Chris Ross, outgoing head of integrated supply chain operations

Mer­ck KGaA shuf­fles or­ga­ni­za­tion to boost its CD­MO op­er­a­tion as a top ex­ec re­tires

Mer­ck KGaA is re­or­ga­niz­ing af­ter a key sup­ply chain ex­ec­u­tive’s re­tire­ment, build­ing out a new life sci­ence unit with a ful­ly in­te­grat­ed CD­MO and con­tract test­ing ser­vice busi­ness.

Dirk Lange

In Burling­ton, MA, about 15 miles north­west of down­town Boston, the new life sci­ences ser­vices unit (LSS for short) will com­bine the ex­ist­ing CD­MO and con­tract test­ing units, along with the re­spec­tive mar­ket­ing, sales, re­search and de­vel­op­ment, man­u­fac­tur­ing and sup­ply chain op­er­a­tions. Every­thing from mon­o­clon­al an­ti­bod­ies to high po­ten­cy APIs, AD­Cs and vi­ral and gene ther­a­pies will be housed in­side LSS. It will al­so in­clude the com­pa­ny’s mR­NA op­er­a­tions, which have re­cent­ly been boost­ed with ac­qui­si­tions of AmpTec in 2021 and Ex­e­lead, which was an­nounced last month.

Mer­ck KGaA has been up­ping its op­er­a­tions around lipids. In tak­ing over 11-year-old In­di­anapo­lis-based Ex­e­lead for $780 mil­lion, Mer­ck KGaA will set it­self up nice­ly for all of the Covid-19 vac­cine mak­ers who have turned to out­side man­u­fac­tur­ers for help meet­ing glob­al de­mand.

Matthias Heinzel

The US gov­ern­ment inked a $137 mil­lion con­tract to ramp up pro­duc­tion of rapid Covid-19 tests amid the worst of the Omi­cron vari­ant’s reign, at the end of 2021. Mil­li­pore Sig­ma, a unit of the com­pa­ny, will build a new fa­cil­i­ty to make ni­tro­cel­lu­lose mem­branes, the pa­per that shows the test re­sults, and its She­boy­gan, WI plant will al­low for an­oth­er 85 mil­lion tests a month.

Dirk Lange will head that op­er­a­tion and take over on Feb. 15. He brings 20 years of ex­pe­ri­ence to the ta­ble and comes over from KBI Bio­phar­ma, a CD­MO based in Durham, NC. He pre­vi­ous­ly spent time in Eu­rope, work­ing for big-name bio­phar­mas such as San­doz and No­var­tis.

“Sci­ence and tech­nol­o­gy are ad­vanc­ing at an un­prece­dent­ed speed, and with that are the needs and ex­pec­ta­tions of our cus­tomers world­wide. Hav­ing the right op­er­at­ing mod­el in place will ac­cel­er­ate our abil­i­ty to pro­vide the best prod­ucts and ser­vices to our cus­tomers and de­liv­er on our high am­bi­tions for long-term prof­itable growth,” board mem­ber Matthias Heinzel said in a press re­lease. “Ul­ti­mate­ly, our goal is to make a pos­i­tive im­pact on pa­tients by en­abling the de­vel­op­ment of life-sav­ing ther­a­pies and vac­cines.”

Ivan Donzelot

The trans­for­ma­tion, strat­e­gy and busi­ness de­vel­op­ment units and qual­i­ty and reg­u­la­to­ry units will stay the same. Chris Ross, the head of in­te­grat­ed sup­ply chain op­er­a­tions for the last two years, will re­tire af­ter near­ly 14 years with the com­pa­ny. Ivan Donzelot will take over on April 1, the day af­ter Ross’ last day at the com­pa­ny. The in­te­grat­ed sup­ply chain and op­er­a­tions team is based out of Switzer­land, and Donzelot will help of­fer sup­port to the busi­ness as it grows and nav­i­gates the cur­rent sup­ply chain.

“I wish our new lead­ers great suc­cess in their roles, and on be­half of our en­tire or­ga­ni­za­tion, I thank Chris Ross for his many years of ser­vice and for his tire­less ef­forts in help­ing to bring life-sav­ing prod­ucts to pa­tients around the world,” said Heinzel.

