Union members strike in France, AP Images

Paul Hud­son faces down French unions in fight to re­struc­ture Sanofi

Sanofi CEO Paul Hud­son is fac­ing a fa­mil­iar ad­ver­sary in his ef­forts to cut up to 1,680 jobs from the French phar­ma gi­ant: French unions.

Around 200 union mem­bers staged a one-day strike Tues­day at Sanofi’s main Covid-19 vac­cine plant in Mar­cy-l’Étoile to protest the cuts, The As­so­ci­at­ed Press re­port­ed, with oth­er mem­bers join­ing at oth­er fa­cil­i­ties across the coun­try.

France’s fi­nance min­is­ter Bruno Le Maire, mean­while, went on French ra­dio twice this week to talk about the com­pa­ny. On Mon­day, per Reuters, he told RTL that Sanofi would not close any plants or lay off any em­ploy­ees in the re­struc­tur­ing. But on Wednes­day morn­ing, he re-emerged on BFM and said he would like three things from the drug­mak­er, in­clud­ing con­fir­ma­tion that there will be no site clo­sures and lay­offs.

The con­tro­ver­sy is the lat­est stand­off be­tween Sanofi and France’s sig­nif­i­cant la­bor move­ment. Chris Viehbach­er, the com­pa­ny’s first non-French CEO, re­port­ed­ly lost his job in part be­cause he pro­posed cut­ting 5% to 7% of the com­pa­ny’s work­force, trig­ger­ing mas­sive pub­lic blow­back. His re­place­ment, Olivi­er Brandi­court, put unions back on high alert two months af­ter he got the job, by talk­ing about the high cost of in­dus­tri­al plants and promis­ing a new five-year strate­gic plan.

The newest tus­sle is over Paul Hud­son’s own strate­gic plan. Short­ly af­ter the No­var­tis ex­ec was tapped as Brandi­court’s re­place­ment, he be­gan out­lin­ing the re­think. In June, he an­nounced plans to cut 1,680 jobs, in­clud­ing 1,000 in France, over the fol­low­ing 3 years. It was one step in a larg­er ef­fort to save more than €2 bil­lion by 2022 and re­ori­ent the com­pa­ny around a heav­ier but more tai­lored ap­proach to R&D, scrap­ping car­dio­vas­cu­lar and di­a­betes pro­grams but dou­bling down on ar­eas such as on­col­o­gy and gene ther­a­py.

In a state­ment this week pro­vid­ed to End­points News, Sanofi in­sist­ed that any em­ploy­ee de­par­tures would be vol­un­tary and not­ed that they planned to spend €6 bil­lion in R&D in France over the next 3 years.

“Sanofi has en­gaged in di­a­logue and in-depth lis­ten­ing to the sug­ges­tions of the so­cial part­ners in or­der to de­fine the so­cial sup­port mea­sures most suit­ed to the em­ploy­ment is­sues of each of the em­ploy­ees like­ly to be af­fect­ed,” they said. “Ne­go­ti­a­tions with our so­cial part­ners are based on ac­com­pa­ny­ing mea­sures that are ex­clu­sive­ly vol­un­tary and with­out con­straints.”

Le Maire com­mend­ed Sanofi on their de­ci­sion to shift R&D ef­forts, call­ing it “wise,” but asked for greater clar­i­ty on what that R&D strat­e­gy would look like for France.

CGT, the largest trade union in France, mean­while, has ar­gued that per­sis­tent cuts have ac­tu­al­ly ham­pered Sanofi’s R&D ef­forts, even play­ing a role in the sig­nif­i­cant set­backs they’ve seen in their ef­forts to de­vel­op a Covid-19 vac­cine with Glax­o­SmithK­line, the newswire RFI re­port­ed.  The cuts, they said, are part of a pat­tern of a 15-year-long dis­in­vest­ment that re­sult­ed in Sanofi “los­ing the race for the vac­cine against Covid.”

UP­DAT­ED: Mer­ck pulls Keytru­da in SCLC af­ter ac­cel­er­at­ed nod. Is the FDA get­ting tough on drug­mak­ers that don't hit their marks?

In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders?

Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,400+ biopharma pros reading Endpoints daily — and it's free.

The 2021 top 100 bio­phar­ma in­vestors: As the pan­dem­ic hit and IPOs boomed, VCs swung in­to ac­tion like nev­er be­fore

The global pandemic may have roiled economies, killed hundreds of thousands and throttled entire industries, but the only effect it had on biopharma venture investing was to help turbocharge the field to giddy new heights.

Below you’ll find the new top 100 venture investors in the industry, ranked by the number of deals they were publicly involved in, as tracked by DealForma chief Chris Dokomajilar. The numbers master then calculated the estimated amount of money they put into each deal — divvying up the cash by the number of players — to indicate how they managed their syndicates.

