Steve Christo – Corbis | Corbis News | Getty Images
Novo Nordisk‘s blockbuster diabetes drug Ozempic may reduce the risk of developing Alzheimer’s disease, suggesting its potential to delay or prevent the memory-robbing condition, according to a study released Thursday.
Semaglutide, the active ingredient in Ozempic, was associated with a 40% to 70% lower risk of a first-time Alzheimer’s diagnosis in patients with Type 2 diabetes compared with seven other diabetes medications. That includes insulin and older so-called GLP-1 drugs similar to Ozempic, the research said.
Alzheimer’s disease is often diagnosed in the mild dementia stage, when a person has significant trouble with memory and thinking. Almost 7 million Americans have the condition, the fifth-leading cause of death for adults over 65, according to the Alzheimer’s Association. But the number of Alzheimer’s patients is projected to rise to almost 13 million in the U.S. by 2050.
There are no cures for Alzheimer’s, only drugs that treat the symptoms of the disease or slow the progression of the condition in people at the early stages of it. But a potential preventive treatment such as semaglutide may prove even more useful, said lead study co-author Dr. Rong Xu, a biomedical informatics professor at Case Western Reserve University.
That’s because by the time many patients are diagnosed with the disease, “it’s often too late for treatment,” Xu told CNBC. She added that many of the risk factors of Alzheimer’s, such as obesity, diabetes and smoking, are preventable and “modifiable.”
The results add to mounting evidence that GLP-1s, a popular class of obesity and diabetes medications, may offer health benefits beyond promoting weight loss and regulating blood sugar. That includes Ozempic, Novo Nordisk’s weight loss injection Wegovy, and drugs from Eli Lilly that work slightly differently.
Novo Nordisk and rival Eli Lilly have been studying their drugs as potential treatments for chronic conditions such as sleep apnea and fatty liver disease. Novo Nordisk, which did not fund the new Case Western study, is also examining semaglutide in a late-stage study on Alzheimer’s patients.
The new Case Western study released Thursday builds on other research released in July on a once-daily drug for diabetes and obesity called liraglutide, which Novo Nordisk sells under the brand names Saxenda and Victoza. In the liraglutide research, data from a midstage trial found that the drug may slow the progression of Alzheimer’s disease by protecting patients’ brains.
In the study released Thursday, researchers from Case Western analyzed three years of electronic records of nearly 1 million U.S. patients with diabetes who did not have a prior Alzheimer’s diagnosis. The study was partly funded by the National Institutes of Health.
The study compared semaglutide with seven different diabetes medications, including insulin and a drug called metformin. It also includes other GLP-1s, such as liraglutide and a medication from Eli Lilly called dulaglutide.
Semaglutide was associated with a roughly 70% lower risk of first-time Alzheimer’s diagnosis compared with insulin, a nearly 60% lower risk compared with metformin and a 40% lower risk compared with other GLP-1s, according to the study. Semaglutide was also associated with significantly lower prescriptions for Alzheimer’s disease-related medications, the study said.
Similar reductions in risks were seen across patients in the trial, regardless of their gender, age group and whether they had obesity.
But the study has limitations since it relies on data from electronic health records. Xu called for more research, specifically clinical trials that randomly assign patients to receive semaglutide or other treatments, to confirm how much Ozempic and other GLP-1s can help prevent or delay Alzheimer’s disease.
Xu and the team of researchers also plan to study whether GLP-1s can prevent Alzheimer’s in patients with obesity, but they want to wait one or two years for GLP-1s approved for weight loss to be on the market longer so there is more patient data for them to analyze. Wegovy won approval in the U.S. in 2021, while Eli Lilly’s weight loss injection Zepbound only entered the market last fall.
Boxes of Ozempic and Wegovy made by Novo Nordisk are seen at a pharmacy in London, Britain March 8, 2024.
Hollie Adams | Reuters
A version of this article first appeared in CNBC’s Healthy Returns newsletter, which brings the latest health-care news straight to your inbox. Subscribe here to receive future editions.
Yet another study shows that blockbuster GLP-1 drugs may offer health benefits beyond diabetes and weight loss.
This time, more research is showing that they may significantly curb addictive behaviors.
Drugs such as Novo Nordisk‘s highly popular diabetes injection Ozempic can cut drug and alcohol abuse by around half, according to a new study published last week in the scientific journal Addiction. That suggests Ozempic and similar medications could potentially become a new treatment for opioid and alcohol use disorder.
“This study not only contributes to the evolving landscape of substance use therapy but also opens avenues for more comprehensive and effective treatment strategies for those affected by” the two disorders, the study authors wrote.
Here’s why that’s important.
More tools are needed to address the ongoing U.S. opioid epidemic, which was declared a public health emergency in 2017. In 2021, an estimated 2.5 million people ages 18 or above in the U.S. had opioid use disorder in the past year, but only 22% received medications to treat it, according to the National Institute on Drug Abuse. Opioids are a factor in around 72% of overdose deaths in the U.S., the National Center for Drug Abuse Statistics says.
Meanwhile, nearly 29 million people ages 12 and above had alcohol use disorder in the past year, according to a 2023 national survey. Excessive alcohol use is the leading preventable cause of death in the U.S., asabout 178,000 people die from it each year, according to the Centers for Disease Control and Prevention.
