Eli Lil­ly un­veils piv­otal da­ta from the star of its Der­mi­ra buy­out. But can it ri­val Dupix­ent in atopic der­mati­tis?

It’s been just over a year and a half since Eli Lil­ly shelled out $1.1 bil­lion for Der­mi­ra and its old Roche castoff le­brik­izum­ab for atopic der­mati­tis. Now the phar­ma says it has the Phase III re­sults it was look­ing for — but are they good enough to ri­val Re­gen­eron and Sanofi’s block­buster Dupix­ent?

Ac­cord­ing to topline re­sults, the IL-13 in­hibitor helped more than half of adults and ado­les­cents in two tri­als achieve at least 75% clear­ance of their eczema (mea­sured by the Eczema Area and Sever­i­ty In­dex). The stud­ies met the pri­ma­ry and key sec­ondary end­points at Week 16, Eli Lil­ly said on Mon­day, in­clud­ing skin clear­ance and itch im­prove­ment.

The stud­ies — dubbed AD­vo­cate 1 and AD­vo­cate 2 — are part of five on­go­ing le­brik­izum­ab stud­ies, in­clud­ing two monother­a­py stud­ies and a com­bi­na­tion study. There are al­so longterm ex­ten­sion and ado­les­cent open la­bel tri­als in the works. The re­cent stud­ies en­rolled adults and ado­les­cents be­tween the ages of 12 and 18 with mod­er­ate-to-se­vere AD.

AD, al­so known as atopic eczema, is known to cause an in­tense, per­sis­tent itch that can af­fect sleep and dai­ly ac­tiv­i­ties.

In a Phase IIb study, a 250 mg dose of le­brik­izum­ab helped 44.6% of pa­tients achieve clear­ing or near-clear­ing of skin le­sions, as mea­sured by an IGA score of 0 or 1, and a re­duc­tion of at least 2 points from base­line, com­pared to 15.3% with place­bo (p=0.0023). And 60.6% of le­brik­izum­ab treat­ed pa­tients achieved a re­duc­tion of at least 75% from base­line in EASI-75, com­pared to 24.3% on place­bo (p=0.0005).

Eli Lil­ly says the full re­sults from AD­vo­cate 1 and 2 are com­ing in 2022.

And ac­cord­ing to some an­a­lysts, the num­bers bet­ter be good if Eli Lil­ly wants to chal­lenge Dupix­ent. The lat­ter is al­ready ap­proved for ado­les­cents and chil­dren as young as 6 years old with atopic der­mati­tis — and last year, the drug net­ted just over $4 bil­lion, ac­cord­ing to Sanofi. When com­bined with top­i­cal cor­ti­cos­teroids, 75% of chil­dren who re­ceived Dupix­ent in a Phase III tri­al achieved EASI-75, com­pared to just un­der 30% of pa­tients who got the cor­ti­cos­teroids alone, Re­gen­eron and Sanofi said.

When Eli Lil­ly ac­quired le­brik­izum­ab last Jan­u­ary, Jef­feries’ Biren Amin wrote:

While ini­tial ef­fi­ca­cy is promis­ing, we think the pro­file is not yet suf­fi­cient to dif­fer­en­ti­ate from Dupi, con­sid­er­ing the lat­ter’s first-to-mar­ket ad­van­tage. Fur­ther­more, the AD land­scape is in­creas­ing­ly com­pet­i­tive, which sug­gests new en­trants will face an ever-in­creas­ing bar to dif­fer­en­ti­ate from Dupi and each oth­er.

Lil­ly made it clear that le­brik­izum­ab was the star of its $1.1 bil­lion buy­out, lat­er sell­ing three an­ti-in­flam­ma­to­ry can­di­dates back to Der­mi­ra vets and mak­ing plans to shut­ter the biotech’s Men­lo Park fa­cil­i­ty, putting 163 jobs on the chop­ping block.

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.

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David Loew (Ipsen)

Ipsen snags an ap­proved can­cer drug in $247M M&A deal as an­oth­er bat­tered biotech sells cheap

You can add Paris-based Ipsen to the list of discount buyers patrolling the penny stock pack for a cheap M&A deal.

The French biotech, which has had plenty of its own problems to grapple with, has swooped in to buy Epizyme $EPZM for $247 million in cash and a CVR with milestones attached to it. Epizyme shareholders, who had to suffer through a painfully soft launch of their EZH2a inhibitor cancer drug Tazverik, will get $1.45 per share along with a $1 CVR tied to achieving $250 million in sales from the drug over four consecutive quarters as well as an OK for second-line follicular lymphoma by 1 Jan. 2028.

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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.

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GSK says its drug for chron­ic hep B could ‘lead to a func­tion­al cure’ — but will it be alone or in com­bi­na­tion?

GSK, newly branded and soon-to-be demerged, shared interim results from its Phase II trial on its chronic hepatitis B treatment, one that it says has the “potential to lead to a functional cure.”

At a presentation at the EASL International Liver Congress, GSK shared that in around 450 patients who received its hep B drug bepirovirsen for 24 weeks, just under 30% had hepatitis B surface antigen and viral DNA levels that were too low to detect.

Sanofi, GSK tout 72% Omi­cron ef­fi­ca­cy in PhI­II tri­al of next-gen, bi­va­lent shot — with an eye to year-end roll­out

Sometimes, being late can give you an advantage.

That’s what Sanofi and GSK are trying to say as the Big Pharma partners report positive results from a late-stage trial of their next-gen bivalent Covid-19 vaccine, which was designed to protect against both the original strain of the SARS-CoV-2 virus and the Beta variant. Specifically, against Omicron, they note, the vaccine delivered 72% efficacy in all adults and 93.2% in those previously infected.

Matt Kapusta, uniQure CEO

In trou­bled Hunt­ing­ton’s space, uniQure’s gene ther­a­py shows ear­ly promise

In randomized clinical trial data from a small number of patients, Dutch biotech uniQure shared that its gene therapy for Huntington’s disease seems to reduce the amount of the mutant protein responsible for the disease over the course of a year.

In seven patients with early-stage Huntington’s — four who got the treatment and three who got a placebo — mutant huntingtin protein levels in the cerebrospinal fluid decreased by an average of just over 50% in patients who got the gene therapy compared to around a 17% drop in patients who got the placebo after a year.

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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.

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.”