Ab­b­Vie gets its FDA OK for JAK in­hibitor upadac­i­tinib, but don’t look for this one to hit ex­ecs’ lofty ex­pec­ta­tions

An­oth­er big drug ap­proval came through on Fri­day af­ter­noon as the FDA OK’d Ab­b­Vie’s upadac­i­tinib — an oral JAK1 in­hibitor that is hit­ting the rheuma­toid arthri­tis mar­ket with a black box warn­ing of se­ri­ous ma­lig­nan­cies, in­fec­tions and throm­bo­sis re­flect­ing fears as­so­ci­at­ed with the class.

It will be sold as Rin­voq — at a whole­sale price of $59,000 a year — and will like­ly soon face com­pe­ti­tion from a drug that Ab­b­Vie once con­trolled, and spurned. Reuters re­ports that a 4-week sup­ply of Hu­mi­ra, by com­par­i­son, is $5,174, adding up to about $67,000 a year.

I asked for the 4-week cost break­down for the new drug, but the spokesper­son for Ab­b­Vie was stick­ing sole­ly with that $59,000 fig­ure.

Ab­b­Vie was wide­ly ex­pect­ed to gain an ap­proval, but there will be grow­ing doubts about the drug’s abil­i­ty to live up to ex­ecs’ high-fly­ing ex­pec­ta­tions of megablock­buster sales in the $6 bil­lion-plus range. Eval­u­ate comes in at a far more mod­est — though still block­buster — es­ti­mate of $2.5 bil­lion in 2024.

This is part of Ab­b­Vie’s plan to de­sign a fu­ture for it­self af­ter Hu­mi­ra los­es patent pro­tec­tion in the US, though the com­pa­ny has won a re­prieve with a num­ber of an­a­lysts af­ter strik­ing a deal to buy Al­ler­gan and the Botox fran­chise.

The black box warn­ings weigh down a whole seg­ment of JAK in­hibitors, led by Pfiz­er’s Xel­janz and Eli Lil­ly’s Olu­mi­ant.

Cred­it Su­isse Evan Seiger­man thinks the OK here with the black box will like­ly sig­nal the same for Gilead’s fil­go­tinib — part­nered with Gala­pa­gos — when it ar­rives at the mar­ket in the near fu­ture.

We think that FDA could give fil­go. a sim­i­lar black box warn­ing if ap­pvd. Fil­go. is like­ly to be com­pet­i­tive; how­ev­er, GILD will need to be ag­gres­sive in mar­ket­ing and con­tract­ing.

Ab­b­Vie gave up fil­go­tinib and the rich li­cens­ing deal it had inked in fa­vor of its pro­gram for upadac­i­tinib.

Roy M. Fleis­chmann TREG

Rheuma­toid arthri­tis is a big and busy field. A Sanofi/Re­gen­eron team won an ap­proval for their IL-6 drug sar­ilum­ab (Kevzara). J&J was per­ma­nent­ly shunt­ed aside af­ter the FDA spurned its ap­pli­ca­tion on sirukum­ab over safe­ty con­cerns.

“De­spite the avail­abil­i­ty of mul­ti­ple treat­ment op­tions with vary­ing mech­a­nisms of ac­tion, many pa­tients still do not achieve clin­i­cal re­mis­sion or low dis­ease ac­tiv­i­ty—the pri­ma­ry treat­ment goals for rheuma­toid arthri­tis,” said Roy M. Fleis­chmann, pri­ma­ry in­ves­ti­ga­tor for SE­LECT-COM­PARE and clin­i­cal pro­fes­sor at the Uni­ver­si­ty of Texas South­west­ern Med­ical Cen­ter at Dal­las.

So­cial im­age: Ab­b­Vie

 

Elias Zerhouni (Photo by Vincent Isore/IP3/Getty Images)

Elias Zer­houni dis­cuss­es ‘am­a­teur hour’ in DC, the de­struc­tion of in­fec­tious dis­ease R&D and how we need to prep for the next time

Elias Zerhouni favors blunt talk, and in a recent discussion with NPR, the ex-Sanofi R&D and ex-NIH chief had some tough points to make regarding the pandemic response.

Rather than interpret them, I thought it would be best to provide snippets straight from the interview.

On the Trump administration response:

It was basically amateur hour. There is no central concept of operations for preparedness, for pandemics, period. This administration doesn’t want to or has no concept of what it takes to protect the American people and the world because it is codependent. You can’t close your borders and say, “OK, we’re going to be safe.” You’re not going to be able to do that in this world. So it’s a lack of vision, basically just a lack of understanding, of what it takes to protect the American people.

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George Yancopoulos (Regeneron)

Re­gen­eron co-founder George Yan­copou­los of­fers a com­bat­ive de­fense of the po­lice at a high school com­mence­ment. It didn’t go well

Typically, the commencement speech at Yorktown Central School District in Westchester — like most high schools — is an opportunity to encourage students to face the future with confidence and hope. Regeneron president and co-founder George Yancopoulos, though, went a different route.

