Some big themes become apparent as you get into the details on the world’s top 15 R&D players, ranked by overall spending in 2021.
Bottom line, this new look includes a $124 billion total for the Endpoints R&D 15, up $22 billion from the 2018 numbers. That’s a 22% jump in just three years, including a fast and furious assault on Covid-19, with distinctly mixed results. While many tried, only one of these big players — Pfizer — turned a historic opportunity into a major money earner with long-term potential. Merck, GSK with Vir, Eli Lilly, J&J and AstraZeneca, all made smaller — sometimes temporary — advances in vaccines or therapeutics. But the long-term potential for the second-tier players seems stunted compared to what Pfizer achieved.
Many had a few shots on goal but achieved nothing. And now it appears that the global campaign to vaccinate the world will end far short of that goal, even though the virus is still very much with us.
The pandemic triggered some amazing overnight changes in R&D, inspiring a shift to Zoom that enhanced instant cooperation and allowed for a new and faster way to develop vaccines and therapeutics. But beneath the surface optics of an industry enjoying a brief turn in the sun of positive public opinion, some underlying trends were remorselessly driving costs up. We’ve moved toward a new generation of combination approaches that has only made clinical trials more expensive for many. The competition for talent has never been so intense as now. And the supply chain disarray that afflicted everyone clearly left its mark on Big Pharma as well, where developers hunting the next best-in-class, first-in-class drugs experienced the same kind of broken logistics and rising costs that swell budgets.
Those costs remain high, while public opinion is already fast turning against the industry again, as drug pricing remains the perennial unsolved challenge for the US.
Pharma, though, enjoys big margins in the US, and that makes it possible — while necessary — to foot some very large bills like you’ll see below. But if you do the math on drug development, you’ll find that even at this lofty height, Big Pharma’s inability to accurately pick Phase III winners will make it essential to snap up drugs from biotechs to fill pipelines. That goes double for the big outfits spinning out less profitable operations in order to focus more directly on innovation.
For the last few years, the big boom that made it possible for biotech to take their drugs all the way to the regulatory finish line ended with a market implosion earlier this year. Now, biotech will once become the R&D pantry for this slate of players who continue to perform well and desperately need more candidates they can line up for approvals in the 2025 to 2030 time frame.
But don’t look for overall costs to go anywhere but up as the race to develop new blockbusters continues to heat up.
- Bristol Myers Squibb
- Eli Lilly
- Boehringer Ingelheim
- Change: +14%
- Sales revenue: 65.9 billion
- R&earlyD chief – gRED: Aviv Regev
- R&earlyD chief – pRED: Hans Clevers
- Compensation: N/A
- Ticker: $RHHBY
- Employees: 101,000
R&D spending 2021: $15.7 billion (14.8B Swiss francs)
R&D spending 2020: $13.8 billion (13B Swiss francs)
R&D as a percentage of sales: 23%
The scoop: Roche’s annual R&D investment has swelled 74% over the past decade, making their gRED and pRED operations large enough to both fit into the top 10 big spenders list, if the budget was split evenly between the two.
Back in 2009, when Roche bought out all of Genentech and shuttered its old campus in Nutley, NJ, the big question was whether it was making a wise choice, or would just smother it to death with Swiss German regimentation. No one seriously discusses that anymore, as Genentech continues to deliver — even as having Genentech on the resume makes their R&D staff among the most sought after in the industry.
Genentech/Roche — along with Novartis — have virtually trained a generation of industry leaders that have fanned out around the globe.
More recently, the Genentech side of that research equation has been undergoing a sea change with Aviv Regev running the early development show. The Broad Institute scientist came in with some completely new thinking about AI and machine learning that has the pharma giant’s chief dealmaker, James Sabry, scouring the globe for a whole new set of partners on the early end of the discovery/development journey.
Over at pRED, meanwhile, William Pao recently departed to a bustling Pfizer as development chief, with Hans Clevers jumping from the board to replace him. Clevers has had a prominent position at Utrecht University, which will earn him some quick respect in an organization traditionally based in Europe with the rump of the old New York organization beefing up its ranks.
Roche got shut out of the NDA list for original drugs in 2021, but the year before it counted three approvals: Evrysdi, a potential blockbuster, along with Enspryng and Gavreto. And early this year they added an Eylea rival, Vabysmo, to the portfolio. In this league, counting 4 OKs in 28 months qualifies as a success story. And they can boast of an industry-leading position in the CD20xCD3 space with mosunetuzumab and glofitamab.
Roche has a big focus on diagnostics, which played to its advantage during the pandemic, but that’s a solid bit of business that does little to thrill the investor class. On that end, there’s a hyper-focus on gantenerumab for Alzheimer’s, an old anti-amyloid drug that failed decisively 8 years ago but was brought back from the dead with a new Phase III development plan. We’re now nearing a new pivotal readout that will spell the fate of this drug once and for all, along with the whole amyloid hypothesis. Investors have been dizzied by dreams of massive, windfall profits, which led Biogen to the precipice — and over the edge.
Analysts continue to give this one a solid shot at blockbuster status, but who among us would actually be surprised if the drug didn’t actually move the dial on efficacy?
Then there’s the whole I/O 2.0 field, where Roche hopes to make history with its TIGIT tiragolumab, with 4 landmark readouts due out this year. The first round of data proved a sore disappointment, with a failure in small cell lung cancer. But the jury is still out on TIGIT and Roche — for now. The Phase III NSCLC readout in combination with Tecentriq looms this quarter, with analysts eager to see if Roche has stolen the lead on the path to I/O 2.0, or will disappoint once again after other attempts failed badly.
It’s to Roche’s credit, however, that win or lose they will make drug development history yet again. The R&D group doesn’t lack ambition — or budget.
Inevitably, that ambition leads to failure, which is what we saw as etrolizumab went down for the final count this year. When you aim for the bleachers as often as Roche has, it’s only natural to fan-out from time to time. It’s avoiding the big swings that land you in serious trouble.
- Change: +47%
- Sales revenue: $81.3 billion
- R&D chief: Mikael Dolsten
- Compensation: $10.9 million
- Ticker: $PFE
- Employees: 79,000
2. Pfizer: A global player helps orchestrate a blockbuster R&D revolution. What’s next?
R&D spending 2021: $13.8 billion
R&D spending 2020: $9.4 billion
R&D as a percentage of sales: 17%
The scoop: For Pfizer CEO Albert Bourla, winning the war on R&D started out as a math lesson.
If you run the numbers on average success rates, Bourla has noted, you can pretty much expect that average performance will generate a certain number of new products that can be used to generate added sales. With sheer financial muscle on the order Pfizer commands, that will buy you growth as you stuff more clinical stage products into the pipeline, along the lines of etrasimod, the late stage S1P picked up in the $6.7 billion Arena buyout.
