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

Scott Gottlieb, AP Images

Scott Got­tlieb is once again join­ing a team that en­joyed good times at the FDA un­der his high-en­er­gy stint at the helm

Right after jumping on Michael Milken’s FasterCures board on Monday, the newly departed FDA commissioner is back today with news about another life sciences board post that gives him a ringside chair to cheer on a lead player in the real-world evidence movement — one with very close ties to the FDA.

Aetion is reporting this morning that Gottlieb is joining their board, a group that includes Mohamad Makhzoumi, a general partner at New Enterprise Associates, where Gottlieb returned after stepping out of his role at the FDA 2 years after he started.

Gottlieb — one of the best connected execs in biopharma — knows this company well. As head of FDA he championed the use of real-world evidence to help guide drug developers and the agency in gaining greater efficiencies, which helped set up Aetion as a high-profile player in the game.

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Deborah Dunsire. Lundbeck

UP­DAT­ED: Deb­o­rah Dun­sire is pay­ing $2B for a chance to leap di­rect­ly in­to a block­buster show­down with a few of the world's biggest phar­ma gi­ants

A year after taking the reins as CEO of Lundbeck, Deborah Dunsire is making a bold bid to beef up the Danish biotech’s portfolio of drugs in what will likely be a direct leap into an intense rivalry with a group of giants now carving up a growing market for new migraine drugs.

Bright and early European time Monday morning the company announced that it will pay up to about $2 billion to buy Alder, a little biotech that is far along the path in developing a quarterly IV formulation of a CGRP drug aimed at cutting back the number of crippling migraines patients experience each month. In a followup call, Dunsire also noted that the company will likely need 200 to 250 reps for this marketing task on both sides of the Atlantic. And analysts were quick to note that the dealmaking at Lundbeck isn’t done, with another $2 billion to $3 billion available for more deals to beef up the pipeline.

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Tower Bridge in London [Shutterstock]

#UK­BIO19: Join GSK’s Hal Bar­ron and a group of top biotech ex­ecs for our 2nd an­nu­al biotech sum­mit in Lon­don

Over the past 10 years I’ve made a point of getting to know the Golden Triangle and the special role the UK biopharma industry plays there in drug development. The concentration of world class research institutes, some of the most accomplished scientists I’ve ever seen at work and a rising tide of global investment cash leaves an impression that there’s much, much more to come as biotech hubs are birthed and nurtured.

San Diego cou­ple charged with steal­ing trade se­crets, open­ing Chi­nese biotech as DOJ crack­down con­tin­ues

A San Diego couple has been charged with stealing trade secrets from a US hospital and opening a business based off those secrets in China as the controversial industry-wide crackdown on alleged corporate espionage continues. On the same day, the Department of Justice announced they had arrested Beijing representative Zhongsan Liu for allegedly trying to obtain research visas for government recruiters.

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UP­DAT­ED: Bio­gen pulls the plug on prized IPF drug from $562M+ Stromedix buy­out

One of Biogen’s attempts to branch out has flopped as the biotech scraps a mid-stage program for idiopathic pulmonary fibrosis.

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Warts for the win: Aclar­is' lead drug clears piv­otal study

Aclaris Therapeutics has found a way to get rid of the warts and all.

The company — which earlier this month decided to focus on its arsenal of kinase inhibitors — on Monday unveiled positive data from a pivotal study testing its lead experimental drug for use in common warts.

The drug, A-101, was tested in a 502-patient study called THWART-2 — patients enrolled had one to six warts before qualifying for the trial. Patients either self-administered A-101 topical solution or a vehicle twice a week over a two-month period. A higher proportion of patients on the drug (a potent hydrogen peroxide topical solution) saw their warts disappear at day 60, versus the vehicle (p<0.0001) — meeting the main goal of the study.  Each secondary endpoint also emerged in favor of A-101, the company said.

Charles Nichols, LSU School of Medicine

Could psy­che­delics tack­le the obe­si­ty cri­sis? A long­time re­searcher in the field says his lat­est mouse study sug­gests po­ten­tial

Psychedelics have experienced a renaissance in recent years amid a torrent of preclinical and clinical research suggesting it might provide a path to treat mood disorders conventional remedies have only scraped at. Now a preclinical trial from a young biotech suggests at least one psychedelic compound has effects beyond the mind, and — if you believe the still very, very early hype — could provide the first single remedy for some of the main complications of obesity.

It’s fi­nal­ly over: Bio­gen, Ei­sai scrap big Alzheimer’s PhI­I­Is af­ter a pre­dictable BACE cat­a­stro­phe rais­es safe­ty fears

Months after analysts and investors called on Biogen and Eisai to scrap their BACE drug for Alzheimer’s and move on in the wake of a string of late-stage failures and rising safety fears, the partners have called it quits. And they said they were dropping the drug — elenbecestat — after the independent monitoring board raised concerns about…safety.

We don’t know exactly what researchers found in this latest catastrophe, but the companies noted in their release that investigators had determined that the drug was flunking the risk/benefit analysis.

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Ac­celeron drops a de­vel­op­ment pro­gram as #2 drug fails to spark func­tion­al ben­e­fits in pa­tients with a rare neu­ro­mus­cu­lar ail­ment

Acceleron is scrapping a muscular dystrophy development program underway for its number 2 drug in the pipeline after pouring over some failed mid-stage secondary data.

Gone is the ACE-083 project in patients with facioscapulohumeral muscular dystrophy. Their drug hit the primary endpoint on building muscle but flopped on key secondaries for functional improvements in patients, which execs felt was vital to the drug’s success.