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BlackRock joins Andrew Lo's risk analysis firm to search for odds-on biotech bets in turbulent times
2. Eisai shutters oncology unit, cuts around 80 jobs
3. Biogen sees more than 330 departures from MA-based sites since last summer
4. GSK's consumer health unit Haleon off to a rough start
5. Pharma R&D spending in the US more than doubles in a decade, PhRMA survey finds
6. Amgen expands StoryCorps oncology campaign with celebrity actor, preps for upcoming health equity stories
7. Samsung’s CDMO arm commits to $324M land purchase for a second bio campus
8. Europe buys 54,000 more doses of Bavarian Nordic's monkeypox vaccine as cases increase
9. Khloé Kardashian strikes again with migraine med Nurtec marketing in ‘all in one’ push
10. GSK nets a deal with Canadian government for flu vaccine manufacturing
11. MilliporeSigma uses DOD funds to expand Wisconsin-based IVD manufacturing site
more stories
 
Zachary Brennan
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Welcome back to our daily pharma newsletter. We hope you had a good weekend. Today's issue features more clarity around a few pharma companies' layoffs, the launch of GSK's Haleon, the return of Khloé Kardashian to pharma marketing, and much more.

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Zachary Brennan
Senior Editor, Endpoints News
@ZacharyBrennan
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MIT professor Andrew Lo (Credit: J.T. MacMillan Photography at Endpoints #BIO22)
1

MIT fi­nance pro­fes­sor An­drew Lo has more in­sid­er con­nec­tions than just about any oth­er aca­d­e­m­ic play­er you’ll find in any in­dus­try. And to­day, if you val­ued his biotech con­nec­tions in fi­nan­cial terms, it just spiked.

Lo’s QLS Ad­vi­sors LLC (that stands for Quan­ti­ta­tive Life Sci­ences) has just joined forces with Black­Rock Sys­tem­at­ic. To put it sim­ply, Lo’s QLS will now put its ma­chine learn­ing ap­proach to de­ter­min­ing drug de­vel­op­ment risk to work with Black­Rock ex­ecs to guide their tar­get­ed strat­e­gy for find­ing biotech win­ners.

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Ping Zhu, H3 Biomedicine's president and CSO
2
by Nicole DeFeudis

Days af­ter an­nounc­ing a re­or­ga­ni­za­tion plan to fo­cus on deep learn­ing and its “most im­por­tant project,” the Bio­gen-part­nered Alzheimer’s drug lecanemab, Ei­sai is shut­ter­ing its on­col­o­gy unit H3 Bio­med­i­cine.

The news comes af­ter H3 re­vealed in pub­lic doc­u­ments last week that it’s lay­ing off em­ploy­ees at its Cam­bridge, MA, head­quar­ters. In to­tal, 88 jobs will be af­fect­ed, a spokesper­son said. Ac­cord­ing to Mass­a­chu­setts pub­lic doc­u­ments, at least 79 will be laid off by Sept. 15.

The can­cer unit’s work will be con­tin­ued un­der Ei­sai’s Deep Hu­man Bi­ol­o­gy Learn­ing de­part­ment, ac­cord­ing to Fierce­Biotech, which first re­port­ed the news.

H3 was es­tab­lished back in 2011 to de­vel­op pre­ci­sion can­cer treat­ments with the “re­source and ex­per­tise of a large phar­ma­ceu­ti­cal com­pa­ny” and the “agili­ty and in­no­va­tion of a small biotech,” ac­cord­ing to the com­pa­ny’s web­site.

Its lead can­di­date, dubbed H3B-6545, is a small mol­e­cule se­lec­tive es­tro­gen re­cep­tor co­va­lent an­tag­o­nist de­signed to treat breast can­cer pa­tients with es­tro­gen re­cep­tor al­pha mu­ta­tions. While that can­di­date is in Phase II, H3 al­so has a hand­ful of Phase I pro­grams for he­pa­to­cel­lu­lar car­ci­no­ma, non-mus­cle in­va­sive blad­der can­cer, ad­vanced sol­id tu­mors and oth­er can­cers.

Back in Jan­u­ary, H3 grant­ed Roivant the rights to its small mol­e­cule drug H3B-8800, which was in Phase I for myelodys­plas­tic syn­dromes, acute myeloid leukemia and chron­ic myelomono­cyt­ic leukemia.

