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


At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

Stéphane Bancel, Moderna CEO

'This is not go­ing to be good': Mod­er­na CEO Ban­cel warns of a 'ma­te­r­i­al drop' in vac­cine ef­fi­ca­cy as Omi­cron spreads

Even as public health officials remain guarded about their comments on the likelihood Omicron will escape the reach of the currently approved Covid-19 vaccines, there’s growing scientific consensus that we’re facing a variant that threatens to overwhelm the vaccine barricades that have been erected.

Stéphane Bancel, the CEO of Moderna, one of the leading mRNA players whose quick vault into the markets with a highly effective vaccine created an instant multibillion-dollar market, added his voice to the rising chorus early Tuesday. According to Bancel, there will be a significant drop in efficacy when the average immune system is confronted by Omicron. The only question now is: How much?

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Ap­peals court puts the fi­nal nail in the cof­fin for Tec­fidera patent, adding to Bio­gen's bur­geon­ing set­backs

In another setback for Biogen, the big biotech lost its appeal to revive a patent for the once-blockbuster drug Tecfidera, marking a likely conclusion to the case.

The US Court of Appeals for the Federal Circuit issued the ruling Tuesday morning, saying Biogen failed to satisfy the “written description” requirement for patent law. As a result, Mylan-turned-Viatris will be able to sell its multiple sclerosis generic without fear of infringement and Biogen will have to find a new revenue driver elsewhere.

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Philip Dormitzer, new GSK global head of vaccines R&D

Glax­o­SmithK­line poach­es Pfiz­er's vi­ral vac­cines lead in rush to cap­i­tal­ize on fu­ture of mR­NA

GlaxoSmithKline has appointed Philip Dormitzer, formerly chief scientific officer of Pfizer’s viral vaccines unit, as its newest global head of vaccines R&D, looking to leverage one of the leading minds behind Pfizer and BioNTech’s RNA collaboration that led to Covid-19 jab Comirnaty, the British drug giant said Tuesday.

Dormitzer had been with Pfizer for a little more than six years, joining up after a seven-year stint with Novartis, where he reached the role of US head of research and head of global virology for the company’s vaccines and diagnostics unit.

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In­tro­duc­ing End­points Stu­dio, a new way to ad­ver­tise with End­points-craft­ed brand­ing cam­paigns

Since our start in 2016, Endpoints has grown fast while executing our mission to cover biopharma’s most critical developments for industry pros worldwide. As readership has grown, our advertising business has too. Endpoints advertising partners support the mission and engage their desired audiences through announcements on our email and web platforms, brand recognition in our event coverage and sponsorships of Endpoints daily and weekly reports.

As lead drug runs in­to a wall, De­ci­phera slims down its pipeline, puts 140 jobs on the chop­ping block

Barely a month after disappointing data shattered hopes for a major label expansion for the GI tumor drug Qinlock, Deciphera is making a major pivot — scrapping development plans for that drug and discarding another while it hunkers down and focuses on two remaining drugs in the pipeline.

As a result, 140 of its staffers will be laid off.

The restructuring, which claims the equivalent of 35% of its total workforce, will take place across all departments including commercial, R&D as well as general and administrative support functions, Deciphera said, as it looks to streamline Qinlock-related commercial operations in the US while concentrating only on a “select number of key European markets.”

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How to use reg­istry da­ta to sup­port FDA de­ci­sion mak­ing: Agency ex­plains in new guid­ance

Drugmakers looking to design a new registry or use an existing one to support a regulatory decision on a drug’s effectiveness or safety will need to consult with a new draft guidance released Monday by the FDA.

The agency’s reliance on registry data for regulatory decisions dates back more than two decades, at least, as in 1998 Bayer won approval for its anticoagulant Refludan (withdrawn from the market in 2013 for commercial reasons) based in part on a historical control group pulled from a registry.

Tillman Gerngross (Adagio)

Till­man Gern­gross on Omi­cron: 'It is a grim sit­u­a­tion...we’re go­ing to see a sig­nif­i­cant drop in vac­cine ef­fi­ca­cy'

Tillman Gerngross, the rarely shy Dartmouth professor, biotech entrepreneur and antibody expert, has been warning for over a year that the virus behind Covid-19 would likely continue to mutate, potentially in ways that avoid immunity from infection and the best defenses scientists developed. He spun out a company, Adagio, to build a universal antibody, one that could snuff out any potential mutation.

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In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.