Obesity “wonder drug” Wegovy is expected to be on sale in Ireland in the next 10 days but, even now, the woman charged with overseeing new product launches of the drug’s developer, Novo Nordisk, is hedging her bets.
Camilla Sylvest’s caution is possibly to be expected from an executive of a company that, until mid-2022, was known only for its critical but unspectacular business as a maker of insulin and other medicines for diabetes.
According to investment analyst Morningstar, the Danish company that has been in the diabetes market for 85 years supplies about a third of the $80 billion-plus (€74 billion) diabetes treatment market globally and roughly half of the more than $15 billion insulin market.
Ozempic changed all that. A treatment that helped people with type 2 diabetes to manage their blood glucose levels, one of its side effects was weight loss. When Hollywood celebrities latched on to the potential of that side effect in 2022, the drug quickly became a social media sensation.
Overwhelmed by demand, Novo Nordisk struggled to make supplies available, which only exacerbated demand.
Social media was not the first to realise the significance of Ozempic for weight loss. Novo Nordisk had already grasped its potential and added a new treatment to its portfolio. Using the same active ingredient as Ozempic but in a higher dose, Wegovy, which is specifically marketed as a weight loss therapy, was approved by the European Medicines Agency in January 2022.
As Sylvest, in her role as executive vice-president of commercial strategy and corporate affairs, and her team plotted the drug’s roll-out, the company coping with two significant challenges – manufacturing capacity and reimbursement.
Ireland was among the countries targeted for investment as the company looked to build manufacturing capacity.
In June 2023, the company paid €51 million for an 85-acre site at Grange Castle to develop a big fill and packaging facility that promised 1,100 jobs in an investment of up to €2 billion.
But just under a year later, it U-turned on those plans, withdrawing a planning application mid-process and walking away from the site purchase.
That decision did not come from Sylvest’s desk but she says the company “generally looks for scalability, we’re looking for flexibility and then of course we’re also looking at how do we set up our distribution network from our suppliers in the best possible way”.
Another consideration, she notes, is “the financial element”, presumably the company’s own spending commitments, which would have been stretched by its rapid, multi-country expansion of capacity as well as the incentives available in different locations.
Also in 2023, Novo Nordisk acquired the old Elan Drug Technologies site in Athlone from Alkermes in an €85 million deal that brought with it 400 new staff. It will be the group’s first manufacturing base in Ireland but it, too, does not seem to figure in the company’s plans for its latest blockbusters.
“It’s important for us to have a strategic site in Ireland,” Sylvest says before adding, tellingly, “and we also are thinking that this will become an important place for us in terms of some of the oral medications that we are looking to produce in the future”.
“We are very happy that we have finally been able to buy an opportunity for a site in Ireland. We try to retain as much flexibility as we can in all of our sites so that they can be flexible for different parts of our production.”
Reimbursement has also proved difficult.
Ozempic is only licensed in Ireland for the treatment of diabetes. And Wegovy has yet to be approved even though an application for reimbursement was initially made almost three years ago.
As of now, the only drug approved for weight management in Ireland is an older Novo Nordisk medicine, called Saxenda. And it can be prescribed only in limited cases – for patients with a body mass index of 35 or higher who are also prediabetic and at high risk of cardiovascular disease.
To put that into context, obesity in BMI terms is defined as any reading over 30. Anything over 35 is considered to be severely obese, with a reading above 40 termed morbidly obese.
BMI can be a somewhat blunt instrument but to put some figures on it, an adult woman of 5ft 5in in height, would have a BMI of 35 if she weighed just over 96kg (15 stone, one pound). For a man of 5ft 10in, the threshold is about 112kg (17 stone, nine pounds).
Anyone lighter than that will not be given access to Saxenda under the drug payment scheme or a medical card.
Wegovy’s European approval allows it to be used by adults with a BMI of 30 – or 27 in people with weight-related health problems such as diabetes, high blood pressure, abnormal levels of fats in the blood, obstructive sleep apnoea or a history of heart attack, stroke or blood vessel problems.
But, as with rival Eli Lilly’s Mounjaro – also called Zepbound – which entered the Irish market last month, it is likely that anyone looking to purchase Wegovy will have to pay for it out of their own pocket.
Sylvest is neither surprised nor perturbed.
“Wegovy is in many countries reimbursed for a very limited population, but then people are very willing to pay themselves out of pocket. So, if I may just take the example of Denmark, we have 5.5 million people here, and here everyone is paying out of pocket for Wegovy, even if we have never been used to that in Denmark.
“And we now have more than 1 per cent of the population that is willing to do that.
