Paul Hudson, AP Images

Sanofi has a name for its in­gre­di­ents spin­off, taps Cen­tri­ent head Karl Rot­thi­er as first CEO

As part of CEO Paul Hud­son’s mis­sion to re­vamp the com­pa­ny’s strat­e­gy around on­col­o­gy and im­munol­o­gy R&D, Sanofi un­wrapped plans in Feb­ru­ary to hive off its lega­cy API busi­ness. But Sanofi wants to main­tain its EU her­itage for the new com­pa­ny, and now has a name and new leader to move the spin­off ahead.

Sanofi will name its ac­tive phar­ma­ceu­ti­cal in­gre­di­ents spin­off Eu­roAPI, a nod to the com­pa­ny’s roots in the EU and planned op­er­a­tions home base for what will be the sec­ond largest in­gre­di­ents pro­duc­er in the world, Sanofi said in a re­lease.

Hop­ing to dri­ve its way to $1.22 bil­lion in sales by 2022, Sanofi has tapped for­mer Cen­tri­ent Phar­ma­ceu­ti­cals CEO Karl Rot­thi­er, a 29-year vet­er­an of bio­phar­ma, to take the lead role at the new com­pa­ny. Eu­roAPI stands to be­come the world’s sin­gle largest pro­duc­er of small mol­e­cule API and sec­ond-largest API pro­duc­er over­all when it launch­es its planned French IPO in 2022, Sanofi said.

Rot­thi­er will help cor­ral what is ex­pect­ed to be an ini­tial work­force of 3,200 em­ploy­ees work­ing across six Sanofi sites in Italy, Ger­many, the UK, France and Hun­gary. The com­pa­ny’s ini­tial port­fo­lio will come with more than 200 APIs ap­proved for prod­ucts in 80 in­ter­na­tion­al mar­kets.

Sanofi an­nounced the API spin­off in Feb­ru­ary 2020 as the French drug­mak­er looks to piv­ot its re­sources around on­col­o­gy and im­munol­o­gy de­vel­op­ment and away from the his­tor­i­cal­ly low-mar­gin API game. How­ev­er, Sanofi isn’t to­tal­ly walk­ing away: The drug­mak­er will hold a 30% in­vest­ment stake in the spin­off and will al­lo­cate enough cap­i­tal to keep the new­co debt-free with “op­ti­mal con­di­tions for suc­cess,” the drug­mak­er said in a re­lease.

With its place near the top of the field en­sured, Eu­roAPI will look to se­cure rough­ly 6% an­nu­al growth each year, Rot­thi­er said in a state­ment. The com­pa­ny will po­si­tion it­self as an EU-based al­ter­na­tive in an API mar­ket large­ly dom­i­nat­ed by in­gre­di­ents pro­duced in In­dia and Chi­na.

Un­like the US, which has been en­gaged in a run­ning trade war with Chi­na dur­ing the Trump ad­min­is­tra­tion, the EU has worked more close­ly with the East Asian coun­try on eco­nom­ic pol­i­cy. How­ev­er, Covid-19 dis­rup­tions have high­light­ed the need for re­dun­dant sup­ply chains for phar­ma­ceu­ti­cals in West­ern na­tions.

With­out its API busi­ness on board, Sanofi is re­align­ing its mis­sion un­der Hud­son’s lead­er­ship, hop­ing to cen­ter its busi­ness growth around its blos­som­ing on­col­o­gy port­fo­lio and block­buster im­munol­o­gy med Dupix­ent, a part­nered drug with New York’s Re­gen­eron. Sanofi is pro­ject­ing around $12 bil­lion in sales for Dupix­ent, which has seen bil­lions in sales so far tied to its ap­proval in atopic der­mati­tis, or eczema.

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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Sana, Codex­is lay off staff, reshuf­fle pipeline in bid to fo­cus cell ther­a­py, en­zyme en­gi­neer­ing work

As its market cap shrinks to a fraction of its heyday, flashy cell therapy startup Sana Biotechnology is laying off 15% of its staffers in a move to rejig the pipeline and restructure the company.

Sana is among a growing group of biotechs that, feeling the weight of a broader market downturn and seeing their shares tumble steadily, are tightening the purse strings and adjusting their focus. Also on Tuesday, Codexis, an enzyme engineering company based in California and now helmed by former Sierra Oncology CEO Stephen Dilly, announced it will reduce the workforce by 18%.

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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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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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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.

Jeb Keiper, Nimbus Therapeutics CEO

PhI­Ib win puts Nim­bus one step clos­er to chal­leng­ing Bris­tol My­ers in TYK2

Bristol Myers Squibb might be the first to clinch an FDA approval for a TYK2 inhibitor, but Nimbus Therapeutics is out to prove that it has the best drug in the class. The biotech says it now has positive mid-stage data to back up those claims — although it’s saving the hard numbers for now.

Topline results from a Phase IIb study involving 259 patients with moderate-to-severe plaque psoriasis showed that Nimbus’ drug, NDI-034858, hit the primary endpoint of helping more patients achieve PASI-75 than placebo at 12 weeks.