Let’s dive into the new data.
Researchers from Loyola University Chicago examined the electronic health data of more than 500,000 people with a history of opioid use disorder, 8,000 of whom were taking either GLP-1s or similar treatments called GIPs, such as Eli Lilly‘s weight loss treatment Mounjaro. Mounjaro mimics GLP-1 and another gut hormone called GIP to tamp down appetite and regulate blood sugar, while Ozempic only targets GLP-1.
People taking GLP-1s or GIPs had a 40% lower rate of opioid overdose compared with those who didn’t, the study found. Similarly, an analysis of more than 5,000 people with a history of alcohol use disorder and who took those treatments had a 50% lower rate of intoxication compared with those who didn’t take them.
The results are no surprise. It’s consistent with other studies showing the potential of GLP-1s and GIPs to reduce substance-seeking behaviors such as alcohol and nicotine use. Other research has also shown their promise in treating kidney failure, fatty liver disease, Alzheimer’s disease and obstructive sleep apnea.
Novo Nordisk’s weight loss drug Wegovy also won approval in the U.S. in March for slashing the risk of serious cardiovascular complications in adults with obesity and heart disease.
But more research is likely needed to confirm the findings of the new study. Researchers have called for more clinical trials that randomly assign patients with a substance use disorder to receive a GLP-1 or a placebo, to confirm the potential treatment benefits of drugs like Ozempic, Wegovy and Mounjaro.
We’ll continue to monitor what other research in this area comes out, so stay tuned for our coverage.
Latest in health-care tech: Tech companies talk future of AI in health care
This is Ashley, reporting live from Las Vegas.
I’ve spent the last few days on the exhibition floor at the health-care technology conference called HLTH. Companies like Microsoft, Nvidia, Amazon, Google and more than 12,000 other industry leaders convened there this year.
This was my second time attending, and while there’s a certain irony in walking through smoke-filled casinos to get to meetings about the future of health care, it’s a helpful way to gauge what technologies the industry is excited about.
As I predicted in my coverage on Sunday, generative AI dominated my discussions, much like it did last year. However, the focus was less about the promise or potential of the tech, and more about practical, near-term use cases for the technology. If you’re still skeptical about whether health systems are serious about AI, the answer is undoubtedly yes.
Providers want AI tools that will drive real returns for their organization, both from cost-savings and efficiency standpoints. They’re not willing to wait long to start seeing results. Providers are also looking for guidance about how to effectively evaluate and implement the hundreds of solutions that have exploded onto the market. And investors are asking tougher questions about what a viable business model for a health-care AI company actually looks like.
There was a big focus on how AI could help to reduce the mountains of documentation that doctors and nurses are responsible for, which is a major cause of burnout in the industry. This has been a hot topic all year, so it wasn’t a surprise to me. Microsoft, Google, GE HealthCare and Amazon all introduced new tools to address the issue, for instance.
“Primary care has always been plagued by administrative tasks. This is pervasive in health care, but it’s especially acute in primary care,” Dr. Andrew Diamond, chief medical officer at Amazon’s primary care business One Medical, told CNBC. “AI holds tremendous promise to automate or streamline a huge amount of that work.”
But while AI for administrative burnout was certainly popular, other themes also started to emerge. There was lots of talk about AI agents, for example, which can help users answer questions, automate processes and perform specific tasks. Several companies are also working on AI tools that can help identify and streamline relevant clinical trials for patients. Microsoft and GE HealthCare both announced early stage tools in these areas.
AI isn’t going to change the industry overnight, but I was told over and over again that the innovation is happening fast – especially by the standards of health care, which has a reputation for being slow to adopt new tech.
These companies are trying to tackle complex problems, but there was a real sense of optimism on the floor. Providers, large tech incumbents and startups all seem to agree that AI is here to stay, and they clearly intend to use it.
Feel free to send any tips, suggestions, story ideas and data to Ashley at ashley.capoot@nbcuni.com.
A health worker prepares a dose of the Novavax vaccine as the Dutch Health Service Organization starts with the Novavax vaccination program on March 21, 2022 in The Hague, Netherlands.
Patrick Van Katwijk | Getty Images
Novavax on Wednesday said the Food and Drug Administration has put a hold on its application for a combination shot targeting Covid and influenza and a stand-alone flu vaccine, sending the company’s shares down sharply.
The biotech company’s stock fell nearly 20% on Wednesday. The so-called clinical hold is due to a single report of nerve damage in a patient who received the combination shot in a phase two trial that finished in July last year.
A clinical hold is an order issued by the FDA to a manufacturer to delay or suspend a proposed clinical investigation on a drug.
It is unclear if the pause will impact Novavax’s ability to start and release data on phase three trials on those vaccines. Still, it appears to be a setback for the biotech company, which is scrambling to bring new products to market as demand for its Covid vaccine plummets worldwide.
Novavax said it was working with the FDA to resolve the clinical hold on its combination shot and stand-alone flu vaccine. The company said other trials of its Covid and flu shots had not shown any safety concerns related to the type of nerve damage reported in the patient.