Last Au­gust, the com­pa­ny tapped No­var­tis In­sti­tutes for Bio­med­ical Re­search vet­er­an Ping Zhu as CSO, and Ross Pet­tit, who cut his teeth at BeiGene, Ot­su­ka and EMD Serono, as deputy pres­i­dent over­see­ing busi­ness op­er­a­tions.

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3
by Zachary Brennan

The de­cline and fall of Bio­gen's con­tro­ver­sial Alzheimer's drug Aduhelm ⁠— from snap ap­proval to pay­er cov­er­age de­nials and now a re­quire­ment for more da­ta — has led the com­pa­ny to aban­don the drug, and cut staff over the past year, in­clud­ing 331 de­par­tures from its Mass­a­chu­setts-based sites.

The lay­offs in Cam­bridge and We­st­on, first re­port­ed by the Boston Busi­ness Jour­nal, are part of $1 bil­lion in over­all cuts.

The com­pa­ny told End­points News that cur­rent­ly 2,469 of its em­ploy­ees work in Mass­a­chu­setts, where­as last Au­gust, an in­dus­try re­port said that 2,800 Bio­gen em­ploy­ees worked in the state, mak­ing the com­pa­ny the third largest bio­phar­ma em­ploy­er there.

A spokesper­son said in a state­ment:

We are not pro­vid­ing speci­fici­ty around the to­tal num­ber of po­si­tions that have been re­duced giv­en the re­duc­tions in­clude open po­si­tions that are not be­ing filled, at­tri­tion, op­tions to trans­fer to oth­er po­si­tions if qual­i­fied, and lay­offs...How­ev­er, with this said, we have shared that we have sub­stan­tial­ly elim­i­nat­ed the in­fra­struc­ture sup­port­ing Aduhelm.

With the de­par­ture of Bio­gen CEO Michel Vounatsos, the cuts are part of the com­pa­ny's de­ci­sion to sig­nif­i­cant­ly re­duce glob­al com­mer­cial in­fra­struc­ture sup­port­ing Aduhelm as well as oth­er cost re­duc­tions that are ex­pect­ed to yield about $500 mil­lion in an­nu­al­ized sav­ings, in ad­di­tion to oth­er, pre­vi­ous­ly an­nounced $500 mil­lion in sav­ings.

"This brings to­tal ex­pect­ed an­nu­al­ized sav­ings to ap­prox­i­mate­ly $1 bil­lion, a por­tion of which will be rein­vest­ed in strate­gic ini­tia­tives over the com­ing years," Bio­gen said.

The news comes as Bio­gen and part­ner Ei­sai are hav­ing a sec­ond go at the amy­loid plaque the­o­ry, with an­oth­er hope­ful ac­cel­er­at­ed ap­proval for their drug lecanemab.

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4
by Nicole DeFeudis

GSK may re­gret turn­ing down that of­fer from Unilever.

The phar­ma gi­ant’s con­sumer health unit Ha­le­on of­fi­cial­ly de­buted on the Lon­don Stock Ex­change on Mon­day — but it did so with a val­u­a­tion much low­er than Unilever’s takeover bid back in Jan­u­ary.

Ha­le­on HLN start­ed trad­ing at 330 pence, but by mid-morn­ing the stock had fall­en to around 317 pence. That leaves the com­pa­ny’s mar­ket val­ue around £31 bil­lion (rough­ly $37 bil­lion), far low­er than Unilever’s £50 bil­lion ($68 bil­lion) of­fer.

AJ Bell an­a­lyst Dan­ni Hew­son​ not­ed on Mon­day morn­ing:

Ha­le­on has so far got off to a mixed start. Trad­ing start­ed at 330p, but the shares had slipped to 326p in the first half hour of the UK mar­ket be­ing open. Soon af­ter they jumped to 337p.  With a mar­ket val­ue of ap­prox­i­mate­ly £31 bil­lion, in­vestors might be won­der­ing why GSK didn’t ac­cept the much high­er bid from Unilever.

The com­pa­ny’s al­so launch­ing with about £10.3 bil­lion (more than $12 bil­lion) in debt, GSK con­firmed a cou­ple of weeks ago.

Bar­clays an­a­lysts have pre­vi­ous­ly called the con­sumer busi­ness, which owns pop­u­lar brands such as Sen­so­dyne tooth­paste and Ro­bi­tussin cough syrup, the “largest list­ing in Eu­rope for over a decade.” The split has been in the works for four years, as CEO Em­ma Walm­s­ley looks to steer a slim­mer GSK to new heights.

