to boost research and development of mRNA vaccines in the UK, including building a factory that could produce up to 250mn vaccines a year.

Mani Foroohar, an analyst at Leerink Partners, said Moderna had been “spending aggressively” in the hope that the market for Covid-19 vaccines rebounds, and that in many countries, including the UK, the vaccine market was largely driven by government sales.

“In markets that don’t have a commercial component that are largely government-driven it is not entirely uncommon for pharma companies to hire former regulators and government officials in an attempt to strengthen their government relations,” he said.

The government has stipulated that, as part of his role at Moderna, Van-Tam is not allowed to lobby the Department of Health and Social Care or its executive agencies and is not allowed to have any involvement in bids relating to the health ministry or its executive agencies until March 2024, nor is he supposed to use privileged government information to further business interests.

Jordan Urban, a researcher at the Institute for Government think-tank, said people should not be “overly concerned” when specialists leave government to go into industry. However, he said the broader problem was that the government’s rules “have no teeth” and “the individuals to which they apply can ignore them with no penalty”.

This story originally appeared on: Financial Times - Author:Hannah Kuchler

The funding was announced on Wednesday as health secretary Steve Barclay travelled to India for his first G20 health ministers meeting, where discussions will include how to address AMR. 

Antimicrobial resistance, where bacteria evolve so they cannot be destroyed by antibiotics, is linked to about 1.3mn deaths a year, with some studies estimating that it is more deadly than malaria or HIV.

Barclay said antimicrobial resistance is a “silent killer” that poses a “significant threat” to public health. 

“It’s vital it is stopped in its tracks and this record funding will allow countries most at risk to tackle it and prevent it from taking more lives across the world, ultimately making us safer at home,” he said. 

In 2019, AMR caused between 7,000 and 35,000 deaths in the UK, according to the government. Experts warn that a resistant bug could cause a future pandemic, and inhibit vital treatments, from surgery to chemotherapy, which rely on infection control.

Globally, there has been a dearth of new antibiotics because of poor incentives for drugmakers to invest in the field. Existing generic drugs are cheap to buy and new antibiotics must be used sparingly to avoid resistance developing.

To encourage drug companies to develop new medicines, Britain plans to expand its subscription model, where the government pays drug companies a fixed fee for supplying antibiotics.

Last month, the UK announced it intends to pay up to £20mn a year per antibiotic sold, no matter how many are prescribed. 

Barclay said some G20 countries are looking to implement the same subscription model to address the market failure.

The US has proposed a similar idea in the Pasteur Act, which has yet to pass Congress, while the EU is looking at other ways to encourage pharmaceutical companies to invest. 

But incentives targeted at western countries will not solve the problem in developing economies, where antibiotics are often overused because they are available without prescription.

The UK’s latest investment, taken from the health department budget, will support the Fleming Fund, which the government established in 2015 to fight antimicrobial resistance in low and middle income countries.

It will fund laboratories, disease monitoring systems and a global workforce to increase surveillance of potentially problematic pathogens in 25 countries where the threat is highest, including Indonesia, Ghana and Kenya.

The UK will also partner with India on surveillance, in an investment worth £3mn, and fund genomic sequencing technology that can help rapidly identify the pathogens developing resistance.

This story originally appeared on: Financial Times - Author:Hannah Kuchler

Kimmel was needling Hollywood for its newfound dependence on the diabetes medication that spurs weight loss, which has reportedly become de rigueur among the wealthy and famous. 

Novo Nordisk, the company behind semaglutide — branded as Ozempic for diabetes and Wegovy for weight loss — has benefited from a surge in demand from patients inspired by celebrities’ transformations. But the drug’s reputation as a “skinny jab” has not helped persuade health systems and insurers, or payers, to cover the cost of it. 

This week, the Danish drugmaker published headline trial data that it believes will make the difference. In a trial of patients with obesity and cardiac conditions, Wegovy was shown to cut the risk of serious events such as heart attacks and strokes by 20 per cent, proving that the drug improves heart health — and has the potential to reduce high healthcare costs. 

Lars Fruergaard Jørgensen, Novo Nordisk’s chief executive, tells the Financial Times that the “whole reason” the company did the trial was to help win the argument with payers.