“We expect that, outside the US, the majority of the usage of Wegovy will be out-of-pocket payments.”
And how much will that cost? Eli Lilly’s Mounjaro costs about €290 for a one-month supply of a 2.5mg dose and you can pay closer to €350 for the 5mg dose.
“It costs actually very close to the cash offering that we made available in the US [to people not covered by medical insurance] of around $499. So, around $500 is approximately what we pay in Denmark out of pocket for a monthly script,” Sylvest says.
It has been reported that only the highest 2.4mg dose will be coming into Ireland initially, though patients are advised to move gradually from a starting dose of 0.5mg to that 2.4mg dose over a four-month period.
Sylvest is not prepared to provide detail, only saying Novo Nordisk is “continuing our roll-out and we are right now in more than 15 countries. But we will expand to many more countries this year and, of course, Ireland is in general a very important country for us so we will also be bringing Wegovy to Ireland”.
Shares in Novo Nordisk, which has grown in recent years to become the largest listed company in Europe, took a hammering last December – slumping almost 18 per cent in one day and wiping €90 billion off the market cap on disappointing news from a clinical trial for its next-generation therapy.
Called CagriSema, it performed just marginally better than Eli Lilly’s Mounjaro/Zepbound, which delivers more effective weight loss than Wegovy or Ozempic.
The shares have not recovered that ground since and are trading at just above $79 in the US.
Competition is intense as the two companies battle for dominance in a market that has grown tenfold since 2020 to see the global spend on anti-obesity medications top $30 billion in 2024, according to data analytics firm Iqvia. Every other big pharma group is pouring billions into research to get a slice of a market that grew by more than 20 per cent last year alone.
Sylvest bridles at the suggestion that Lilly currently has pole position.
“When you say that we are not ahead on Wegovy versus Tirzepatide [Mounjaro/Zepbound], I assume you refer to the weight loss. Because when you look at the impact on co-morbidities, Wegovy is the only brand that is proven to reduce big adverse cardiovascular events, and we also have data on the reduction in risk of diabetes and the reduction in risk of cardiovascular death.
“One thing is about weight loss but the really concerning things for patients and the very expensive thing for society is the impact on these comorbidities and there Wegovy is the only brand that has proven that 20 per cent reduction in the big adverse cardiovascular events.
“So, I think from that point of view we have a very strong product when you think about cost-effectiveness also.”
Asked whether that means any likely reimbursement in Ireland will ultimately focus on that impact on cardiovascular health, Sylvest says it will “because those are the things that lead to hospitalisations, it’s the things that are truly expensive”.
“Weight loss in itself can, of course, be great, but ... we really also see that it’s not the weight loss in itself, it is driving the reduction in the risk of these comorbidities.”
This comes in the context of recent comments from Prof Michael Barry, who assesses medicines’ value for money in his role as director of the National Centre for Pharmacoeconomics (NCPE), that even if the State agreed to pay for weight loss drugs, it would probably come with similar conditions.
“I don’t envisage a situation where all patients who would potentially benefit from these drugs will actually be receiving them through the community drug schemes,” he said. “I just think that that would be unaffordable.”
As someone who spent time in previous roles at Novo Nordisk working on pricing and health economics, Sylvest is acutely aware that medicines ultimately need to deliver value for money for the health service – and for wider society.
Already, Sylvest and Novo Nordisk are thinking ahead to other pipeline treatments for obesity and to the use of the science behind those drugs for other conditions.
As we speak, Novo Nordisk is examining whether in the same way that Wegovy acts by making people think they feel full – to put it at its simplest – they can help reduce cravings in drug addicts using the same GLP1 inhibitors that lie behind Ozempic and Wegovy.
Later this year, it is also expecting results from a trial of the use of the same GLP1 inhibitors to slow the onset of Alzheimer’s disease.
Study also continues on the impact of the long-term use of obesity drugs, given that, at present, they work only for as long as people continue on the therapy. In tandem with that, Novo Nordisk’s top researchers are also starting to think about how you might halt obesity before it starts.
“It is very early days, and it will take a long time to do it,” Sylvest said in another recent interview. “But if we don’t start now, it will take even longer.”
CV
Name: Camilla Sylvest
Age: 52
Position: Executive vice-president, commercial strategy & corporate affairs
Family: Lives with two children in Copenhagen.
Interests: Outdoor life – including with the family dog
Something you might expect: She likes numbers and facts, not surprising from a trained economist.
Something that might surprise: She’s a Novo Nordisk lifer, having joined initially as an unpaid trainee 29 years ago.
