Lilly CEO David Ricks (Photographer: David Paul Morris/Bloomberg via Getty Images)

Eli Lil­ly ver­sus the 800-pound go­ril­la in atopic der­mati­tis? It may just have a shot — at 2nd place

Eli Lil­ly turned a few heads when the mar­ket ma­jor bought out the IL-13 le­brik­izum­ab for $1.1 bil­lion a lit­tle more than 2 years ago. And late last year it kept up the rah-rah when CEO Dave Ricks tapped this drug as a top-5 drug in the late-stage pipeline.

Could El­li Lil­ly and Eu­ro­pean part­ner Almi­rall re­al­ly think they could take on the Il-13/IL-4 Dupix­ent, the 800-pound bi­o­log­ic go­ril­la in atopic der­mati­tis, from Re­gen­eron and Sanofi?

Over the week­end, though, they man­aged to turn a few more heads with the de­fin­i­tive — and quite pos­i­tive — Phase III da­ta they’re tak­ing to the FDA. Now the ques­tion isn’t can they com­pete, but is it good enough to change the course of one of the in­dus­try’s most suc­cess­ful drug fran­chis­es?

We knew the top-line re­sults were pos­i­tive go­ing in­to the de­tailed re­veal. But when you are tak­ing on a dom­i­nant play­er in a field, every­one wants to see how it com­pares to the ti­tle­hold­er. And Jef­feries ran those num­bers, flag­ging 2 crit­i­cal cross-com­par­isons:

  • EASI-75: le­brik­izum­ab 33%-43% vs Dupix­ent 32%-36%
  • IGA 0 or 1: le­brik­izum­ab 22%-30% vs Dupix­ent 28%

As an­tic­i­pat­ed, le­brik­izum­ab ap­pears su­pe­ri­or when it comes to ef­fi­ca­cy treat­ing itch, the key symp­tom of is­sue for pa­tients, with 27%-34% im­prove­ment no­table ver­sus Dupix­ent 26%-29%, in our view.

Giv­en Dupix­ent’s mar­ket-crush­ing dom­i­nance, com­pa­ra­ble da­ta are good da­ta. But Jef­feries al­so notes that one of the key com­par­isons they were look­ing ea­ger­ly to com­pare, in­ci­dents of con­junc­tivi­tis, on­ly came out mar­gin­al­ly in le­brik­izum­ab’s fa­vor.

(W)e note the 7%-8% con­junc­tivi­tis is high­er than we were ex­pect­ing (2.7% in Phase IIb), and just be­low the 10% ob­served with Dupix­ent monother­a­py. Re­call, a po­ten­tial for low­er rates of con­junc­tivi­tis could have been con­sid­ered dif­fer­en­ti­at­ing for le­brik­izum­ab.

And that means that “main­te­nance da­ta 1H22E will be key to de­ter­mine po­ten­tial for more con­ve­nient 4-week­ly dos­ing vs Dupix­ent 2-week­ly.”

With bi­o­log­ics tapped to sig­nif­i­cant­ly grow mar­ket share, they con­clud­ed that their cur­rent €400m peak sales es­ti­mate was hold­ing firm.

Eli Lil­ly is no lit­tle biotech. It is a glob­al pow­er­house not­ed for a se­ries of steps for­ward — and back. On the oth­er hand, Sanofi plus Re­gen­eron has turned out to be the pow­er play­er to beat for the bi­o­log­ics share of atopic der­mati­tis. Both are in­tense­ly sales-fo­cused on the mar­ket­ing side, and Dupix­ent has now had 5 long years to es­tab­lish it­self with physi­cians and pa­tients.

Beat­ing Dupix­ent with these da­ta seems out of the ques­tion right now. But the fact that Lil­ly may just land a blow or two looks like a big win — pro­vid­ed no nasty sur­pris­es await be­tween now and a pre­sumed FDA ap­proval.

IDC: Life Sci­ences Firms Must Em­brace Dig­i­tal Trans­for­ma­tion Now

Pre-pandemic, the life sciences industry had settled into a pattern. The average drug took 12 years and $2.9 billion to bring to market, and it was an acceptable mode of operations, according to Nimita Limaye, Research Vice President for Life Sciences R&D Strategy and Technology at IDC.

COVID-19 changed that, and served as a proof-of-concept for how technology can truly help life sciences companies succeed and grow, Limaye said. She recently spoke about industry trends at Egnyte’s Life Sciences Summit 2022. You should watch the entire session, free and on-demand, but here’s a brief recap of why she’s urging life sciences companies to embrace digital transformation.

Paul Hudson, Sanofi CEO (Eric Piermont/AFP via Getty Images)

Up­dat­ed: Hit by an­oth­er PhI­II flop, Sanofi culls breast can­cer drug — sound­ing alarm for the class

Sanofi is officially giving up on its oral SERD.

The French drugmaker put out word Wednesday morning that it will discontinue the global development program of amcenestrant, the selective estrogen receptor degrader once billed as a top late-stage prospect. Having already failed a Phase II monotherapy test earlier this year, a combo with the drug also missed the bar in a second trial for breast cancer, triggering the decision to drop the whole program.

