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Good morning. It’s been a while since I shared some local news: Chicago has yet again proved itself not only to be the best, but also the rattiest city in the U.S. It beat out Los Angeles and New York as the most rodent-infested city, an honor that we have proudly held for a decade now.
Now let’s get into the biotech news of the day.
The need-to-know this morning
Novo escalates its fight against compounders
Novo Nordisk has asked the FDA to bar compounding pharmacies from making copies of its blockbuster drugs semaglutide, arguing that the medication is too complex for the pharmacies to safely make.
Some patients have turned to compounded products as the branded drugs have been in shortage and remain financially out of their reach. Novo’s request to the FDA is an escalation of its attempt to stem the wave of compounding that’s arisen, after filing lawsuits against compounders and telehealth companies.
The move comes as Eli Lilly is also engaged in a heated fight of its own against compounders that make copies of tirzepatide.
Pfizer needs a prescription; Starboard only has vague advice
My colleague Matthew Herper shares his take: The activist investor Starboard Value released a slide deck yesterday explaining why it bought a large stake in Pfizer, why it thinks the company needs to change, and why it believes there is substantial upside in the stock if the drugmaker listens.
Some of Starboard’s points are inarguably true. Many of the experimental drugs Pfizer touted before the pandemic did not pan out, its acquisitions arguably did not deliver adequate returns, and it has frequently missed quarterly expectations. Worse, the drug giant dramatically overestimated the sales of its Covid vaccine, and planning for a scenario closer to reality would have helped it steer through the decline in vaccine sales.
But unlike most activist investors, Starboard had surprisingly little to say about what Pfizer’s board of directors should do. It stopped short of asking for the resignation of Pfizer CEO Albert Bourla. “The board needs to hold management accountable to achieve the appropriate returns on capital” is the Wall Street equivalent of a doctor telling you to eat healthy — and far less prescriptive than just being handed Lipitor to lower your cholesterol. “Pfizer deserves to be best in class,” the firm writes. But exactly how does Pfizer do that?
Amgen to launch Eylea biosimilar after appeals win
Amgen said it will launch a biosimilar version of Regeneron’s eye drug Eylea, after an appeals court ruled yesterday ruled in the company’s favor.
Eylea is Regeneron’s top-selling drug, with 2023 sales of $5.9 billion. Pavblu and other biosimilars would compete against a low-dose formulation of Eylea that comprises about 80% of the drug’s sales. Regeneron has been trying to switch patients to a higher-dose formulation of the drug that has longer patent protection.
First patient dosed with in-vivo CAR-T therapy
From my colleague Jason Mast: Interius BioTherapeutics said it has dosed the first ever patient with an in-vivo CAR-T treatment, beating out several competitors. The treatment, which is being tested first in Australia, is designed as a more tolerable and more scalable version of the cell therapies that have transformed treatment for several blood cancers over the last decade.
Traditional, so-called ex-vivo, treatments require researchers to remove a patient’s immune cells, strap them in the lab with a cancer-homing GPS, and then re-infuse the treatments. It’s expensive and requires patients to receive high doses of chemotherapy to clear out old cells and make room for the old ones. Patients also have to wait for the treatment to be manufactured.
The hope is that, with in-vivo CAR-T treatments, researchers can transform a patient’s cells into cancer-fighting drones while they remain nestled safely in the patient’s body. Interius uses a heavily neutered and modified HIV virus, delivered via IV infusion. Umoja Biopharma, which also recently received clearance to start a trial, uses a similar technology, as does Kelonia. Some companies are also trying to use lipid nanoparticles, the bubbles of fat used in Covid vaccines and CRISPR treatments.
Although Interius’s preclinical data has generated excitement, experts caution the technology remains a long way from market. Another alternative, more scalable version of CAR-T — called allogeneic or off-the-shelf CAR-T — generated significant hope years ago, before delivering mixed results in clinical trials.
Wojcicki projects confidence amid 23andMe stumbles
From my colleague Mohana Ravindranath: 23andMe CEO Anne Wojcicki continues to maintain a strong outlook despite recent high-profile stumbles — including her attempt, so far unsuccessful, to take the company private and a mass resignation by the company’s board.
Asked by STAT’s Nicholas St. Fleur at the HLTH conference yesterday if she could lead the company past recent hurdles — the stocks’ precipitous tumble, a cyberattack last year compromising data from millions of users, and tumult within the board — Wojcicki projected confidence. “I am here, and I am on stage, and the team that I have is extraordinary,” she said. “I am incredibly optimistic about the future.”
“We are a long-term company. I’m 100 percent dedicated to this industry,” she said later.
The company’s test kits and emphasis on giving patients their own data is in line with the “rising tide of consumer empowerment” seen at conferences like HLTH, she said.
Key health policies to watch after the election
The lame-duck period between Election Day and when newly elected lawmakers take office is an opportune moment to pass legislation. Lawmakers on their way out are free to vote their conscience without worrying about re-election, and they can package several health care policies into large omnibus bills.
My colleague John Wilkerson compiled a list of the key policies to watch in this period and into next year. They include the BIOSECURE Act, under which biotech firms that do business with Chinese “companies of concern,” including WuXi AppTec and WuXi Biologics, could no longer contract with or get grants from the federal government. This bill is popular with both parties, but has lost some momentum recently.
Another issue to watch is whether Congress renews the FDA’s ability to award priority review vouchers for rare pediatric drugs. These vouchers, which grant faster drug reviews, can be sold for on average $100 million, so they help attract investors for rare drug research.
Read more from STAT’s John Wilkerson.
More reads
- Q&A: Mark Cuban explains his beef with traditional PBMs — and why he thinks they’re destined to fail, STAT
- Starboard’s Kenvue complaints are much different than those levied at Pfizer, Endpoints
- More state Medicaid programs consider covering GLP-1 drugs, STAT
- Michelle Tarver to lead FDA medical device center, STAT