Roche sells off its strug­gling IL-13 drug le­brik­izum­ab in $1.4B Der­mi­ra deal

Af­ter watch­ing its late-stage asth­ma pro­gram for its IL-13 drug le­brik­izum­ab floun­der with mixed and marked­ly unim­pres­sive re­sults, Roche is out­li­cens­ing the bulk of the de­vel­op­ment rights to Der­mi­ra $DERM in a $1.4 bil­lion deal — which starts off with $135 mil­lion in near-term cash.

Der­mi­ra is plan­ning to hus­tle its new drug di­rect­ly in­to a Phase IIb study for atopic der­mati­tis so it can line up a dose as quick­ly as pos­si­ble that re­searchers can take in­to Phase III.

The phar­ma gi­ant, which once count­ed le­brik­izum­ab as one of its top late-stage ef­forts, is set­tling for $80 mil­lion up­front, $55 mil­lion next year, $40 mil­lion on the Phase III launch and an­oth­er $1.24 bil­lion in mile­stones. It’s al­so keep­ing de­vel­op­ment rights to in­ter­sti­tial lung dis­eases, such as id­io­path­ic pul­monary fi­bro­sis.

The bloom came off the rose on le­brik­izum­ab in ear­ly 2016, when it scored one win and one loss in iden­ti­cal Phase III stud­ies for asth­ma. The set­back came as Re­gen­eron/Sanofi were rack­ing up stel­lar da­ta from a slate of tri­als for Dupix­ent — ap­proved for atopic der­mati­tis in late March — as ri­vals from As­traZeneca, Te­va and GSK were ei­ther en­ter­ing the mar­ket or in late-stage de­vel­op­ment.

Eu­gene Bauer

The re­sults were pub­lished in The Lancet Res­pi­ra­to­ry Med­i­cine, which al­so con­clud­ed that Roche’s two Phase III stud­ies for le­brik­izum­ab fell far short of the bar on ef­fi­ca­cy. A sum­ma­ry con­demns the drug with slight crit­i­cism:

The find­ings sug­gest that the drug, which blocks IL-13, may not be suf­fi­cient to pro­vide clin­i­cal­ly mean­ing­ful im­prove­ments in re­duc­ing asth­ma ex­ac­er­ba­tions.

Ever­core ISI’s Umer Raf­fat says he was in­trigued by the Phase II atopic der­mati­tis da­ta on this drug, which looks com­pa­ra­ble to Dupix­ent but may not stand up for the land haul.

He adds that “this could be a po­ten­tial $1B+ op­por­tu­ni­ty (amidst a po­ten­tial ~$5B atopic der­mati­tis class for bi­o­log­ics as per con­sen­sus),” but if so, why would Roche sell off rights to a block­buster?

That ques­tion seemed to weigh on in­vestors to­day, as Der­mi­ra’s shares grad­u­al­ly buck­led, drop­ping 15% by late af­ter­noon.

Find­ing out what this drug can do in atopic der­mati­tis won’t come cheap. Af­ter you add in the ear­ly pay­ments to Roche, Der­mi­ra says it will spend about $200 mil­lion on land­ing the Phase IIb da­ta. At that point, it will have a much bet­ter idea of where it stands.

“Le­brik­izum­ab is a po­tent and spe­cif­ic in­hibitor of IL-13 with a dif­fer­en­ti­at­ed mech­a­nism of ac­tion and at­trac­tive phar­ma­co­ki­net­ic prop­er­ties,” said Eu­gene Bauer, chief med­ical of­fi­cer of Der­mi­ra. “Da­ta from pre­clin­i­cal and clin­i­cal stud­ies, in­clud­ing phar­ma­co­ki­net­ic and phar­ma­co­dy­nam­ic re­sults from ear­ly clin­i­cal ex­pe­ri­ence in atopic der­mati­tis, are en­cour­ag­ing and sug­gest high­er dos­es of le­brik­izum­ab could lead to greater ef­fi­ca­cy in atopic der­mati­tis, while po­ten­tial­ly of­fer­ing a less fre­quent and there­fore more con­ve­nient dos­ing reg­i­men rel­a­tive to ex­ist­ing ther­a­pies. If suc­cess­ful­ly de­vel­oped, we be­lieve that le­brik­izum­ab could be a best-in-class IL-13 in­hibitor and could have a best-in-dis­ease pro­file.”

