Richard Gonzalez, AbbVie CEO (AP Images)

Ab­b­Vie chas­es its next gold­en goose in a post-Hu­mi­ra fu­ture with new ul­cer­a­tive col­i­tis da­ta for Rin­voq

Still bathing in the af­ter­glow of its big-mon­ey ac­qui­si­tion of Al­ler­gan, Ab­b­Vie faces the dark cloud of a post-Hu­mi­ra fu­ture — and the dead­line is ap­proach­ing fast. Key to Ab­b­Vie’s plan are two im­munol­o­gy launch­es with ag­gres­sive clin­i­cal dreams; one of those, JAK in­hibitor Rin­voq, is now one step clos­er to an­oth­er Hu­mi­ra-match­ing ap­proval.

Ab­b­Vie’s Rin­voq (upadac­i­tinib) best­ed place­bo in help­ing ul­cer­a­tive col­i­tis pa­tients achieve clin­i­cal re­mis­sion at the eight-week mark and sig­nif­i­cant­ly re­duced key symp­to­matic bio­mark­ers, in­clud­ing gas­troin­testi­nal in­flam­ma­tion, ac­cord­ing to da­ta from the Phase III U-Achieve study un­veiled Wednes­day.

Twen­ty-six per­cent of pa­tients dosed with a once-dai­ly, 45-mg dose of Rin­voq hit clin­i­cal re­mis­sion af­ter two months com­pared with just 5% on place­bo, Ab­b­Vie said. Rin­voq al­so in­duced gas­troin­testi­nal im­prove­ment in 36% of pa­tients; mean­while, just 7% pa­tients on place­bo hit that mark.

Rin­voq al­so aced its oth­er sec­ondary end­points over place­bo, in­clud­ing achiev­ing clin­i­cal re­sponse in pa­tients and re­duc­ing swelling of the mu­cos­al lin­ing. U-Achieve is one of two in­duc­tive stud­ies Ab­b­Vie has planned for Rin­voq in UC along with three piv­otal tri­als for a pos­si­ble reg­u­la­to­ry sub­mis­sion.

Rin­voq’s UC quest is part of a wide-rang­ing clin­i­cal pro­gram for the drug that in­cludes on­go­ing late-stage tri­als for un­ap­proved in­di­ca­tions in atopic der­mati­tis, pso­ri­at­ic arthri­tis, ax­i­al spondy­loarthri­tis, Crohn’s dis­ease, gi­ant cell ar­teri­tis and Takaya­su’s ar­teri­tis.

The end goal is sim­ple and dri­ven by a loom­ing axe in Ab­b­Vie’s port­fo­lio: Rin­voq must even­tu­al­ly snare enough in­di­ca­tions to make up for the sales loss of megablock­buster Hu­mi­ra, which is fac­ing US biosim­i­lar com­pe­ti­tion start­ing in 2023.

That time­line would give Rin­voq, which orig­i­nal­ly notched an FDA ap­proval to treat mod­er­ate-to-se­vere rheuma­toid arthri­tis back in Au­gust 2019, rough­ly three years to gain enough mo­men­tum to be­gin off­set­ting Hu­mi­ra’s ex­pect­ed de­cline. But it won’t be a sure-fire path to suc­cess: Rin­voq sports a JAK class warn­ing la­bel for se­ri­ous in­fec­tions, ma­lig­nan­cy and throm­bo­sis that has spooked many rheuma­tol­o­gists off the drugs and could make a ma­jor mar­ket en­try in­to any of those new in­di­ca­tions a dif­fi­cult road.

Luck­i­ly, Ab­b­Vie isn’t putting all its eggs in­to one bas­ket as it looks in­to the post-Hu­mi­ra fu­ture. The Chica­go drug­mak­er al­so sports re­cent pso­ri­a­sis launch Skyrizi, which it hopes to pair up with Rin­voq as a one-two punch to match Hu­mi­ra high­est sales peak. Ab­b­Vie is so gung-ho about the pair’s chances that CEO Rick Gon­za­lez posit­ed in Jan­u­ary at the JP Mor­gan Health­care Con­fer­ence that the two drugs could hit a com­bined $20 bil­lion in an­nu­al sales if they snag all of Hu­mi­ra’s ap­provals and add more — atopic der­mati­tis, for in­stance.

Mean­while, Ab­b­Vie is still in the process of di­gest­ing its $63 bil­lion ac­qui­si­tion of Al­ler­gan, which brought aes­thet­ic/ther­a­peu­tic block­buster Botox in­to the fold. Al­ler­gan came in sport­ing boom­ing an­tipsy­chot­ic Vray­lar as well, tack­ing a sec­ond growth dri­ver on­to the new com­pa­ny’s lapel.

Martin Landray, Protas CEO (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Those big bil­lion-dol­lar PhI­II stud­ies? Mar­tin Lan­dray says they can be done for a tiny frac­tion of the cost

Martin Landray knows what controversy in clinical drug development feels like, from first-hand experience.

Landray was the chief architect of RECOVERY, a study that pitted a variety of drugs against Covid-19. And he offered some landmark data that would help push dexamethasone out into broader use as a cheap treatment, while helping ice hydroxy’s reputation as a clear misfire.

“Lots of people told us we shouldn’t use it,” Landray says about dexamethasone and Covid-19. “It was dangerous. We shouldn’t even do a trial. They also cared about hydroxychloroquine and lots of people said we shouldn’t do a trial because it must be used. I’ve got the letters from both sets of people.”

