Ab­b­Vie gets a big boost in the ma­jor league rheuma­toid arthri­tis fi­nals with promis­ing PhI­II da­ta

Ab­b­Vie passed on a big part­ner­ship it had set up with Gala­pa­gos on the promis­ing rheuma­toid arthri­tis drug fil­go­tinib so it could fo­cus all of its ef­forts on an in-house pro­gram for upadac­i­tinib (ABT-494). And to­day the block­buster gam­ble was re­ward­ed with a round of stel­lar da­ta from their first Phase III study of the oral JAK in­hibitor.

Both the 15 mg and 30 mg dos­es swept the pri­ma­ry and sec­ondary end­points in the study, with 64% and 66% re­spec­tive­ly hit­ting ACR20, with a min­i­mum 20% im­prove­ment in the dis­ease score.  ACR50 came in at 38% and 43%. Low dis­ease ac­tiv­i­ty was marked by about half of the pa­tients while on­ly 17% of the place­bo arm could say the same.

Here’s the full chart:

There have been a host of ma­jor league ri­vals go­ing af­ter RA re­cent­ly, with mixed re­sults. So how does ABT-494 stack up?

At the top of the set­back list is Eli Lil­ly’s baric­i­tinib, part­nered with In­cyte, which the FDA re­ject­ed in April for large­ly un­known rea­sons. J&J and Glax­o­SmithK­line re­cent­ly stum­bled in a head-to-head with sirukum­ab against Hu­mi­ra, a main­stay in the mar­ket. The 50 mg and 100 mg sirukum­ab num­bers hit 27% and 35% on ACR50 com­pared to 32% of the Hu­mi­ra group. But Re­gen­eron and Sanofi scored with sar­ilum­ab (Kevzara), win­ning an ap­proval for the IL-6 drug re­cent­ly af­ter be­ing de­layed over man­u­fac­tur­ing is­sues.

Ab­b­Vie has high hopes for the oral upadac­i­tinib, wide­ly tapped as a block­buster-to-be. It’s al­ready well in­to a late-stage pro­gram on pso­ri­at­ic arthri­tis fol­lowed by Crohn’s dis­ease, ul­cer­a­tive col­i­tis and atopic der­mati­tis. And Ge­of­frey Porges at Leerink was quick to of­fer the com­pa­ny ku­dos for the way this ther­a­py is be­ing po­si­tioned. He not­ed:

The place­bo-ad­just­ed ACR20 ben­e­fit rates for upadac­i­tinib with methotrex­ate of 28%-30% are nu­mer­i­cal­ly su­pe­ri­or to com­peti­tor LLY (OP)/IN­CY’s (OP) baric­i­tinib of 22-26% in the same tri­al with pa­tients who had in­ad­e­quate re­spons­es to DMARD, and the more strin­gent place­bo-ad­just­ed ACR50 and ACR70 rates for upadac­i­tinib are al­so high­er than seen in the baric­i­tinib tri­al. We cur­rent­ly mod­el $1.6bn in peak sales for upadac­i­tinib com­pared to con­sen­sus ex­pec­ta­tions of $2.5bn in 2027E, and we be­lieve that the su­pe­ri­or da­ta and re­cent FDA re­jec­tion of baric­i­tinib fa­vor­ably po­si­tion Ab­b­Vie in the JAK mar­ket seg­ment, and could lead to ma­te­r­i­al up­side to fore­casts.

The phar­ma com­pa­ny was so pumped about its prospects with this drug, with peak sales pro­jec­tions run­ning in­to the bil­lions, that it walked away from its $150 mil­lion up­front on a ri­val oral ther­a­py, which Gilead quick­ly scooped up for it­self.

Gerd Burmester

“Achiev­ing the tar­get of low dis­ease ac­tiv­i­ty in near­ly half of the pa­tients by 12 weeks and do­ing so at both high and low dose lev­els is en­cour­ag­ing,” said Gerd Burmester, pro­fes­sor of med­i­cine, De­part­ment of Rheuma­tol­ogy and Clin­i­cal Im­munol­o­gy, Char­ité Berlin, in a state­ment. “Cur­rent treat­ment rec­om­men­da­tions rec­og­nize the im­por­tance of this clin­i­cal tar­get for pa­tients, as achiev­ing low dis­ease ac­tiv­i­ty has re­mained an un­met need in rheuma­toid arthri­tis.”

Vac­cine doc­u­ments, young lead­ers and mar­ket tur­moil: End­points' 10 biggest sto­ries of 2022

It’s been a volatile year in the world of biopharma. Market declines reset M&A valuations, and may be beginning to tempt bigger buyers back into dealmaking. Russia’s war in Ukraine disrupted drug sales and clinical trials. A new generation of young biotech leaders emerged in the Endpoints 20(+1) Under 40. And as capital runs dry in a tough environment for raising new funds, companies big and small are taking a look at their headcounts and operations for ways to make it through lean times.

