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.”

Un­lock­ing ESG strate­gies for growth with Gilead Sci­ences

RBC Capital Markets explores what is material in ESG for biopharma companies with the ESG leads at Gilead Sciences. Gilead has long focused on sustainability but recognized a more robust framework was needed. Based on a materiality assessment, Gilead’s ESG strategy today focuses first on drug access and pricing, while also addressing D&I and climate change. Find out why Gilead’s board is “acutely aware” of the contribution that ESG makes to firm’s overall success.

What con­tro­ver­sy? Eli Lil­ly plots Alzheimer's BLA fil­ing lat­er this year as FDA taps more an­ti-amy­loid drugs as break­throughs

The FDA is keeping the good news coming for Alzheimer’s drug developers. And Eli Lilly is taking them up on it.

Amid continued controversy around whether Biogen’s new flagship drug, Aduhelm, should have been approved at all — and swelling, heated debates surrounding its $56,000 price tag — the agency had no issue handing them and their Japanese partner Eisai a breakthrough therapy designation for a second anti-amyloid beta antibody, lecanemab, late Wednesday.

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Richard Pazdur (vis AACR)

FDA en­cour­ages in­clud­ing in­cur­able can­cer pa­tients in tri­als, re­gard­less of pri­or ther­a­pies

The FDA on Thursday called to include those with incurable cancers (when there is no potential for cure or for prolonged/near normal survival) in appropriate clinical trials, regardless of whether they have received existing alternative treatments.

Historically, many cancer clinical trials have required that participating patients previously received multiple therapies, according to Richard Pazdur, director of the FDA’s Oncology Center of Excellence.

New FDA doc­u­ments show in­ter­nal dis­sent on Aduhelm ap­proval

In a lengthy review document and a pair of memos from top officials, the FDA released on Tuesday night its most detailed argument yet for approving Biogen’s intensely controversial Alzheimer’s drug aducanumab.

The documents amount to an agency attempt to quench the firestorm their decision kindled, as outside advisors members resigned and experts warned that an unproven drug now could stretch Medicare’s budget to a breaking point. Ultimately, the documents show how CDER director Patrizia Cavazzoni and Office of New Drugs director Peter Stein both concurred with FDA neuroscience head Billy Dunn on the accelerated approval while the staff at FDA’s Office of Biostatistics did not think an approval was warranted.

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Hervé Hoppenot, Incyte CEO (Jeff Rumans)

ODAC echoes FDA con­cern over In­cyte PD-1, as Paz­dur sig­nals broad­er shift for ac­cel­er­at­ed ap­proval

After the FDA lambasted their PD-1 ahead of an adcomm earlier this week, Incyte ran into new trouble Thursday as ODAC panelists voted against an accelerated OK by a wide margin.

Members of the Oncologic Drugs Advisory Committee recommended with a 13-4 vote to defer a regulatory decision on Incyte’s retifanlimab until after more data can be collected from a placebo-controlled trial. The PD-1 therapy is due for a PDUFA date in late July after receiving priority review earlier this year.

Karen Flynn, Catalent

Q&A: When the pan­dem­ic struck, Catal­en­t's CCO had just joined the team

Karen Flynn came aboard Catalent’s team just in time.

The company was going through a surge of changes, and she had been brought over from her role as CCO of West Pharmaceutical Services to serve in the same capacity for the New Jersey-based CDMO. Then a few months later, the pandemic was in full-force.

Since then, Catalent’s been in hyper-expansion mode. In early May, it acquired Promethera’s Hepatic Cell Therapy Support SA subsidiary and its 32,40-square-foot facility in Gosselies, Belgium. Prior to that, the company acquired Belgian CDMO Delphi Genetics, wrapped up the expansion of an already-existing site in Madison, WI and added an ultra-low temperature freezer partner in Sterling. As Emergent has botched millions of doses of AstraZeneca’s vaccine, the company has swooped in to move that production to its Maryland plant as well.

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Yuval Cohen, Corbus CEO (Corbus via YouTube)

An­oth­er Cor­bus pro­gram hits the skids af­ter late-stage flop, plum­met­ing the small biotech's shares

Corbus Pharmaceuticals’ plans to position lenabasum as a pipeline-in-a-product aren’t going so well.

After shelving a program in scleroderma, the Norwood, MA-based biotech has revealed that its lead candidate failed both the primary and secondary endpoints in another Phase III trial.

Lenabasum failed to show a statistically significant difference in total improvement compared with placebo in treating dermatomyositis, a rare disease that causes muscle inflammation and skin rash, the company said Thursday. The news sent Corbus’ $CRBP stock spiraling around 30% early Thursday morning.

On heels of Aduhelm ap­proval, Bris­tol My­ers jumps back in­to Alzheimer's race

Bristol Myers Squibb last put major resources behind an Alzheimer’s drug nearly a decade ago, when their own attempt at targeting amyloid flamed out in mid-stage studies. They invented another molecule, a Tau-targeted antibody, but jettisoned it to Biogen in 2017 as they dropped out of neuroscience altogether.

But on Thursday, the New York pharma announced they were getting back in the game. Bristol Myers exercised an $80 million option to bring a tau-targeted antibody from Prothena into a Phase I study. The opt-in, which Bristol Myers triggered ahead of analyst expectations, opens the door for another $1.7 billion in milestones down the road.

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Elizabeth Warren (Michael Brochstein/Sipa USA)(Sipa via AP Images)

Sen­a­tors call for hear­ing to ex­am­ine how Medicare will han­dle Bio­gen's new Alzheimer's drug

Two top Senate Finance committee senators on Thursday called for a hearing to examine the questions and challenges for Medicare arising from the FDA’s recent approval of Biogen’s Aduhelm, the controversial new drug approved to treat Alzheimer’s disease.

In a letter to Senate Finance chair Ron Wyden (D-OR) and ranking member Mike Crapo (R-ID), subcommittee chair Elizabeth Warren (D-MA) and Bill Cassidy (R-LA) hinted at making policy changes to enable Medicare to more directly connect prescription drug pricing to clinical effectiveness. They raised questions about the “dramatic implications for our health care system” from the approval, which they said “stretch well beyond the scope of FDA’s jurisdiction.”

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