Novavax said it does not believe there’s an established connection that the vaccine had caused the nerve damage in the patient, but said it is working to provide more information to the FDA.
More CNBC health coverage
“Our goal is to successfully resolve this matter and to start our Phase 3 trial as soon as possible,” Dr. Robert Walker, Novavax’s chief medical officer, said in a release.
Public health officials see Novavax’s protein-based Covid vaccine as a valuable alternative for people who don’t want to take mRNA shots from Pfizer and Moderna, which use a newer vaccine method to teach cells how to make proteins that trigger an immune response against Covid.
Novavax’s shot, meanwhile, fends off the virus with protein-based technology, a decades-old method used in routine vaccinations against hepatitis B and shingles.
Microsoft on Thursday announced new health-care data and artificial intelligence tools, including a collection of medical imaging models, a health-care agent service and an automated documentation solution for nurses.
The tools aim to help health-care organizations build AI applications quicker and save clinicians time on administrative tasks, a major cause of industry burnout. Nurses spend as much as 41% of their time on documentation, according to a report from the Office of the Surgeon General.
“By integrating AI into health care, our goal is to reduce the strain on medical staff, foster the collective health team collaboration, enhance the overall efficiency of healthcare systems across the country,” Mary Varghese Presti, vice president of portfolio evolution and incubation at Microsoft Health and Life Sciences, said in a prerecorded briefing with reporters.
The new tools are the latest example of Microsoft’s efforts to establish itself as a leader in health-care AI. Last October, the company unveiled a series of health features across its Azure cloud and Fabric analytics platform. It also acquired Nuance Communications, which offers speech-to-text AI solutions for health care and other sectors, in a $16 billion deal in 2021.
Many of the solutions Microsoft announced on Thursday are in the early stages of development or only available in preview. Health-care organizations will test and validate them before the company rolls them out more broadly.Microsoft declined to share what these new tools will cost.
Health-care AI models
Microsoft’s model catalog
Courtesy of Microsoft
Roughly 80% of hospital and health system visits include an imaging exam because doctors often rely on images to help treat patients.
Microsoft is launching a collection of open-source multimodal AI models that can analyze data types beyond just text, such as medical images, clinical records and genomic data. Health-care organizations can use the models to build new applications and tools.
For example, digitizing a single pathology slide can require more than a gigabyte of storage, so many existing AI pathology models have trained on small pieces of slides at a time. Microsoft and Providence Health & Services built a whole-slide model that improves on mutation prediction and cancer subtyping, according to a paper published in the peer-reviewed journal Nature.
Now, health systems can build on it and fine-tune it to meet their needs.
“Getting a whole-slide foundation model for pathology has been a challenge in the past … and now we’re actually able to do it,” Sara Vaezy, chief strategy and digital officer at Providence, told CNBC in an interview. “It was really sort of a game changer.”
The models are available in the model catalog within Azure AI Studio, which serves as Microsoft’s generative AI development hub.
Health-care agent service
Microsoft’s health-care agent service.
Courtesy of Microsoft
Microsoft also announced a new way for health systems to build AI agents.
AI agents vary in complexity, but they can help users answer questions, automate processes and perform specific tasks.
Through Microsoft Copilot Studio, these organizations can create agents equipped with health-care-specific safeguards. When an answer contains a reference to clinical evidence, for instance, the source is shown, and a note indicates if the answer is AI-generated. Fabrications and omissions are also flagged, Microsoft said.
For example, a health-care organization could build an AI agent to help doctors identify relevant clinical trials for a patient. Microsoft said a physician could type the question, “What clinical trials for a male 55-year-old with diabetes and interstitial lung disease?” and receive a list of potential options. It would save the doctor the time and effort of finding each trial.
AI agents that can help patients answer basic questions have been popular among the health systems that have already begun testing the service, Hadas Bitran, general manager of health AI at Microsoft Health and Life Sciences, said in a Q&A with reporters. Agents that can help doctors answer questions about recent guidelines and patients’ history are also common, she added.
Microsoft’s health-care agent service is available in a preview capacity starting Thursday.
Bringing automated documentation to nurses
In August, Microsoft announced that the next phase of its partnership with Epic Systems would be dedicated to building an AI-powered documentation tool for nurses, and the company detailed those plans on Thursday.
Epic is a health-care software vendor that houses the electronic health records of more than 280 million people in the U.S. It has a yearslong relationship with Microsoft.
Microsoft’s Nuance already offers an automated documentation tool for doctors called DAX Copilot, which it unveiled last year. It allows doctors to consensually record their visits with patients, and AI automatically transforms them into clinical notes and summaries.
Ideally, this means doctors don’t have to spend time typing out these notes themselves every time they see a patient.
The technology has exploded in popularity this year. Nuance announced that DAX Copilot was generally available within Epic’s electronic health record in January – a coveted stamp of approval within the health-care industry. Integrating a tool like DAX Copilot directly into doctors’ EHR workflow means they won’t need to switch apps to access it, which helps save time and reduces administrative workload.
But so far, DAX Copilot has only been available to doctors. Microsoft said that’s changing. It’s building a similar tool optimized for nurses.