But it doesn’t actually work that way in Big Pharma, and Bourla’s been giving a master class on the real world of major league R&D success. Right now, all the numbers look great for Pfizer. And therein lies the promise and peril for what lies ahead.
For Pfizer, the most important development on the R&D side comes down to one vaccine: Comirnaty, the Covid-19 jab that has saved lives globally and opened a door to huge commercial success. It also carved a similarly speedy path for Paxlovid, its antiviral pill which has continued to ring up endorsements from the WHO and others as so many rival treatments have been iced by the variants.
Its alliance with BioNTech set the stage for the dream event in R&D: A monumental and important program completed in record time, allowing Pfizer to leverage its manufacturing power to seize the leading role in mRNA and enjoy its time in the spotlight.
Windfalls, of course, are dicey. Just ask the crew that once ran Gilead during the hep C heyday. For Pfizer, it sets up a bit of a dilemma. How do you keep your numbers climbing after you’ve blown the doors off the old budget?
Pfizer also has to reckon with its poor historical record in drug development, with plenty of misses and thorny safety issues. Its JAK portfolio has been dicey and its big commitment to gene therapy is now hung up on a safety issue of its own.
It’s got a closely watched RSV vaccine that now enjoys back-to-back breakthrough designations as chief rivals wrestle with setbacks. But that still has a ways to go to play out. And then there’s the next big gamble in mRNA, with flu added to Covid. But they have a big challenge there as well.
When you’re sitting on cash like Pfizer has, the obvious answer to hedging bets is more bolt-ons. And you’d think that with biotech beaten down on Wall Street, the deals would be flying. Again, though, it’s not about numbers. No one wants to scoop up a bunch of struggling biotechs and then pay to see how the dice roll in clinical studies.
For Pfizer, the view from the top is beautiful. But add in the prospect of a couple of late-stage disasters and a fading pandemic, the big question will be how long before the law of averages Bourla consults starts to raise more doubts than expectations.
Today, the biopharma world is dominated by Pfizer. Tomorrow? We’ll see.
- Change: -8%
- Sales revenue: $48.7 billion
- R&D chief: Dean Li
- Compensation: $5.5 million
- Ticker: $MRK
- Employees: 68,000
3. Merck: The new team on top angle for a bigger future, with Keytruda paying the freight
R&D spending 2021: $12.25 billion
R&D spending 2020: $13.4 billion
R&D as a percentage of sales: 25%
The scoop: Merck may have cut a bit off the top of its R&D budget in 2021, but it’s still a top player on the Endpoints list. In 2018, they spent less than $10 billion on drug development, but now the focus is fixed on Merck 2.0, and innovation doesn’t come cheap.
The bear case against Merck is that it’s been riding a lucky streak on Keytruda for years, putting off the reckoning that awaits in 2028 when the patent expires, if the cash cow doesn’t actually get taken down earlier by something that’s just as good and a whole lot less expensive.
But it’s hard to argue with the way Roger Perlmutter and Ken Frazier handled the dominant I/O franchise in oncology, quickly leaping in front of a Bristol Myers Squibb that suffered a self-inflicted wound with Opdivo. There were select deals along the way, but the New Merck crowd in charge has embraced the challenge — though they are a long way from making an effective case that they’re ready for the end of the Keytruda jackpot.
You could see that all front and center with the $11.5 billion Acceleron buyout, which delivered a new contender for blockbuster status in cardio, a field where Merck once dominated but long since faded. New R&D chief Dean Li recently set out to make a case that CV will deliver more than $10 billion in peak sales, but little room was left for failure — and failure is a constant in drug R&D, particularly in cardio.
If Merck’s been lucky, though, that streak has shown no sign of ending. Innovent/Eli Lilly, which threatened to take on Keytruda with a bargain-basement price on their PD-1, got taken down by none other than Richard Pazdur, who dealt the whole China sphere a blow with his adamant objections to China-only data.
That leaves EQRx, which would have quite a task taking on an established drug star-like Keytruda with nothing but its price to recommend it.
One thing is absolutely certain: Merck clearly needs to get busy with the checkbook, using those deep cash reserves in place to refit the pipeline. Six years is a considerable amount of time to ring up OKs for new blockbusters. But they can’t trust on time for long.
- Change: 24%
- Sales revenue: $93.7 billion
- R&D chief: Mathai Mammen
- CSO: Paul Stoffels (recently departed)
- Compensation: $15 million
- Ticker: $JNJ
- Employees: 141,700
4. J&J: Betting big on innovation, with a fortune on the line
R&D spending 2021: $11.9 billion (pharma); $14.7 billion, total
R&D spending 2020: $9.6 billion (pharma); $12.1 billion, total
R&D as a percentage of sales: 16% (of total)
The scoop: J&J is the one true conglomerate on this list, which is why I break out their pharma R&D budget line out of the R&D total. And pretty soon, J&J will do some breaking up of its own, spinning out consumer health into a separate operation and doubling down on innovation as the key to the future.
To get there, J&J R&D chief Mathai Mammen has been willing to take some pretty bold bets. One standout: A gamble to partner with China’s Legend on a first-in-class BCMA CAR-T, approved a few weeks ago. Legend brought the CAR-T to the party, J&J’s powerhouse oncology group made a major play in bringing it to the regulatory finish line in quick time — without any of the data messiness that blighted Eli Lilly’s shot with its PD-1 from Innovent.
The same ambition was applied to Covid-19, which registered an early win as the third vaccine available in the US. But their jab never gained the kind of traction as the market-leading mRNA shots from Pfizer/BioNTech and Moderna. Why? Regulators balked at the evidence of blood clots, sidelining their vaccine. And it never fully recovered from the bad publicity, even though the risk/benefit was obvious to all experts. Last week, J&J dropped its annual guidance on the vaccine, as its prospects dwindled while Omicron burned out.
So what’s next?
Mammen is doubling down on his promise of major new entries. Literally. Instead of 4 significant new OKs every 3 years, well ahead of the typical success goal of one per year, J&J is promising 8 major new approvals every 3 years through 2025.
Carvykti and the other new approval — Rybrevant — top the list of big new drugs, with nipocalimab, an immunology candidate acquired in a $6.5 billion buyout of Momenta that will also likely face a crowded market, and milvexian, a Bristol Myers Squibb-partnered Factor XIa inhibitor, slated for $5 billion each in annual sales.
Promising big payoffs are one thing, delivering is another. And new CEO Joaquin Duato is hedging his bets, with promises of new buyouts ahead that fall into the small, medium and large categories.
In this environment, with a multitude of targets to pick from in a languishing marketplace, it’s a pretty sure bet that this is one goal that J&J can certainly hit.