Shares in the company and its main rival, the US pharma group Eli Lilly, shot to record highs, as investors hoped that payers would not be able to refuse to cover the drugs for much longer. Evan Seigerman, an analyst at the Canadian investment bank BMO, added tens of billions of dollars to his sales estimates for the weight loss and diabetes drugs after the announcement. He now forecasts the entire market will one day be worth $130bn to $140bn. 

Drugmakers believe the medicines will help save on the healthcare costs related to obesity, which add up to about $170bn a year in the US, according to the Centers for Disease Control and Prevention.

However, health insurers and public payers argue that they have no way to magic up the money to pay for the drugs that would be needed to cater to a potential market of tens of millions of patients in the US alone, at a list price of about $1,300 a month, for the rest of their lives.

James Gelfand, president of the ERISA Industry Committee, which represents large US employers that provide health benefits, says the conflict is taking over his LinkedIn feed. 

“It’s a war zone between patient advocates and doctors who are extolling the virtues of these drugs, and then plan sponsors, administrators, actuaries, etc, who are saying these drugs are a massive profiteering scheme,” he says. 

Health effects

After decades of drugs that either offered lacklustre weight loss, or serious side effects, semaglutide was a breakthrough for the treatment of obesity.

First developed to treat diabetes, the compound was trialled by Novo in patients with obesity who were not diabetics. Results published in 2021 showed participants taking the weekly injection lost an average of about 15 per cent of their body weight, compared to about 2 per cent with just diet and exercise.

The next year, a trial showed that Eli Lilly’s similar drug tirzepatide could help patients on the highest dose lose an average of 22.5 per cent of their body weight. Tirzepatide is not yet approved for obesity, though the same active ingredient is available branded as Mounjaro, for diabetes. 

The drugs have side effects — most commonly nausea and gastrointestinal problems — and in animal studies, Wegovy increased the risk of thyroid cancer. But many people frustrated with not being able to lose weight solely through diet and exercise were prepared to put up with these risks to finally see an impact on their size and their health. 

While many clinicians presumed the drugs would improve heart health because obesity is a major risk factor for heart disease, Novo Nordisk invested in its largest ever trial — following over 17,000 people since 2018 — to obtain proof. 

The initial result was “out of this world”, says Martin Lange, executive vice-president of development for Novo Nordisk. The data from trials suggests the drug is not just having an impact by helping people lose weight, he says, but also by lowering blood pressure, changing the balance of lipids in the blood, and reducing inflammation.

He adds that this significant impact on people who already have heart disease suggests that the drug may also help cut the risk for people who have not yet developed it.

The full study, which will be released at an academic conference and is yet to be peer reviewed, will also show the drug’s impact on 28 other factors, including on other expensive conditions such as kidney disease. 

Analysts believe the trial could also help build confidence that the benefits of the drug outweigh the risks, after the European regulator began investigating reports of patients having suicidal thoughts, and a US lawsuit claiming that Novo and Lilly’s diabetes drugs cause “stomach paralysis”. Lange says the heart trial showed no causal link with suicidal ideation or thyroid cancer. Novo and Lilly have said patient safety is their top priority. 

Novo hopes that being armed with this data will help it overcome the competition when Lilly enters the obesity market with its own medication, which is in the same category of so-called GLP-1 receptor agonists.

But Lilly believes Novo’s data will also help it sell its weight loss drug, even though the results of its comparable trial won’t be ready until 2027. On an earnings call this week, Lilly’s president of diabetes, Mike Mason, declared it a “fantastic day for people living with obesity”. 

“It is an important milestone in a long-term goal to get broad access for anti-obesity medications,” he said. 

The question of coverage

Despite Wegovy’s sudden ubiquity in popular culture, less than half of all US commercial insurers cover the weight loss drug. Medicare, the government-backed insurance for seniors, is prohibited by Congress from paying for any obesity medications.

In Europe, where supply problems mean Novo Nordisk is only just slowly starting to launch the drug, public health systems are restricting who qualifies for it. The UK’s National Institute for Health and Care Excellence (Nice), for example, will pay for it for patients at the higher end of the body mass index, who already have at least one weight-related condition, and then for only two years, despite evidence showing that if you stop taking the drug, you regain weight. 

