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.

Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; 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.

I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 157,500+ biopharma pros reading Endpoints daily — and it's free.

Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 157,500+ biopharma pros reading Endpoints daily — and it's free.

CBER Director Peter Marks (Susan Walsh/AP Images)

FDA ad­vi­so­ry com­mit­tee votes unan­i­mous­ly in fa­vor of bi­va­lent Covid shots re­plac­ing pri­ma­ry se­ries

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

No­var­tis' ap­proved sick­le cell dis­ease drug fails to beat place­bo in PhI­II

Novartis’ sickle cell drug, approved in 2019 and branded as Adakveo, has failed an ongoing Phase III, according to preliminary results.

The Swiss pharma giant unveiled early data from the ongoing STAND Phase III study on Friday, saying that crizanlizumab showed no statistically significant difference between the drug at two different dose levels compared to placebo in annualized rates of vaso-occlusive crises that lead to a healthcare visit over the first year since being randomized into the trial.

FDA ap­proves an­oth­er in­di­ca­tion for Keytru­da, this time in the ad­ju­vant NSCLC set­ting

Merck’s blockbuster cancer treatment Keytruda has been handed another indication by the FDA.

The US regulator announced on Thursday that it has approved Keytruda to serve as an adjuvant treatment for non-small cell lung cancer (NSCLC), which is its fifth indication in NSCLC and 34th indication overall.

According to a Merck release, the approval is based on data from a Phase III trial, dubbed Keynote-091, which measured disease-free survival in patients who received chemotherapy following surgery. The data from Merck displayed that Keytruda cut down on the risk of disease recurrence or death by 27% versus placebo.

Ying Huang, Legend CEO

J&J, Leg­end say Carvyk­ti beat stan­dard ther­a­py in ear­li­er-line blood can­cer

J&J and Legend Biotech’s next step in turning their CAR-T therapy Carvykti into a potential megablockbuster has succeeded, the companies said Friday.

Carvykti achieved the primary endpoint — progression-free survival — in an open-label Phase III study testing the treatment in second- to fourth-line multiple myeloma patients. The CARTITUDE-4 trial, for which there aren’t any hard data yet, represents the biggest development for Carvykti’s ability to compete with Bristol Myers Squibb’s Abecma since its approval last February.

Rodney Rietze, iVexSol CEO

Bris­tol My­ers, Charles Riv­er join Se­ries A fund­ing for iVex­Sol

Massachusetts-based iVexSol has secured funding to the tune of $23.8 million in its latest Series A round. The new investors include Bristol Myers Squibb, manufacturer Charles River Laboratories and Asahi Kasei Medical.

iVexSol is a manufacturer of lentiviral vectors (LVV), used in making gene therapies, and this latest round of fundraising brings its total Series A total over $39 million, which will be used to recruit more employees and bolster its technology.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 157,500+ biopharma pros reading Endpoints daily — and it's free.