STAT

STAT+: Pharmalittle: We’re reading about Cigna biosimilar plans, a Vertex deal in South Africa, and more

And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is likely to be low key. We plan to manicure the Pharmalot grounds, promenade with the official mascots, and catch up on our napping.

We may also hold a listening party, where the rotation may include this, this, this and this. And what about you? This is a lovely time of year to enjoy the great outdoors. Perhaps you can catch a view of some cherry blossom trees while there is still time. You could stroll city streets to take in the sights. Life is with people, as they say. Or you could hold your breath and spend time catching up on the news of the world. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …

Cigna plans to make copies of AbbVie’s Humira arthritis drug available with no out-of-pocket payment to eligible patients in the U.S. using its Accredo specialty pharmacy beginning in June, Reuters writes. Cigna said it will stock high- and low-concentration versions from Boehringer Ingelheim, Teva Pharmaceutical, and Alvotech, which will be priced at about 85% lower than the $6,922.62 monthly list price of Humira. Deals were made with the manufacturers as well as its distributor Quallent to bring the out-of-pocket cost down to $0. Cigna said the move should save around $3,500 on average per year for some of the 100,000 Accredo patients using either Humira or biosimilar.

The World Health Organization says new evidence shows the extensive overuse of antibiotics during the Covid-19 pandemic worldwide, which may have exacerbated “silent” spread of antimicrobial resistance. While only 8% of hospitalized patients with Covid-19 had bacterial co-infections requiring antibiotics, some 75% of patients have been treated with antibiotics “just in case” they help. Overall, antibiotic use did not improve clinical outcomes for patients with Covid-19. The highest rate of antibiotic use was seen among patients with severe or critical Covid-19, with a global average of 81%. In mild or moderate cases, there was a considerable variation across regions.

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1 year 1 month ago

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STAT

STAT+: Pharmalittle: We’re reading about BIO’s China challenge, Zepbound shortages, and more

Rise and shine, everyone, another busy day is on the way. Sadly, gray skies are hovering over the Pharmalot campus again, but our spirits remain sunny, nonetheless. Why?

We recall a bit of insight from the Morning Mayor, who taught us that “Every new day should be unwrapped like a precious gift.” To celebrate the notion, we are brewing still more cups of stimulation and inviting you to join us. Our choice today is pistachio creme. Remember, a prescription is not required. So no need to mess with rebates. Meanwhile, here are a few items of interest. Hope you have a meaningful and productive day and, of course, do stay in touch. …

A photo shows the WuXi Biologics chief executive officer shaking hands with John Crowley, the incoming head of the Biotechnology Innovation Organization, but three months later, a sister company, WuXi AppTec and BIO, ended their relationship and Crowley openly supported legislation to ban many U.S. biotechs from doing business with the Chinese behemoth, STAT says. The about-face illustrates the difficulty the biotech industry faces in dealing with an issue that, fueled by national security concerns, is moving fast and forcefully. It also tests the ability of Crowley, who lacks a background in politics, to navigate a domestic policy issue that is tangled up in U.S.-China relations.

Cerevel Therapeutics, a neuroscience biotech that AbbVie is acquiring, reported that its Parkinson’s disease drug improved motor symptom control as an add-on therapy in a late-stage trial, STAT writes. When AbbVie announced its $8.7 billion acquisition of Cerevel last year, it emphasized a different drug in the biotech’s pipeline, emraclidine, which is being tested for schizophrenia and has potential in dementia-related psychosis in Alzheimer’s disease and Parkinson’s. While tavapadon doesn’t appear to be the key drug AbbVie focused on its acquisition, the new positive results still represent a win for the pharma company as it completes the deal.

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1 year 1 month ago

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STAT

STAT+: Cerevel drug for Parkinson’s disease improved symptom control in trial

Cerevel Therapeutics, a neuroscience biotech that AbbVie is acquiring, reported that its drug for Parkinson’s disease improved motor symptom control as an add-on therapy in a late-stage trial.

Cerevel Therapeutics, a neuroscience biotech that AbbVie is acquiring, reported that its drug for Parkinson’s disease improved motor symptom control as an add-on therapy in a late-stage trial.

The 27-week study found that patients taking the drug, tavapadon, on top of a common Parkinson’s treatment called levodopa, experienced 1.7 hours of improvement in “on time” without dyskinesia, which is the amount of time patients function well without involuntary movements that can be brought on by levodopa. That compared to 0.6 hours of improvement among patients taking placebo and levodopa.

This difference was statistically significant and clinically meaningful, Cerevel said in a press release Thursday. There was also a statistically significant decrease in “off time,” the amount of time patients experienced symptoms. The full results will be submitted for presentation at future medical meetings.

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1 year 1 month ago

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STAT

STAT+: Pharmalittle: We’re reading about Lilly’s Zepbound for sleep apnea, the FDA budget, and more

Good morning, everyone, and welcome to the middle of the week. Congratulations on making it this far, and remember there are only a few more days until the weekend arrives. So keep plugging away. After all, what are the alternatives? While you ponder the possibilities, we invite you to join us for a delightful cup of stimulation.