After the heart trial data, financial analysts believe this reluctance will have to change. BMO’s Seigerman says not covering a drug that is potentially life-saving will be “unethical”. 

“Before the data, a lot of these weight loss drugs were seen as vanity, no one was treating obesity as a medical condition, a precursor to negative health outcomes,” he explains. “If you have cancer, they are not going to deny you a cancer drug. Now, you’re going to treat obesity as a medical condition.” 

Novo Nordisk’s Jørgensen says that with broader coverage, the company hopes to reach more patients with the highest BMIs and comorbidities, even though “some of the less fortunate individuals will not be able to pay out of pocket”. 

Novo and other drugmakers have been lobbying Congress to pass a law reversing the ban on Medicare coverage of drugs designed to address obesity. Seigerman is optimistic that the new data will eventually help pass the law, because it will prove that it will save Medicare money in the long run, on hospitalisations for heart attacks and strokes. 

Stacie Dusetzina, professor of health policy at Vanderbilt University, says it is “incredibly difficult” for legislation to pass through Congress at the moment. But she said the fact that Medicare does cover semaglutide for treatment of diabetes suggests that, after the new data, it could cover the drug for people with cardiac conditions. The Centers for Medicare & Medicaid Services did not respond to a request for comment. 

In the UK, Jørgensen says Nice could be willing to expand coverage when a trial shows the health benefits go beyond two years. 

Trained as a health economist, he says the drugs could help not just save healthcare costs but also get people back to work. “If you can turn them back from being consumers of healthcare services to consume less of those and actually be active in the workforce and taxpayers, that economic model would be very beneficial for most typical European societies where healthcare is funded by tax payments,” he says. 

‘Very hard to justify’ 

But for insurers and health systems, the conundrum has barely changed.

David Rind, chief medical officer at the Institute for Clinical and Economic Review, a non-profit that estimates fair prices for the US health system, says he does not think the heart trial has changed the ethics of not covering the drugs.

ICER’s cost effectiveness assessment concluded they represented low long-term value for money — and it already assumed the obesity medications had some cardiac benefit. 

The biggest problem is the sheer number of people who could qualify for the drug: at current prices, ICER estimated that only 0.1 per cent could be treated within five years without “major budget disruptions” for the insurers. 

“The options are to move money away from other healthcare, raise premiums, or taxes if you’re the government, or manufacturers could lower the price to a cost effective price and still make enormous amounts of money because enormous numbers of patients want this,” Rind says. 

Drugmakers will be reluctant to offer big discounts on such a popular drug, but the opacity of the US drug pricing system means they could do deals to offer larger rebates if volumes increase.

Gelfand, who represents large US employers that provide health benefits, says the price tag is still “very hard to justify”, particularly given patients have to take the drug for life. He expects employers to stick to covering very narrow patient groups, if any at all.

Otherwise, he says, premiums in the US could rise 15 to 20 per cent, increasing the likelihood that healthy people stop buying insurance, and making the remaining population riskier to cover. 

A single heart trial was never likely to change payers’ position on the drugs overnight, and even if it had, Novo Nordisk would not have enough of the drug to supply the world.

But it could be the first in a series of data releases that proves how weight loss drugs prevent the serious consequences of obesity — eventually reshaping not just patients, but also the healthcare industry and the broader economy.

Emily Field, an analyst at Barclays, says that the benefits of the drugs are “only just starting to be understood” and eventually, doctors will become used to treating obesity before other health problems develop.

“This is like the smartphone, it is going to change society in a big way,” she says. “This trial is a huge validation that it is not just cosmetic.”

Additional reporting by Jamie Smyth in New York

This story originally appeared on: Financial Times - Author:Hannah Kuchler

The UK-listed pharma group now expects revenue to increase by 8 to 10 per cent this year, up from previous guidance of 6 to 8 per cent, and adjusted earnings per share growth of 14 to 17 per cent, above its previous forecast of 12 to 15 per cent. 

