Ab­b­Vie preps fran­chise de­ci­sion af­ter Abl­ynx’s IL-6 drug goes head-to-head against Actem­ra

Ab­b­Vie was will­ing to bet up to $840 mil­lion that Abl­ynx’s nanobody tech could help it pro­tect and ex­pand its $14 bil­lion megafran­chise for Hu­mi­ra. To­day, Ab­b­Vie $AB­BV is get­ting a look at new Phase IIb da­ta for their part­nered IL-6 drug vo­bar­il­izum­ab (ALX-0061) that mea­sures up against Roche’s Actem­ra as it moves clos­er to its de­ci­sion on whether or not it will take it in­to Phase III.

But there’s no clear cut win here. In fact, on key ef­fi­ca­cy mea­sures, a low­er dose failed to mea­sure up to Actem­ra.

A high dose of vo­bar­il­izum­ab pro­vid­ed every two weeks did just man­age to edge out Actem­ra in two out of three stan­dard ef­fi­ca­cy mea­sures, though not by a sig­nif­i­cant amount. But Abl­ynx $ABLX al­so high­light­ed an edge on safe­ty da­ta and dropouts among the pa­tients with mod­er­ate to se­vere rheuma­toid arthri­tis that is re­sis­tant to methotrex­ate. And there’s ev­i­dence of low­er dis­ease ac­tiv­i­ty and an eas­i­er treat­ment reg­i­men to con­sid­er as well, with the most ef­fec­tive high dose pro­vid­ed every two weeks com­pared to Actem­ra’s week­ly sched­ule.

“We’re get­ting re­al­ly stand-out da­ta, which is great, and it is the first step for us in pro­vid­ing a da­ta pack­age to Ab­b­Vie, who will de­cide lat­er in the year whether to take up their op­tion and li­cense the prod­uct,” Abl­ynx CEO Ed­win Moses told Reuters in an in­ter­view. And Moses claims the drug has block­buster po­ten­tial.

But is that go­ing to fly with Ab­b­Vie?

When Ab­b­Vie struck the deal with Abl­ynx in 2013, they were look­ing to see if an IL-6 an­ti­body could pro­vide an al­ter­na­tive to Hu­mi­ra when pa­tients gen­er­at­ed an­ti­bod­ies against their an­ti-TNF drug. But now Ab­b­Vie is fight­ing against a host of biosim­i­lar man­u­fac­tur­ers look­ing to mus­cle in on their big U.S. fran­chise. And in this mar­ket­ing en­vi­ron­ment, any­thing that doesn’t mea­sure up as a big gain for pa­tients can be hard to sell.

There’s al­so a pre­ferred late-stage pro­gram at Ab­b­Vie to con­sid­er. Last fall, Ab­b­Vie axed a col­lab­o­ra­tion it has in place with Gala­pa­gos for their JAK1 in­hibitor fil­go­tinib (GLP0634), say­ing it pre­ferred to take their in-house pro­gram for ABT-494 in­to Phase III for arthri­tis.

“We be­lieve ABT-494 has the po­ten­tial to be­come a best-in-class ther­a­py, par­tic­u­lar­ly in the most chal­leng­ing pa­tient pop­u­la­tion of TNF-in­ad­e­quate re­spon­ders,” Ab­b­Vie CSO Michael Sev­eri­no not­ed af­ter the Phase II da­ta came out in Sep­tem­ber. The Phase III start­ed in Jan­u­ary.

Abl­ynx still has da­ta on a methotrex­ate com­bi­na­tion com­ing up in a mat­ter of weeks.

Ab­b­Vie has shown no re­luc­tance from walk­ing away from any part­nered pro­gram that doesn’t mea­sure up to ex­pec­ta­tions. Ab­b­Vie proved that when it re­cent­ly dropped its col­lab­o­ra­tion with In­fin­i­ty Phar­ma­ceu­ti­cals af­ter their blood can­cer drug du­velis­ib post­ed pos­i­tive but rel­a­tive­ly weak da­ta on in­do­lent non-Hodgkin dis­ease.

The Price of Re­lief: Ex­plor­ing So­lu­tions to the Ris­ing Costs of On­col­o­gy Drugs

In 2020, The National Cancer Institute estimated about 1.8 million new cases of cancer diagnosed in the United States, while the costs associated with treatment therapies continued to escalate. Given the current legislative climate on drug pricing, it’s never been more important to look at the evolution of drug pricing globally and control concerns of sustainable and affordable treatments in oncology.

Lat­est news on Pfiz­er's $3B+ JAK1 win; Pacts over M&A at #JPM22; 2021 by the num­bers; Bio­gen's Aduhelm reck­on­ing; The sto­ry of sotro­vimab; 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.

For those of you who attended #JPM22 in any shape or form, we hope you had a fruitful time. Regardless of how you spent the past hectic week, may your weekend be just what you need it to be.

