Celebrating the founding of Sanofi's future Evolutive Vaccines Facility (EVF) production unit (L-R): CEO Paul Hudson; Olivier Véran, Minister of Health; Frédérique Vidal, Minister of Higher Education, Research and Innovation; Jean Castex, Prime Minister; Agnès Pannier-Runacher, Minister of Industry; Eric Bellot, Mayor of Neuville-sur-Saône (courtesy Sanofi)

Sanofi CEO Paul Hud­son sketch­es a $1B-plus in­vest­ment on its new mR­NA cen­ter

Over the years, Paris-based Sanofi has had a com­plex re­la­tion­ship with its home coun­try of France. One for­mer CEO (Chris Viehbach­er) seemed to en­joy prod­ding the coun­try’s R&D work­force for a lack of pro­duc­tiv­i­ty — un­til the board chose a French­man (Olivi­er Brandi­court) to re­place him. If on­ly tem­porar­i­ly.

But CEO Paul Hud­son, an ur­bane British ex­ec­u­tive with a glob­al ré­sumé, is mak­ing him­self quite at home in the Eu­ro­pean coun­try.

On Mon­day, Hud­son met up with the prime min­is­ter of France to tout a ma­jor in­vest­ment of more than $1 bil­lion in France, rough­ly half of the €2 bil­lion ($2.2 bil­lion) glob­al plan he un­veiled last sum­mer as Sanofi in­vest­ed in a big fu­ture in­volv­ing mR­NA, the tech plat­form that gave birth to 2 megablock­buster vac­cines in record time.

Sanofi is spend­ing €490 mil­lion ($536 mil­lion) over 5 years to build a “ful­ly dig­i­tized bio­pro­duc­tion fa­cil­i­ty de­signed to en­able more ag­ile and flex­i­ble man­u­fac­tur­ing across mul­ti­ple vac­cine and bi­o­log­i­cal plat­forms, in­clud­ing mR­NA,” the com­pa­ny said in a state­ment sent to End­points News.

“I am proud to an­nounce that France is at the heart of Sanofi’s mR­NA strat­e­gy,” Hud­son told the gath­er­ing for the for­mal found­ing of its fu­ture Evo­lu­tive Vac­cines Fa­cil­i­ty (EVF) pro­duc­tion unit in Neuville-sur-Saône.

Sanofi in­tends to lever­age its $3.2 bil­lion buy­out of Trans­late Bio in­to 6 mR­NA vac­cines in 3 years. It al­so plans to be front and cen­ter for the next pan­dem­ic, when­ev­er that might oc­cur, af­ter be­ing left at the start­ing gate when its first stab at a more tra­di­tion­al job for Covid-19 flopped bad­ly.

Sanofi has been flesh­ing out plans out­lined last sum­mer to spend €400 mil­lion ($437 mil­lion) a year on its mR­NA ef­fort, in­te­grat­ing the work of 400 staffers in Cam­bridge, UK and Mar­cy l’Étoile, Ly­on in France around the project. They’re com­pet­ing against 2 up­start ri­vals that have seen their stock prices soar — and swoon — over the last 24 months. As the pan­dem­ic has waned, so have their mar­ket caps. But each is still sig­nif­i­cant­ly larg­er in terms of fi­nan­cial fire­pow­er than they were in their pre-rev­enue days. And both have their own plans for stay­ing out front.

Susan Galbraith, AstraZeneca EVP, oncology R&D, at EUBIO22 (Rachel Kiki for Endpoints News)

Up­dat­ed: As­traZeneca jumps deep­er in­to cell ther­a­py 2.0 space with $320M biotech M&A

Right from the start, the execs at Neogene had some lofty goals in mind when they decided to try their hand at a cell therapy that could tackle solid tumors.

Its founders have helped hone a new approach that would pack in multiple neoantigen targets to create a personalized TCR treatment that would not just make the leap from blood to solid tumors, but do it with durability. And they managed to make their way rapidly to the clinic, unveiling their first Phase I program for advanced tumors just last May.

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Ei­sai’s ex­pand­ed Alzheimer’s da­ta leave open ques­tions about safe­ty and clin­i­cal ben­e­fit

Researchers still have key questions about Eisai’s investigational Alzheimer’s drug lecanemab following the publication of more Phase III data in the New England Journal of Medicine Tuesday night.

In the paper, which was released in conjunction with presentations at an Alzheimer’s conference, trial investigators write that a definition of clinical meaningfulness “has not been established.” And the relative lack of new information, following topline data unveiled in September, left experts asking for more — setting up a potential showdown to precisely define how big a difference the drug makes in patients’ lives.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

Twit­ter dis­ar­ray con­tin­ues as phar­ma ad­ver­tis­ers ex­tend paus­es and look around for op­tions, but keep tweet­ing

Pharma advertisers on Twitter are done — at least for now. Ad spending among the previous top spenders flattened even further last week, according to the latest data from ad tracker Pathmatics, amid ongoing turmoil after billionaire boss Elon Musk’s takeover now one month ago.