“The nursing workflow is very different from that of physicians, and any solution developed for nurses needs to integrate with the way they work,” Presti said during the briefing. “Our team has spent hours shadowing nurses during their shifts to see how they carry out their tasks and to discover where the greatest points of friction exist throughout their day.”
Microsoft is working with organizations like Stanford Health Care, Northwestern Medicine and Tampa General Hospital to develop it.
Two scientists’ groundbreaking research on worms has earned them the Nobel Prize in medicine. Victor Ambros and Gary Ruvkun uncovered microRNA, tiny molecules that help control what cells do, which could help develop new medicines.
Be the first to know
Get browser notifications for breaking news, live events, and exclusive reporting.
Blue Origin CEO Dave Limp, left, and founder Jeff Bezos look up at a New Glenn rocket on at the company’s LC-36 facility in Florida.
Blue Origin
Dave Limp had only one question for Jeff Bezos when he interviewed last year to become CEO of Blue Origin, the billionaire’s space venture.
“Jeff, is Blue Origin a hobby or a business?” Limp asked.
After 14 years as a senior Amazon executive, Limp told CNBC he made it clear to Bezos that he wasn’t interested in leading Blue Origin if the nearly 25-year-old venture wasn’t intended to be a serious company.
“I don’t know how to run a hobby,” Limp said, adding that “if it was a hobby, it’s not right for me.”
But he said Bezos was adamant that Blue Origin needed to be a business.
Read more CNBC space news
Limp admitted that it took some convincing from Bezos for him to make the move over to the space sector. “My initial reaction was: It’s not the right role for me because I’m not an aerospace engineer,” he said. But he decided to take the leap of faith.
“Jeff felt that [Blue Origin] needed manufacturing expertise; it needed decisiveness; it need a little bit of energy,” Limp said.
Limp has now been the CEO of Blue Origin for nine months and counting. He took the reins from prior leadership who had widely expanded the company’s workforce and infrastructure but had fallen years behind on several major programs and lost competitions for key government contracts.
CEO Dave Limp, third from the left, with Blue Origin employees at the company’s New Glenn facility in Florida.
Blue Origin
Blue Origin for years has been flying tourists and research to the edge of space on short jaunts, including Bezos himself. And over the past two decades, Bezos has been spending billions of dollars a year to turn Blue Origin into a space sector powerhouse. The company’s projects reach from rockets and spacecraft to space stations and lunar landers.
Yet in the industry table stakes of orbital missions, Blue Origin has not entered the serious rocketry game, as the U.S. launch market remains dominated by SpaceX, followed by United Launch Alliance, Rocket Lab and Firefly Aerospace.
But the company said it’s closer than ever to the long-awaited debut of its New Glenn rocket. Towering about 320 feet tall, the launch vehicle is advertised as lifting as much as 45,000 kilograms (or over 99,000 pounds) to low Earth orbit — double that of SpaceX’s workhorse Falcon 9 rocket.
A New Glenn rocket stands at LC-36 for the firs time for tanking and mechanical system testing on Feb. 21, 2024.
Blue Origin
Like Falcon 9, New Glenn is designed to be partly reusable. Blue Origin aims to return and land the rocket’s booster, its largest and most valuable section, to unlock the kind of cost and time efficiencies that SpaceX claims with its rockets.
Originally the company was aiming for the audacious feat of flying NASA’s ESCAPADE mission to Mars on New Glenn’s debut. But with a dwindling launch window, the agency delayed ESCAPADE to a later launch. In the mission’s place, Blue Origin will fly a demonstration of its spacecraft Blue Ring on the first New Glenn launch.
Culture shift
Company employees stand below a New Glenn rocket during testing in February 2024.
Blue Origin
Headquartered in the Seattle suburb of Kent, Washington, Blue Origin has over 10,000 employees there and in half a dozen other major locations around the country, including in industry strongholds of Texas, Florida and Alabama. Speaking plainly, Limp said Blue Origin has been “in kind of an R&D phase for a long time,” an aspect of the company’s culture he’s trying to change.
“We were very, very good at building shiny factories and very good at building high fidelity prototypes. And some of those prototypes even flew … but that’s not what we want to do to scale to be a world class manufacturer,” Limp said.
“We need to be able to build things a lot,” he added.
But he said he sees genuine excitement for space across Blue’s workforce, calling that passion the foundation of a “missionary culture.” In Limp’s view, Amazon’s customer-centric principles drive the tech giant’s culture — but Amazon doesn’t have “the vehement mission that exists at Blue.”
“People’s eyes light up, almost to a T. They grew up thinking about space, they always wanted to work in the space industry and here they are at Blue working on space,” Limp said.
Now he’s trying to install Amazon’s customer-centric focus as a key part of Blue Origin. While Blue’s customers — the likes of NASA, ULA, and suborbital astronauts — are quite a bit different than the consumers Limp used to focus on, his message to Blue’s employees is to make delivering for its customers the top priority.
“Even if the technology is really nice and fun … the customer has to be front and center,” Limp said.