In a fiery speech, the outspoken billionaire defended the police against the “prejudice and bias against law enforcement” that has erupted around the country in street protests from coast to coast. And for many who attended the commencement, Yancopoulos struck the wrong note at the wrong time, especially when he combatively challenged someone for interrupting his speech with a honk for “another act of cowardness.”

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Pfiz­er shares surge on pos­i­tive im­pact of their mR­NA Covid-19 vac­cine — part­nered with BioN­Tech — in an ear­ly-stage study

Pfizer and their partners at the mRNA specialist BioNTech have published the first glimpse of biomarker data from an early-stage study spotlighting the “robust immunogenicity” triggered by their Covid-19 vaccine, which is one of the leaders in the race to vanquish the global pandemic.

Researchers selected 45 healthy volunteers 18-55 years of age for the study. They were randomized to receive 2 doses, separated by 21 days, of 10 µg, 30 µg, or 100 µg of BNT162b1, “a lipid nanoparticle-formulated, nucleoside-modified, mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein RBD.” Their responses were compared against the effect of a natural, presumably protective defense offered by a regular infection.

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An ex­pe­ri­enced biotech is stitched to­geth­er from transpa­cif­ic parts, with 265 staffers and a fo­cus on ‘new bi­ol­o­gy’

Over the past few years, different teams at a pair of US-based biotechs and in labs in Japan have labored to piece together a group of cancer drug programs, sharing a single corporate umbrella with research colleagues in Japan. But now their far-flung operations have been knit together into a single unit, creating a pipeline with 10 cancer drug development programs — going from early-stage right into Phase III — and a host of discovery projects managed by a collective staff of some 265 people.

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Sec­ond death trig­gers hold on Astel­las' $3B gene ther­a­py biotech's lead pro­gram, rais­ing fresh con­cerns about AAV

Seven months after Astellas shelled out $3 billion to acquire the gene therapy player Audentes, the biotech company’s lead program has been put on hold following the death of 2 patients taking a high dose of their treatment. And there was another serious adverse event recorded in the study as well, with a total of 3 “older” patients in the study affected.

The incidents are derailing plans to file for a near-term approval, which had been expected right about now.

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Joseph Kim, Inovio CEO (Andrew Harnik, AP Images)

Pos­i­tive Covid-19 vac­cine da­ta? New mouse study? OWS in­clu­sion? Yep, but some­how, the usu­al tid­bits from In­ovio back­fire

You don’t go more than 40 years in biotech without ever getting a product to market unless you can learn the art of writing a promotional press release. And Inovio captures the prize in baiting the hook.

Tuesday morning Inovio, which has been struggling to get its Covid-19 vaccine lined up for mass manufacturing, put out a release that touched on virtually every hot button in pandemic PR.

There was, first and foremost, an interim snapshot of efficacy from their Phase I program for INO-4800.

Jan van de Winkel, Genmab CEO

Seat­tle Ge­net­ics, Gen­mab turn on TV for a high­light reel in cer­vi­cal can­cer — but a ri­val biotech promis­es a bet­ter show

Seattle Genetics $SGEN and their partners at Genmab $GMAB polished up some positive Phase II numbers for their antibody drug conjugate tisotumab vedotin — you can call it TV — for recurrent cervical cancer. And while they mapped out a shortcut to a potential quick approval, the big challenge for this team is being presented by a rival biotech which muscled its way into the spotlight for the same indication a year ago.

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Randy Schatzman, Bolt CEO (Bolt Biotherapeutics)

Bolt Bio­ther­a­peu­tics nabs $93.5M to push Provenge in­ven­tor's new idea deep­er in the clin­ic

A cancer-fighting concept from the inventor of the first cancer vaccine is nearing prime time, and its biotech developer has received a significant new infusion of cash to get it there.

Bolt Biotherapeutics announced a $93.5 million Series C round led by Sofinnova Investments and joined by more than 9 others, including Pfizer Ventures and RA Capital Management. That money will go toward pushing the San Francisco biotech’s platform of innate immune-boosting warheads through its first trial on metastatic solid tumors and into several more.

Days af­ter In­ter­cept re­jec­tion, Akero surges on ‘un­prece­dent­ed‘ NASH da­ta

A year and a half after scoring a $70 million Series B and a top Gilead executive as CEO, Akero Therapeutics has announced new data on their NASH drug. And with the field still reeling from a surprise FDA rejection this week, the news was enough to send their stock surging.

Akero had already said in March that its lead drug had beaten placebo in its Phase II trial, reducing liver fat by 14% in the highest dose group compared to 0.3% in placebo, according to MRI scans. But although NASH is an obesity-related condition and results from fatty buildup in the liver, the real immediate question for any therapy is whether it can resolve the fibrosis and inflammation that results from that buildup. Those data require biopsying the patients, a longer and more invasive process that was further complicated by a pandemic.