As­traZeneca shuf­fles the deck, deals out a new hand for two trou­bled drugs

Sev­er­al months ago, an As­traZeneca spokesman in­sist­ed that the late-stage tralok­inum­ab may have been qui­et­ly dropped for id­io­path­ic pul­monary fi­bro­sis, but the IL-13 ther­a­py still had re­al po­ten­tial for asth­ma and atopic der­mati­tis (AD); even af­ter fail­ing a Phase IIb study last year.

To­day, the phar­ma gi­ant an­nounced that it has out­li­censed tralok­inum­ab’s glob­al AD rights to Leo Phar­ma for $115 mil­lion in cash and up to a bil­lion dol­lars in mile­stones. And as an ex­tra, the com­pa­ny is al­so trans­fer­ring Eu­ro­pean rights on the ques­tion­able bro­dalum­ab pro­gram over to Leo, get­ting that back from a deeply dys­func­tion­al Valeant Phar­ma.

As­traZeneca once in­sist­ed it thought high­ly of bro­dalum­ab as well, even af­ter Am­gen bailed on its part­ner­ship af­ter con­clud­ing that the sui­ci­dal think­ing the drug trig­gered in some pa­tients made it com­mer­cial­ly un­vi­able in a crowd­ed field. In the end, though, As­traZeneca doesn’t hes­i­tate to of­fload drugs that don’t fit its pipeline pro­file any more.

As­traZeneca says that it will now fo­cus on its Phase III study for asth­ma.

It was a dif­fer­ent sto­ry ear­li­er in the year.

“It is well ac­cept­ed that the dis­ease patho­phys­i­ol­o­gy un­der­ly­ing IPF is both com­plex and very dif­fer­ent to that of asth­ma and AD (atopic der­mati­tis). IL-13 is a key Th2 cy­tokine im­pli­cat­ed in both asth­ma and AD and we are com­mit­ted to the on­go­ing pro­gram of stud­ies,” the com­pa­ny said in a state­ment at the time.

Now, it’s just stick­ing with asth­ma, even though Roche has al­so had trou­ble with its ri­val IL-13 drug le­brik­izum­ab.

Luke Miels, Ex­ec­u­tive Vice Pres­i­dent, Glob­al Prod­uct and Port­fo­lio Strat­e­gy, As­traZeneca, said: “This agree­ment al­lows us to con­cen­trate our ef­forts on tralok­inum­ab’s po­ten­tial for pa­tients with se­vere asth­ma, a pri­or­i­ty area for As­traZeneca, while ben­e­fit­ting from LEO Phar­ma’s ex­per­tise in der­ma­tol­ogy for the con­tin­ued de­vel­op­ment and com­mer­cial­i­sa­tion of tralok­inum­ab in atopic der­mati­tis and oth­er der­ma­tol­ogy con­di­tions.”

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: Pfiz­er teams with Gilead on remde­si­ivr; Japan, Brazil, Switzer­land, In­dia get vac­cines

Pfizer has joined the list companies helping Gilead manufacture remdesivir. The pharma giant announced today they signed a multi-year agreement to provide Gilead with contract manufacturing services at their McPherson, Kansas plant. The deal is part of a broad effort by Gilead to scale up the drug, the only currently authorized therapy for Covid-19, to 2 million doses this year.

That effort now includes 40 different companies on 3 continents, according to a press release the biotech put out yesterday, not including the generic drugmakers the company has allowed to produce the anti-viral for low and middle-income countries. Dozens of state governments, though, have said those efforts have not been extensive enough to keep up with demand and have called upon the federal government to sidestep Gielad’s patents and begin scaling the drug itself.  – Jason Mast

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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.

President Trump (AP Images)

FDA takes the lead on defin­ing es­sen­tial un­der Trump's 'Buy Amer­i­can' ex­ec­u­tive or­der — as in­dus­try 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.

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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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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