In this week’s edition of InnovationRx, we look at Eli Lilly’s weight-loss pill stockpiling, scaling stem cell manufacturing, the growing measles outbreak in Texas, and more. To get it in your inbox, subscribe here.
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Eli Lilly is stockpiling massive quantities of an oral weight-loss drug that’s at least a year from launch, with total “pre-launch inventory” of nearly $550 million at Dec. 31, 2024, according to its 10-K financial statements released last week.
The unusual move represents a massive bet on a new once-daily pill for weight loss called orforglipron, at a time when GLP-1 drugs from Lilly and its competitor Novo Nordisk have taken the market by storm. Lilly’s tirzepatide drugs, Zepbound for obesity and Mounjaro for diabetes, both of which are administered by injection, accounted for $5.4 billion in revenue in the fourth quarter alone.
Orforglipron showed good results in a phase 2 trial published in the New England Journal of Medicine in June 2023. The highest dose of the drug resulted in 14.7% weight loss after 36 weeks for people who were obese or overweight. Lilly has begun stage 3 research, and CEO Dave Ricks said last month that the drug could receive FDA approval as early as next year.
“The level of excitement here is high,” Patrik Jonsson, Lilly’s president of cardiometabolic health, told Forbes in an interview at the J.P. Morgan healthcare conference in January. “This could potentially be game-changing when it comes to reaching more patients across the globe.”
Oral medications, after all, don’t require the cold-chain storage and transportation that injectables do, and they’re less complicated to manufacture. They’re also more appealing to patients, especially those who have needle phobias.
What the easier production and distribution means for the price of orforglipron when it hits the market remains to be seen. On Tuesday, Lilly began selling higher doses of Zepbound in the U.S. at a discount of $150 compared to the injector pen versions, Reuters reported. Then, on Wednesday, it said that it would invest $27 billion in four new U.S. manufacturing plants.
Research firm Coherent Market Insights estimates the global GLP-1 market at $25 billion in 2024 and forecasts that it will surpass $55.7 billion by 2031.
Cellino Inks A Deal To Build A Stem Cell Foundry At Mass General
Cellino CEO Nabiha Saklayen
Cellino
For more than a decade, biotech researchers have been exploring the possibility of regenerating damaged parts of the body as a way to treat degenerative diseases such as Parkinson’s and type 1 diabetes. One of the most promising technologies to do so are induced pluripotent stem cells (iPSCs), which can be programmed to turn into basically any kind of cell.
The catch: making these cells is a labor-intensive process that can cost millions of dollars to produce tissue for just one patient. Biotech startup Cellino, cofounded in 2017 by CEO and Forbes 30 Under 30 alumna Nabhiha Saklayen, is now one step closer to scaling iPSC manufacturing. It’s building its first foundry at Massachusetts General Brigham’s Gene and Cell Therapy Institute. Cellino has raised a total of $100 million in venture funding at a valuation of $140 million as of January 2022, according to Pitchbook.
The foundry will use the automated systems that Cellino has developed (read more about the tech here) to generate iPSCs from patients’ blood or skin cells on-site. The company estimates that use of the foundry, which is set to go online next year, could reduce costs by a factor of ten. More importantly, a scalable, consistent process will make it easier to manufacture new treatments that can go through the clinical trial process and eventually be commercialized, CEO Sakaylen told Forbes.
“With high quality cells, we can start to see what the readout is in patients and know how potent the medicine is,” she said. “That’s hard to tell if the manufacturing isn’t standardized. So that’s what I’m really excited about.”
BIOTECH AND PHARMA
Last December, the FDA approved Mesoblast’s drug Ryoncil, which is the first time a mesenchymal stromal cell (MSC) therapy has received a green light from the agency. MSCs are adult stem cells found in bone marrow that can turn into different types of cells. Ryoncil is used to treat children with severe graft-versus-host disease (GVH) following a stem cell transplant, which is typical for leukemia patients. It’s also the first approved treatment for children with this disease who don’t respond to steroids.
Mesoblast CEO Silviu Itescu told Forbes last week that the company plans to begin commercial sales of the drug this quarter, with the remaining obstacles being setting pricing with payers and shipping product to hospital. “We have inventory for at least the next couple of years for children with acute GVH,” he said. The company is also pursuing clinical trials for adults with GVH as well as for the use of its stem cell products for children with severe Crohn’s disease, he said.
The publicly traded company’s shares are down 21% so far this year, at a recent $16.
