The cheap fat jabs sending big pharma into a frenzy

Yahoo

a day ago

For many Americans who tuned in to watch the Super Bowl earlier this year, it was a surprise to find themselves fat-shamed during the ad break.
'Obesity is America's deadliest epidemic,' a voiceover said, as images of wobbling bellies, greasy burgers and giant apple pies flashed across TV screens.
The Super Bowl's 127m-strong audience, who were tucking into an estimated 1.5bn chicken wings during the event, were warned that 'obesity leads to half a million deaths each year'.
But Hims and Hers, the US online medicines company behind the ad, said people should not blame themselves.
Instead, its advert claimed that 'the system' was keeping them 'sick and stuck', adding that 'there are medications that work, but they're priced for profits, not patients'.
To the relief of viewers, Hims and Hers offered a 'life-changing' solution.
Rather than paying hundreds of dollars each month for well-known, branded weight-loss jabs such as Wegovy, households could instead try Hims and Hers' cheaper, replica versions.
'This is the future of healthcare,' it argued. 'Join us in the fight for a healthier America.'
However, for the likes of Danish obesity drug maker Novo Nordisk and US pharma rival Eli Lilly, which have claimed the rise of copycat jabs poses potential health risks, such claims have become a serious headache.
Over the past few decades, both businesses have poured billions of dollars into obesity drug research – recently yielding blockbuster drugs Wegovy and Mounjaro.
The rapid uptake of such drugs has prompted a surge in revenues for big pharma.
But bosses are now increasingly worried that demand among American patients has been dented by a cluster of smaller, copycat companies.
According to industry estimates from November, around a quarter of the 8m Americans on weight-loss drugs were taking knock-off replica versions.
These medicines, known as 'compound' drugs, were priced at around $200 ($148) a month, compared to over $1,300 for some branded versions.
Barclays analyst Emily Field says the boom in copycat weight-loss drugs has been a 'unique phenomenon' in the US, sparking an inevitable surge in legal claims that has drawn the attention of regulators.
So-called compound drugs are essentially custom-made medicines created by pharmacies using the same active ingredients of patented drugs.
Historically, compounding pharmacies create custom versions of medicines if they need to personalise them for patients. For example, if someone is unable to take a standard oral medicine in pill form, or is allergic to an ingredient in an existing medicine.
Compounding pharmacies are also typically blocked from mass-producing their drugs.
For weight-loss drugs, though, it has been a different story.
After the US Food and Drug Administration (FDA) put semaglutide – marketed as the blockbuster obesity drug Wegovy – and tirzepatide – the same for Eli Lilly's Mounjaro – on the shortage list in 2022, compounders were allowed to ramp up production.
'It was almost like these companies found a loophole where they were allowed to do this on a mass scale,' says Field.
The impact has been significant. At the start of this year, Novo Nordisk estimated that the copycat drugs accounted for around a third of the entire weight-loss market.
That is despite warnings from the FDA about the health risks posed by compounded medicines, which do not have to be approved by the regulator.
Beth, from Washington, says she was tempted by online ads for the compound medicines, having struggled with her weight since the pandemic.
For her, the drugs helped her at a time when it seemed impossible to lose weight or stick to a diet. She dropped 30lbs over a few months of taking a compound weight-loss medicine.
Others say they had little choice but to opt for compound versions, given that the branded medicines were too expensive and not covered by their health insurance.
However, the situation is rapidly changing.
Last month, the FDA banned mass production of copycat weight-loss treatments that use semaglutide, the ingredient in Novo Nordisk's Wegovy.
It also removed tirzepatide from its shortage list last October.
Novo Nordisk said the law has now made things clearer.
'Moving forward, any compounder that mass produces or sells knock-off drugs is breaking the law and compromising patient safety,' a spokesman said.
Eli Lilly says the products 'pose potentially life-threatening health risks', adding: 'Patients shouldn't be exposed to risky, unapproved products when regulator-approved medicines are available.'
Online medicines firms, also known as telehealth businesses, are now racing to find a way to continue getting cheaper, personalised replica drugs out to patients.
Noom, a rival to Hims and Hers, has suggested it will still be able to sell compounded weight-loss drugs to patients under an exception set aside for 'personalised' medicines.
Hims and Hers, meanwhile, has already struck a new deal with Novo to offer its branded obesity drug to patients.
The US firm also said this month it was exploring expansion in the UK, after acquiring European rival Zava.
Andrew Dudum, the Hims and Hers chief, suggested there could be 'expansive options in obesity that include that type of personalisation, or similar types', telling the Financial Times that it could sell replica obesity medicines in the UK and Europe.
David Meinertz, the boss of Zava, agrees that there are opportunities for the business to grow outside of America.
'There's clearly the experience and expertise that Hims and Hers have built up in the US,' he says. 'But then we have things like the regulatory knowledge here in Zava, and this is where we combine our experiences and spearhead this effort.'
Still, the situation in the UK is very different to the US. Here, the compounding pharmacy market is much smaller, with pharmacies able to prepare personalised medicines for patients if it is prescribed by a doctor.
Elizabeth Philp, the co-founder of compounding pharmacy Roseway Labs, says there could be a role for more personalisation of medicines.
'The NHS will say wasted medication is one of their top issues – people who try medication, put it in their bathroom cupboard and never use it again because it didn't suit them,' she says.
'We can really help with that.'
However, drug insiders argue it would be a 'very bad idea' if the UK started to think about bringing in cheaper compound medicines for weight loss.
'The real drugs are getting very cheap at volumes,' says one senior drug leader. 'Supply is not an issue.'
It will be a message that Novo and Eli Lilly will seek to drum home as they seek to prevent smaller rivals from selling cheaper weight-loss medicines to patients.
Still, the effects of this debate are already being felt by many in the US battling to lose weight.
'I cannot afford the full price at this time,' says Beth. 'I think it's awful that people are losing access to this medication due to finances or compounded meds going away.
'These drugs are literally life-changing.'