News from Sage, Sanofi, Novartis, Novovax

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good morning Today I had the unexpected opportunity to wake up a little too early, not unlike the way Bristol Myers Squibb CEO Chris Boerner had the unexpected opportunity to testify in front of Bernie Sanders earlier in year

The need to know this morning

• After several test failures, Sage Therapeutics is cutting a third of its workforce and reshuffling some of its executives.
• Like their counterparts in Europe, Australian regulators decided to refuse Eisai i biogen‘s Alzheimer’s treatment Leqembi, saying that the benefits do not outweigh the risks. Eisai is attractive.
• Sanofi is paying €300 million (roughly $325 million) to take a 16% stake in Orano Medwho works on radioligand therapies for cancer.
• Novartis is paying $70 million up front to license an experimental cancer treatment from the Chinese biotech Chengdu Baiyu.

A select few physician groups are behind the telehealth GLP-1 boom

Over the past two years, dozens of telehealth companies have begun offering the wildly popular GLP-1 drugs. A new STAT examination has found that just a handful of networks of doctors, nurse practitioners and physician assistants are writing prescriptions for a slew of websites that offer weight-loss drugs, including compounded versions that have been subject to debate

Many telehealth platforms do not disclose the medical groups they work with. But of the 81 in STAT’s analysis who did, the majority, nearly two-thirds, were affiliated with just four medical networks: Beluga Health, MD Integrations, OpenLoop Health and Colchis Medical Group, the network associated with telehealth site Henry meds.

Telehealth companies have been able to hit the ground running in a matter of days using the services of these “white label” medical networks, which have established themselves as an invisible but critical piece of the puzzle that enables the accumulation of digital cash surrounding the GLP-1s. . That online “gold rush,” doctors and digital health experts have warned, could put patients at risk by reducing the delivery of care to the mere sale of a drug.

Read more from STAT’s Katie Palmer.

Former Trump Official: GOP Must Revisit IRA

Joe Grogan, a former Trump White House official, said Republicans must repeal or revise the Medicare drug bargaining authority granted in the Inflation Reduction Act, if Donald Trump is re-elected.

Speaking at the STAT Summit yesterday, Grogan said that as the IRA provisions have gone into effect, premiums have risen, which he predicted could lead to a “death spiral” in Part D of Medicare, the program’s prescription drug benefit.

If Republicans can’t repeal the drug pricing law, they’ll have to find new ways to get around it, Grogan said, suggesting more people switch to Medicare Advantage plans.

Read more from STAT’s Sarah Owermohle.

BMS’s new CEO on the company’s ‘key pivot point’

From my colleague Jason Mast: A year into his job, Bristol Myers Squibb CEO Chris Boerner needs to find cash. Eliquis, the blood thinner, will fall under Medicare price negotiation. Top-selling cancer drugs Opdivo and Yervoy will face biosimilar competition. Like many other big pharmas, you will need to replace that income. “We’re really pivoting the organization,” he said at the STAT Summit yesterday. “To some extent, we’re part of an industry that’s at a tipping point.”

How will the company fill this gap? Part of the answer is to “continue to work with both Republicans and Democrats” as drugmakers push back on drug price negotiations, Boerner said. (Asked if there was a candidate who would be better for the industry, he quickly deflected the question.)

Scientifically, he said, the company is focused on cardiovascular disease, oncology and neuroscience, which it just re-entered with the $14 billion purchase of Karuna Therapeutics and approval of the first novel mechanism for the ‘schizophrenia in decades. (He wore a small “new age” bracelet to mark the advance.)

The company has a new generation drug to replace Eliquis and a new pipeline of radiopharmaceuticals thanks to the purchase of RayzeBio. The company has also been incorporating new AI approaches, though Boerner said the work is still early. “I think there’s an opportunity to drive incremental innovation,” he said of machine learning, for example, finding a new patient population for a drug. “I think what we all hope for is when you can discover something fundamentally new.”

Lilly CSO: Beware of candidates who would weaken patents

For Eli Lilly’s chief scientific officer, Dan Skovronsky, a key issue in the upcoming election is how the candidates approach the role of patents.

In a First Opinion article, he wrote that there are many “fallacies” surrounding patents, drug discovery and affordability. Many elected leaders today underestimate the role of patents progressive innovation and drug discovery and instead seek policies to weaken patents, he said.

“They believe that drug patents are barriers to patient access and combine them with harmful monopolies that cause high drug prices. However, no company has a monopoly on treating a disease,” he wrote.

Read more

More evidence on GLP-1 and opioid addiction

From my colleague Megan Molteni: Between e.gFor people with alcohol or opioid use disorders, use of GLP-1 drugs was linked to a lower risk of opioid overdose or alcohol poisoning, according to a new study by Loyola University researchers.

They found that prescriptions for drugs such as Ozempic, Wegovy, Mounjaro and Trulicity were associated with 40% lower hospitalization rates for heroin overdoses and 50% lower rates of alcohol poisoning, based on eight years of de-identified electronic record observation data from over 1.5 million Americans. The findings add to a limited but growing body of evidence that GLP-1 drugs have potential in the addiction space.

Last month, a smaller observational study led by the National Institute on Drug Abuse found that semaglutide, the active ingredient in Wegovy and Ozempic, was associated with lower overdose rates among patients with type 2 diabetes and with opioid use disorders. And earlier this year, data from a small clinical trial showed that GLP-1 drugs can also reduce opioid cravings, apparently through the same mechanism by which they reduce people’s appetite, by targeting se to the circuits in the brain that drive desire.

The latest findings put more pressure on drug companies to launch large-scale studies of GLP-1 to treat addiction, something they have so far resisted.

Novovax faces another vaccine setback

From my colleague Helen Branswell: Nothing seems to be easy for Novavax, whose Covid-19 vaccine is still being used under an emergency use authorization, long after Covid shots made by competitors Pfizer and Moderna were granted full licensing .

Yesterday, the company announced that the FDA had suspended an investigational new drug application for Novavax’s stand-alone flu vaccine and a combination flu and Covid vaccine in development, prompting a drop in its shares almost 20%. The reason: Someone in the phase 2 trial of the combination vaccine developed motor neuropathy, an autoimmune disease that affects the body’s motor nerves, causing weakness and lack of control.

Although associations between some vaccines and a similar disease, Guillain-Barré syndrome, have occasionally been noted, it is not clear here that receipt of the vaccine triggered the disease. The individual, who resided outside the US, was vaccinated in January 2023 and developed motor neuropathy in September 2024.

“While we do not believe causation has been established for this serious adverse event, we are committed to working quickly to address the FDA’s requests for more information,” said Novavax Chief Medical Officer Robert Walker. which added that the company hopes that retention will be possible. must be cleared in order to initiate a phase 3 trial.

More readings

• For this cancer-focused digital health startup, an FDA rejection spelled the end of the road, STAT
• Wave hails first for human RNA editing with GSK collaborative perspective, sending shares skyward Fierce Biotech
• Britain to study use of Lilly’s weight-loss drug to get people back to work Reuters