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Bayer's first DTC ad campaign for chronic kidney disease drug Kerendia spells out its benefits

Bay­er aims to sim­pli­fy the com­plex­i­ties of CKD with an ABC-themed ad cam­paign

Do you know the ABCs of CKD in T2D? Bayer’s first ad campaign for Kerendia tackles the complexity of chronic kidney disease with a play on the acronym (CKD) and its connection to type 2 diabetes (T2D).

Kerendia was approved last year as the first and only non-steroidal mineralocorticoid receptor antagonist to treat CKD in people with type 2 diabetes.

In the TV commercial launched this week, A is for awareness, B is for belief and C is for cardiovascular, explained in the ad as awareness of the connection between type 2 and kidney disease, belief that something can be done about it, and cardiovascular events that may be reduced with treatment.

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James Mock, incoming CFO at Moderna

Mod­er­na taps new CFO from PerkinElmer af­ter for­mer one-day CFO oust­ed

When Moderna hired a new CFO last year,  it didn’t expect to see him gone after only one day. Today the biotech named his — likely much more vetted — replacement.

The mRNA company put out word early Wednesday that after the untimely departure of then brand-new CFO Jorge Gomez, it has now found a replacement in James Mock, the soon-to-be former CFO at diagnostics and analytics company PerkinElmer.

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Tom Barnes, Orna Therapeutics CEO

UP­DAT­ED: 'We have failed to fail': Mer­ck gam­bles $250M cash on a next-gen ap­proach to mR­NA — af­ter punt­ing its big al­liance with Mod­er­na

Merck went in deep on its collaboration with Moderna on new mRNA programs, and dropped them all over time, including their RSV partnership. But after writing off what turned out as one of the most successful infectious disease players in the business, Merck is coming in this morning with a new preclinical alliance — this time embracing a biotech that hopes to eventually outdo the famously successful mRNA in a new run at vaccines and therapeutics.

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Joe Jonas (Photo by Anthony Behar/Sipa USA)(Sipa via AP Images)

So­lo Jonas broth­er car­ries Merz's new tune in Botox ri­val cam­paign

As the lyrics of his band’s 2019 pop-rock single suggest, Joe Jonas is only human — and that means even he gets frown lines. The 33-year-old singer-songwriter is Merz’s newest celebrity brand partner for its Botox rival Xeomin, as medical aesthetics brands target a younger audience.

Merz kicked off its “Beauty on Your Terms” campaign on Tuesday, featuring the Jonas brother in a video ad for its double-filtered anti-wrinkle injection Xeomin.

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Marisol Peron, Genmab SVP of communications and corporate affairs

Gen­mab launch­es cor­po­rate cam­paign am­pli­fy­ing its ‘knock your socks off’ an­ti­bod­ies

Genmab often talks about its “knock-your-socks-off” antibodies — and now the term is getting its own logo and corporate campaign.

The teal and purple logo for the acronym KYSO — Genmab pronounces it “ky-so” — debuts on Wednesday and comes on the heels of Genmab’s newly announced 2030 vision. That aspiration aims to expand Genmab’s drug development beyond oncology to include other serious diseases, while also doubling down on its own drug development.

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Kate Haviland, Blueprint Medicines CEO

Blue­print met all its end­points in bid for ex­pand­ed Ay­vak­it la­bel — but stock trends low­er any­way

Blueprint Medicines announced this morning that the second part of its study on Ayvakit in non-advanced systemic mastocytosis (SM) — a rare disease in which a type of white blood cells known as mast cells builds up — met all endpoints, but the biopharma left key questions unanswered.

In 212 patients, with 141 in the treatment arm and 71 in the control arm, patients who got Ayvakit saw an average 15.6-point decrease in their symptom scores compared to a 9.2-point decrease in the placebo arm at 24 weeks. In an extension study, those on Ayvakit saw their symptom scores drop by 20.2 points by week 48.

President Joe Biden signs the Democrats' landmark climate change and health care bill. From L-R: Sen. Joe Manchin (D-WV), Senate Majority Leader Chuck Schumer (D-NY), House Majority Whip James Clyburn (D-SC), Rep. Frank Pallone (D-NJ) and Rep. Kathy Castor (D-FL). (Susan Walsh/AP Images)

Pres­i­dent Biden signs ma­jor drug pric­ing re­forms in­to law: What's com­ing for bio­phar­ma?

President Joe Biden yesterday afternoon signed into law historic, decades-in-the-making new drug pricing reforms as part of a wider reconciliation bill that will likely take a chunk out of biopharma companies’ profits for some blockbusters just prior to generic or biosimilar competition.

The partisan bill (all Democrats in the House and Senate voted for it, and all Republicans voted against it) includes not only Medicare price negotiations — which won’t kick off until 2026, leaving ample time for a legal challenge — but mandatory inflation-related rebates, and a $2,000 annual cap on what seniors’ pay for their prescription drugs.

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