Our choice today is maple bourbon. Remember that no prescription is required. Meanwhile, here is the latest menu of tidbits to help you on your way. Have a wonderful day, and please do stay in touch…

Eli Lilly reported positive results for its obesity drug Zepbound in obstructive sleep apnea, giving the medication a new edge in the highly competitive obesity market, STAT tells us. The results also pave the way for Zepbound to potentially become the first approved treatment for obstructive sleep apnea, or OSA, a common disorder characterized by breathing interruptions during sleep. Obesity is a major risk factor of OSA, which is estimated to affect approximately 39 million U.S. adults, though many cases are undiagnosed, according to the National Council on Aging. Getting approval for indications other than weight loss would help Lilly in its attempts to expand insurance coverage.

Sage Therapeutics will stop development of its experimental drug to treat Parkinson’s disease after the treatment failed a mid-stage study, sending the company’s shares tumbling 36% before stock trading opened, Reuters reports. Parkinson’s disease, a progressive movement disorder of the nervous system, affects about 1 million people in the U.S. The failure is the latest hurdle for Sage Therapeutics after the U.S. health regulator last year approved the company’s and partner Biogen’s pill Zurzuvae as a treatment for postpartum depression, but rejected it for clinical depression, which is a much larger market.

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1 year 1 month ago

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STAT

STAT+: Pharmalittle: We’re reading about CVS and Humira biosimilars, Schumer’s broken insulin promise, and more

Top of the morning to you, and a fine one it is. Clear blue skies and cool breezes are currently enveloping the placid Pharmalot campus, where the official mascots are snoozing cozily in their respective corners and the usual din of motor cars is nowhere to be heard. So this calls for a celebratory cup of stimulation. Our choice today is the oh-so tasty hazelnut mocha.

Please feel free to join us. Meanwhile, here are a few items of interest to start you on your journey, which we hope is productive and meaningful. Have a grand day, and do keep in touch. …

The number of new prescriptions written for biosimilar versions of the Humira rheumatoid arthritis treatment, one of the best-selling medicines in the U.S., surged to 36% from just 5% during the first week of April, thanks to the expanding reach that CVS Health has over the prescription drug market, STAT writes. The big jump was attributed to one particular biosimilar called Hyrimoz, which is manufactured by Sandoz, a former unit of Novartis that is a leading supplier of generic and biosimilar medicines. However, Hyrimoz is jointly marketed with Cordavis, a new subsidiary that CVS created last August specifically to sell biosimilar medicines in the U.S.

Shah Capital is seeking a change in leadership at Novavax and wants to appoint two handpicked directors, Pharmaphorum notes. In an open letter, the hedge fund accuses Novavax’s leadership of squandering its “many significant competitive advantages and sizeable market opportunity” due to “self-inflicted problems” under the current team led by chief executive John Jacobs. The bid by Shah Capital – which owns 6.7% of Novavax and is one of its top five shareholders – comes as the company has seen its share price come under massive pressure since the midst of the Covid-19 pandemic, when its shares were trading above $290 and it had a valuation of more than $40 billion.

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1 year 1 month ago

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STAT

STAT+: Thanks to CVS, a biosimilar version of AbbVie’s Humira is grabbing huge market share

The number of new prescriptions written for biosimilar versions of the Humira rheumatoid arthritis treatment, one of the best-selling medicines in the U.S., surged to 36% from just 5% during the first week of April, thanks to the expanding reach that CVS Health has over the prescription drug market.

The big jump was attributed to one particular biosimilar called Hyrimoz, which is manufactured by Sandoz, a former unit of Novartis that is a leading supplier of generic and biosimilar medicines. However, Hyrimoz is jointly marketed with Cordavis, a new subsidiary that CVS created last August specifically to sell any number of biosimilar medicines in the U.S.

This connection is crucial to the sudden jump in Hyrimoz prescriptions. How so? On April 1, CVS Caremark, which is one of the largest pharmacy benefit managers in the U.S., removed Humira from its major national formularies for health plans that cover about 30 million lives. Then, Hyrimoz was added to the formularies, which are the lists of medicines that are covered by health insurance.

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1 year 1 month ago

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STAT

STAT+: Pharmalittle: We’re reading about Boehringer biosimilar frustrations, FTC warnings, and more

And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is still shaping up, but we expect to catch up on our reading, promenade extensively with our official mascots, and hold another listening party with Mrs. Pharmalot.