To further shift Blue’s culture, Limp highlighted a number of key leadership additions: Allen Parker as CFO after past executive finance roles at Zillow and Amazon; Jennifer Pena-Leanos as chief people officer, after running human resources in Limp’s prior Amazon Devices team; Ian Richardson as senior vice president of manufacturing operations after a long stint as SpaceX production director; and Tim Collins as the vice president of global supply chain after previously leading global operations for Flexport and Amazon.
Limp also made a change by moving more of the company’s headcount to the factory floor.
“You can walk into a factory and know when it’s running well and know when it’s not,” he said. “It doesn’t matter how much capex you put in place, what kind of machines you have, if you’re not using them the right way. It’s like having a shiny new car that just sits in the driveway — what fun is that?”
2024 top priorities
A test of a BE-4 engine at Blue Origin’s Launch Site One facility in West Texas, Aug. 2, 2019.
Blue Origin
Limp has two main goals for his first year as CEO: Launch New Glenn and get Blue’s engine production humming.
“We aren’t going anywhere without engines, and we had to figure out how to build engines at rate,” Limp said.
Blue Origin’s BE-4 engine powers both its New Glenn rocket as well as ULA’s Vulcan rocket. The latter requires two engines per launch.
With ULA aiming for four Vulcan launches this year — with two down and two to go — Blue has delivered eight flight-ready BE-4 engines to ULA, as well as seven BE-4 engines for its first New Glenn launch. On the first two Vulcan launches, the BE-4 engines performed as expected.
“We’d like to [be delivering] about an engine a week by the end of the year. I’m not sure we’ll get exactly to a week, but it’ll be sub-10 days … [and] by the end of 2025, we have to be faster than that,” Limp said.
A United Launch Alliance Vulcan Centaur rocket launches from pad 41 at Cape Canaveral Space Force Station at 7:25 a.m. on October 4, 2024 in Cape Canaveral, Florida.
Paul Hennessy | Anadolu | Getty Images
Limp has “a very high level of confidence” that New Glenn will launch before the end of the year. And Blue plans to scale the cadence of New Glenn missions quickly, wanting to perform as many as 10 New Glenn launches next year. Yet it still has a ways to go to rival SpaceX, which is targeting nearly 150 Falcon rocket launches this year.
Perhaps even more optimistically, Blue aims to land New Glenn on its very first launch, cheekily naming the booster “So You’re Telling Me There’s a Chance.” No company has stuck the landing on the first try with an orbital rocket booster, and New Glenn will be aiming for a 200-foot-wide pad on a vessel named Jacklyn in the Atlantic Ocean.
“It’ll be adventurous. It’ll be fun. I’m excited about it … but if we [don’t] stick the landing the first time, that’s OK. We’ve got another booster right behind it. We’ll build more,” Limp said.
The first flight New Glenn rocket booster.
Blue Origin
It seems almost inevitable that New Glenn’s future will involve a crew spacecraft — especially given Blue’s long-standing mission: “We envision millions of people living and working in space for the benefit of Earth.” Currently, only SpaceX’s Dragon spacecraft is certified by NASA to fly astronauts to-and-from orbit after Boeing’sStarliner suffered another setback this summer.
But Limp deferred when asked about development of a New Glenn crew capsule: “Nothing to say about that.”
Blue Origin has gained experience in the lower-risk, suborbital realm of human spaceflight with its New Shepard rocket and capsule. Limp noted that Blue Origin is working to get “New Shepard back to a cadence of regular flights,” flying both crews and research cargo.
It’s done two New Shepard missions this year, and is aiming for a third next week. That mission will also feature a new rocket booster and capsule to add a second vehicle “to better meet growing customer demand,” the company said, having lost a booster during a cargo flight failure in September 2022.
As for Limp, he’s spending his time on “a little bit of a round trip between” Blue Origin’s facilities every 2½ weeks. He goes from its Seattle headquarters, to meeting with customers in Washington, D.C., to seeing engine production and testing in Huntsville, Alabama, and finally checking out New Glenn work at Cape Canaveral, Texas. It’s all part of his interest in leading a proper space company, rather than a billionaire’s hobby.
“Let’s have the financial discipline to build a business that we love, and let’s make decisions quickly, knowing that we’ll make some mistakes. But let’s not make the same mistakes, and let’s cure them quick,” Limp said.
Eli Lilly will spend $4.5 billion to build a center aimed at finding better ways to manufacture its medicines.
The facility, called the Lilly Medicine Foundry, will house development of new manufacturing methods with an eye toward efficiency. It’s a strategy that’s already paying off with Lilly’s obesity and weight loss drugs Mounjaro and Zepbound, and Lilly wants it to propel the rest of its pipeline.
The foundry serves a dual purpose: researching new manufacturing procedures, then putting them into practice with production of drugs for clinical trials. Lilly says the facility will be the first of its kind to combine research and production in a single location.
“The idea is to take molecules from a bench in a lab to scaled for medicines in a pharmacy, and this research and development site will do that work,” Eli Lilly Chief Executive Officer David Ricks said in an interview from the company’s headquarters in Indianapolis.
The center, which is slated to open in late 2027, will be equipped to make small molecules, biologics and genetic medicines. It will be near a $9 billion manufacturing complex Lilly is building in Lebanon, Indiana, to produce pharmaceutical ingredients like tirzepatide, the active ingredient in Mounjaro and Zepbound.
