Pfiz­er jumps in­to the heat­ed PhI­II race for new-wave JAK in­hibitors — but safe­ty frets loom large

Pfiz­er has racked up a pos­i­tive slate of Phase III da­ta for its an­ti-in­flam­ma­to­ry JAK1 in­hibitor abroc­i­tinib (PF-04965842), which the phar­ma gi­ant is hop­ing to steer to the FDA rel­a­tive­ly soon as it looks to get in­to a heat­ed block­buster race that’s been heav­i­ly over­shad­owed by new safe­ty warn­ings for the class.

All we’re get­ting now are some un­spec­i­fied — though promis­ing — re­sults, with the phar­ma gi­ant lay­ing claim to a sta­tis­ti­cal­ly sig­nif­i­cant re­sult against a place­bo for atopic der­mati­tis. Pfiz­er, though, wants to go up against some deeply en­trenched ri­vals in a high­ly com­pet­i­tive field, and there’s no re­al in­sight to of­fer on how that stacks up. 

Abroc­i­tinib is a JAK1 in­hibitor, look­ing to bust in­to a mar­ket dom­i­nat­ed by its own fran­chise drug Xel­janz, with Eli Lil­ly’s Olu­mi­ant an­gling in for a slice of the pie af­ter the FDA ap­proved on the low dose of the drug af­ter ini­tial­ly re­ject­ing it on safe­ty fears. 

The field was rat­tled bad­ly more re­cent­ly when Pfiz­er not­ed that the high dose of their block­buster JAK1/JAK3 in­hibitor Xel­janz was linked to a high­er rate of blood clots and death. That trig­gered reg­u­la­to­ry warn­ings on both sides of the At­lantic as they re­viewed the sit­u­a­tion. And days ago In­cyte an­nounced that it will stop co-fund­ing Olu­mi­ant as ques­tions about the cat­e­go­ry abound.

One of the many ques­tions now is whether the safe­ty is­sue at Pfiz­er will bleed over to Ab­b­Vie, which has its own JAK1, upadac­i­tinib, now un­der reg­u­la­to­ry re­view for rheuma­toid arthri­tis on both sides of the At­lantic. Gilead al­so has a lot rid­ing on fil­go­tinib, wide­ly tapped as a po­ten­tial block­buster in its own right. 

And now Pfiz­er gets to join that ma­jor league crew.

Here’s what we know:

Their drug, des­ig­nat­ed a break­through ther­a­py by the FDA, hit on the pri­ma­ry end­point for the In­ves­ti­ga­tor Glob­al As­sess­ment score of clear or al­most clear skin and a ≥2 point im­prove­ment. The drug al­so scored on the pro­por­tion of pa­tients who achieved at least a 75% or greater change from base­line in their Eczema Area and Sever­i­ty In­dex (EASI) score. “The key sec­ondary end­points were the pro­por­tion of pa­tients achiev­ing a 4 point or larg­er re­duc­tion in itch sever­i­ty mea­sured with the pru­ri­tus nu­mer­i­cal rat­ing scale and the mag­ni­tude of de­crease in the pru­ri­tus and Symp­toms As­sess­ment for Atopic Der­mati­tis.”

Dis­con­tin­u­a­tion rates for the two dos­es test­ed were low­er than in the place­bo arm, but no de­tails on ad­verse events were re­port­ed.

More Phase III re­sults will be avail­able lat­er in the year.

Michel Younatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen scores a pri­or­i­ty re­view for its Alzheimer's drug ad­u­canum­ab, mov­ing one gi­ant leap for­ward in its con­tro­ver­sial quest

Biogen scored a big win at the FDA today as regulators accepted their application for the controversial Alzheimer’s drug aducanumab and gave it a priority review.

The PDUFA date is March 7, 2021.

Significantly, Biogen says it did not use its priority review voucher to win special treatment at the FDA. The agency handed that out gratis.

That’s the ideal scenario Biogen was looking for as disappointed analysts wondered aloud about the delayed application earlier in the year.

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Ryan Watts, Denali CEO

Bio­gen hands De­nali $1B-plus in cash, $1B-plus in mile­stones to part­ner on late-stage Parkin­son’s drug

Biogen is handing over more than a billion dollars cash to partner with the up-and-coming neurosciences crew at Denali on a new therapy for Parkinson’s. And the big biotech is ready to pile on more than a billion dollars more in milestones — if the alliance is a success.

For Biogen $BIIB, the move on Denali’s small molecule inhibitors of LRRK2 puts them in line to collaborate on a late-stage program for DNL151, which is scheduled to start next year.

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Alex­ion cre­ates new post for chief di­ver­si­ty of­fi­cer; Bar­ry Greene step­ping down at Al­ny­lam, Yvonne Green­street named as suc­ces­sor

Alexion has carved out a new position for chief diversity officer and filled it with an inside promotion.