GSK expects a strong performance in the second half, but lower growth than in the first six months of the year because of a tougher comparison to the second half of 2022. 

The upgrade to the group’s full-year forecasts comes as chief executive Emma Walmsley seeks to overhaul the business, having spun off its consumer division Haleon, which sells over-the-counter medicines, last year.

Walmsley said the company’s “momentum” supported the increase in its financial guidance and “further increases our confidence in delivering longer term profitable growth for shareholders”. 

Walmsley, who took over in 2017, has been trying to transform GSK by restructuring it to focus on pharmaceuticals and vaccines, by splitting from Haleon and replenishing its drugs pipeline. 

During the quarter, GSK had Arexvy, the first vaccine for the common respiratory disease RSV in older adults, approved in the US and the EU. It also completed the $2bn acquisition of Bellus Health, adding a speciality medicine for a debilitating and persistent cough. 

But Walmsley has struggled to convince many investors that her plan is working and the share price was dragged down last year by concerns about the potential cost of lawsuits over the heartburn drug Zantac. Shares in GSK are down 21 per cent in the last year. 

In the second quarter, GSK reported sales of £7.2bn, higher than the consensus forecast for £6.8bn, and up 4 year on year at constant exchange rates.

Sales of vaccines rose by 18 per cent year on year, with Shingrix, the company’s blockbuster shot for shingles, delivering 20 per cent growth. Sales of HIV medicines increased by 12 per cent year on year at constant exchange rates. 

GSK reported continuing earnings per share of 40.1p, adjusted for the spin-off of Haleon, a rise of more than 100 per cent year on year, and above the average analyst estimate of 34.7p.

This story originally appeared on: Financial Times - Author:Hannah Kuchler

The regulator said on Thursday it would grant full approval to lecanemab, now known by the brand name Leqembi, which was developed by Japanese drugmaker Eisai and US biotech Biogen.

Teresa Buracchio, acting director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, said a confirmatory study had shown that Leqembi was a “safe and effective treatment” for patients with Alzheimer’s.

“Today’s action is the first verification that a drug targeting the underlying disease process of Alzheimer’s disease has shown clinical benefit in this devastating disease,” she said.

Chris Viehbacher, chief executive of Biogen, said the approval was a “breakthrough” in the treatment of Alzheimer’s. “We are proud to be at the forefront of ushering in a new era of advances for a disease that was previously considered untreatable,” he added.

More than 6.5mn Americans suffer from Alzheimer’s, which along with other dementias will cost the US about $345bn in 2023, according to the Alzheimer’s Association.

The drug is the first to tackle the progression of the disease, rather than just treat its symptoms. But some researchers are concerned that the effect on the rate of cognitive decline is not “clinically meaningful”.

Last month, the FDA’s panel of experts unanimously voted that Leqembi shows “clinical benefit”. 

It comes after decades during which many big pharmaceutical companies lost hope and cut investment in Alzheimer’s research. Lecanemab was discovered by Swedish start-up BioArctic, which then partnered with the larger companies.

The FDA gave the drug accelerated approval in January, based on late-stage trial results that showed it slowed the rate of cognitive decline in early Alzheimer’s patients by 27 per cent.

Some patients in the trial experienced brain swelling and bleeding. Three of the 1,795 participants died from brain bleeds, including two people who were also taking blood-thinning medicines. Eisai said the drug could not be directly linked to the deaths.

Now that the drug has full approval, Medicare, the US government-backed insurance for seniors, will pay for it for early-stage Alzheimer’s patients, as long as their doctors participate in a database to collect evidence about how the drug works in practice. The drug will have a US list price of $26,500 a year, although health insurers will negotiate that down.

The Centers for Medicare & Medicaid Services decision to provide coverage for the treatment is crucial to enable a wide rollout of the treatment.

Its decision against widely covering Aduhelm, an Alzheimer’s drug from Biogen and Eisai — which secured a form of conditional approval two years ago — contributed to Biogen scrapping the commercial rollout. Aduhelm’s trial did not show as significant a benefit for patients as Leqembi and the data was controversial after one of the studies failed.

Patients in the EU will have to wait until early next year when the regulator is due to give its verdict on the drug. In the UK, Eisai submitted the drug for approval in May.