- Change: +2%
- Sales revenue: $45 billion
- EVP research and early development: Rupert Vessey
- Compensation: $7.8 million
- Ticker: $BMY
- Employees: 32,200
5. Bristol Myers Squibb: Big wins, big setbacks set the stage for a new round of deals
R&D spending 2021: $11.35 billion
R&D spending 2020: $11.14 billion
R&D as a percentage of sales: 25%
The scoop: Welcome to the bigger R&D group at Bristol Myers. The $74 billion Celgene buyout almost doubled their R&D expense line, and that’s continued right through last year and into the future.
CEO Giovanni Caforio has been a high roller at Bristol Myers, and unlike every other chief executive in the wake of a big buyout, he didn’t look to hatchet down research expenses or engage in a wholesale pullback from the deals they acquired. On the contrary, the global player proved just how willing it is to go in with the big money when Bristol Myers paid $650 million in cash to pick up the rights to Eisai’s MORAb-202, an ADC which combines the in-house folate receptor antibody and the chemotherapy eribulin (Halaven) last June.
It’s been a bit quiet on the BD front, but chief dealmaker Elizabeth Mily has been frank about waiting out the frothy biotech market that brewed up during the pandemic. So now is their time, with a host of biotechs flattened by a bear market and a large swathe of small and midcap players in bad need of a deal.
They’ll need to get busy on signing some deals. Two of their blockbusters — Pomalyst and Revlimid — are going up against knockoffs in the next few years, leaving the executive team touting the prospects of CELMoDs iberdomide and CC-92480 for multiple myeloma. Their 2.0 approach, now in mid-stage development, has a tremendous amount of money riding on their success, so you can bet that they’ll want to improve their odds with some more shots on goal.
Looking back, Bristol Myers has wagered big sums on some bad bets. Most notable: The $3.6 billion IL-2/Opdivo alliance with Nektar, a deal that has now been swept away.
Bristol Myers remains a big winner in PD-1 with their longtime blockbuster Opdivo, but for one brief, shining moment, they held the lead over Keytruda — and then they blew it with the wrong development strategy. Now revenue has flattened out as Keytruda keeps surging ahead with its megablockbuster, which has carried their pipeline now for years.
- Change: +62%
- Sales revenue: $36.5 billion
- EVP research and early development: Mene Pangalos and Susan Galbraith (oncology)
- Compensation: N/A
- Ticker: $AZN
- Employees: 83,100
6. AstraZeneca: Oncology momentum and a big buyout tops a big turnaround
R&D spending 2021: $9.73 billion
R&D spending 2020: $6 billion
R&D as a percentage of sales: 26%
The scoop: It wasn’t that many years ago that Pascal Soriot was in the same shoes worn by every new CEO of a pharma giant in bad need of a turnaround. The R&D group took a lot of chances, and they kept getting shot down. Treme seemingly could never break through. And the mortality rate of drugs in development was gruesome.
Until it wasn’t.
The early Lynparza approval positioned AstraZeneca to dominate PARP. Tagrisso came through with flying colors. And the brief appearance of Jose Baselga set up the Enhertu deal, positioning the pharma giant for a major new cancer franchise as it continued to perform admirably in the China market, with high growth rates.
As a result, analysts have been quite willing to overlook the latest disasters, like the roxa CRL, that have come their way. There was some grumbling about the Alexion buyout — buying revenue like that isn’t innovation. But the numbers work — at least until we see whether rival drugs and near-term biosimilars sour the brew — and set up Soriot to deliver on a huge revenue promise he had made to investors as he twisted out of Pfizer’s arms.
What Soriot has now is a reliable money machine, deepening proven franchises and allowing Susan Galbraith and Mene Pangalos a clear shot at advancing some next-gen plays along. And it’s still doing deals like the $200 million upfront that landed eplontersen (IONIS-TTR-LRX) — a late-stage ATTR amyloidosis drug added to the Alexion pipeline.
You can’t argue with success. It would take a hell of a mishap to derail this train anytime soon.
- Change: +6%
- Sales revenue: $51.6 billion
- NIBR chief: Jay Bradner
- Compensation: $6 million
- Development chief: Shreeram Aradhye
- Ex-development chief: John Tsai
- Compensation: $4.25 million
- Ticker: $NVS
- Employees: 108,000
7. Novartis: Scoring on innovation, but falling far too short in the all-important US market
R&D spending 2021: $9.54 billion
R&D spending 2020: $9 billion
R&D as a percentage of sales: 18%
The scoop: Novartis under Vas Narasimhan has made much of its intention to reimagine medicine. But it’s a line that runs a little thin after a short time, more company line than deep-seated belief.
Big and somewhat unwieldy, Novartis execs have a habit of referring to the sheer size of the pipeline — 20 potential blockbusters in the pipeline — as proof of its innovative culture. But the recent shakeup, with Narasimhan’s successor as development chief John Tsai pushed out and a move to unify strategy and BD under one roof evidence to Tim Anderson at Wolfe that “a coherent innovation vision was lacking at Novartis.”
There’s nothing unusual about a reorganization at Novartis, with thousands of layoffs expected in its huge global workforce. Winkling out costs and driving efficiency is a regular campaign event at the pharma giant. The question this time is whether Novartis can really deliver major new drugs.
Novartis is a case study in critical R&D weakness — Big Pharma style. While it scores plenty of successes in terms of FDA OKs, the drugs typically aren’t $5 billion category killers. And it’s relatively low standing in the US market highlights its success at pioneering new meds that don’t bring in a ton of money. That’s something that will occupy Shreeram Aradhye, who’s going back to Novartis to take the development chief post.
There are a couple of Novartis drugs on the market, Cosentyx and Leqvio, that could go on to star status, but that hasn’t been enough to satisfy the doubters among the analysts following Novartis. What they want is a narrower focus on core research fields, with fewer low-margin plays and clear evidence that the company can do important things in drug development — the kind of important things that earn big paydays.
- Change: +8%
- Sales revenue: $56.2 billion
- President: Michael Severino (recently left for Flagship)
- Compensation: $11 million
- Ticker: $ABBV
- Employees: 50,000
8. AbbVie: A blockbuster future takes shape as Humira knockoffs loom
R&D spending 2021: $7.08 billion
R&D spending 2020: $6.56 billion
R&D as a percentage of sales: 12.5%
The scoop: From the moment that AbbVie was born in a major spin-off 9 years ago, the strategy was clear: Hang on to Humira and fend off knockoffs as long as possible while jacking up the price and developing new drugs that could take the bestseller’s place.
Those generics are now poised to take over next year, and AbbVie has largely succeeded at its mission, hurrying along Skyrizi and Rinvoq — which has had more than its share of safety issues dragging it back — to blockbuster sales with added indications while tacking on aesthetics and Botox through the Allergan acquisition and beefing up its pipeline to keep new drugs pumping.