Clin­i­cal tri­al di­ver­si­ty da­ta show mis­match be­tween en­roll­ment and dis­ease preva­lence, GSK says

A lack of diversity in clinical trials has persisted despite decades of initiatives to try to turn the tide.

In a recent review of 17 years of clinical trials, drugmaker GSK found that there were some mismatches between the demographics of its US-based trials and how prevalent diseases were in those populations.

The results, the company says, will help GSK and others design studies that better represent epidemiological rates within races and ethnicities.

Jean-Paul Clozel, Idorsia CEO (Patrick Straub/Keystone via AP Images)

Idor­si­a's brain bleed drug flunks PhI­II tri­al, a decade af­ter pre­vi­ous flop

Idorsia’s long journey with clazosentan came to an abrupt “unexpected result” Monday morning with a Phase III flop.

The Swiss biopharma said the drug did not meet the main goal of the late-stage REACT study, conducted in the US, Canada and Europe since early 2019.

The 409-patient trial tested the intravenous drug’s ability to prevent complications due to delayed cerebral ischemia following aneurysmal subarachnoid hemorrhage (aSAH), in which blood vessels in the brain narrow and blood accumulates around the brain’s surface, which then dials up the pressure on the brain.

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Kenji Yasukawa, Astellas CEO (Photographer: Akio Kon/Bloomberg via Getty Images)

Astel­las taps chief strat­e­gy of­fi­cer as next CEO to 'go on the ag­gres­sive'

Five years into its big R&D revamp, Astellas says it’s time for a changing of the guard.

Kenji Yasukawa, who took over as president and CEO in 2018, will step down to become chairman of the board in April, making room for Naoki Okamura to take over. Okamura joined the company in 1986 and has served in a variety of finance, business and strategy roles, including most recently as chief strategy officer.

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The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; 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.

With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

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Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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Giovanni Caforio, Bristol Myers Squibb CEO (Nicolas Messyasz/Sipa via AP Images)

Bris­tol My­ers turns at­ten­tion to new prod­ucts in wake of Revlim­id patent loss

Bristol Myers Squibb CEO Giovanni Caforio is shifting his focus to newer products as generic sales continue to gnaw at the company’s blockbuster myeloma drug Revlimid.

Both Revlimid and Abraxane sales took a dive last year thanks to generic rivals, BMS reported in its Q4 and full-year results on Thursday. As a result, Q4 sales dipped 5% and full-year sales remained flat. However, Caforio sees a silver lining — or rather, two of them.

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Rob Davis, Merck CEO

Mer­ck’s Keytru­da nears $21B in sales, dou­bles down on com­bo tri­als

Merck’s cancer immunotherapy Keytruda notched sales of $20.9 billion in 2022, cementing its status as one of the world’s top-selling drugs. However, it’s far from resting on that accomplishment.

Merck executives touted nine ongoing trials in its annual earnings call on Thursday, including five studies in Phase III, for Keytruda (pembrolizumab) in combination with other immuno-oncology drugs. The trials include combinations with Merck’s own developments as well as other pharma companies’ candidates, including its melanoma collaboration with Moderna and its mRNA technology plus Keytruda, aimed at creating a personalized vaccine treatment to reduce the risk of cancer recurrence or death.

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Uğur Şahin, BioNTech CEO (Andreas Arnold/picture-alliance/dpa/AP Images)

BioN­Tech opens new plas­mid DNA man­u­fac­tur­ing fa­cil­i­ty in Ger­many

German mRNA player BioNTech opened the doors to a new manufacturing facility on Thursday, this one just about 75 miles north of its headquarters in Mainz, Germany.

BioNTech announced on Thursday that it has completed the construction of its first plasmid DNA manufacturing facility in Marburg, Germany. The facility will produce materials for mRNA-based vaccines and therapies along with cell therapies.

FDA ap­proves GSK's ane­mia drug with safe­ty warn­ing — af­ter bat­ting back sim­i­lar drugs

GSK has secured the first of four US approvals it’s hoping for this year, as the FDA greenlit daprodustat as a treatment for anemia due to chronic kidney disease.

But the FDA limited the use of the drug, to be marketed as Jesduvroq, to patients who have been receiving dialysis for at least four months and stopped short of approving it for patients not dependent on dialysis — in line with the recommendations of the advisory committee it consulted.

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