Jean-Charles Wirth

The com­pa­ny will al­so roll out a sci­ence and lab so­lu­tions di­vi­sion that com­bines the re­search so­lu­tions and ap­plied so­lu­tions units to pro­vide a more seam­less ex­pe­ri­ence, the com­pa­ny said. The unit will in­clude the reagents, con­sum­ables, de­vices, in­stru­ments, soft­ware and sci­en­tif­ic dis­cov­ery ser­vices port­fo­lios, and will be led by Jean-Charles Wirth. Wirth is cur­rent­ly the head of ap­plied so­lu­tions and has been with Mer­ck KGaA since 2006.

An­drew Bulpin

Mer­ck KGaA’s process so­lu­tions unit will still be led by 16-year com­pa­ny vet­er­an An­drew Bulpin, but will now col­lab­o­rate with the LSS to of­fer phar­ma­ceu­ti­cal de­vel­op­ment and man­u­fac­tur­ing.

Mer­ck KGaA al­so snatched up Chord Ther­a­peu­tics about a year af­ter it emerged from stealth, adding its lead can­di­date — a small mol­e­cule oral ver­sion of the chemother­a­py drug cladrib­ine. It was Mer­ck KGaA’s sec­ond go-around at cladrib­ine, af­ter a 2019 ap­proval from the FDA of its own tablets for mul­ti­ple scle­ro­sis.

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

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

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls



Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Lynn Baxter, Viiv Healthcare's head of North America

Vi­iV dri­ves new cor­po­rate coali­tion in­clud­ing Uber, Tin­der and Wal­mart, aimed at end­ing HIV

ViiV Healthcare is pulling together an eclectic coalition of consumer businesses in a new White House-endorsed effort to end HIV by the end of the decade.

The new US Business Action to End HIV includes pharma and health companies — Gilead Sciences, CVS Health and Walgreens — but extends to a wide range of consumer companies that includes Tinder, Uber and Walmart.

ViiV is the catalyst for the group, plunking down more than half a million dollars in seed money and taking on ringmaster duties for launch today on World AIDS Day, but co-creator Health Action Alliance will organize joint activities going forward. ViiV and the alliance want and expect more companies to not only join the effort, but also pitch in funding.

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Roche HQ in Basel, Switzerland. (Image credit: Kyle LaHucik/Endpoints News)

As com­peti­tors near FDA goal­post, Roche spells out its re­peat Alzheimer's set­back

Before Roche can turn all eyes on a new version of its more-than-once-failed Alzheimer’s drug gantenerumab, the Big Pharma had to flesh out data on the November topline failure at an annual conference buzzier than in years past thanks to hotly watched rivals in the field: Eisai and Biogen’s lecanemab, and Eli Lilly’s donanemab.

There was less than a 10% difference between Roche’s drug and placebo at slowing cognitive decline across two Phase III trials, which combined enrolled nearly 2,000 Alzheimer’s patients. In its presentation at the conference Wednesday, Roche said it saw less sweeping away of toxic proteins than it had anticipated. For years, researchers and investors have put their resources behind the idea that more amyloid removal would equate to reduced cognitive decline.

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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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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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Fed­er­al claims court rules in fa­vor of Gilead in CDC Tru­va­da patent case

Gilead pulled a win last week in its ongoing patent battle with the CDC over the HIV drug Truvada for pre-exposure prophylaxis (PrEP).

The US Court of Federal Claims ruled on Nov. 21 that the government breached certain agreements with Gilead by failing to promptly notify the company of its patent applications for Truvada for PrEP, according to documents unsealed on Wednesday.

The issue traces back to around 2004 when Truvada won an accelerated approval to treat HIV. Because HIV is known to develop resistance to therapy, patients at the time were often required to take more than one drug at a time. Truvada combines Gilead’s prior HIV drugs, Emtriva and Viread, making life easier for patients who were taking separate pills daily. Shortly after, the CDC and Gilead struck up a partnership to research Truvada’s use as a preventative measure prior to exposure.