Through it all, they’ve been subjected to repeated exposure to scorn in Washington DC for maintaining a patent wall around Humira — something Wall Street would consider a small price to pay for a franchise that is still growing, largely through price hikes.
The marketing team also has 2 CGRP drugs in play: Ubrelvy for acute migraine and Qulipta for episodic migraine. Restasis, meanwhile, is getting ripped by knockoffs with Imbruvica, Vraylar, and Orilissa under pressure.
Analysts, though, have been ready to roll with the changes, as the executive team delivered on its big promises.
So that’s the back story on what’s worked. What are they betting the future on?
Telisotuzumab vedotin, or Teliso-V, is one of the most closely watched drugs in the pipeline. The ADC targets c-MET, a next-gen play that some analysts believe could get into blockbuster range, beginning with a potential approval next year. This one was stamped with the FDA’s “breakthrough” tag, so success here would be provided plenty of open doors.
Just a little under 2 years ago AbbVie paid Genmab $750 million in cash with billions in milestones on the table, lining up a new alliance that spotlighted the CD20xCD3 bispecific epcoritamab. Just a few days ago, they offered a 63.1% overall response rate in large B cell lymphoma, making them a contender in a field with some heavyweight rivals, comparing favorably to the data we’ve seen so far from Roche’s glofitamab.
That also encouraged notions of a near-term application and another blockbuster earner.
Then there’s the CF triplet, which few analysts are enthusiastic about backing. Vertex is the 800-pound gorilla in cystic fibrosis, with landmark successes in the field. Beating that team won’t be easy.
- Change: +16%
- Sales revenue: $28.3 billion
- R&D chief: Dan Skovronsky
- Compensation: $7.5 million
- Ticker: $LLY
- Employees: 35,000
9. Eli Lilly: Not afraid to gamble on huge markets, never underestimate this giant’s ambitions
R&D spending 2021: $7.03 billion
R&D spending 2020: $6.08 billion
R&D as a percentage of sales: 21%
The scoop: Eli Lilly has been a top biopharma player in terms of market performance. Investors have been happy to see Trulicity dominate its field. And they’ve played hard at drug development, ushering up a slate of late-stage therapies that are being positioned for major markets.
It’s not without major risk, though.
The top drug headed to the FDA is donanemab, billed as the better aducanumab when it comes to clearing amyloid beta from the brains of Alzheimer’s patients. We just don’t know yet, though, whether the drug can actually improve people’s lives to any substantial level. And with Medicare flagging a refusal to cover unproven drugs for the general population on a biomarker, Eli Lilly has a tough path to blaze in an extraordinarily controversial field — and that’s if it gets an approval at a bruised and battered FDA.
The other key drug analysts are watching is tirzepatide, billed as the successor to their diabetes drug Trulicity and the keeper of the keys to the fortune associated with that franchise. And then there’s lebrikizumab, which just showed it could perform well against Dupixent — the awesome drug that Sanofi just tapped as a $14.5 billion superstar.
Generally, any drug as well established as Dupixent would find it easy to brush off new competition. But Eli Lilly has proven time and again that it has the marketing muscle to compete at every level, and they shouldn’t be discounted at this stage of the game.
Not everything has come up roses for the Lilly R&D team, though. An attempt by its oncology group at winning an approval for their PD-1 sintilimab, partnered with Innovent, on China-only data was snubbed by the FDA’s Richard Pazdur — eliminating an early shot at fielding a heavily discounted player against Keytruda and Opdivo and the rest of the high-priced PD-1s. While Lilly also enjoyed brief success in fighting Covid-19, it’s also seen bamlanivimab/etesevimab and bamlanivimab defeated by variants, as Congress debates funding for more.
Lilly, though, doesn’t quit. While its early antibodies were beaten by variants, its followup bebtelovimab is now the only FDA authorized antibody against Omicron BA.2.
When you are constantly focused on a new drug approval schedule, you can suffer some high-profile setbacks along the way. And Lilly has been a proven performer in staying focused.
- Change: +2%
- Sales revenue: $44.7 billion (34.1 billion pounds)
- R&D chief: Hal Barron
- Compensation: $12.5 million
- Ticker: $GSK
- Employees: 90,000+
10. GlaxoSmithKline: An avoidance of late-stage risk has sapped R&D enthusiasm
R&D spending 2021: $6.9 billion (5.28 billion pounds)
R&D spending 2020: $6.7 billion (5.1 billion pounds)
R&D as a percentage of sales: 15%
The scoop: You don’t have to look beyond the R&D budget at GSK to see how cash-constrained they’ve been at the London-based pharma giant. The big bet under CEO Emma Walmsley came on an approved product — the PARP therapy Zejula — that cost $5 billion. And the revenue is divvied up, leaving GSK with only part of a story to tell.
That’s not grounds for much excitement.
And it didn’t change all that much with the recent $1.9 billion acquisition of Sierra and its lead drug, momelotinib. They’re already lined up at the FDA’s 1-yard line with pivotal data, making this more of a commercial story now rather than something for R&D to direct.
True, there have been several major alliances inspired by departing GSK R&D chief Hal Barron, but many have chased rivals with a head start — and face some serious risks in the clinic. GSK aligned with CureVac on mRNA, choosing the biotech player that badly missed its first shot at a Covid vaccine. That’s not a kiss of death by any means, as we’ve seen some progress. But for a vaccine player that largely stayed on the sidelines during the global outbreak — contributing an adjuvant to Sanofi’s struggles doesn’t count for a lot — it’s not encouraging.
For a company that promised to do big new things in oncology, where’s their Enhertu?
True, the Vir alliance briefly delivered a major new Covid antibody, but as we’ve learned, antibodies are notoriously vulnerable to getting sidelined by variants. Sotrovimab just got cut from the Covid pharmacopeia, and new products won’t be easy to find.
Walmsley does have an ace up her sleeve, and now that the pandemic is waning globally it looks like it will get some added play. Shingrix, their big shingles vaccine, is waiting to be the cash cow many believe is only inevitable. And the spinoff of the consumer division later in the year will be helpful in freeing up the company.
That underlying success story has helped revive the multinational’s flagging share price over the past year — now up 20% despite an attack on Walmsley from an activist investor. San Francisco-based Barron will soon be gone from the R&D post, replaced by Tony Wood in London. A few new moves in the UK market, closer to the research hub in Stevenage, will also help restore some hometown glory, which GSK needs.
Wood has a shot now at stirring some excitement. And Barron should be much happier focused on an early, cutting-edge tech like cell rejuvenation. Discovery was always one of his chief enthusiasms. He’s good at it, loves to explain what he’s working on, and has an infectious enthusiasm. The long haul story, though, doesn’t play well in Big Pharma.
