October 17, 2024

The need-to-know this morning

After a number of trial failures, Sage Therapeutics is cutting a third of its staff and reshuffling some of its executives.
Like their counterparts in Europe, Australian regulators moved to reject Eisai and Biogen's Alzheimer's treatment Leqembi, saying the benefits did not outweigh the risks. Eisai is appealing.
Sanofi is paying 300 million Euros (roughly $325 million) to take a 16% stake in Orano Med, which is working on radioligand therapies for cancer.
Novartis is paying $7o million upfront to license an experimental cancer treatment from the Chinese biotech Chengdu Baiyu.

glp-1s

A select few doctor groups are behind telehealth's GLP-1 boom

Over the last two years, dozens of telehealth companies have started to offer 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 the slew of websites offering the weight loss drugs, including the compounded versions that have been the subject of debate.

Many telehealth platforms do not disclose the medical groups they work with. But of the 81 in STAT's analysis that 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.

MeCnh-medical-networks-prescribing-compounded-glp-1s(2)

Telehealth companies have been able to get off the ground in a matter of days by using the services of these "white label" medical networks, which have established themselves as an invisible but critical piece of the puzzle enabling the digital cash grab surrounding GLP-1s. That online "gold rush," clinicians and digital health experts have warned, could put patients at risk by reducing the provision of care to the mere sale of a drug.

policy

Former Trump official: GOP needs to revisit IRA

Joe Grogan, a former Trump White House official, said that Republicans need to repeal or revisit Medicare's drug negotiation authority granted in the Inflation Reduction Act, should Donald Trump take office again.

Speaking at the STAT Summit yesterday, Grogan said that as the IRA's provisions have gone into effect, they've raised premiums, which he forecasted could cause a "death spiral" in Medicare Part D, the program's prescription drug benefit.

If Republicans can't repeal the drug pricing law, then they need to find new ways around it, Grogan said, suggesting getting more people to shift to Medicare Advantage plans.

pharma

BMS' 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 some cash. Blockbuster blood thinner Eliquis will fall under Medicare price negotiation. Best-selling cancer drugs Opdivo and Yervoy will face biosimilar competition. Like several other large pharmas, it will need to replace that revenue. "We're really pivoting the organization," he said at STAT Summit yesterday. "To a certain extent, we're part of an industry that's at a key pivot point."

How is the company going to fill that void? 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 ducked the question.)

Scientifically, he said, the company's focus is on cardiovascular disease, oncology, and neuroscience, which it just re-entered with the $14 billion buyout of Karuna Therapeutics and the approval of the first new mechanism for schizophrenia in decades. (He wore a small "new era" bracelet to mark the advance.)

The company has a next-generation drug to replace Eliquis and a new pipeline of radiopharmaceuticals thanks to the buyout 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 generate incremental innovation," he said of machine learning, for example by finding a new patient population for a drug. "I think what we're all looking forward to is when you can discover something that's fundamentally new."

pharma

Lilly CSO: Beware candidates who would weaken patents

For Eli Lilly's Chief Scientific Officer Dan Skovronsky, a key issue in the upcoming election is how candidates approach the role of patents.

In a First Opinion piece, he wrote that there are many "fallacies" surrounding patents, drug discovery, and affordability. Many elected leaders today undervalue the role of patents in progressing innovation and drug discovery, and they instead look for policies to weaken patents, he said.

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

GLP-1s

More evidence on GLP-1s and opioid addiction

From my colleague Megan Molteni: Among people with opioid or alcohol use disorder, use of GLP-1 drugs was linked to a lower risk of opioid overdose or alcohol intoxication, according to a new study from researchers at Loyola University.

They found that prescriptions for drugs like Ozempic, Wegovy, Mounjaro, and Trulicity were associated with 40% lower rates of hospitalizations for heroin overdoses and 50% lower rates for alcohol intoxication, based on eight years of observational data from de-identified electronic records of more than 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 both type 2 diabetes and opioid use disorder. And earlier this year, data from a small clinical trial showed that GLP-1 drugs can also reduce opioid cravings, ostensibly via the same mechanism through which they reduce people's appetites — by targeting circuits in the brain that drive desire.

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

infectious disease

Novovax faces another vaccine setback

From my colleague Helen Branswell: Nothing appears to come easy for Novavax, whose Covid-19 vaccine is still being used under an emergency use authorization, long after the Covid shots made by competitors Pfizer and Moderna earned full licensure.

Yesterday, the company announced that the FDA had placed a hold on an investigational new drug application for Novavax's stand-alone influenza vaccine and a combination Covid and flu shot under development, leading its stock to fall nearly 20%. The reason: Someone in the Phase 2 trial of the combined shot developed motor neuropathy, an autoimmune condition that affects the body's motor nerves, leading to weakness and lack of control.

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

"While we do not believe causality has been established for this serious adverse event, we are committed to working expeditiously to fulfill requests for more information from the FDA," said Novavax chief medical officer, Robert Walker, who added the company hopes the hold will be cleared so it can start a Phase 3 trial.

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