Extending patent protection doesn’t just stretch a drug’s profits — in some cases, doing so can lead to its most significant revenue period, according to a recent analysis published by the Initiative for Medicines, Access & Knowledge, or I-MAK, a nonprofit advocating for drug pricing reforms.

The organization looked at four blockbuster drugs — Humira, Avastin, Rituxan, and Lantus — that had biosimilars launched between 2019 and 2023. On average, each of the drugs in the analysis earned three times the revenue during the patent extension period as they did during the original patent protection period, which gave them an average 13.2 years of unchallenged market presence.

Overall, the drugs made 56% of their overall revenue in the years after the end of the initial patent. In the first 20 years, they made $126 billion of the total $284 billion they earned up until competitors entered the market.

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This was supposed to be the year the biotech industry recovered from its ongoing slump, but that simply hasn’t happened, STAT tells us. The industry remains locked in a slowdown that began in late 2021, with investors saying that despite the profit prospects of weight-loss drugs made by Big Pharma, they’ve soured on the sector at large. That could change if the Federal Reserve lowers interest rates and if more biotechs successfully go public in 2024, according to cautiously optimistic observers.

Japan’s health ministry has approved Leqembi, an Alzheimer’s drug developed by Eisai and Biogen, Reuters explains. Eisai, a Japanese pharma firm, spearheaded work on the drug, which clinical trials found modestly slowed the progression of Alzheimer’s. Eisai must now win reimbursement approval from the country’s national health system, after which the company has said it will begin marketing the drug in Japan within two months.

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In any event, there is work to be done, so as always, we have assembled a few items of interest for you. After all, the world keeps spinning no matter what the thermometer says. Hope you have a successful day and conquer the world. And of course, do keep in touch. Postcards and telegrams are still accepted. …

Novartis is losing its chief commercial officer and president of its innovative medicines group as Marie-France Tschudin is leaving to take up another position elsewhere, Pharmaphorum writes. Tschudin, who has been seen as a rising star in her almost seven years at Novartis, was named chief commercial officer last year as part of chief executive officer Vas Narasimhan’s effort to streamline the company. She also headed the innovative medicines businesses outside the U.S. Patrick Horber, currently head of immunology at AbbVie, will take over later this year, reporting directly to Narasimhan.

The recently approved RSV vaccines have been celebrated as key public health tools, but some vaccine experts have lamented one aspect of the clinical trials that led to their approval — namely, that older adults were largely left out of them, STAT tells us. Among adults, RSV poses the biggest threat to the oldest seniors and people with certain preexisting health conditions. But the trials for the vaccines, which have been approved for adults 60 and older, included few participants 80 and older. People who are immunocompromised and those who live in nursing homes were also not included.

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My first exposure to pharmaceutical shortages happened in 2017 as a new-to-practice nurse working on an inpatient oncology unit. A hurricane in Puerto Rico had left the U.S. short of sodium chloride minibags. Health care providers nationwide were tasked to modify standard medication preparation and administration practices, such as changing medications from IV to oral delivery, avoiding prepping IV lines with saline, or providing IV drugs by push rather than infusion. I was working in a heavily resourced academic institution. It felt absurd that I couldn’t even appropriately administer medications, but I figured this was an emergency.

Eventually, the shortage ended. But it was not an isolated incident.

The recent spotlight on shortages of essential medicines, such as cancer therapies and ADHD drugs, has brought attention to a longstanding public health crisis. Prescription drug shortages across drug classes have been on the radar of our governing bodies for decades. Nearly 10 years ago, up to 83% of oncologists surveyed could not prescribe a preferred chemotherapy agent due to shortages. Yet, the problem persists, with new shortages being identified at alarming rates. Recent reports indicate drug shortages grew by 30% in the past year. At the end of 2022, there were national shortages of 295 medications, including essentials like anesthetics, chemotherapies, and antibiotics.

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Our choice today is salted caramel mocha, a touch of the Jersey Shore. Please feel free to join us. Meanwhile, we have assembled a few items of interest for you to peruse as you being your journey. We hope all goes well and that you conquer the world. And of course, do keep in touch. …

The three companies that recently left the Pharmaceutical Research & Manufacturers of America, the industry trade group, all spent less on lobbying following their departures, STAT reports, citing newly released federal disclosures. AbbVie, Teva Pharmaceutical, and AstraZeneca left over a span of five months following the passage of the drug-pricing reform law pushed by Democrats last year. How large members navigate their exits could be instructive to other firms making decisions about their continued membership in the future. Much of PhRMA’s revenue comes from company dues, so exits hurt its bottom line.

Drug companies are systematically funding grassroots patient groups that lobby the U.K. cost-effectiveness watchdog to approve the rollout of their drugs, The Guardian reveals. Of 173 drug appraisals conducted by the National Institute for Health and Care Excellence since April 2021, 138 involved patient groups with a financial link to the maker of the drug being assessed, or have since received funding. Financial interests were often not clearly disclosed in NICE documents. Many of the groups that received payments later made impassioned pleas to NICE for treatments to be approved. Others made submissions appealing NICE decisions when drugs were refused for being too expensive.

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PhRMA, the brand-drug industry trade group, lost three members over a span of five months following the passage of Democrats’ drug pricing reform law last year. How large members navigate their exits could be instructive to other firms making decisions about their continued membership in the future. Much of PhRMA’s revenue comes from company dues, so exits hurt the group’s bottom line.

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The reasons can vary, from quality control failures at manufacturing plants to surging demand, including significant interest that has at times squelched availability of drugs taken for weight loss.