In pharmaland it’s the late-stage pipeline that has to excite. And there’s still much to be done on that score.
- Change: +3%
- Sales revenue: 37.8 billion euros
- R&D chief: John Reed
- Compensation: N/A
- Ticker: $SNY
- Employees: 95,442
11. Sanofi: A perennial also-ran in R&D is taking a stab at glory. But it’s not going great
R&D spending 2021: $6.2 billion (5.7 billion euros)
R&D spending 2020: $6 billion (5.53 billion euros)
R&D as a percentage of sales: 15.1%
The scoop: Chris Viehbacher tried to revive Sanofi’s R&D group and got fired after moving to Boston.
Olivier Brandicourt took a stab at it, with no effect.
And now Paul Hudson has the Herculean challenge of rousing this sleepy giant’s R&D ops into a major league player, without a whole lot of time to lose. Which is quite the challenge.
Hudson is taking risks, though. Doing nothing will get you nothing. And Hudson has proven to be an accomplished gambler in R&D, buying up new drugs for the pipeline while trying to stir excitement in what they can get through late-stage development.
The data, though, don’t always cooperate, as we saw with the critical late-stage failure of its oral SERD amcenestrant in March. The only way forward for Sanofi is to win approvals on new drugs that can successfully lay claim to first- or best-in-class status. A bunch of also-rans won’t fly when you’re out to prove you can innovate.
Then there was the earlier Phase III failure for rilzabrutinib, the number 2 BTK drug picked up in the $3.7 billion Principia buyout. Mocked by short-seller Sahm Adrangi, Sanofi bet big on its near-term success, but the pharma giant had to concede defeat in a trial for pemphigus. Sanofi vowed to make this into a pipeline in a product, though, and there’s much more work to be done.
But the bloom is off the rose.
Some other setbacks: The less than persuasive data for the RSV antibody nirsevimab, partnered with AstraZeneca, we saw a few weeks ago. They’re playing in an intensely competitive field here, and while Sanofi is out front, Pfizer may yet bull ahead in RSV.
Then there was the clinical hold on fitusiran, which raised some big questions about safety, which now dominate the conversation as late-stage data roll in. And last summer Sanofi raised doubts about its plans for rare diseases when it killed a program for venglustat after a trial failure — strike two for that drug.
Hudson, of course, inherited some of these setbacks, but it doesn’t help him change the company’s rep.
Throughout, though, Hudson’s trump card is never far away. Whoever concluded that partnering with Regeneron on this category killer saved Sanofi from a world of hurt. Even as the late-stage stumbles multiplied, Hudson could burnish ever-larger projections for Dupixent, though Eli Lilly has recently shown that it might just be able to compete.
It doesn’t take a lot of wins in Phase III to encourage investors, but Sanofi has some more dealmaking ahead if it wants to prove that Hudson can pick a winner.
- Change: +6%
- Sales revenue: $27.3 billion
- CMO: Merdad Parsey
- Compensation: $6.5 million
- Ticker: $GILD
- Employees: 13,600
12. Gilead: Dan O’Day is working on the turnaround, but the data aren’t cooperating
R&D spending 2021: $5.35 billion
R&D spending 2020: $5.04 billion
R&D as a percentage of sales: 19%
The scoop: Gilead has had its ups and downs over the 3 years since Dan O’Day was brought in to position the big biotech for the future. But the stock price is almost exactly where he found it at the start — and that’s not the kind of track record he or investors were looking for.
That’s enough time to see how well Gilead has been able to do on the BD front, with a slate of deals that have either encountered some shocking implosions (Galapagos), setbacks (CD47) or disappointments (Trodelvy). But the Roche veteran isn’t budging from his established path, looking to advance a slate of approved oncology drugs while looking out 8 years to a promised land with some 20 new approvals in the mix.
Gilead, though, has been long on promise and short on performance for years now, snagged repeatedly by clinical holds or outright failure. On the upside, they rolled out Biktarvy and Descovy to solidify their top position in HIV. But to achieve significant top-line growth, they need to score with Trodelvy on the TROPiCS-02 data as well as the upcoming reveal on the Arcus/domvanalimab TIGIT data if they want to gin up some excitement.
Supporters on the sell-side are doing what they can, but the unease is palpable. They’ve been burned before.
The old regime, which built the HIV foundation, scored a huge — though temporary — success with hep C. Turns out that actually offering patients a painless cure could effectively wipe out a drug market, after reaping a fortune.
Some of the money they harvested went to the Kite buyout, and Christi Shaw’s group has been successful in growing the franchise around Yescarta. The problem, similar to a slew of drug innovations, is that it’s not easy translating remarkable clinical success into marketing windfalls.
Over the last few months, we’ve seen a lineup of major league CEOs and R&D chiefs offering up a bright vision of the future for their companies. But you have to have a pretty good track record to win much support these days. And the track record at Gilead is largely downbeat now. They need to get better, or luckier if they want to break out of the holding pattern they are in.
- Change: +14%
- Sales revenue: $26 billion
- R&D chief: David Reese
- Compensation: $7.6 million
- Ticker: $AMGN
- Employees: 24,200
13. Amgen: The CEO is making some bold promises. But do the numbers add up?
R&D spending 2021: $4.8 billion
R&D spending 2020: $4.2 billion
R&D as a percentage of sales: 18%
The scoop: Every year, Amgen comes in near the bottom of the list of the top 15 big spenders in R&D. And every year you can credit Amgen with a couple of late-stage or newly approved drugs competing for blockbuster or breakthrough recognition among the multitude of competitors in that space.
That’s where you’ll find Tezspire (tezepelumab), despite mixed data in asthma, where it was approved in late 2021. And it came through with a very wide label, not restricted by high eosinophils. Lumakras, its high-profile KRAS drug, also won a key approval early on, though later data tended to highlight limitations on its efficacy past non-small cell lung cancer.
CEO Bob Bradway opted to switch out the usual earnings call for 2021 with what was essentially a sales pitch for the next 8 years. After some stagnation this year, he’s promising investors mid-single-digit annual advances on compound annual growth rate.
The pipeline, topped by Tezspire and Lumakras, will lead that growth, with Bradway pushing some very ambitious growth numbers in revenue. Then he added some major promises on biosimilars, where they have been scoring positive late-stage data and project moderating discounts will swell revenue, with Repatha breaking away from the PCSK9 competition with billions in added annual sales. There’s more, but that’s the heart of the argument.
All their projected numbers are way, way ahead of consensus, and there’s some serious competition ahead on KRAS, biosimilars and PCSK9, leading me to think that Bradway is going to look to a few significant deals to actually deliver on these promises. He just doesn’t have the goods, and now’s the time to be a buyer, as biotech valuations languish.
