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.”

Alexander Lefterov/Endpoints News

A new can­cer im­munother­a­py brings cau­tious hope for a field long await­ing the next big break­through

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

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In a set­back, FDA or­ders Gilead to hit the brakes on their late-stage, $5B can­cer play

Gilead’s $5 billion drug magrolimab has run into a serious setback.

The FDA ordered Gilead to halt enrollment on their studies of the drug in combination with azacitidine after investigators reports revealed an “apparent imbalance” in the suspected unexpected serious adverse reactions between study arms. And the halt is raising questions about Gilead’s plans for a quick pitch to regulators.

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Bahija Jallal, Immunocore CEO

BREAK­ING: FDA hur­ries up a quick ap­proval for the world's first TCR -- af­ter a 14-year R&D trek

Over the 14 years since Immunocore was spun out of MediGene in a quest to develop a gamechanging cancer med, the biotech has raised record sums and undergone a major shakeup on a long roller coaster ride of valuations for investors. But they survived and thrived and today they’re popping the champagne corks to celebrate an FDA approval of their first TCR drug.

Immunocore flagged the FDA’s green light for tebentafusp Wednesday morning by highlighting a series of firsts.

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Dominic Borie, Kyverna Therapeutics CEO

Well-con­nect­ed, Gilead-backed biotech gets an­oth­er stack of cash to pur­sue CAR-Ts for au­toim­mune dis­ease

Almost exactly two years after its debut at the 2020 JP Morgan confab — and on the heels of a new partnership with the gene editing experts at Intellia — a Gilead-backed, autoimmune disease-focused startup has returned to the well with a clearer outline of just what it plans to do with its CAR-T platform.

Kyverna brought in $85 million in its oversubscribed Series B, the company announced Wednesday. Northpond Ventures led the round, and Westlake Village BioPartners, Vida Ventures, Gilead and Intellia all contributed as well.

Days af­ter Gilead yanks PI3K drug, In­cyte with­draws NDA for its own PI3K — say­ing con­fir­ma­to­ry tri­als would take too long

The FDA’s intensifying scrutiny on accelerated approvals isn’t just putting pressure on drugmakers with marketed products. It is also subtly reshaping the regulatory dynamics.

Case in point: Incyte announced late Tuesday that it has made the “business decision” to withdraw an NDA for parsaclisib, its oral PI3Kδ inhibitor, after deciding that running the confirmatory studies the agency was asking for to support an accelerated approval wouldn’t be worth it.

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Roy Baynes, Merck

FDA bats back Mer­ck’s ‘pipeline in a prod­uct,’ de­mands more ef­fi­ca­cy da­ta

Despite some heavy blowback from analysts, Merck execs maintained an upbeat attitude about the market potential of its chronic cough drug gefapixant. But the confidence may be fading somewhat today as Merck puts out news that the FDA is handing back its application with a CRL.

Dubbed by Merck’s development chief Roy Baynes as a “pipeline in a product” with a variety of potential uses, Merck had fielded positive late-stage data demonstrating the drug’s ability to combat chronic cough. The drug dramatically reduced chronic cough in Phase III, but so did placebo, leaving Merck’s research team with a marginal success on the p-value side of the equation.

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Graphic: Alexander Lefterov for Endpoints News

Small biotechs with big drug am­bi­tions threat­en to up­end the tra­di­tion­al drug launch play­book

Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

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Mar­ket­ingRx roundup: Pfiz­er de­buts Pre­vnar 20 TV ads; Lil­ly gets first FDA 2022 pro­mo slap down let­ter

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

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Florida Gov. Ron DeSantis (AP Photo/Wilfredo Lee, File)

Opin­ion: Flori­da is so mAb crazy, Ron De­San­tis wants to use mAbs that don't work

Florida Gov. Ron DeSantis is trying so hard to politicize the FDA and demonize the federal government that he entered into an alternate universe on Monday evening in describing a recent FDA action to restrict the use of two monoclonal antibody, or mAb, treatments for Covid-19 that don’t work against Omicron.

Without further ado, let’s break down his statement from last night, line by line, adjective by adjective.