King Keytru­da: Mer­ck­'s PD-1 star scores #1 po­si­tion and $22B+ pre­dic­tion in an­oth­er top 10 block­buster list for 2025

Pre­dict­ing which of the cur­rent block­busters will as­cend to new heights is any­one’s game, and one that high­lights the cur­rent dy­nam­ics of the in­dus­try. On Fri­day it’s Glob­al­Da­ta’s turn to pick out the ther­a­pies that it be­lieves will come out on top in some in­tense­ly com­pet­i­tive spaces.

Hu­mi­ra may still top the chart for best-sell­ing drugs in the world, but Keytru­da is set to over­take the shrink­ing fran­chise in around five years time — with four oth­er drugs set to get ahead of Ab­b­Vie’s biggest cash cow.

The $22.2 bil­lion es­ti­mate for Keytru­da is among the high­est num­ber put for­ward by an­a­lysts. Eval­u­ate pegged world­wide sales in 2024 at $17 bil­lion, while Mizuho’s Mara Gold­stein’s fore­cast was that it would sur­pass $20 bil­lion by then.

Mer­ck’s R&D en­gine — which has pumped out a se­ries of clin­i­cal wins en­abling new fil­ings — is cru­cial to its growth, ac­cord­ing to Glob­al­Da­ta phar­ma an­a­lyst Ke­shali­ni Sabarat­nam. Just days ago the phar­ma gi­ant cel­e­brat­ed an­oth­er mile­stone in the form of an OK in Chi­na for front­line non-small cell lung can­cer.

“It has re­ceived mar­ket ap­provals for over 20 on­col­o­gy in­di­ca­tions in the US, and is con­tin­u­ing to ex­pand in­to new in­di­ca­tions and mar­kets glob­al­ly,” she said in a state­ment.

What Bris­tol-My­ers Squibb lagged in Op­di­vo 2025 sales, though, it is like­ly mak­ing up in num­bers. The #2, #3 and #4 drugs on the list will be its by then, in­clud­ing the blood thin­ner Eliquis ($18.7 bil­lion), Cel­gene’s mul­ti­ple myelo­ma drug Revlim­id ($12.4 bil­lion), and the PD-1 check­point ($12 bil­lion).

J&J’s Im­bru­vi­ca comes next at $11.9 bil­lion, with an­a­lysts en­cour­aged by the BTK in­hibitor’s use in mul­ti­ple can­cers as well as chron­ic graft-ver­sus-host-dis­ease.

Bik­tarvy’s #6 po­si­tion just af­ter Hu­mi­ra con­tin­ues to un­der­score Gilead’s dom­i­nance in the HIV mar­ket, with $10 bil­lion pen­ciled in.

An­a­lysts al­so ap­pear un­fazed by the threats posed by ri­val CDK4/6 drugs from No­var­tis and Eli Lil­ly against Pfiz­er’s Ibrance, just trail­ing Bik­tarvy. While the drug on­ly gar­nered $2.8 bil­lion in 2018, the pre­dict­ed 2024 sales is as high as $9 bil­lion.

Round­ing out the list are J&J’s Ste­lara and Eli Lil­ly’s Trulic­i­ty, the on­ly rep­re­sen­ta­tives in the crowd­ed pso­ri­a­sis and di­a­betes field, which are filled with oth­er block­buster con­tenders.

A new chap­ter in the de­cen­tral­ized clin­i­cal tri­al ap­proach

Despite the promised decentralized trial revolution, we haven’t yet moved the needle in a significant way, although we are seeing far bolder commitments to this as we continue to experience the pandemic restrictions for some time to come. The vision of grandeur is one thing, but operationalizing and execution are another and recognising that change, particularly mid-flight on studies, is worthy of thorough evaluation and consideration in order to achieve success. Here we will discuss one of the critical building blocks of a Decentralized and Remote Trial strategy: TeleConsent; more than paper under glass, it is a paradigm change and key digital enabler.

Su­per-se­cre­tive an­ti-ag­ing biotech Cal­i­co tees up the first vis­i­ble clin­i­cal tri­al of an ex­per­i­men­tal drug. And it’s for can­cer?

Over the past 7 years, Calico has been so much more than your average, run-of-the-mill secretive biotech players. It’s a riddle, wrapped in a mystery, inside an enigma, to repurpose an old Winston Churchill line dating from the time he confronted the Iron Curtain surrounding Stalin’s thoughts.

Launched by industry legend Art Levinson of Genentech fame, with the infinitely deep pockets of Google for support, one of the few big headlines the anti-aging biotech has sparked focused on a major alliance with AbbVie — a giant outfit that conversely likes to show off its drug prospects whenever it can. Together, they’ve been focused on diseases that limit life span — quite an arc of ailments.