Keep in mind, Bradway came up through the finance side of the business and he knows these numbers better than anyone. There’s no passionate pursuit of scientific theory, just a deadly seriousness about getting to first-in-class or best-in-class status ASAP. Not to be discounted: He’s just days away from his 10th anniversary of being selected as CEO, a serious stretch in the Big Pharma side of the business. He understands the math, and there’s a lot going on that subtracts value now.
Bradway’s track record points to single-drug deals, like the $1.9 billion acquisition of Five Prime, that gave Amgen the anti-FGFR2b antibody bemarituzumab. Bradway paid $400 million to get in on the anti-OX40 antibody KHK4083 for atopic dermatitis, which was another Phase III threshold drug.
Bradway also fully understands the demographics in play. As he’s making promises about CAGR, he knows that key drug markets will gray considerably between now and 2030, offering a steadily growing patient population in their core disease areas. Right now, the odds are against him. But don’t think for a second that he doesn’t understand the game.
- Change: +15%
- Sales revenue: $30.2 billion (forecast)
- R&D chief: Andy Plump
- Compensation: N/A
- Ticker: $TAK
- Employees: 49,578
14. Takeda: Following some big setbacks, R&D execs retool the late-stage pipeline
R&D spending 2021: $4.7 billion (forecast: Takeda’s fiscal year runs through March)
R&D spending 2020: $4.1 billion
R&D as a percentage of sales: 15%
The scoop: The big picture at Takeda has been dominated by Christophe Weber’s task of turning the 241-year-old Japanese company into a global player with a bright future in drug development. That’s why they bought Shire, and that’s why Andy Plump’s research group is based in Boston.
To help achieve that goal, Plump has been positioning Takeda as a cell and gene therapy 2.0 player, laying out a web of investments and buyouts aimed at putting the global player at the forefront of one of the hottest fields in next-gen drug development — although one with plenty of challenges to overcome.
You could see that come together with the GammaDelta buyout last fall, following up on the network they’ve been building in cell therapy. Three months later they scooped up a GammaDelta spinout called Adaptate, deepening its work in I/O. And just a few weeks ago Takeda execs inked an alliance with Evozyne on a lineup of gene therapies for rare diseases — the latest in a series of deals on that front.
Moving up the food chain, Takeda has been working on getting the Novavax Covid-19 vaccine — TAK-019 — through in Japan. On the more traditional side of vaccine development, Takeda has been inching along for years with its dengue vaccine, TAK-003, looking for a regulatory green light in Europe this year. Takeda has an open road on this tropical vaccine niche after Sanofi’s candidate imploded in the Philippines several years ago. Peak sales, though, likely won’t be overly impressive — and with big generic competition looming for Vyvanse (next year) and Entyvio (2026), impressing Wall Street is a major consideration right now.
While Takeda has plenty of shots on goal lined up, the failure of its narcolepsy program for TAK-994 on top of the big pevonedistat setback as well as the Eohilia (budesonide oral suspension, from Shire) CRL, later axed, has raised some serious concerns on whether Takeda can deliver. The -994 setback also put its orexin agonists TAK-861, now being accelerated through proof of concept, and TAK-925 under a bit of a cloud, making any additional potential setbacks particularly serious for the pipeline.
Other top drug hopefuls include its RNAi drug TAK-999, partnered with Arrowhead Pharmaceuticals and provided with the FDA’s breakthrough therapy status, and TAK-007 for hematological malignancies, set for a hoped-for 2023 launch. Takeda investors have learned that wishes don’t always come true at Takeda, making some R&D successes critical right now.
- Change: +12.5%
- Sales revenue: $22.4 billion (20.6 billion euros)
- R&D chief: Michel Pairet
- Compensation: N/A
- Ticker: N/A
- Employees: 52,000
15. Boehringer Ingelheim: A private German pharma bulls its way into the top 15
R&D spending 2021: $4.5 billion
R&D spending 2020: $4 billion
R&D as a percentage of sales: 20%
The scoop: Here’s a new one for the Endpoints R&D 15.
While all the numbers have been headed up for years, the company names generally stay the same. It takes a major M&A deal to move the dial enough on R&D spend to force a changeup. And yet, here we are, with a new player in the top 15, now following Takeda, which has been holding steady in the $4 billion-plus a year range in R&D expenses after acquiring Shire.
As a private company, Boehringer has free rein to report its numbers or not, a rare large player that doesn’t have to conform to the public company reporting rules. But they aren’t in the least bit shy about quoting their R&D budgets now — in fact, they’re quite proud of the big boost in spending over the past few years.
Now the German pharma player is talking up the prospect of 15 new product launches through 2025, with a slate of breakthrough therapy designations to boast about. Boehringer is still backing important new R&D on Jardiance, partnered with Eli Lilly.
At the top of that list you’ll find:
Spesolimab, an IL-36 specific monoclonal antibody for the treatment of generalized pustular psoriasis, a terrible ailment that can leave the entire body covered with sterile pustules. The FDA is hurrying it along, but peak sales may not be so impressive.
The German outfit may eventually deem its R&D spend as excessive. But right now the focus is on justifying the cost with some landmark advances. To play in this league, you have to be ready to swing the big bat.pound pandemic covid-19 congress trump vaccine treatment fda clinical trials antibodies therapy mortality japan europe uk china
New study: COVID-19 may cause or accelerate neurological diseases
Danish researchers published a study suggesting that COVID-19 increases the risk of neurodegenerative diseases such as Alzheimer’s and Parkinson’s…
New study: COVID-19 may cause or accelerate neurological diseases
Danish researchers published a study suggesting that COVID-19 increases the risk of neurodegenerative diseases such as Alzheimer’s and Parkinson’s disease.
They presented the research at the European Academy of Neurology (EAN) Congress in Vienna, and the results were published in Frontiers in Neurology.
Specifically, after analyzing data from health records in Denmark, they found that people who tested positive for COVID-19 were more likely to suffer from Alzheimer’s disease, Parkinson’s disease and ischemic stroke.
“COVID-19 has had a disproportionate impact on people with dementia, their carers and their families,” Sara Imarisio, Ph.D., head of research at Alzheimer’s Research UK, said of the study. “The risk of developing Alzheimer’s disease, the leading cause of dementia, is caused by a complex mix of age, genetics and other environmental factors. This research suggests that having COVID-19 is linked to an increased risk of being diagnosed with Alzheimer’s disease, however, this was no stronger than the link to other respiratory diseases like the flu.”
She noted that diseases such as Alzheimer’s develop in the brain over many years, but COVID-19 has only been present outside China since early 2020. “It may be that people in the very early stages of Alzheimer’s are more susceptible to catching diseases like COVID-19,” Imarisio added.