Uzair Qadeer will now be responsible for their “diversity, inclusion and belonging” strategy, looking to reshape the biotech’s corporate culture. A veteran of Deloitte and Bristol Myers Squibb, Qadeer was working on executive coaching and helping create the diversity program he now leads.

Covid-19 roundup: Gates Foun­da­tion pours $150M in­to In­dia’s Serum In­sti­tute; Pfiz­er teams with Gilead on remde­sivir

By CEO and scion Adar Poonawalla’s estimation, the Serum Institute in India has already poured hundreds of millions of dollars into scaling up the unproven Covid-19 vaccine being developed by AstraZeneca and Oxford for use in low and middle income countries. It’s meant taking on a risk that other companies, including AstraZeneca, have mitigated with huge amounts of government funding.

Now, for the first time, Poonawalla is getting some outside help. The Gates Foundation has agreed to pay the institute $150 million to supply 100 million vaccines to India and other emerging economies next year, Reuters reported. That includes both the vaccine being developed by AstraZeneca and the one being developed by Novavax. Those vaccines will be available in 92 countries and be priced at $3 per dose.

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In sur­pris­ing set­back, com­bo of Roche’s Tecen­triq and chemo fails to help pa­tients with triple-neg­a­tive breast can­cer

Roche broke ground last year when they secured the first FDA approval for a checkpoint therapy in triple-negative breast cancer, a notoriously difficult-to-treat indication that has been passed over by the wave of targeted therapies.

Now, though, doctors are puzzling over why a combination of drugs meant to make that therapy more potent instead appeared to make it less effective.

Roche said Thursday that in a Phase III trial, combining their PD-1/L1 checkpoint therapy Tecentriq with the chemotherapy paclitaxel, did not significantly improve progression-free survival for patients with locally advanced or metastatic triple-negative breast cancer over giving those patients chemotherapy alone. In fact, patients on the Tecentriq-chemo arm had lower overall survival than patients on chemo, although the drugmaker cautioned that the trial was not powered for that endpoint and the data were immature.

Jan Hatzius (Photographer: Christopher Goodney/Bloomberg via Getty Images)

When will it end? Gold­man econ­o­mist gives late-stage vac­cines a good shot at tar­get­ing 'large shares' of the US by mid-2021 — but the down­side is daunt­ing

It took decades for hepatitis B research to deliver a slate of late-stage candidates capable of reining the disease in.

With Covid-19, the same timeline has devoured all of 5 months. And the outcome will influence the lives of billions of people and a multitrillion-dollar world economy.

Count the economists at Goldman Sachs as optimistic that at least one of these leading vaccines will stay on this furiously accelerated pace and get over the regulatory goal line before the end of this year, with a shot at several more near-term OKs. That in turn should lead to the production of billions of doses of vaccines that can create herd immunity in the US by the middle of next year, with Europe following a few months later.

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J&J gets a fresh OK for es­ke­t­a­mine, but is it re­al­ly the game-chang­er for de­pres­sion Trump keeps tweet­ing about?

Backed by an enthusiastic set of tweets from President Trump and a landmark OK for depression, J&J scooped up a new approval from the FDA for Spravato today. But this latest advance will likely bring fresh scrutiny to a drug that’s spurred some serious questions about the data, as well as the price.

First, the approval.

Regulators stamped their OK on the use of Spravato — developed as esketamine, a nasal spray version of the party drug Special K or ketamine — for patients suffering from major depressive disorder with acute suicidal ideation or behavior.

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President Trump (AP Images)

UP­DAT­ED: FDA takes the lead on defin­ing es­sen­tial un­der Trump's 'Buy Amer­i­can' ex­ec­u­tive or­der — as phar­ma warns of sup­ply chain dis­rup­tion

President Donald Trump has signed an executive order detailing how the federal government should help on-shore drug manufacturing — and the FDA will play a central role.

The agency now has three months to draw up the list of “essential medicines, medical countermeasures, and their critical inputs” that the US must have available at all times. Various departments and agencies are then directed to buy these drugs and their ingredients from American manufacturers.

Douglas Fambrough, Dicerna CEO (Boehringer Ingelheim via YouTube)

Roche-backed Dicer­na push­es in­to the pack rac­ing to­ward the block­buster hep B goal line, armed with PhI da­ta

Dicerna has lined up a set of proof-of-concept data from a small cohort of hepatitis B patients in a match-up against some heavyweight rivals which got out in front of this race. And right in the front row you’ll find a team from Roche, which paid $200 million in cash and offered another $1.5 billion in milestones to partner with Dicerna $DRNA on their RNAi program for hep B.

Right now it’s looking competitive, with lots of big challenges ahead.

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