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Tom Riga, Spectrum Pharmaceuticals CEO

Spec­trum im­plodes af­ter a harsh pub­lic slap­down and now a CRL from Richard Paz­dur

The FDA has gone out of its way several times to flatten any expectations for Spectrum’s lung cancer drug poziotinib, including slamming the regulatory door in the biotech’s face four years ago when the their executive crew came calling for a breakthrough drug designation and encouragement from the oncology wing of the FDA.

That stinging early rebuke pointed straight down the path to a corrosive in-house agency review of Spectrum’s attempt to land an accelerated approval for the oral EGFR TKI and a public whipping that included a classic takedown by none other than Richard Pazdur, who slammed the company for “poor drug development” that led to confusion over the dose needed for a slice of NSCLC patients harboring HER2 exon 20 insertion mutations.

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Big Phar­ma's Twit­ter ex­o­dus; Mer­ck wa­gers $1.35B on buy­out; $3.5M gene ther­a­py; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

As you start planning for #JPM23, we hope you will consider joining Endpoints News for our live and virtual events. For those who are celebrating Thanksgiving, we hope you are enjoying the long weekend with loved ones. And if you’re not — we’ll see you next week!

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Robert Califf, FDA commissioner (Jose Luis Magana/AP Images)

Fourth ac­cel­er­at­ed ap­proval in Duchenne? Sarep­ta gets pri­or­i­ty re­view for gene ther­a­py amid FDA scruti­ny

Sarepta is once again on the accelerated approval path for a Duchenne drug, picking up a priority review Monday morning.

The FDA granted the accelerated review to SRP-9001, Sarepta announced Monday, which would become the biotech’s fourth Duchenne drug if approved. Much like SRP-9001 will do, each of the previous three therapies went through the accelerated approval pathway. But unlike the others, SRP-9001 is a gene therapy.

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Albert Bourla, Pfizer CEO (John Thys/POOL/AFP via Getty Images)

Pfiz­er CEO un­der fire from UK watch­dog over vac­cine com­ments — re­port

Pfizer CEO Albert Bourla told the BBC last December that he had “no doubt in my mind that the benefits, completely, are in favor” of vaccinating 5- to 11-year-olds for Covid-19. Almost a year later, those comments have reportedly landed him in trouble with a UK pharma watchdog.

Children’s advocacy group UsForThem filed a complaint with the UK’s Prescription Medicines Code of Practice Authority (PMCPA) last year accusing Bourla of making “disgracefully misleading” statements during the BBC interview, including one that “Covid in schools is thriving.” At the time, UK regulators had not yet cleared the vaccine for the 5 to 11 age group, though the vaccine did have a positive opinion from the EMA’s human medicines committee.

FDA tells Catal­ent to fix is­sues at two man­u­fac­tur­ing sites on its own

The CDMO Catalent will have to fix issues at two manufacturing plants in the US and Europe that were subject to inspections by the FDA this summer, giving the company room to correct the issues without facing further regulatory action.

The FDA gave Catalent a “voluntary action indicated” response to two inspections at the contract manufacturer’s site in Bloomington, IN, and Brussels, Belgium. Fixing the issues on its own is a preferable outcome to facing an “official action indicated” response, meaning that an official warning would be sent out or a sit-down with the FDA would be required.

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Merck targets vaccine-hesitant parents in its latest 'Why Vaccines' campaign. (Image: Shutterstock)

Mer­ck­'s lat­est 'Why Vac­ci­nes' cam­paign seeks to bet­ter in­form vac­cine-hes­i­tant moms

From Hollywood couple endorsements to targeted equity efforts, Merck has been pushing the value of vaccinations, especially since the Covid-19 pandemic disruption. Now the pharma is turning to a new target — vaccine-hesitant parents, and moms in particular.

Merck’s “Why Vaccines” latest social media and digital campaign spotlights real-life new moms who have questions about vaccinating their children.

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In­dus­try groups, CVS pick apart FDA's pro­posed path­way for gener­ics to carve out OTC in­di­ca­tions

Pharma industry groups like the Association for Accessible Medicines (AAM) and PhRMA are raising pointed questions about an FDA plan to create a new pathway for marketing prescription drugs with an additional condition for nonprescription use (ACNU), which would require more safeguards than the current OTC pathway but essentially carve out new OTC uses for some generic drugs.

Chief among the concerns were: Insurance companies dropping coverage for the Rx version, new ACNU patents to block competition, and industry essentially governing the pathway.

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Marc de Garidel, CinCor Pharma CEO (Eric Piermont/AFP via Getty Images)

Cin­Cor’s hy­per­ten­sion can­di­date flops a PhII test but plans to charge ahead with piv­otal study

Toward the end of summer, Massachusetts-based CinCor Pharma was riding high with a $225 million raise, touting a positive data readout. But a closer look under the hood has revealed a few hiccups in its Phase II.

CinCor on Monday unveiled topline results from its Phase II trial, dubbed HALO, evaluating baxdrostat in patients with uncontrolled hypertension who are taking up to two blood pressure medications. The trial whiffed on its primary endpoint of evaluating change from the “baseline in mean seated” systolic blood pressure (SBP) in the intent-to-treat population in all dosage levels.