The study analyzed 919,731 people who tested positive for COVID-19. Of them, 43,375 had a 3.5 times increased risk of being diagnosed with Alzheimer’s disease, 2.6 times higher risk of Parkinson’s disease, 2.7 times higher risk of ischemic stroke and 4.8 times higher risk of intracerebral hemorrhage. It’s possible that neuroinflammation increased the development of neurodegenerative disorders. The patients evaluated were in- and outpatients in Denmark between February 2020 and November 2021. It also included influenza patients from the corresponding pre-pandemic period.
“More than two years after the onset of the COVID-19 pandemic, the precise nature and evolution of the effects of COVID-19 on neurological disorders remained uncharacterized,” Dr. Pardis Zarifkar, M.D., lead author, department of neurology, Rigshospitalet, Copenhagen, Denmark, explained. “Previous studies have established an association with neurological syndromes, but until now it is unknown whether COVID-19 also influences the incidence of specific neurological diseases and whether it differs from other respiratory infections.”
The risk of most neurological diseases was no higher in COVID-19 patients than in people diagnosed with the flu or other respiratory diseases, although COVID-19 patients over 80 had 1.7 times higher risk of ischemic stroke compared to influenza and bacterial pneumonia. The researchers found no increase in other neurodegenerative diseases like multiple sclerosis, myasthenia gravis, Guillain-Barre syndrome and narcolepsy for any of the viral diseases.
Zarifkar added, “We found support for an increased risk of being diagnosed with neurodegenerative and cerebrovascular disorders in COVID-19 positive compared to COVID-negative patients, which must be confirmed or refuted by large registry studies in the near future. Reassuringly, apart from ischemic stroke, most neurological disorders do not appear to be more frequent after COVID-19 than after influenza or community-acquired bacterial pneumonia.”
A 2021 study described a potential link between COVID-19 and the onset of Parkinson’s disease. The study out of the University of Twente in The Netherlands showed in laboratory assays that the SARS-CoV-2 N-protein interacts with alpha-synuclein, a protein in the brain, and increases the speed of the formation of amyloid fibrils, which is a defining feature of Parkinson’s disease. Interestingly, one of the predominant features of both early Parkinson’s disease and COVID-19 infection is the loss of sense of smell.
It has been clear for some time that COVID-19 is more than a respiratory disease, with a broad range of symptoms including “brain fog,” blood clots and strokes, possible gastrointestinal and other issues. In addition to links to neurological diseases, an increase in new-onset diabetes has been tied to COVID-19 infections.
Recent research from Osaka University in Japan suggests the association has to do with the insulin/IGF signaling pathway, a key pathway in energy metabolism regulation and cell survival. COVID-19 infection appears to impair insulin/IGF signaling by increasing IRF1 expression, which disrupts blood sugar metabolism.
In light of these discoveries, researchers will likely dig deeper to discover how and why COVID-19 is associated with a higher risk of other seemingly unrelated diseases.
Source: BioSpacelink pandemic covid-19 congress japan european uk netherlands china
#CannesLions2022: Pharma and health marketers lose spotlight at creativity ad fest, but does it matter?
Pharma advertising has long been considered second-tier when compared to the rest of the advertising industry. And there are some legitimate reasons why….
Pharma advertising has long been considered second-tier when compared to the rest of the advertising industry. And there are some legitimate reasons why. Nike sneakers and Coca-Cola soda ads will likely always be more entertaining or exciting than regulated campaigns for diabetes and heart disease.
Still, the Cannes Lions advertising festival of creativity was pharma and healthcare advertising’s annual chance to shine. For the past eight years, pharma agencies and clients stood side by side with consumer companies and agency hotshots on the biggest advertising award stage in the world at the Palais in Cannes, France.
However, something changed this year. While the awards for pharma and health and wellness were handed out to widespread applause on the first night of the show, for much of the rest of the time, healthcare marketing was relegated to the back of the room and mostly off the main stages.
The pharma and health and wellness category award finalists, for instance, were tucked in the back corner of the basement of the main building. Even people who wanted to see the work complained that they had to search for them. Only three Cannes Lions official sessions this year covered health or pharma advertising topics and were mostly general topics about creativity, diversity or empathy.
There were no pharma and health case study dissections or deep dives into the unique challenges in health and pharma advertising — and, maybe more importantly for the industry, there were no pharma executives on the Cannes stages as they have been in the past. Patricia Corsi was the lone pharma-connected executive; she is the chief marketing officer of Bayer Consumer Health and served as both a speaker and health and wellness jury president.
Patricia Corsi speaks on a judge’s panel (Clara Bui/Endpoints News)
Click on the image to see the full-sized version
Even among this year’s health and wellness award winners, no gold prizes went to pharma companies. Unexpected winners like Heineken and Harley Davidson did, however, take home the gold for their respective vaccination and “Tough Turban” campaigns.
There are two schools of thought about the disappearance of Cannes Lions Health as an official programmed track. On one hand, it signifies the parity of the industry with big consumer brands, but on the other hand, it also meant fewer conversations, less networking opportunities and an overall dimming of the industries’ presences at Cannes Lions.
“I would be lying if I didn’t say that I was disappointed so far,” said Rich Levy, chief creative officer of Klick Health on the first day of the show. “When you’re talking about a multibillion dollar industry in the US, I thought that 31 short list for pharma was remarkably small … I don’t think it’s an accurate view of the work that the industry is doing.”
Pharma and health and wellness entries both were way down this year. Total pharma entries dropped to 298, down from 509 last year with 11 total Lion awards given out. In health and wellness, there were 1,213 entries, down from 1,300 last year. There were Grand Prix awards given in both categories, but this was the first year it was required — in the past, judges could pass over a category for the top award if they thought it didn’t rise to the level of Grand Prix.
For the second year in a row, the Grand Prix in the pharma category went to a non-pharma company. Dell Technologies and Intel snagged the top prize for their voice app for people with motor neuron disease. The entry — created by VMLY&R New York and called “I Will Always Be Me” — helps people with MND bank a digital copy of their voice by reading a story book.
In the health and wellness category, Maxx Flash’s mosquito repellent campaign “The Killer Pack” took the top prize. The repellent is designed to address India’s mosquito problem, with a biodegradable packaging that kills mosquitoes outside while a nontoxic coil fights them inside.
Other health creatives and executives agreed with Levy’s award assessment, but also expressed concern about the limited health content. The health and pharma panels and award deep dives that were presented got solid reviews, but there were scant few in the official program, along with a handful of unofficial ones outside the main venues.
