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.”

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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David Ricks, Eli Lilly CEO (David Paul Morris/Bloomberg via Getty Images)

Eli Lil­ly set to in­vest $2.1B in home state man­u­fac­tur­ing boost

Eli Lilly is looking to expand its footprint in its home Hoosier State by making a major investment in manufacturing.

The pharma is investing $2.1 billion in two new manufacturing sites at Indiana’s LEAP Lebanon Innovation and Research District in Boone County, northwest of Lilly’s headquarters in Indianapolis.

The two new facilities will expand Lilly’s manufacturing network for active ingredients and new therapeutic modalities, including genetic medicines, according to a press release.

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US sees spike in Paxlovid us­age as Mer­ck­'s mol­nupi­ravir and As­traZeneca's Evusheld are slow­er off the shelf

New data from HHS show that more than 162,000 courses of Pfizer’s Covid-19 antiviral Paxlovid were administered across the US over the past week, continuing a streak of increased usage of the pill, and signaling not only rising case numbers but more awareness of how to access it.

In comparison to this week, about 670,000 courses of the Pfizer pill have been administered across the first five months since Paxlovid has been on the US market, averaging about 33,000 courses administered per week in that time.

Almirall is tapping artificial intelligence on behalf of its sales force for insights and efficiencies. (via Shutterstock)

Almi­rall rolls out sales rep ar­ti­fi­cial in­tel­li­gence sys­tem, cut­ting pre-call prep and 'wind­shield time'

Dermatology specialty pharma Almirall is making its sales reps smarter. Not with extra training or educational courses, but instead with artificial intelligence tools.

It began a soft launch of a sales rep AI and machine learning platform it calls Polaris last August in one of its 7 US coverage regions. The platform from Aktana gathers information from across Almirall internal sources and external ones – such as claims and prescribing data – to generate insights for reps. Now, instead of spending hours prepping for a sales call, Polaris can generate details about a physician’s preferences, past behaviors and prescription habits for reps in minutes, said Almirall head of commercial operations Vincent Cerio.

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Pfiz­er and CD­MOs ramp up Paxlovid man­u­fac­tur­ing with Kala­ma­zoo plant ex­pan­sion lead­ing the way

As the Covid-19 pandemic continues to evolve, pharma companies and manufacturers are exploring how to step up production on antivirals.

Pfizer is planning to expand its Kalamazoo-area facility to increase manufacturing capabilities for the oral Covid-19 antiviral Paxlovid, according to a report from Michigan-based news site MLive. The expansion of the facility, which serves as Pfizer’s largest manufacturing location, is expected to create hundreds of “high-skilled” STEM jobs, MLive reported. No details about the project’s cost and timeline have been released, but according to MLive, Pfizer will announce the details of the expansion at some point in early June.

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FDA spells out the rules and re­stric­tions for states seek­ing to im­port drugs from Cana­da

The FDA is offering more of an explanation of the guardrails around its program that may soon allow states to import prescription drugs in some select circumstances from Canada, but only if such imports will result in significant cost reductions for consumers.

While the agency has yet to sign off on any of the 5 state plans in the works so far, and PhRMA’s suit to block the Trump-era rule allowing such imports is stalled, the new Q&A guidance spells out the various restrictions that states will have to abide by, potentially signaling that a state approval is coming.

Greg Mayes, Antios Therapeutics CEO

An­tios' HBV col­lab axed af­ter clin­i­cal hold, but biotech be­lieves safe­ty in­ci­dent is not treat­ment-re­lat­ed

The FDA has placed a clinical hold on a Phase IIa study of Antios Therapeutics’ investigational hepatitis B med, CEO Greg Mayes confirmed to Endpoints News in an emailed statement.

A safety report was delivered to the biotech on May 17 after a patient dosed in a triple combination cohort of the study had experienced bradycardia and hypotension. The triple combo included Antios’ ATI-2173, Assembly Biosciences’ vebicorvir and Viread, an approved antiviral for HIV and hepatitis B.

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Tim Schoen, BioMed Realty CEO

Life sci­ences de­vel­op­er Bio­Med Re­al­ty buys San Fran­cis­co ho­tel for $75M — re­port

In a somewhat unconventional deal, life sciences real estate developer BioMed Realty has bought a 169-room Hilton Garden Inn in South San Francisco for $75 million, the San Francisco Business Times reported.

BioMed Realty, an affiliate of Blackstone, has multiple life sciences and technology office projects in the Bay Area, including three sites within a five-minute drive of the hotel.

While the sale of the hotel property was announced earlier this month, the sellers, Summit and GIC, did not identify the buyer at the time.

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Pfizer CEO Albert Bourla at the World Economic Forum (Gian Ehrenzeller/Keystone via AP Images)

All about ac­cess: Pfiz­er moves to a non-prof­it mod­el for drug sales in 45 low­er-in­come coun­tries

Leading the way to increase access to cheaper drugs worldwide, Pfizer said Wednesday it will provide all current and future patent-protected medicines and vaccines available in the US or EU on a not-for-profit basis to about 1.2 billion people in 45 lower-income countries.

Rwanda, Ghana, Malawi, Senegal and Uganda are the first five countries to sign on to this accord, which will also seek to blaze new paths for quick and efficient regulatory and procurement processes to reduce the usual delays in making new medicines and vaccines available in these countries.