The cranes and steel frames of the active construction site stick out amid the flat farmland, about a 40-minute drive from Lilly’s Indianapolis headquarters.
The investments are part of Lilly’s plan to build upon its success with Mounjaro and Zepbound, which are riding a wave of popularity in so-called GLP-1 drugs with Novo Nordisk’s Ozempic and Wegovy.
Mounjaro and Zepbound are expected to bring in $50 billion alone by 2028 – almost twice the company’s entire full-year revenue in 2022. That gives Lilly more freedom to invest, but it also puts pressure on the company to find and develop more new medicines to keep growing in the years to come.
Lilly is already charting its future beyond tirzepatide. The company also wants to develop more drugs for Alzheimer’s disease and other neurodegenerative conditions like amyotrophic lateral sclerosis, or ALS.
“There are all of these huge opportunities to improve human health that are hiding in plain sight,” said Dr. Dan Skovronsky, Lilly’s chief scientific officer. “In our industry, people usually like to see what’s popular and then follow the leader. So a lot of the other companies are now stopping their different research projects so they can try and figure out how to catch up to us in obesity and Alzheimer’s disease. OK, we’re working on the next thing. Sorry.”
A sign with the company logo sits outside of the headquarters of Eli Lilly in Indianapolis, Indiana, on March 17, 2024.
Scott Olson | Getty Images
Lilly wants to look for “breakthrough ideas” in areas where the company already has a foothold such as oncology and immunology, as well as newer areas like cardiovascular disease, chronic pain and hearing loss, Skovronsky said.
Neuroscience is one area where he and Ricks want to put particular focus. Lilly has a long history in the space between its antidepressant Prozac and its newly approved Alzheimer’s drug Kisunla, but they see more work to do.
“Neuropsych is a huge unmet need,” Ricks said. “Addiction and mental health, but also neurodegenerative conditions, so we’re investing heavily there. And perhaps the gains we’ve made in obesity can help fund the research in new areas.”
That’s not to say Lilly is done with obesity.
More CNBC health coverage
Ricks acknowledged that one drug won’t meet all needs and that Lilly needs to keep moving the science forward. The company has 11 obesity drugs in its pipeline with different mechanisms of action and modes of delivery, he said. That includes two closely watched drugs in Phase 3 trials: an experimental pill called orforglipron and another injectable medicine called retatrutide.
Lilly is investing everywhere it thinks makes sense in obesity, Ricks said, but he recognizes other companies might explore new mechanisms that it’s possible Lilly hasn’t. He wants to see more pills, especially ones that can go after multiple targets. He’s also interested in technologies that mean giving injections less frequently, such as short interfering RNA.
Any new advances could help Lilly become the first trillion-dollar health-care company. The company’s stock has soared nearly 65% over the past year, giving Lilly a market capitalization of about $840 billion.
Ricks downplays the importance of hitting the trillion-dollar mark, saying it would be an outcome, not a goal, for Lilly.
“We want to do valuable things, and if we’re successful, we create value,” Ricks said. “That’s how we’ll get to a bigger number.”
The Food and Drug Administration on Thursday approved Bristol Myers Squibb‘s highly anticipated schizophrenia drug Cobenfy, the first novel type of treatment for the debilitating, chronic mental disorder in more than seven decades.
Schizophrenia affects how a person thinks, feels and behaves, and can cause paranoia, delusions, hallucinations, and changes in emotions, movements and behavior. Those symptoms can disrupt a patient’s everyday life, making it difficult to go to school or work, socialize and complete other daily activities. Most people are diagnosed in their late teens to early 30s.
Bristol Myers Squibb expects the twice-daily pill, which will be sold under the brand name Cobenfy, to be available in late October, executives told CNBC. The drug is a badly needed new optionfor the nearly 3 million adults in the U.S. living with schizophrenia, some medical experts say.
Only 1.6 million of those patients are treated for the condition, and 75% of them stop takingexisting medications in the first 18 months because they struggle to find treatments that are effective or easy for them to tolerate, according to the drugmaker.
Cobenfy could also be a huge long-term sales opportunity for Bristol Myers Squibb, which faces pressure to offset the potential loss of revenue from top-selling treatments that will see their patents expire. The drug comes from the company’s whopping $14 billion acquisition of biotech company Karuna Therapeutics at the end of last year.
In a July research note, Guggenheim analysts said they view Cobenfy as a “longer-term multi-billion dollar opportunity” for the company. But they said the drug will likely have a slow launch, so it may not meaningfully contribute to Bristol Myers Squibb’s top line in 2024 and 2025.
“I think there’s potentially a really transformational moment in how we treat and talk about schizophrenia. And what you have is, unfortunately, an often disadvantaged population that doesn’t get the attention they deserve from a research and health-care perspective,” Andrew Miller, founder and former president of research and development of Karuna Therapeutics and now an advisor to Bristol Myers Squibb, told CNBC.
“I think the most important moment is going to be five or 10 years from now, when we look back and say we’ve actually made a difference,” he continued. “We’ve helped people, we’ve improved outcomes, we’ve provided caregivers and physicians with another tool that they can use.”
