Pascal Prigent (Genfit)

Gen­fit prunes near­ly half its work­force af­ter NASH ex­it — but CEO promis­es a fu­ture in PBC, di­ag­nos­tics

Two months af­ter Gen­fit’s lead drug, elafi­bra­nor, failed a close­ly-watched Phase III show­down, the French biotech threw in the tow­el on NASH al­to­geth­er. An­oth­er two months lat­er, top ex­ecs are lay­ing off 40% of the work­force — 75 po­si­tions in to­tal — as they look to re­build.

The re­struc­tur­ing is part of a plan to re­duce the cash burn by more than half, ac­cord­ing to Gen­fit, from €110 mil­lion an­nu­al­ly be­fore the Phase III RE­SOLVE-IT da­ta dropped to around €45 mil­lion in 2022. With few­er than 125 staffers be­tween France and the US, the down­sized com­pa­ny will fo­cus on push­ing elafi­bra­nor in pri­ma­ry bil­iary cholan­gi­tis and com­mer­cial­iz­ing a di­ag­nos­tic tool for NASH.

It will take some time and ex­tra mon­ey to ful­ly close RE­SOLVE-IT, CEO Pas­cal Pri­gent not­ed, in ad­di­tion to shut­ting down pre­vi­ous com­mer­cial launch prepa­ra­tions.

In an an­a­lyst call of Gen­fit’s fu­ture pri­or­i­ties, he ex­plained that the de­ci­sion to ex­it NASH didn’t just have to do with the da­ta but lat­est de­vel­op­ments of the field:

We con­sid­ered the FDA’s feed­back re­gard­ing the oth­er com­plet­ed Phase 3 NASH pro­gram as well as new da­ta from sev­er­al on­go­ing NASH pro­grams, and we feel con­fi­dent we made the right de­ci­sion. In­deed, clin­i­cal tri­als in the NASH space are large, long and very ex­pen­sive. Con­sid­er­ing the evolv­ing NASH land­scape and the re­sults of the analy­sis from our com­plete dataset, we de­ter­mined that the cost to prob­a­bil­i­ty of suc­cess ra­tio was not ac­cept­able to con­tin­ue de­vel­op­ment of elafi­bra­nor in NASH, and of­fi­cial­ly ter­mi­nat­ed RE­SOLVE-IT, in line with our ear­li­er guid­ance in Ju­ly.

It is quite a damn­ing as­sess­ment com­ing from one of the two biotechs that, at the be­gin­ning of the year, were tapped as the play­ers to watch fol­low­ing a slew of fail­ures at oth­er com­pa­nies in 2019.

The oth­er, In­ter­cept, bit­ter­ly re­port­ed in June the FDA’s re­jec­tion of their NDA for obeti­cholic acid — a ma­jor set­back that they blamed on reg­u­la­tors’ change of heart re­gard­ing a sur­ro­gate end­point.

De­spite al­ready book­ing rev­enue from the drug, which is ap­proved as Ocali­va for PBC, In­ter­cept was still forced to chop 170 jobs — 25% of the head­count — and tight­en its belt while try­ing to win the FDA back.

For Gen­fit, the OK in PBC won’t come for quite some time. Hav­ing just start­ed pa­tient en­roll­ment, which they en­vi­sion will take 18 months af­ter fac­tor­ing in Covid-19 con­straints, ex­ecs are ex­pect­ing re­sults from the Phase III EL­A­TIVE study in 2023. Their drug is a dual ag­o­nist of PPAR-al­pha and PPAR-delta.

In the mean­time, though, it does ex­pect to start earn­ing mon­ey soon with its di­ag­nos­tic arm.

Gen­fit struck a deal with Lab­Corp just two days ago where the di­ag­nos­tics gi­ant would lead the mar­ket­ing ef­fort of its NIS4 test, de­signed to de­ter­mine whether a pa­tient needs to be treat­ed for NASH based on four blood-based bio­mark­ers.

While the di­ag­nos­tic was orig­i­nal­ly de­vel­oped as part of the elafi­bra­nor NASH pro­gram, Pri­gent be­lieves it has a fu­ture on its own. Biop­sies, af­ter all, are a way-too-ex­pen­sive, re­source-in­ten­sive and painful way to find out if pa­tients are at the stage of need­ing treat­ment. Launch­ing the test now, the rea­son­ing goes, paves the way for when the di­ag­nos­tic mar­ket takes off with the first NASH drugs.

Gen­fit’s blood test promis­es to be a sim­ple way to find pa­tients with at-risk NASH, mean­ing fi­bro­sis stage 2 above and a dis­ease ac­tiv­i­ty score of at least 4.

“As a re­minder, the scope of the ini­tial agree­ment was to pro­vide a so­lu­tion for spon­sors run­ning clin­i­cal tri­als in NASH,” Pri­gent said. “By us­ing NIS4 as a pre­screen­ing tool, spon­sors have been able to dras­ti­cal­ly re­duce the num­ber of screen fail­ures, thus ex­pe­dit­ing re­cruit­ment and sav­ing both, time and mon­ey, as well as bet­ter pro­tect­ing pa­tients.”

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Vlad Coric, Biohaven CEO

Vlad Coric charts course for new Bio­haven with neu­ro­science push and Big Phar­ma vets on board

What’s Biohaven without its CGRP portfolio? That’s what CEO Vlad Coric is tasked with deciding as he maps out the new Biohaven post-Pfizer takeover.