The rotation will likely include this, this, this, this and this. And what about you? If it is true that spring has sprung — and we are still awaiting definitive evidence — you might want to enjoy the great outdoors and watch the trees and flowers slowly come to life. If huddling inside your castle is preferable, there is always the option of staring at the telly and binge-watching a few things. Or if you prefer old-fashioned contact sports, reach out to someone special. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …

Boehringer Ingelheim will lay off an undisclosed number of sales reps due to poor U.S. sales of its biosimilar version of AbbVie’s blockbuster arthritis treatment Humira, STAT reports. The drugmaker will switch to a hybrid model that mixes in-person and virtual sales by June 30, in large part because pharmacy benefit managers kept Humira on their formularies. That led to less uptake of biosimilar versions of Humira in the U.S., including Boehringer’s Cyltezo. Boehringer launched Cyltezo last July but has only managed to sell 1,487 prescriptions, according to IQVIA data. Almost 2.8 million Humira prescriptions have been written during that time.

An unprecedented crisis looms in India over supplies of injectable poliomyelitis vaccine, or IPV — a crucial tool in efforts to eradicate polio — now that Sanofi has shut its manufacturing plants in the country, The Economic Times reports. Sanofi, which is a leading supplier of the vaccine, ceased production of its IPV vaccine in December 2023, triggering concerns among health experts about an imminent supply disruption that may hobble the country’s most ambitious immunization campaign. IPV is made by only two companies — Sanofi Pasteur and Serum Institute of India, which started its supplies in 2021. Sanofi is believed to cater to over 80% of India’s IPV dose requirements.

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1 year 2 months ago

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STAT

STAT+: Boehringer Ingelheim layoffs are a sign of dysfunctional Humira biosimilar market

WASHINGTON — Boehringer Ingelheim is laying off or relocating its sales staff for its Humira biosimilar Cyltezo in a sign of how difficult it’s been to get drug middlemen to adopt less-expensive versions of the blockbuster, the company confirmed. Some employees may find positions elsewhere in the company, but they are mostly being pulled from the field.

After two decades on the U.S. market, Humira (adalimumab) last year began facing competition from multiple less-expensive biosimilar versions of the blockbuster therapy. Cyltezo is one of the only biosimilars that can be substituted for Humira at the pharmacy counter without a doctor’s permission, so it is in a better competitive position than most others. 

The price of Humira rose 470% in the 20 years following its launch in 2003 to reach upward of $84,000 annually. List prices of Humira biosimilars are as much as 85% lower

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1 year 2 months ago

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STAT

STAT+: Pharmalittle: We’re reading about a European probe into vaccine talks; net drug prices falling, and more

Rise and shine, everyone, another busy day is on the way. We can tell because our inbox is overflowing with correspondence and interesting ideas, a sure sign that we will be fully engaged for hours to come. To cope, yes, we are firing up the trusty coffee kettle and brewing some cups of stimulation. Our choice today is blueberry muffin. And yes, you are invited to join us.

Meanwhile, here is the latest menu of tidbits for you to digest. We hope you have smashing day and conquer the world. And do keep in touch. We enjoy the missives very much. …

Top European prosecutors are investigating allegations of criminal wrongdoing in connection with vaccine negotiations between European Commission President Ursula von der Leyen and the Pfizer chief executive officer, Politico reports. Investigators from the European Public Prosecutor’s Office have in recent months taken over from Belgian prosecutors investigating von der Leyen over “interference in public functions, destruction of SMS, corruption and conflict of interest.” No one has yet been charged in connection with the case. The probe was originally opened by Belgian judicial authorities in early 2023 after a criminal complaint was lodged by a local lobbyist.

The net prices that health plans paid for medicines — after subtracting rebates, discounts, and fees — fell by 2.8% in last year’s fourth quarter, STAT writes, adding this is the largest decline ever measured by SSR Health, a research firm that tracks the pharmaceutical industry and its pricing trends. A key reason for the big drop — which dwarfed the 0.4% decline seen at the same time a year earlier — was pricing pressure on the Humira treatment for rheumatoid arthritis and psoriasis from biosimilar versions of the medicine. The Humira net price fell to roughly $29,800 at the end of last year from $48,000 at the end of 2022, a nearly 38% drop.

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1 year 2 months ago

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STAT

STAT+: As Humira biosimilars take over the market, CVS has created a new ploy: the drug ‘rebate credit’

The biggest enticement that large pharmacy benefit managers offer to the employers that hire them is drug rebates — a steady stream of money sent back to their clients, a tangible symbol of the discounts that PBMs are able to wrangle out of pharmaceutical companies.

PBMs, the middlemen of drug pricing negotiations, also claim portions of those lucrative rebates for themselves. So when new market developments threaten to diminish or wipe away that revenue stream, PBMs find crafty ways to keep as much of those dollars as possible — often at the expense of employers.

One such case occurred last year, when a wave of Humira biosimilars entered the market and drug companies slashed the list prices of their insulin products. CVS Caremark, the PBM owned by CVS Health that oversees the prescription drug benefits of 103 million people, told its employer clients that it anticipated “more lower-cost products (including specialty biosimilars) may become preferred products” on its lists of approved drugs for 2024, according to documents obtained by STAT.

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1 year 2 months ago

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