Cobenfy will cost $1,850 for a month’s supply or $22,500 annually before insurance and other rebates, Bristol Myers Squibb executives said.
They said that pricing is in line with existing branded oral schizophrenia treatments and that they expect most patients, particularly those enrolled in Medicare and Medicaid plans, to have minimal out-of-pocket costs for the drug. Around 80% of patients living with the condition are covered by government insurance, according to Bristol Myers Squibb.
The company intends to launch a program aimed at helping patients afford Cobenfy, executives added.
It’s still unclear how much that program will increase access for people without insurance.
Cobenfy will have to compete with some existing schizophrenia drugs – called antipsychotic treatments – with lower list prices, particularly generic copycats of branded treatments. For example, patients without insurance can get the generic version of an antipsychotic treatment called Abilify for as little as $16 for 30 once-daily tablets with free coupons from GoodRx.
Existing schizophrenia drugs work by directly blocking the dopamine receptors in the brain to generally improve symptoms in patients.
But they come with a long list of serious potential side effects that can cause patients to stop treatment, including weight gain, excessive fatigue and involuntary, uncontrollable movements. Roughly a third of people with schizophrenia are also resistant to conventional antipsychotic treatments, according to WebMD.
Cobenfy is the first treatment approved from a new class of drugs that do not directly block dopamine to improve symptoms of schizophrenia, Dr. Samit Hirawat, Bristol Myers Squibb’s chief medical officer, told CNBC.
He said one part of Cobenfy is a drug called xanomeline, which activates certain so-called muscarinic receptors in the brain to decrease dopamine activity without causing the side effects associated with antipsychotics. The second part of Cobenfy is called trospium, which reduces the gastrointestinal side effects linked to xanomeline, such as nausea, vomiting, diarrhea and constipation.
“The majority of these patients have already cycled through one or two of these products,” Adam Lenkowsky, Bristol Myers Squibb’s chief commercialization officer, told CNBC. “So the enthusiasm that we’re hearing from physicians is the opportunity to have a patient go onto treatment without seeing the side effects but also getting unprecedented like efficacy.”
More CNBC health coverage
Lenkowsky said the company expects Cobenfy to eventually become the standard treatment for schizophrenia as physicians learn more about the drug and get more comfortable with prescribing it to patients.
But the price could limit use of the drug to patients who have already tried and failed with other existing treatments, said Nina Vadiei, clinical associate professor of pharmacotherapy and translational sciences at the University of Texas at Austin College of Pharmacy.
“If it were up to me, I wouldn’t necessarily say we have to try X number of antipsychotics first. But I know from experience in a hospital setting that that is probably what’s going to have to happen because of cost, mainly,” said Vadiei, a clinical psychiatric pharmacist who sees patients with schizophrenia at San Antonio State Hospital.”
Trial results and upcoming research
The approval was based on data from three clinical trials comparing Cobenfy to a placebo, as well as two longer-term studies that examined how safe and tolerable the drug is for up to one year. Cobenfy met the main goal of the three trials, significantly decreasing symptoms of schizophrenia compared with a placebo, according to Bristol Myers Squibb.
In the studies, Cobenfy mostly led to mild to moderate side effects, which were mainly gastrointestinal and dissipated over time, Miller said.
Bristol Myers Squibb said Thursday’s approval for schizophrenia may only be the beginning for Cobenfy.
For example, the company has ongoing late-stage clinical trials examining Cobenfy’s potential in treating Alzheimer’s disease patients with psychosis. Bristol Myers Squibb said it expects to release data from those studies in 2026.
The company also plans to study Cobenfy’s potential to treat bipolar mania and irritability associated with autism.
“When we think about Cobenfy, we think about it as multiple indications packed in one product … because we are really developing the drug not only for schizophrenia but six other indications,” Hirawat said, referring to other potential uses for the drug.
— CNBC’s Angelica Peebles contributed to this report.
A box of Ozempic made by Novo Nordisk is seen at a pharmacy in London, Britain March 8, 2024.
Hollie Adams | Reuters
Novo Nordisk‘s blockbuster diabetes drug Ozempic may decrease the risk of opioid overdoses in certain patients, demonstrating its potential as an alternative treatment for opioid use disorder, according to a new study released Wednesday.
The active ingredient in Ozempic, semaglutide, was associated with a “significantly lower” opioid overdose risk than other diabetes medications in people diagnosed with both Type 2 diabetes and opioid use disorder, said the paper published in JAMA Network Open.
The results suggest that Ozempic could offer potential as a tool for addressing the ongoing U.S. opioid epidemic, which was declared a public health emergency in 2017. There are currently three effective medications to prevent overdoses from opioid use disorder, but a new alternative is needed because some patients simply don’t use them, said lead study co-author Dr. Rong Xu, a biomedical informatics professor at Case Western Reserve University.
In 2022, only about a quarter of patients with opioid use disorder received recommended medications for it, and many discontinued treatment within six months, according to the Centers for Disease Control and Prevention. The National Center for Drug Abuse Statistics says opioids are a factor in around 72% of overdose deaths in the U.S.
