Sanofi un­der for­mal in­ves­ti­ga­tion for De­pakine al­le­ga­tions; Beam li­cens­es CAR-T tech from Ox­ford Bio­med­ica

Sanofi is fac­ing a for­mal in­ves­ti­ga­tion on manslaugh­ter charges, due to ac­cu­sa­tions that its epilep­sy drug De­pakine caused birth mal­func­tions and slow neu­ro­log­i­cal de­vel­op­ment when tak­en dur­ing preg­nan­cy.

The French phar­ma was for­mal­ly charged in Feb­ru­ary, years af­ter ev­i­dence sur­faced that the drug, sodi­um val­proate, posed neu­rode­vel­op­men­tal risks. Sodi­um val­proate first hit the mar­ket in 1967 for the treat­ment of epilep­sy and bipo­lar dis­or­der, and is cur­rent­ly pre­scribed in more than 100 coun­tries.

Be­tween 2006 and 2014, France’s so­cial af­fairs in­spec­tion agency IGAF be­lieves that 425 to 450 ba­bies ex­posed to the drug suf­fered con­gen­i­tal birth de­fects or were still­born, ac­cord­ing to a Reuters re­port. The EMA re-eval­u­at­ed the drug in 2014, and the fol­low­ing year rec­om­men­da­tions were en­forced that prac­ti­tion­ers not pre­scribe the treat­ment for women of child­bear­ing age.

Sanofi de­nied the al­le­ga­tions. “All these el­e­ments do not in any way pre­judge the re­spon­si­bil­i­ty of the com­pa­ny,” the com­pa­ny wrote in a state­ment to Reuters.

The As­so­ci­a­tion for the as­sis­tance of par­ents of chil­dren suf­fer­ing from an­ti-con­vul­sant syn­drome (APE­SAC) ini­ti­at­ed the crim­i­nal in­ves­ti­ga­tion. To be­gin a for­mal in­ves­ti­ga­tion, an in­ves­tiga­tive judge had to deem the case se­ri­ous enough to war­rant a fur­ther look, ac­cord­ing to Reuters. — Nicole De­Feud­is

Beam inks CAR-T deal with Ox­ford Bio­med­ica

The gene edit­ing ex­perts at Beam Ther­a­peu­tics have added Ox­ford Bio­med­ica’s LentiVec­tor plat­form to its CART- reper­toire. The li­cense gives Beam ac­cess to the same tech­nol­o­gy No­var­tis and Juno have lever­aged to man­u­fac­ture their cell ther­a­pies.

By car­ry­ing out tar­get­ed base changes, Beam promis­es to knock out the ex­pres­sion of mul­ti­ple cell sur­face tar­gets on T cells at once.

Un­der the new deal, Ox­ford Bio­med­ica was paid an undis­closed up­front sum to kick off de­vel­op­ment and man­u­fac­tur­ing for one pre­clin­i­cal pro­gram. More pay­ments and mile­stones are to come. — Am­ber Tong

Red­Hill grabs full com­mer­cial­iza­tion rights to ex-As­traZeneca drug

When Red­Hill Bio­phar­ma bought Movan­tik, a treat­ment for opi­oid in­duced con­sti­pa­tion, from As­traZeneca in April, it al­so in­her­it­ed a co-com­mer­cial­iza­tion al­liance with Dai­ichi Sankyo. It’s now re­vised the deal to grab ex­clu­sive re­spon­si­bil­i­ty to mar­ket the drug and pay roy­al­ties to the Japan­ese phar­ma in­stead.

“The clos­ing of this new agree­ment with Dai­ichi Sankyo will al­low us to have full con­trol over brand strat­e­gy and com­mer­cial­iza­tion ac­tiv­i­ties for Movan­tik in the U.S. while al­so in­creas­ing our mar­gins,” Rick Scrug­gs, Red­Hill’s chief com­mer­cial of­fi­cer and head of US op­er­a­tions, said in a state­ment.

In ad­di­tion to a mid-teen roy­al­ty rate on net sales, Dai­ichi is en­ti­tled to three lump sums pay­ments from 2021 to 2023. They al­so re­ceived 283,387 Amer­i­can De­posi­tary Shares of Red­Hill’s stock $RDHL as part of a sub­scrip­tion agree­ment.

Movan­tik, a pe­riph­er­al­ly act­ing μ-opi­oid re­cep­tor an­tag­o­nist, gen­er­at­ed $96 mil­lion in the US last year. Red­Hill ac­quired glob­al rights to the drug ex­clud­ing Eu­rope, Cana­da and Is­rael. — Am­ber Tong

PPD en­ters three-year agree­ment with Pfiz­er 

Wilm­ing­ton, NC-based con­tract re­search or­ga­ni­za­tion PPD has inked a three-year agree­ment to help grow Pfiz­er’s port­fo­lio in “mul­ti­ple ther­a­peu­tic ar­eas.” The deal builds on the com­pa­nies’ cur­rent re­la­tion­ship, in which PPD of­fers lab ser­vices and clin­i­cal de­vel­op­ment ex­per­tise to fa­cil­i­tate drug de­vel­op­ment. PPD and Pfiz­er are cur­rent­ly keep­ing the fi­nan­cial terms un­der wraps.

Pfiz­er has 23 drugs in Phase III de­vel­op­ment, rang­ing from vac­cines to on­col­o­gy. It’s cur­rent­ly work­ing with BioN­Tech on four Covid-19 vac­cine pro­grams, two of which are be­ing fast tracked by the FDA. Their can­di­date BNT162b2 just en­rolled in a Phase II/III study, set­ting it up for reg­u­la­to­ry re­view as soon as Oc­to­ber. — Nicole De­Feud­is

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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Uğur Şahin, BioNTech CEO (ddp images/Sipa USA/Sipa via AP Images)

BioN­Tech bets on dif­fi­cult STING field via small mol­e­cule pact with a Pol­ish biotech

BioNTech is beefing up its relatively thin small molecule pipeline by adding weight to a clinically difficult corner of oncology R&D: STING agonists. To do so, BioNTech is teaming up with a 15-year-old Polish biotech and doling out €40 million, about $41.5 million, to start.

The deal is broken into two parts: First, BioNTech obtains an exclusive global license to develop and market Ryvu Therapeutics’ STING agonist portfolio as small molecules, whether alone or in combination with other agents.

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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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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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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