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RBC's Bri­an Abra­hams holds a mock ad­comm on Bio­gen's iffy ad­u­canum­ab da­ta — and most of these ex­perts don't see a path to an ap­proval

As catalysts go, few loom larger than the aducanumab adcomm slated for Nov. 6.

With its big franchise under assault, Biogen is betting the ranch that its mixed late-stage Alzheimer’s data can squeak past the experts and regulators and get onto the market. And the topic — after a decade of Alzheimer’s R&D disasters in what still represents the El Dorado of drug markets — remains in the center ring of discussions around late-stage pipeline prospects.

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Af­ter near­ly a year of de­bate, the Covid-19 vac­cine chal­lenge tri­als are of­fi­cial­ly com­ing

After nearly a year of public advocacy and often rancorous ethical debate, human challenge trials for Covid-19 vaccines are getting off the ground in London.

The UK government’s Covid-19 Vaccine Taskforce and the contract research firm Open Orphan announced today £10 million ($13 million) plan to test experimental Covid-19 vaccines in volunteers whintentionally exposed to the novel coronavirus. The studies, which won’t launch until early 2021, come after 9 months of debate over whether such studies were safe and would actually hasten vaccine development, and they follow a long history of researchers using challenge models to study other respiratory viruses, including flu and the coronaviruses that cause the common cold.

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Derek Chalmers, Cara Ther

Cara lines up a $440M deal for US rights to its late-stage drug for se­vere itch, with $150M cash on the ta­ble

With plans afoot to file an NDA for what could be its first approved drug, Cara Therapeutics is pivoting its focus to commercialization. And Swiss company Vifor Pharma is willing to surrender up to $440 million to market the candidate in the US.

Cara $CARA CEO Derek Chalmers said an NDA submission is coming this quarter for their intravenous drug Korsuva in chronic kidney disease-associated pruritus (CKD-aP), a severe itching condition. The Stamford, CT-based biotech read out positive topline data from a Phase III pivotal study back in April, and announced plans to approach EMA regulators shortly after filing with the FDA.

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Joe Biden (Carolyn Kaster, AP Images)

What about the Ger­man ne­go­ti­a­tion mod­el? Biden steers drug pric­ing de­bate to a show­down

From an ill-fated proposal to ban rebates for pharmacy benefit managers to an executive order demanding a “most-favored-nation price” for Medicare, if nothing else President Donald Trump has introduced Americans to a flurry of ideas to rein in pharma, an industry he once accused of “getting away with murder.” And now we’re getting the first glimpse of what a Joe Biden presidency might mean for prescription drug pricing.

Covid-19 roundup: Pars­ing Bourla, a top an­a­lyst sees im­proved chances for Pfiz­er vac­cine; Fau­ci: No sur­prise that Trump was hit by Covid-19

With a medley of adverse events hobbling the late-stage development of vaccines and drugs, Pfizer CEO Albert Bourla’s latest — extended — timeline for the mRNA approach they’re working on with BioNTech is giving some top analysts added confidence that the pharma giant can come up with the regulatory goods next month.

Parsing Bourla’s language in his comments last week, SVB Leerink’s Geoffrey Porges notes that Bourla’s decision to say they “may” be able to nail down the positive efficacy of their vaccine in a matter of days — a big change from his earlier certainty — may also indicate a delay on that to early November.

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Daniel O'Day, Gilead CEO (Kevin Dietsch/UPI/Bloomberg via Getty Images)

Gilead feels the heat as close al­ly Gala­pa­gos re­ports a big set­back on one of their top ex­per­i­men­tal drugs

The bad news keeps stacking up at Galapagos — which quite likely just lost control of a billion-dollar deal — and by extension their close partners at Gilead.

The biotech $GLPG reported after the bell Thursday that GLPG1972, one of their top development programs, flat failed a mid-stage study for osteoarthritis, flunking the primary and all secondary endpoints.

Testing 3 different doses of their drug, which relies on ADAMTS-5 inhibition, investigators concluded that none of them triggered a statistically significant response — as measured by cartilage thickness.

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IN8bio CEO William Ho (IN8bio)

Bring­ing their ge­net­i­cal­ly mod­i­fied gam­ma delta T cells to Nas­daq, IN8bio files for $86M IPO

The biotech IPO parade continues marching forward as 2020 turns toward the fourth quarter.

IN8bio, a New York-based company focused on genetically modified gamma delta T cell therapies, filed to go public Friday seeking an $86 million raise. The company has two clinical-stage candidates being studied in glioblastoma and leukemia, respectively.

By any stretch of the imagination, 2020 has already been a huge year for biotech, and nowhere does it appear more obvious than the vast amounts of companies hitting the public market.