The study results also add to mounting evidence that a highly popular class of diabetes and obesity treatments called GLP-1s may have several health benefits beyond regulating blood sugar and promoting weight loss. Novo Nordisk, its rival Eli Lilly and independent researchers have been racing to study those drugs’ potential in patients with chronic conditions ranging from kidney disease and sleep apnea to addictive behaviors such as nicotine and alcohol use.
In the study released Wednesday, researchers from Case Western Reserve University and the National Institutes of Health analyzed the electronic records of nearly 33,000 patients who were prescribed semaglutide or other diabetes medications between December 2017 and June 2023. The study was not funded by Novo Nordisk.
Around 3,000 people were prescribed semaglutide injections, while the remaining patients received treatments that ranged from insulins to older GLP-1s for diabetes. That includes dulaglutide, the active ingredient in Eli Lilly’s drug Trulicity, and liraglutide, which is the active ingredient in Novo Nordisk’s Victoza.
Researchers monitored how many opioid overdose cases occurred in patients during a one-year period after they stopped treatment with semaglutide or other drugs. For example, there were 42 cases of opioid overdose among a group of patients that received semaglutide, compared with 97 cases among another group that received insulins, according to the study.
That reflects a 58% lower risk of opioid overdose in patients who took semaglutide, Xu said.
But Xu noted the study has limitations since it relies on data from electronic health records.
More CNBC health coverage
More research, specifically clinical trials that randomly assign patients to receive semaglutide or other treatments, is needed to confirm how much Ozempic and other GLP-1s can help those with opioid use disorder, according to the study authors.Those randomized studies can also determine whether those treatments are beneficial to the general opioid use disorder population or only certain patients with the condition.
“The extent to which GLP-1 medications could benefit treatment of opioid use disorders and help prevent overdoses is unclear,” Dr. Nora Volkow, lead study co-author and director of the National Institute on Drug Abuse of the National Institutes of Health, said in a statement to CNBC. “The preliminary findings from this study point to the possibility that GLP-1 medications may have value in helping to prevent opioid overdoses.”
Xu added that the researchers plan to study semaglutide in patients with opioid use disorder and obesity.
Pfizer‘s experimental drug for a common, life-threatening condition that causes cancer patients to lose their appetite and weight showed positive results in a midstage trial, the drugmaker said Saturday.
Patients with the condition, called cancer cachexia, who took Pfizer’s treatment saw improvements in body weight, muscle mass, quality of life and physical function, according to the drugmaker. The results could pave the way for the drug, a monoclonal antibody called ponsegromab, to become the first treatment approved in the U.S. specifically for cancer cachexia.
The condition affects about 9 million people worldwide, and 80% of cancer patients suffering from it are expected to die within one year of diagnosis, according to the company.
Patients with cancer cachexia don’t eat enough food to meet their body’s energy needs, causing significant fat and muscle loss and leaving them weak, fatigued and, in some cases, unable to perform daily activities. Cancer cachexia is currently defined as a loss of 5% or more body weight over the past six months in cancer patients, along with symptoms such as fatigue, according to the National Cancer Institute.
The symptoms of the condition can make cancer treatments less effective and contribute to lower survival rates, Pfizer said.
“We would see ponsegromab fitting into the treatment of cancer patients, really addressing that unmet need in cachexia, and through that, improving their wellness, their ability to care for themselves, and we would also hope their ability to tolerate more treatment,” Charlotte Allerton, Pfizer’s head of discovery and early development, told CNBC in an interview.
Pfizer has not disclosed the estimated revenue opportunity of the drug, which could potentially be approved for different uses.
The company presented the data Saturday at the European Society for Medical Oncology 2024 Congress, a cancer research conference held in Barcelona, Spain. The results were also published in The New England Journal of Medicine.
The phase two trial followed 187 people with non-small cell lung cancer, pancreatic cancer or colorectal cancer and high levels of a key driver of cachexia called growth differentiation factor 15, or GDF-15. It is a protein that binds to a certain receptor in the brain and has an impact on appetite, according to Allerton.
After 12 weeks, patients who took the highest dose of ponsegromab — 400 milligrams — saw a 5.6% increase in weight compared with those who received a placebo. Patients who took a 200-milligram or 100-milligram dose of the drug saw a roughly 3.5% and 2% increase in body weight, respectively, compared with the placebo group.
Allerton said a work group of experts defines a weight gain of greater than 5% as a “clinically meaningful difference in cancer patients with cachexia.” She added that the drug’s effect on other measures of wellness, such as increased appetite and physical activity, is “really what offers us the encouragement.”
Pfizer said it did not observe any significant side effects with the drug. Treatment-related side effects occurred in 8.9% of people taking a placebo and 7.7% of those who took Pfizer’s treatment, the company said.
The company said it is discussing late-stage development plans for the drug with regulators, and aims to start studies in 2025 that can be used to file for approval. Pfizer is also studying ponsegromab in a phase two trial in patients with heart failure, who can also suffer from cachexia.
Pfizer’s drug works by reducing the levels of GDF-15. Pfizer believes this can improve appetite and enable patients to maintain and gain weight.
“For most of us, we have low levels of GDF-15 in our tissues when we’re healthy, but we really do see this up regulation of GDF-15 in more of these chronic conditions, and in this case, cancer,” Allerton said.