But the problem is not easily fixed. Most active pharmaceutical ingredients are made in China, and boosting production in the U.S. is not like flipping a switch. Many of the drugs in short supply are generics made in India, where regulators often find serious production lapses. So what to do? Along with a colleague, Marta Wosińska, a senior fellow in economic studies at The Brookings Institution, has three ideas to alleviate shortages of generic sterile injectable medicines, in particular. They suggest the U.S. government should provide incentives to upgrade facilities and create a buffer inventory. But they also argue hospital purchasing is in need of an overhaul. We discussed the possibilities; our conversation has been lightly edited. 

I’ve been writing about drug shortages on and off for many years, but the problem never goes away. And now, it seems even worse. Obviously, something has to change. But what exactly has been lacking with our policies to date?

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Speaking of which, we have gathered the latest bushel for your perusal if you scroll down a wee bit. Of course, all of this means that it is time to get cracking. So here we go. We hope you have a smashing day and conquer the world. And as always, please do stay in touch …

Eisai announced that Ivan Cheung, who ran its global Alzheimer’s drug program, will retire at the end of the month and be replaced by the son of Eisai chief executive officer Haruo Naito, STAT writes. The move comes after Cheung led the push for U.S. approval of the breakthrough medicine Leqembi. Keisuke Naito, 34, a senior vice president and chief strategy and planning officer, will become acting global Alzheimer’s officer. Cheung’s resignation comes less than a week after Eisai and Biogen were granted full approval for Leqembi in the U.S. The drug is the first medicine shown to slow progression of the disease, which afflicts some 6 million Americans.

Express Scripts will add three biosimilar versions of AbbVie’s blockbuster arthritis treatment Humira to its list of preferred drugs, Reuters notes. The biosimilars include branded and unbranded versions from Sandoz, the generic unit of Novartis, as well as one from Boehringer Ingelheim. Express Scripts, the pharmacy benefits manager owned by Cigna, said the biosimilars would be included as preferred brands on its formulary. The drugs, launched this month, add to competition for Humira in the U.S. that started in January with the launch of a biosimilar by Amgen that is already on Express Scripts formulary.

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By the time he pulled out of the Merrimack College campus, the urge would become a tractor beam, reeling him into the small shop just shy of Route 125 for a slice or three.

It would go on like that for weeks. Intrusive phantom wafts of bubbling hot cheese seeping into his psychic space. An unwelcome rush of saliva. A pizza-shaped itch begging to be scratched. Then suddenly they would be gone. Replaced by a new fixation: coconut jelly sticks from Heav’nly Donuts one month, Dunkin’s Beyond Sausage sandwich the next.

Fernandez knew it was these roving food obsessions that were losing him his latest weight loss battle. The 53-year-old chemistry professor had been hovering between 275 and 295 pounds for most of his adult life. At 5’10”, that made him obese by most body mass index calculations. Then during the first year of the Covid-19 pandemic, while much of the rest of the country struggled with the “quarantine 15,” Fernandez shed 20 pounds while hunkering at his Massachusetts home. When he lost easy access to fast food, the weight followed.

But as stores and restaurants began to open up again, the numbers on his scale crept steadily higher. So did the number of fatty acids and excess sugar in his blood. Around Thanksgiving 2021, Fernandez’s doctor approached him about trying something different: a new weight loss drug called Wegovy.

Originally developed for people with type 2 diabetes like Fernandez’s parents, Wegovy — the brand name for one of an expanding class of injectable medicines known as GLP-1 receptor agonists — was helping people lose up to 15% of their body weight. The needles initially made him hesitate. But by late February last year, Fernandez came around to the idea. The first time he tried Wegovy, he made his wife stand next to him just in case he fainted. But the pen hid the needle from sight and he barely felt it pierce his skin. By the end of that first month, his urges had evaporated.

“From the get-go, I stopped having a lot of those in-between meal cravings,” Fernandez said. “I don’t find that I need those snacks in the middle of the day or late at night. I used to need something after I put the kids to bed. I’d pull out a bag of carrots and a jar of hummus and eat the whole damn thing. I don’t do that anymore.”

Fernandez is among an exploding number of Americans taking these drugs for weight loss — more than 5 million people in the U.S. were prescribed a GLP-1 agonist in 2022, up from about 230,000 in 2019, according to a recent analysis by data insights company Komodo Health. Their rapid adoption is a testament to their striking effectiveness — unmatched by any weight loss drugs in history. But even scientists who’ve spent decades dissecting the actions of the gut hormone these medicines are designed to mimic have been surprised by their potency.

GLP-1 was first identified more than 40 years ago as a chemical messenger produced in the gut that tells the pancreas to crank out more insulin. Scientists learned pretty quickly that it does so by binding to GLP-1 receptors dotting the surface of beta cells in the pancreas. But only in recent years have researchers begun to understand the extent to which the brain also uses GLP-1 as a signaling molecule. It’s through networks of neurons coated with GLP-1 receptors that GLP-1 agonists act to suppress eating — not only, as was long believed, by communicating feelings of fullness, but also by altering circuits in the brain that drive desire.

This wasn’t obvious back when these drugs were beginning to be developed. They weren’t, originally, even designed to get into the brain. But more and more, scientists are learning that’s where they work to cause weight loss. These revelations have the potential to lead to more potent versions of these drugs in the future. They also raise an even more tantalizing question: If hormone hacking can erase food cravings, what other destructive desires might it liberate us from one day?

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Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others. That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going.

And here is our regular feature in which we highlight a different person each week. This time around, we note that Reata Pharmaceuticals hired Rajiv Patni as executive vice president, chief R&D officer. Previously, he worked at Global Blood Therapeutics, where he was chief medical officer.

But all work and no play can make for a dull chief medical officer.

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