This story originally appeared on: Financial Times - Author:Hannah Kuchler

The biotech said on Wednesday that it had reached an agreement with authorities in Beijing to research, develop and manufacture drugs that would “not be exported”.

“Any medicines produced under this agreement will be exclusively for the Chinese people — who face many of the same health challenges that affect other communities around the world,” the company said in a statement.

Drugmakers remain interested in expanding in China, which faces an ageing population, higher rates of chronic diseases and health concerns stemming from an increasingly westernised diet. The Chinese government has also sped up the approval process for innovative medicines, making it an even more attractive market.

“With this announcement, we are taking further steps to deliver on our mission of creating the greatest possible impact to people through mRNA medicines,” the company said.

New York-listed Moderna was one of the biggest winners from the coronavirus pandemic after developing its vaccine. It was among a number of international pharmaceutical groups pushing for Beijing to buy their vaccines.

The Financial Times reported last year that the company had refused a request from Chinese authorities to hand over the core intellectual property behind its vaccine, co-developed with the US government, leading to a collapse in negotiations.

Last October, one individual close to the Moderna team in Greater China said the company had “given up” on its previous efforts to access the Chinese market.

Based in Cambridge, Massachusetts, Moderna is trying to build on the success of its vaccine, which used a platform based on a genetic code called mRNA to teach the body’s immune system to respond to the virus. It is now using the code to develop other treatments including for cancer.

Moderna declined to comment on reports in Chinese media that the mRNA deal was worth $1bn, or on the specific drugs it is aiming to develop in China.

While western drugmakers are pursuing their ambitions in China, Beijing’s tensions with many western governments has prompted some to draw up contingency plans in the event their businesses in China are caught in the crosshairs.

AstraZeneca has drawn up plans to break out its China business and to list it in Hong Kong amid mounting geopolitical tensions.

This story originally appeared on: Financial Times - Author:Hannah Kuchler

Under the new proposal, drugmakers would receive up to £20mn a year for selling their novel antibiotics in England no matter how many were prescribed, double the existing amount NHS England pays under the fixed-fee pilot scheme introduced last year.

The model would also be expanded to Scotland, Wales and Northern Ireland, after the success of the pilot between NHS England and two drugmakers — Pfizer of the US and Japan’s Shionogi. The UK-wide expansion is subject to a 12-week public consultation. 

David Glover, NHS assistant director of medicines analysis, said the health services wanted to lead the response to the global battle against the growing threat of antibiotic resistance, which can undermine the ability to offer routine hospital care. 

“As we continue to take lessons from the Covid-19 pandemic, the development of new antibiotics is absolutely essential to help build resilience to respond rapidly to new superbugs and save lives,” he said. 

The UK has pioneered the scheme as a way to tackle the growing problem of antimicrobial resistance, when bacteria, viruses or fungi develop the ability to defend themselves against drugs designed to kill them. 

Antimicrobial resistant infections caused 1.27mn deaths worldwide in 2019, according to a paper published in the medical journal The Lancet, more than the number of people who died from HIV/Aids and malaria that year combined. It is forecast to cause the deaths of 10mn people a year by 2050, and scientists worry that a future pandemic could be caused by a resistant superbug. 

But despite the huge need for new drugs, many pharmaceutical companies have cut investment in antibiotics research. Drugmakers say it does not make financial sense to invest in risky drug development when they have to compete with cheap generic antibiotics, and that the normal strategy of paying for drugs used does not work, because the new treatments should be used sparingly to prevent resistance developing. 

Instead, the subscription scheme aims to pay drugmakers for the treatments with a fixed fee, so they receive money even if the drugs are just kept in reserve for special cases or an emergency. 

In the pilot scheme, the fee was capped at £10mn a year, but pricing will now be tiered depending on how effective the drugs are and whether they target the most problematic pathogens.

Nick Crabb, programme director, scientific affairs, at the National Institute for Health and Care Excellence, which assesses value for money, said a new panel would play a “critical role” evaluating the antimicrobial drugs using a “novel and pragmatic, clinically led award criteria and scoring system”. 