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

IDC: Life Sci­ences Firms Must Em­brace Dig­i­tal Trans­for­ma­tion Now

Pre-pandemic, the life sciences industry had settled into a pattern. The average drug took 12 years and $2.9 billion to bring to market, and it was an acceptable mode of operations, according to Nimita Limaye, Research Vice President for Life Sciences R&D Strategy and Technology at IDC.

COVID-19 changed that, and served as a proof-of-concept for how technology can truly help life sciences companies succeed and grow, Limaye said. She recently spoke about industry trends at Egnyte’s Life Sciences Summit 2022. You should watch the entire session, free and on-demand, but here’s a brief recap of why she’s urging life sciences companies to embrace digital transformation.

FDA ap­proves one of the prici­est new treat­ments of all time — blue­bird's gene ther­a­py for be­ta tha­lassemia

The FDA on Wednesday approved the first gene therapy for a chronic condition — bluebird bio’s new Zynteglo (beti-cel) as a potentially curative treatment for those with transfusion-dependent thalassemia.

The thumbs-up from the FDA follows a unanimous adcomm vote in June, with outside experts pointing to extraordinary efficacy, with 89% of subjects with TDT who received beti-cel having achieved transfusion independence.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 148,400+ biopharma pros reading Endpoints daily — and it's free.

Geoffrey Porges, new Schrödinger CFO

Long­time an­a­lyst Ge­of­frey Porges de­parts SVB to lead fi­nances at a drug dis­cov­ery shop

Geoffrey Porges has ended his two-decade run as a biotech analyst, as the former SVB Securities vice chair began as CFO of Schrödinger on Thursday.

The long-running analyst, who previously headed up vaccines marketing at Merck before the turn of the millennium, will lead the financial operations of the 700-employee company as Schrödinger broadens its focus from a drug discovery partner to also building out an in-house pipeline, with clinical trial No. 1 set to begin next quarter.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 148,400+ biopharma pros reading Endpoints daily — and it's free.

Bayer's first DTC ad campaign for chronic kidney disease drug Kerendia spells out its benefits

Bay­er aims to sim­pli­fy the com­plex­i­ties of CKD with an ABC-themed ad cam­paign

Do you know the ABCs of CKD in T2D? Bayer’s first ad campaign for Kerendia tackles the complexity of chronic kidney disease with a play on the acronym (CKD) and its connection to type 2 diabetes (T2D).

Kerendia was approved last year as the first and only non-steroidal mineralocorticoid receptor antagonist to treat CKD in people with type 2 diabetes.

In the TV commercial launched this week, A is for awareness, B is for belief and C is for cardiovascular, explained in the ad as awareness of the connection between type 2 and kidney disease, belief that something can be done about it, and cardiovascular events that may be reduced with treatment.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 148,400+ biopharma pros reading Endpoints daily — and it's free.

James Mock, incoming CFO at Moderna

Mod­er­na taps new CFO from PerkinElmer af­ter for­mer one-day CFO oust­ed

When Moderna hired a new CFO last year,  it didn’t expect to see him gone after only one day. Today the biotech named his — likely much more vetted — replacement.

The mRNA company put out word early Wednesday that after the untimely departure of then brand-new CFO Jorge Gomez, it has now found a replacement in James Mock, the soon-to-be former CFO at diagnostics and analytics company PerkinElmer.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 148,400+ biopharma pros reading Endpoints daily — and it's free.

Joe Jonas (Photo by Anthony Behar/Sipa USA)(Sipa via AP Images)

So­lo Jonas broth­er car­ries Merz's new tune in Botox ri­val cam­paign

As the lyrics of his band’s 2019 pop-rock single suggest, Joe Jonas is only human — and that means even he gets frown lines. The 33-year-old singer-songwriter is Merz’s newest celebrity brand partner for its Botox rival Xeomin, as medical aesthetics brands target a younger audience.

Merz kicked off its “Beauty on Your Terms” campaign on Tuesday, featuring the Jonas brother in a video ad for its double-filtered anti-wrinkle injection Xeomin.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 148,400+ biopharma pros reading Endpoints daily — and it's free.

Marisol Peron, Genmab SVP of communications and corporate affairs

Gen­mab launch­es cor­po­rate cam­paign am­pli­fy­ing its ‘knock your socks off’ an­ti­bod­ies

Genmab often talks about its “knock-your-socks-off” antibodies — and now the term is getting its own logo and corporate campaign.

The teal and purple logo for the acronym KYSO — Genmab pronounces it “ky-so” — debuts on Wednesday and comes on the heels of Genmab’s newly announced 2030 vision. That aspiration aims to expand Genmab’s drug development beyond oncology to include other serious diseases, while also doubling down on its own drug development.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 148,400+ biopharma pros reading Endpoints daily — and it's free.

Kate Haviland, Blueprint Medicines CEO

Blue­print met all its end­points in bid for ex­pand­ed Ay­vak­it la­bel — but stock trends low­er any­way

Blueprint Medicines announced this morning that the second part of its study on Ayvakit in non-advanced systemic mastocytosis (SM) — a rare disease in which a type of white blood cells known as mast cells builds up — met all endpoints, but the biopharma left key questions unanswered.

In 212 patients, with 141 in the treatment arm and 71 in the control arm, patients who got Ayvakit saw an average 15.6-point decrease in their symptom scores compared to a 9.2-point decrease in the placebo arm at 24 weeks. In an extension study, those on Ayvakit saw their symptom scores drop by 20.2 points by week 48.