Pfizer officially scooped up Biohaven’s CGRP assets on Monday, including blockbuster migraine drug Nurtec and the investigational zavegepant, for $11.6 billion. As a result, Coric spun the broader pipeline into an independent company on Tuesday — with the same R&D team behind Nurtec but about 1,000 fewer staffers and a renewed focus on neuroscience and rare disease.

In AstraZeneca's latest campaign, wild eosinophils called Phils personify the acting up often seen in uncontrolled asthma

As­traZeneca de­buts an­noy­ing pur­ple ‘Phil’ crea­tures, per­son­i­fied asth­ma eosinophils ‘be­hav­ing bad­ly’

There are some odd-looking purple creatures lurking around the halls of AstraZenca lately. The “Phil” character cutouts are purple, personified eosinophils with big buggy eyes and wide mouths, and they’re a part of AZ’s newest awareness effort to help people understand eosinophilic asthma.

The “Asthma Behaving Badly” characters aren’t only on the walls at AZ to show the new campaign to employees, however. The “Phils” are also showing up online on the campaign website, and in digital and social ads and posts on Facebook and Instagram.

Casey McPherson shows his daughters Rose (left) and Weston around Everlum Bio, a lab that he co-founded to spark a treatment for Rose and others with ultra-rare conditions. (Ilana Panich-Linsman)

Fa­ther starts lab af­ter in­tel­lec­tu­al prop­er­ty is­sues stymie rare dis­ease drug de­vel­op­ment

Under bright lab lights, Casey McPherson holds his 6-year-old daughter, Rose. His free hand directs Rose’s gaze toward a computer screen with potential clues in treating her one-of-a kind genetic condition.

Gray specks on the screen show her cells that scientists reprogrammed with the goal of zeroing in on a custom medicine. McPherson co-founded the lab, Everlum Bio, to spark a treatment for Rose — and others like her. A regarded singer-songwriter, McPherson never imagined going into drug development.

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Dave Marek, Myovant CEO

My­ovant board balks as ma­jor­i­ty own­er Sum­it­o­mo swoops in with a $2.5B deal to buy them out

Three years after Sumitomo scooped up Roivant’s 46% stake in the publicly traded Myovant $MYOV as part of a 5-company, $3 billion deal, they’re coming back for the whole thing.

But these other investors at Myovant want more than what the Japanese pharma company is currently offering to pay at this stage.

Sumitomo is bidding $22.75 a share for the outstanding stock, which now represents 48% of the company after Sumitomo bumped its ownership since the original deal with Roivant. Myovant, however, created a special committee on the board, and they’re shaking their heads over the offer.

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Christophe Bourdon, Leo Pharma CEO

Leo Phar­ma looks 'be­yond the skin' in atopic der­mati­tis aware­ness cam­paign

As Leo Pharma aims to take on heavyweight champ Dupixent in atopic dermatitis, the company is launching “AD Days Around the World,” an awareness campaign documenting real patient stories across Europe.

The project, unveiled on Monday, spotlights four patients: Marjolaine, Laura, Julia and África from France, Italy, Germany and Spain, respectively, in short video clips on the challenges of living with AD, the most common form of eczema.

Ying Huang, Legend CEO

Lentivi­ral vec­tor ramp-up: J&J and Leg­end to in­vest $500M in New Jer­sey man­u­fac­tur­ing to sup­port Carvyk­ti

In response to a question on manufacturing scale at Legend Biotech’s R&D day yesterday, the company’s top exec said its partnership with Johnson & Johnson will be doubling its investment in its New Jersey manufacturing center and will be investing a total of $500 million.

With an eye on their BCMA-directed CAR-T therapy Carvykti (cilta-cel), approved in February as a fifth-line treatment for multiple myeloma, Legend CEO Ying Huang said that the ramp-up in production and the decision to manufacture its own lentiviral vectors — currently in shortage worldwide — means they won’t have to deal with that shortage.

Kite Phar­ma gets FDA to sign off on new Cal­i­for­nia-based vec­tor man­u­fac­tur­ing fa­cil­i­ty

Kite Pharma just got FDA approval to kick off operations at a new manufacturing campus.

The cancer-focused, CAR-T cell therapy player made the announcement Monday, saying that the federal regulatory agency gave the green light to Kite’s 100,000 square-foot, retroviral vector manufacturing facility in Oceanside, CA.

Kite’s global head of technical operations Chris McDonald tells Endpoints News that the facility has been in the works for about four years, after Kite teamed up with its parent company Gilead. Gilead acquired Kite Pharma for just shy of $12 billion in 2017.

Mar­ket­ingRx roundup: No­var­tis re­cruits NFL coach for Leqvio cam­paign; Pfiz­er pro­motes ‘Sci­ence’ merch on so­cial me­dia

Novartis is turning to a winning coach to talk about Leqvio and the struggles of high cholesterol — including his own. Bruce Arians, the retired NFL head coach of the Arizona Cardinals and Super Bowl-winning Tampa Bay Buccaneers, is partnering with the pharma for its “Coaching Cholesterol” digital, social and public relations effort.

In the campaign, Arians talks about the potential for “great comebacks” in football and heart health. Once nicknamed a “quarterback whisperer,” he is now retired from fulltime coaching (although still a front-office consultant for Tampa Bay), and did a round of media interviews for Novartis, including one with People and Forbes.

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