But he added that the UK “could not face this growing challenge on its own, so we will continue to share our learning with international stakeholders and encouraging other countries to offer similar incentives.”

The US is exploring a similar model under the Pasteur Act, reintroduced into Congress last month. The EU is considering an incentive that gives drugmakers that develop an antibiotic an extra year of exclusivity before generics come on to the market, which they can use for another drug of their choice.

This story originally appeared on: Financial Times - Author:Hannah Kuchler

The German drugmaker is now preparing to launch a late-stage trial of its drug, which if approved, would compete with Eli Lilly’s Mounjaro and Novo Nordisk’s Wegovy. US pharma group Pfizer and biotech Regeneron are among the others hoping to enter the market. 

While results are not directly comparable, trial participants on Mounjaro lost an average of 22.5 per cent of their body weight in results published last year, while patients in a Wegovy study lost about 15 per cent. 

Boehringer Ingelheim believes its drug could result in even greater weight loss than in its phase 2 study if taken for longer, as participants did not stop losing weight in its 48-week trial. 

Paola Casarosa, head of therapeutic areas at Boehringer Ingelheim, said it was confident it would see “an even stronger effect” in the larger and longer phase 3 trial that it is discussing with regulators. 

“What we found absolutely very encouraging was there was no sign of plateauing of the effects,” she added. 

Appetite for the first two obesity drugs have transformed the fortunes of the pharmaceutical companies that developed them. Shares in Danish pharma group Novo Nordisk have soared 247 per cent in the past five years, while Indianapolis-based Eli Lilly has become the world’s largest pharmaceutical company by market capitalisation on hopes for its drugs for obesity and Alzheimer’s. 

Companies have struggled to keep up with a surge in demand accelerated by celebrities using the treatments, and similar drugs designed for diabetics, for weight loss. Worldwide obesity rates have tripled since 1975, according to the World Health Organization, and a study from Harvard forecast almost half of Americans are expected to be obese by 2030. 

Survodutide, which Boehringer Ingelheim developed with Danish biotech Zealand Pharma, copies a hormone called GLP-1 to reduce appetite in the same way as the existing drugs. But survodutide also mimics another well-known hormone, glucagon, which speeds up the rate at which a patient burns energy.

“Anecdotally, we know that the less food we ingest, the more our metabolism adjusts,” Casarosa said. “The balance is very important for meaningful and impactful weight loss.” 

The drug can also tackle fat accumulation on the liver, which 70 per cent of obese patients suffer from, and can cause diabetes or cardiovascular conditions. 

But about a quarter of participants dropped out of the trial because of side-effects, which were mainly gastrointestinal, similar to the nausea experienced by many on the approved obesity drugs. Boehringer Ingelheim said this could be avoided if the dose was increased more slowly in future. 

This story originally appeared on: Financial Times - Author:Hannah Kuchler

The government will on Friday unveil reforms worth £650mn to boost the life sciences sector as part of a wider package of measures. 

Hunt backed O’Shaughnessy’s goal to quadruple the number of patients in clinical trials by 2027. The government also accepted his recommendations to cut the time for approving commercial trials to 60 days, and to create a single contract for research across the whole NHS.

Richard Torbett, chief executive of the Association of the British Pharmaceutical Industry, said the measures demonstrated that the government has listened to the industry. 

But he added that improving research is “only one part of the equation”. “To get innovative medicines to patients and fully capture the growth opportunity, we must also fix the commercial environment.”

This story originally appeared on: Financial Times - Author:Hannah Kuchler

Ministers are expected on Friday to unveil more than £150mn of funding for the UK Biobank, a pioneering genomics project, to quadruple its research capacity to advance scientists’ and drugmakers’ understanding of human biology.

The industry has also raised concerns about a drop in clinical trials conducted in the NHS in the past five years, arguing the UK is not making the most of the single health system that should make it easier to do research.

This story originally appeared on: Financial Times - Author:Hannah Kuchler

In an interview with the Financial Times, Streeting laid out a plan to improve patient outcomes by putting clinical research back at the heart of the health service, ahead of the release of a government-commissioned report into the decline in trials.

This story originally appeared on: Financial Times - Author:Hannah Kuchler