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Susan Galbraith, AstraZeneca EVP, Oncology R&D

Can­cer pow­er­house As­traZeneca rolls the dice on a $75M cash bet on a buzzy up­start in the on­col­o­gy field

After establishing itself in the front ranks of cancer drug developers and marketers, AstraZeneca is putting its scientific shoulder — and a significant amount of cash — behind the wheel of a brash new upstart in the biotech world.

The pharma giant trumpeted news this morning that it is handing over $75 million upfront to ally itself with Scorpion Therapeutics, one of those biotechs that was newly birthed by some top scientific, venture and executive talent and bequeathed with a fortune by way of a bankroll to advance an only hazily explained drug platform. And they are still very much in the discovery and preclinical phase.

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A $3B+ peak sales win? Pfiz­er thinks so, as FDA of­fers a tardy green light to its JAK1 drug abroc­i­tinib

Back in the fall of 2020, newly crowned Pfizer chief Albert Bourla confidently put their JAK1 inhibitor abrocitinib at the top of the list of blockbuster drugs in the late-stage pipeline with a $3 billion-plus peak sales estimate.

Since then it’s been subjected to serious criticism for the safety warnings associated with the class, held back by a cautious FDA and questioned when researchers rolled out a top-line boast that their heavyweight contender had beaten the champ in the field of atopic dermatitis — Dupixent — in a head-to-head study.

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Robert Califf, FDA commissioner nominee (Graeme Sloan/Sipa USA/Sipa via AP Images)

Rob Califf ad­vances as Biden's FDA nom­i­nee, with a close com­mit­tee vote

Rob Califf’s second confirmation process as FDA commissioner is already much more difficult than his near unanimous confirmation under the Obama administration.

The Senate Health Committee on Thursday voted 13-8 in favor of advancing Califf’s nomination to a full Senate vote. Several Democrats voted against Califf, including Sen. Bernie Sanders and Sen. Maggie Hassan. Several other Democrats who aren’t on the committee, like West Virginia’s Joe Manchin and Ed Markey of Massachusetts, also said Thursday that they would not vote for Califf. Markey, Hassan and Manchin all previously expressed reservations about the prospect of Janet Woodcock as an FDA commissioner nominee too.

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Michel Vounatsos, Biogen CEO (World Economic Forum/Ciaran McCrickard)

Bio­gen vows to fight CM­S' draft cov­er­age de­ci­sion for Aduhelm be­fore April fi­nal­iza­tion

Biogen executives made clear in an investor call Thursday they are not preparing to run a new CMS-approved clinical trial for their controversial Alzheimer’s drug anytime soon.

As requested in a draft national coverage decision from CMS earlier this week, Biogen and other anti-amyloid drugs will need to show “a meaningful improvement in health outcomes” for Alzheimer’s patients in a randomized, placebo-controlled trial to get paid for their drugs, rather than just the reduction in amyloid plaques that won Aduhelm its accelerated approval in June.

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CRO own­er pleads guilty to ob­struct­ing FDA in­ves­ti­ga­tion in­to fal­si­fied clin­i­cal tri­al da­ta

The co-owner of a Florida-based clinical research site pleaded guilty to lying to an FDA investigator during a 2017 inspection, revealing that she falsely portrayed part of a GlaxoSmithKline pediatric asthma study as legitimate, when in fact she knew that certain data had been falsified, the Department of Justice said Wednesday.

Three other employees — Yvelice Villaman Bencosme, Lisett Raventos and Maytee Lledo — previously pleaded guilty and were sentenced in connection with falsifying data associated with the trial at the CRO Unlimited Medical Research.

‘Skin­ny la­bels’ on gener­ics can save pa­tients mon­ey, re­search shows, but re­cent court de­ci­sions cloud fu­ture

New research shows how generic drug companies can successfully market a limited number of approved indications for a brand name drug, prior to coming to market for all of the indications. But several recent court decisions have created a layer of uncertainty around these so-called “skinny” labels.

While courts have generally allowed generic manufacturers to use their statutorily permitted skinny-label approvals, last summer, a federal circuit court found that Teva Pharmaceuticals was liable for inducing prescribers and patients to infringe GlaxoSmithKline’s patents through advertising and marketing practices that suggested Teva’s generic, with its skinny label, could be employed for the patented uses.

A patient in Alaska receiving an antibody infusion to prevent Covid hospitalizations in September. All but one of these treatments has been rendered useless by Omicron (Rick Bowmer/AP Images)

How a tiny Swiss lab and two old blood sam­ples cre­at­ed one of the on­ly ef­fec­tive drugs against Omi­cron (and why we have so lit­tle of it)

Exactly a decade before a novel coronavirus broke out in Wuhan, Davide Corti — a newly-minted immunologist with frameless glasses and a quick laugh — walked into a cramped lab on the top floor of an office building two hours outside Zurich. He had only enough money for two technicians and the ceiling was so low in parts that short stature was a job requirement, but Corti believed it’d be enough to test an idea he thought could change medicine.

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