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.”

Scott Gottlieb, AP Images

Scott Got­tlieb is once again join­ing a team that en­joyed good times at the FDA un­der his high-en­er­gy stint at the helm

Right after jumping on Michael Milken’s FasterCures board on Monday, the newly departed FDA commissioner is back today with news about another life sciences board post that gives him a ringside chair to cheer on a lead player in the real-world evidence movement — one with very close ties to the FDA.

Aetion is reporting this morning that Gottlieb is joining their board, a group that includes Mohamad Makhzoumi, a general partner at New Enterprise Associates, where Gottlieb returned after stepping out of his role at the FDA 2 years after he started.

Gottlieb — one of the best connected execs in biopharma — knows this company well. As head of FDA he championed the use of real-world evidence to help guide drug developers and the agency in gaining greater efficiencies, which helped set up Aetion as a high-profile player in the game.

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San Diego cou­ple charged with steal­ing trade se­crets, open­ing Chi­nese biotech as DOJ crack­down con­tin­ues

A San Diego couple has been charged with stealing trade secrets from a US hospital and opening a business based off those secrets in China as the controversial industry-wide crackdown on alleged corporate espionage continues. On the same day, the Department of Justice announced they had arrested Beijing representative Zhongsan Liu for allegedly trying to obtain research visas for government recruiters.

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Deborah Dunsire. Lundbeck

UP­DAT­ED: Deb­o­rah Dun­sire is pay­ing $2B for a chance to leap di­rect­ly in­to a block­buster show­down with a few of the world's biggest phar­ma gi­ants

A year after taking the reins as CEO of Lundbeck, Deborah Dunsire is making a bold bid to beef up the Danish biotech’s portfolio of drugs in what will likely be a direct leap into an intense rivalry with a group of giants now carving up a growing market for new migraine drugs.

Bright and early European time Monday morning the company announced that it will pay up to about $2 billion to buy Alder, a little biotech that is far along the path in developing a quarterly IV formulation of a CGRP drug aimed at cutting back the number of crippling migraines patients experience each month. In a followup call, Dunsire also noted that the company will likely need 200 to 250 reps for this marketing task on both sides of the Atlantic. And analysts were quick to note that the dealmaking at Lundbeck isn’t done, with another $2 billion to $3 billion available for more deals to beef up the pipeline.

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Tower Bridge in London [Shutterstock]

#UK­BIO19: Join GSK’s Hal Bar­ron and a group of top biotech ex­ecs for our 2nd an­nu­al biotech sum­mit in Lon­don

Over the past 10 years I’ve made a point of getting to know the Golden Triangle and the special role the UK biopharma industry plays there in drug development. The concentration of world class research institutes, some of the most accomplished scientists I’ve ever seen at work and a rising tide of global investment cash leaves an impression that there’s much, much more to come as biotech hubs are birthed and nurtured.

UP­DAT­ED: Bio­gen pulls the plug on prized IPF drug from $562M+ Stromedix buy­out

One of Biogen’s attempts to branch out has flopped as the biotech scraps a mid-stage program for idiopathic pulmonary fibrosis.

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Warts for the win: Aclar­is' lead drug clears piv­otal study

Aclaris Therapeutics has found a way to get rid of the warts and all.

The company — which earlier this month decided to focus on its arsenal of kinase inhibitors — on Monday unveiled positive data from a pivotal study testing its lead experimental drug for use in common warts.

The drug, A-101, was tested in a 502-patient study called THWART-2 — patients enrolled had one to six warts before qualifying for the trial. Patients either self-administered A-101 topical solution or a vehicle twice a week over a two-month period. A higher proportion of patients on the drug (a potent hydrogen peroxide topical solution) saw their warts disappear at day 60, versus the vehicle (p<0.0001) — meeting the main goal of the study.  Each secondary endpoint also emerged in favor of A-101, the company said.

Charles Nichols, LSU School of Medicine

Could psy­che­delics tack­le the obe­si­ty cri­sis? A long­time re­searcher in the field says his lat­est mouse study sug­gests po­ten­tial

Psychedelics have experienced a renaissance in recent years amid a torrent of preclinical and clinical research suggesting it might provide a path to treat mood disorders conventional remedies have only scraped at. Now a preclinical trial from a young biotech suggests at least one psychedelic compound has effects beyond the mind, and — if you believe the still very, very early hype — could provide the first single remedy for some of the main complications of obesity.

It’s fi­nal­ly over: Bio­gen, Ei­sai scrap big Alzheimer’s PhI­I­Is af­ter a pre­dictable BACE cat­a­stro­phe rais­es safe­ty fears

Months after analysts and investors called on Biogen and Eisai to scrap their BACE drug for Alzheimer’s and move on in the wake of a string of late-stage failures and rising safety fears, the partners have called it quits. And they said they were dropping the drug — elenbecestat — after the independent monitoring board raised concerns about…safety.

We don’t know exactly what researchers found in this latest catastrophe, but the companies noted in their release that investigators had determined that the drug was flunking the risk/benefit analysis.

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Ac­celeron drops a de­vel­op­ment pro­gram as #2 drug fails to spark func­tion­al ben­e­fits in pa­tients with a rare neu­ro­mus­cu­lar ail­ment

Acceleron is scrapping a muscular dystrophy development program underway for its number 2 drug in the pipeline after pouring over some failed mid-stage secondary data.

Gone is the ACE-083 project in patients with facioscapulohumeral muscular dystrophy. Their drug hit the primary endpoint on building muscle but flopped on key secondaries for functional improvements in patients, which execs felt was vital to the drug’s success.