Endpoints Premium

Premium subscription required

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

Hal Barron, Endpoints UKBIO19

GSK, Vir's hopes for a Covid-19 an­ti­body fall flat in NIH 'mas­ter pro­to­col' with no ben­e­fit in hos­pi­tal­ized pa­tients

GlaxoSmithKline and Vir Biotechnology were hopeful that one of their partnered antibodies would carve out a win after getting the invite to a major NIH study in hospitalized Covid-19 patients. But just like Eli Lilly, the pair’s drug couldn’t hit the mark, and now they’ll be left to take a hard look at the game plan.

The NIH has shut down enrollment for GSK and Vir’s antibody VIR-7831 in its late-stage ACTIV-3 trial after the drug showed negligible effect in achieving sustained recovery in hospitalized Covid-19 patients, the partners said Wednesday.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,400+ biopharma pros reading Endpoints daily — and it's free.

As Brain­Storm con­tin­ues to tout ‘clear sig­nal’ on ALS drug, the FDA of­fers a rare pub­lic slap­down on the da­ta

A little more than a week after BrainStorm acknowledged that regulators at the FDA had informed them that the biotech needed more data before it could expect to gain an approval for its ALS treatment NurOwn — while still touting a “clear signal” of efficacy and not ruling out an application — the agency has decided to clarify the record in a most unusual statement.

The FDA statement amounts to a straight slap own, offering a different set of efficacy numbers from the company’s public presentation last November and ruling out any chance of statistical significance.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,400+ biopharma pros reading Endpoints daily — and it's free.

In­tro­duc­ing End­points FDA+, our new pre­mi­um week­ly reg­u­la­to­ry news re­port led by Zachary Bren­nan

CRLs. 483s. CBER, CDER and RWE. For biopharma professionals, these acronyms command attention because of the fundamental role FDA plays in drug development. Now Endpoints is doubling down on regulatory coverage, and launching a weekly report focusing on developments out of White Oak, with analysis and insight into what it all means.

Coverage will be led by our new senior editor, Zachary Brennan. He joins Endpoints from POLITICO, where he covered pharma. Prior to that he was the managing editor for Regulatory Focus, a news publication from the Regulatory Affairs Professionals Society.

Antoine Papiernik, Sofinnova managing director (Business Wire)

Sofinno­va Part­ners stays fo­cused on late-stage deals with a new, $540M crossover fund

One of Europe’s most high-profile biopharma investors is getting $540 million to invest in new crossover deals for late-stage companies.

The Paris-based VC says the fresh Sofinnova Crossover Fund raise positions them as the “largest crossover investor in Europe dedicated to late-stage biopharma and medtech investments.”

They got a leg up in France after winning a special “Tibi” designation from the French government, giving them access to a pool of €6 billion that helped them gain an edge with institutional investors. Since they were founded close to 50 years ago, the venture group has backed more than 500 companies and currently has more than €2 billion under management.

Presage teams with Mer­ck on its Phase 0 test­ing; Kem­Pharm AD­HD drug wins ap­proval in chil­dren aged 6 and up

Seattle-based Presage Biosciences, which approaches drug development through its microdosing platform, has some new partnerships and cash to come with them.

Presage closed a $13 million financing round Tuesday, aiming to expand its network of clinical trial sites and advance development of its microdosing injection devices. They also closed partnership deals with Merck and Maverick Therapeutics.

The financing included $7 million from new investors, including the LabCorp Venture Fund, Bristol Myers Squibb, and InHarv Partners. An additional $6 million convertible note from Takeda Ventures will convert to equity.

Eli Lil­ly claims suc­cess in a new JAK in­di­ca­tion: hair loss

Over the last decade, drugmakers have proven JAK inhibitors can treat a smattering of immune-related diseases ranging from rheumatoid arthritis to Covid-19. Now Eli Lilly has pulled out a new one.

Lilly and its biotech partner Incyte announced Wednesday that their JAK inhibitor baricitinib effectively regrew patients’ hair in a Phase III trial for alopecia areata, an autoimmune condition that can cause sudden, severe and patchy hair loss. Lilly didn’t break down the results from the 546-patient trial, but the primary endpoint was improvement on a standard score for alopecia symptoms.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,400+ biopharma pros reading Endpoints daily — and it's free.

Thank you, next: Take­da hands Ovid $196M cash to rein back in Phase III-ready seizure drug, re­viv­ing bat­tered stock

Soticlestat made it.

Takeda is bringing the drug back into its fold more than four years after first entrusting the team at Ovid with the mid-stage clinical work. For all that — generating what they saw as positive Phase II data in Dravet syndrome and Lennox-Gastaut syndrome — the biotech has been rewarded with $196 million in upfront cash, with another $660 million reserved for regulatory and commercial milestones.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,400+ biopharma pros reading Endpoints daily — and it's free.