Several health agency networks set up off-site slates of healthcare and pharma programming — WPP Health and IPG Health both offered multiple panels and discussions at their own sites. CMI Media Group hosted a panel at the Pandora Beach pavilion on audio branding, while other agency creatives like Levy and Bernardo Romero, along with Ogilvy Health’s Adam Hessel and both panels of judges for pharma and health and wellness, attended sessions and networked with others in the health community.
Still, there just weren’t as many health and pharma people on the ground as there typically have been in the past as agencies cut back rosters of attendees and didn’t invite as many clients. That’s likely in part due to the Covid-19 pandemic recovery year of Cannes Lions this year as well as budget considerations in general.
Dana Maiman, CEO of IPG Health and a long-time Cannes Lions attendee said, “I’m hoping the changes honestly are just temporary. Because I remember when I first started coming here — I think this may be my 10th one or so — but back then it was consolidated. It was really liberating when it was focused and broken out, even though clearly there’s a lot of crossovers and all of that. But I think there is something very special about celebrating the creativity in our world because we can all agree it is more challenging.”
Hessel, chief creative officer at Ogilvy Health, said one reason for fewer entries was heavier curation down to just a few this year, but added that no matter the numbers, Cannes and other marketing award shows still are important for the industry.
“Just celebrating great work in any category is what the industry really needs and also maybe to pull back a bit — everybody’s looking for that one crown jewel, but there’s so much great work out there that should be celebrated,” he said, adding, “When clients see great work, they want that too, so that’s the bar.”
Corsi, meanwhile, said she wants to see more creativity from pharma marketers. She finds that creatives in the pharma industry are often trained to be more conservative, because if you cross the line, you face regulators — but she would like that to change.
“We really believe that there is a great opportunity for us to raise the bar in this category,” she said. “Work in health and wellness consistently across the years has not been the most inspiring.”
That doesn’t necessarily mean the work should be more complicated. According to Corsi, sometimes the simplest idea is the best. What she wants to see, though, is more outside-the-box thinking.
A handful of execs, including Corsi, noted that the Covid-19 pandemic has served as a wake-up call for pharma companies discovering what their role should be with patients. Pharma advertising is becoming more of a conversation as opposed to a one-off encounter, Corsi said. Even companies like Walgreens — which facilitated the vaccination of more than 30 million Americans — are taking a new approach to advertising.
“The pandemic, there’s no going back. You can’t unhear the bell, right? The bell’s been rung,” said Mel Routhier, chief creative officer of the WPP Walgreens team. “It’s a good thing for us to take stock and say we can have more purpose as a brand.”
One thing that hasn’t changed this year? The level of passion that pharma creatives are bringing to the conference.
“What I’m taking away now, that I guess maybe I didn’t really expect, is how much passion people have in the work that they’re doing,” said first-time attendee Gena Pemberton, Omnicom Health Group’s diversity, equity and inclusion director. “[It’s] really impactful to be able to talk with people in different areas, understand a little bit more about the work they’ve done, and just seeing how excited everybody is to be together again.”
In the end, the questions remain. Does Cannes Lions need a separate pharma and health track? Or vice versa, does pharma and healthcare advertising need that spotlight at Cannes? The debate won’t be easily settled.
Franklin Williams, director of experience design at Area 23 and a pharma judge, said, “It doesn’t really matter who’s doing the work as long as the targets are being hit. So I think that’s what you’re starting to see almost as a trend and a theme. It doesn’t have to be, we did pharma because we’re pharma. We did pharma because we wanted to do good.”
The danger, of course, is that without broader inclusion, specific content and more awards, pharma may lose interest in Cannes.
“It becomes a self-fulfilling prophecy. And what I mean by that is fewer winners every year mean fewer entries the following year. And fewer entries mean fewer winners,” Levy said.recovery pandemic covid-19 gold india france
Long COVID: female sex, older age and existing health problems increase risk – new research
A new study has analysed UK data from long-term health surveys and electronic health records to understand how common long COVID is, and who might be at…
About 2 million people in the UK currently have long COVID, according to the latest data from the Office for National Statistics.
In the UK, long COVID is defined as “signs and symptoms that continue or develop after acute COVID-19”. This definition is further split into people who have symptoms between four to 12 weeks after infection (ongoing symptomatic COVID-19) and for 12 weeks or more (post-COVID syndrome).
Symptoms can include fatigue, breathlessness, difficulty concentrating and many more – but the precise nature of the symptoms is not well understood. There are also gaps in our knowledge when it comes to the frequency of long COVID, and whether there are particular factors that put people at higher risk of developing the condition.
All of this is partly because the symptoms used to define long COVID often vary between studies, and these studies tend to be based on relatively few people. So the results may not apply to the wider population.
In a new study published in the journal Nature Communications, my colleagues and I looked at data from ten UK-based long-term studies, alongside 1.1 million anonymised electronic health records from English general practices. Based on this data, we investigated whether the burden of long COVID (how common it is) differs by demographic and health characteristics, such as age, sex and existing medical conditions.
The studies were established before the pandemic, and have tracked participants over many years. From these surveys, we used data from 6,907 people who self-reported they’d had COVID-19. Comparing this with the data from the electronic health records of people diagnosed with COVID allowed us to examine the frequency of long COVID in those who have seen their GP about it and those who haven’t.
We found that of the people who self-reported having COVID in the studies, the proportion who reported symptoms for longer than 12 weeks ranged between 7.8% and 17%, while 1.2% to 4.8% reported “debilitating” symptoms.
In the electronic health records, we found that only 0.4% of people with a COVID diagnosis were subsequently recorded as having long COVID. This low proportion of diagnoses by GPs may be partly because formal logging of long COVID was only introduced for doctors in November 2020.
The proportion of people who reported symptoms for more than 12 weeks varied by age. There was also a lot of variation depending on which definition each study used to capture long COVID. But overall, we found evidence to suggest an increased risk of long COVID was associated with increasing age up to age 70.
The studies include participants across a range of ages, from an average age of 20 to 63. Using a strict definition of symptoms affecting day-to-day function, we found that the proportion of people with symptoms for 12 or more weeks generally rose with increasing age, ranging from 1.2% for 20-year-olds to 4.8% for those aged 63.
We also found that a range of other factors is associated with a heightened risk of developing long COVID. For instance, being female, poorer pre-pandemic mental health and overall health, obesity and having asthma were also identified as risk factors in both the long-term studies and electronic health records.
These findings are broadly consistent with other emerging evidence on long COVID. For example, a recent international review study concluded that women are 22% more likely than men to experience long COVID.
It will be important to understand why these links exist, which is beyond the scope of our research. But identifying who may be at higher risk of long COVID is important, and as we continue to learn more, this could inform public health prevention and treatment strategies.
Ellen Thompson does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.treatment pandemic covid-19 uk
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