DIGITAL HEALTH AND AI
AI biotech startup Genesis Therapeutics entered an agreement with pharmaceutical company Incyte to use Genesis’ AI drug discovery platform, GEMS, to discover small molecule drug candidates against three undisclosed targets. Under the terms of the arrangement, Incyte will pay Genesis $30 million upfront and up to $295 million in milestones and other payments over the course of the collaboration, plus royalties. Incyte, which has a $14 billion market cap, focuses on oncology, immunology and dermatology and other unmet needs. This is the third deal for Genesis since September, following similar collaborations with pharmaceutical company Gilead and AI powerhouse Nvidia.
“We found it was a really natural fit to combine GEMS and its ability to drug challenging targets with some of the needs Incyte had for some of its pipeline programs,” Genesis CEO Evan Feinberg told Forbes, adding that another reason he wanted to work with Incyte is its “track record of pioneering completely new areas of medicine.”
MEDTECH
Medical device maker Medtronic (market cap $116 billion) gained FDA approval for a new self-adjusting deep brain stimulation device for people with Parkinson’s disease, a nervous system disorder that affects movement. The BrainSense Adaptive device works similarly to a cardiac pacemaker, but for the brain, using a surgically implanted neurostimulator to transmit electrical signals to the specific areas of the brain affected by the disease. Medtronic said that the approval was the first for an adaptive deep brain stimulation device for Parkinson’s, and that it would be the largest ever commercial rollout of a brain-computer interface technology. Some 1 million people in the U.S. have been diagnosed with the debilitating neurological disorder.
PUBLIC HEALTH AND HOSPITALS
Measles keeps spreading in West Texas. There are now 124 confirmed cases, most of them in West Texas where the outbreak began. The West Texas outbreak is the largest the state has seen in 30 years, and highlights the difficulties convincing people to get vaccines in the current environment. A first death from the disease was reported on Wednesday morning. A separate, potentially related, measles outbreak in New Mexico has now grown to nine cases. The outbreak has also spurred parents who’d previously chosen not to vaccinate children to change their minds.
Plus: Healthcare hiring unicorn Incredible Health is expanding from nurses to technicians, a workforce that makes up 60% of all healthcare workers and is now facing a shortage. The San Francisco-based startup will also go beyond hospitals to home health organizations and ambulatory care centers. Incredible Health, an alum of the 2021 Forbes Next Billion-Dollar Startups list, has placed more than 1 million nurses in 1,500 hospitals across the country since it launched in 2017. It has been testing hiring of technicians in nine states, including California, New York and Texas, and plans to complete the national rollout by year end.
DEAL OF THE WEEK
Eikon Therapeutics, which is developing a pipeline of drugs to treat cancer, announced it has raised $350 million, bringing its total funding to more than $1.1 billion. The Hayward, Calif.-based company, which was worth $3.7 billion before the latest investment, according to PitchBook, declined to disclose its new valuation. Eikon plans to use the new funds to support the ongoing development of its drug candidates, which target advanced melanoma as well as brain, ovarian, breast, prostate and pancreatic cancer. To facilitate its drug development, the company uses its own advanced fluorescent microscopy technology, which enables it to observe how different substances interact on the cellular level in real time. Eikon CEO Roger Perlmutter was previously head of R&D at Merck.
WHAT WE’RE READING
A newly discovered coronavirus in bats has the potential to spill over into humans using the same pathway as the virus that causes Covid-19.
Billionaire Colossal Biosciences CEO Ben Lamm sees uses for human health in efforts to resurrect the woolly mammoth.
At least three DOGE employees have access to the National Institutes of Health’s systems that control finance, budget and procurement.
How Dr. Oz’s millions collide with Medicare, including as a relentless promoter of controversial private Medicare Advantage insurance plans for older Americans.
FDA rehires staff to its medical devices division after mass layoffs by Elon Musk’s DOGE. Meanwhile, the new administrator in charge of the FDA’s food division appears to have no relevant experience beyond hunting with Donald Trump Jr.
Bird flu wiped out Doug Corwin’s century-old Long Island duck farm, forcing him to cull the entire 100,000 flock.
Two people, one in Wyoming and one in Ohio, have been hospitalized with avian flu.
New research finds that hormone therapy significantly improves the emotional health of young transgender people.
Health clinic workers brush up on constitutional protections for their patients as immigration raids loom.
Trump signed an executive order to reinforce rules for healthcare cost transparency previously enacted by both the Trump and Biden administrations.