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.”

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

15 LGBTQ lead­ers in bio­phar­ma; Paul Stof­fels’ Gala­pa­gos re­vamp; As­traZeneca catch­es up in AT­TR; 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.

A return to in-person conferences also marks a return to on-the-ground reporting. My colleagues Beth Synder Bulik and Nicole DeFeudis were on-site at Cannes Lions, bringing live coverage of pharma’s presence at the ad festival — accompanied by photos from Clara Bui, our virtual producer, that bring you right to the scene. You can find a recap (and links to all the stories) below.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,300+ biopharma pros reading Endpoints daily — and it's free.

AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,300+ biopharma pros reading Endpoints daily — and it's free.

Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

De­spite a slow start to the year for deals, PwC pre­dicts a flur­ry of ac­tiv­i­ty com­ing up

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.

Joe Wiley, Amryt Pharma CEO

Am­ryt Phar­ma sub­mits a for­mal dis­pute res­o­lu­tion to the FDA over re­ject­ed skin dis­ease drug

The story of Amryt Pharma’s candidate for the genetic skin condition epidermolysis bullosa, or EB, will soon enter another chapter.

After the Irish drugmaker’s candidate, dubbed Oleogel-S10 and marketed as Filsuvez, was handed a CRL earlier this year, the company announced in a press release that it plans to submit a formal dispute resolution request for the company’s NDA for Oleogel-S10.

Sen. Thom Tillis (R-NC) (J. Scott Applewhite/AP Images)

Phar­ma-friend­ly sen­a­tor calls on FDA for a third time to show patent pro­tec­tions should­n't be blamed for high drug prices

North Carolina Republican Sen. Thom Tillis made a name for himself in the 2020 election cycle as the darling of the pharma industry, accepting hundreds of thousands in campaign contributions, even from the likes of Pfizer CEO Albert Bourla.

Those contributions have led Tillis to attempt to re-write patent laws in pharma’s favor, a move which failed to gain steam in 2019, and request for a third time since January that the FDA should help stop “the false narrative that patent protections are to blame for high drug prices.”

EMA signs off on 3 drugs re­cent­ly re­ject­ed by FDA, in­clud­ing Bio­Mar­in's new he­mo­phil­ia gene ther­a­py

The EMA’s human medicines committee on Friday recommended three new drugs for approval or conditional approval, even as their US counterparts have rejected these three for various reasons.

In a major move, CHMP offered a thumbs-up to a conditional marketing authorization for the first gene therapy to treat severe hemophilia A, although the agency cautioned that it’s so far unknown how long the effects of infusion will last.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,300+ biopharma pros reading Endpoints daily — and it's free.

Joe Papa (Ryan Remiorz/The Canadian Press via AP, File)

Joe Pa­pa re­signs as chair of Bausch Health as bil­lion­aire John Paul­son takes over

Joe Papa, chair of Bausch Health, officially resigned on Thursday and the board appointed billionaire hedge fund manager John Paulson as the new chair, effective immediately.

The specialty pharma company sought to make clear that Papa’s abrupt departure “was not due to any dispute or disagreement with the Company, its management or the Board on any matter relating to the Company’s operations, policies or practices.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,300+ biopharma pros reading Endpoints daily — and it's free.