Among 18 top advertisers tracked for Endpoints News, only two are spending: GSK and Bayer. GSK spending for the full week through Sunday was minimal at just under $1,900. Meanwhile, German drugmaker Bayer remains the industry outlier upping its spending to $499,000 last week from $480,000 the previous week. Bayer’s spending also marks a big increase from a month ago and before the Musk takeover, when it spent $16,000 per week.

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Vi­a­tris with­draws ac­cel­er­at­ed ap­proval for top­i­cal an­timi­cro­bial 24 years lat­er

After 24 years without confirming clinical benefit, the FDA announced Tuesday morning that Viatris (formed via Mylan and Pfizer’s Upjohn) has decided to withdraw a topical antimicrobial agent, Sulfamylon (mafenide acetate), after the company said conducting a confirmatory study was not feasible.

Sulfamylon first won FDA’s accelerated nod in 1998 as a topical burn treatment, with the FDA noting that last December, Mylan told the agency that it wasn’t running the trial.

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Catal­ent to cut about 200 jobs in Mary­land and Texas

Contract manufacturing company Catalent is cutting about 200 jobs in Maryland and Texas, according to WARN notices, trimming back some of its pandemic-era expansion.

The company will cut 77 jobs by Jan. 15 of next year at a cell therapy facility in Webster, TX, just outside of Houston. In Maryland, the company is reducing staff at two locations, with 82 jobs being eliminated at Catalent’s facility in Gaithersburg, and 53 in Rockville. The layoffs go into effect at those locations on Jan. 14.

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iECURE CEO Joe Truitt and founder Jim Wilson

Jim Wil­son biotech iECURE gets fresh $65M to push pe­di­atric liv­er dis­ease gene ther­a­py in­to the clin­ic

Jim Wilson-founded biotech iECURE has wrapped a $65M Series A extension round to get its lead candidate — a gene replacement therapy for a rare inherited liver disease known as ornithine transcarbamylase deficiency, or OTC — into the clinic.

This round was co-led by Novo Holdings and LYFE Capital, followed by initial investors Versant and OrbiMed as well. In September 2021, iECURE raised a $50 million Series A led by the latter two. The new cash infusion will get iECURE through an initial in-human trial, which CEO Joe Truitt told Endpoints News iECURE hopes to read out in 2024.

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Mar­ket­ingRx roundup: Pfiz­er, BioN­Tech re-up iHeartRa­dio hol­i­day spon­sor­ship; WHO re­names mon­key­pox to 'm­pox'

It’s that time of year again for pop music fans with the return of the iHeartRadio Jingle Ball tour — and Pfizer and BioNTech’s sponsorship. For the second year, the Covid-19 vaccine collaborators are the pharma national sponsors among consumer brand partners, including ESPN, Dunkin, M&Ms, Mercedes and Pepsi.

Pfizer and BioNTech are also sponsoring the official Jingle Ball Radio streaming station on iHeart’s network, programmed with music from past and present concert performers. This year they include Lizzo, Dua Lipa, Dove Cameron and Charlie Puth. Pfizer-sponsored radio ads and online video and digital banner ads encourage listeners to get updated Covid-19 booster shots.

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Mark Schneider, Nestlé CEO (AP Images)

Nestlé re­con­sid­ers peanut al­ler­gy pro­gram two years af­ter $2.6B buy­out

It seems Nestlé is experiencing some buyer’s remorse two years after throwing down $2.6 billion for Aimmune Therapeutics and its peanut allergy pill Palforzia.

CEO Mark Schneider announced on Tuesday that Nestlé is “exploring strategic options” for Palforzia following lower-than-expected demand. A company spokesperson declined to confirm whether a potential sale is in consideration.

“The review is expected to be completed in the first half of 2023. Going forward, Nestlé Health Science will sharpen its focus on Consumer Care and Medical Nutrition,” the company said in a news release.

Tim Walbert, Horizon Therapeutics CEO (via YouTube)

Hori­zon Ther­a­peu­tics in takeover talks with Am­gen, J&J, Sanofi as po­ten­tial buy­ers

Amgen, J&J’s Janssen and Sanofi are all in talks to acquire Horizon Therapeutics, the rare disease biotech disclosed late Tuesday.

Horizon confirmed “highly preliminary discussions” with those companies regarding a potential buyout offer after the Wall Street Journal reported takeover interest.

Although the company — which commands a market cap of close to $18 billion — emphasized that “there can be no certainty that any offer will be made for the Company,” shares $HZNP still surged 31% in after-hours trading to near $103, bringing it to the point where it started the year.

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