Ear­li­er this year, Walm­s­ley punt­ed mul­ti­ple un­so­licit­ed of­fers from Unilever, with the com­pa­ny’s board claim­ing that the of­fer “fun­da­men­tal­ly un­der­val­ued” Ha­le­on.

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Stephen Ubl, PhRMA president and CEO (Photographer: Andrew Harrer/Bloomberg via Getty Images)
5
by Zachary Brennan

While PhRMA is en­gaged in a fierce bat­tle on Capi­tol Hill over new Medicare drug price ne­go­ti­a­tions, which the top phar­ma in­dus­try lob­by ar­gues will take a big cut on in­no­va­tion, the group al­so un­veiled a new re­port find­ing its mem­ber com­pa­nies have spent more than dou­ble on US R&D in 2021 (al­most $80 bil­lion) when com­pared to 2012 ($37 bil­lion).

But that dou­bling in US R&D spend­ing, as well as a dou­bling of world­wide R&D spend­ing in 2021 ($102 bil­lion) when com­pared to 2013 ($51 bil­lion), has not re­sult­ed in a cor­re­spond­ing uptick in new mol­e­c­u­lar en­ti­ty (NME) ap­provals — re­flect­ing both how dif­fi­cult it is to dis­cov­er new, mean­ing­ful drugs, and how the process is get­ting more ex­pen­sive over time.

In 2021, 36 NMEs won ap­proval in the US, ac­cord­ing to Na­ture Re­views Drug Dis­cov­ery, where­as in 2012, 33 NMEs won ap­proval. Those num­bers have fluc­tu­at­ed in the in­ter­ven­ing years, with no clear cor­re­la­tion be­tween R&D spend­ing and NME ap­provals.

But the ap­provals and the amount spent don't tell the full sto­ry giv­en the ex­tent to which most drugs and bi­o­log­ics fail in the clin­ic. The PhRMA sur­vey es­ti­mates that about 30% of those R&D dol­lars go to Phase III tri­als and that it can take de­vel­op­ers more than a decade to bring a new drug to the mar­ket.

How­ev­er, the new PhRMA sur­vey may end up as grist for the mill for those work­ing on Medicare ne­go­ti­a­tions in Con­gress as De­moc­rats rail against the fact that many Amer­i­cans spend dou­ble or triple on med­i­cines that oth­ers in Eu­rope and else­where do.

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Actor Patrick Dempsey doubles down on his Amgen collaborations to raise cancer awareness, this time with a StoryCorps campaign.
6
by Beth Snyder Bulik

Ac­tor Patrick Dempsey is best known for his role as Grey’s Anato­my brain sur­geon “Mc­Dreamy," but he’s al­so a long­time can­cer care ad­vo­cate — and an Am­gen part­ner.

Dempsey found­ed the Dempsey Cen­ter in 2008 to hon­or his moth­er who had ovar­i­an can­cer, and around the same time, struck up an as­so­ci­a­tion with Am­gen that con­tin­ues to­day.

Dempsey be­gan as an Am­gen am­bas­sador for its “Break­away from Can­cer” ef­fort in 2007. Am­gen then be­came a Dempsey Cen­ter part­ner and pre­sent­ing spon­sor of its ma­jor an­nu­al fundrais­er — a run, walk or bike event called Dempsey Chal­lenge that has raised $17 mil­lion to date to en­sure the cen­ter’s can­cer sup­port and health ser­vices re­main free.

The newest ini­tia­tive ex­pands on Am­gen’s al­ready run­ning Sto­ryCorps col­lab­o­ra­tion called “Every Pa­tient Counts, Every Sto­ry Mat­ters,” which be­gan in 2019. The ef­fort doc­u­ments per­son­al can­cer sto­ries with pa­tients, care­givers, doc­tors, nurs­es and re­searchers to raise aware­ness with the non­prof­it oral his­to­ry doc­u­menter. The newest episode fea­tures Dempsey and can­cer sur­vivor Aman­da talk­ing about her ex­pe­ri­ence, as well as the cen­ter and its found­ing.

“When my moth­er was new­ly di­ag­nosed, I felt so help­less. Where do you go? Who do you talk to? And it was like ‘well God, if we’re go­ing through this, how many oth­er peo­ple?’" Dempsey says in the au­dio in­ter­view.

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John Rim, Samsung Biologics CEO
7
by Tyler Patchen

As in­vest­ments in­to CD­MOs are gain­ing steam from sev­er­al South Ko­re­an and Japan­ese con­glom­er­ates, Sam­sung is mak­ing a big land grab.

On Mon­day, Sam­sung Bi­o­log­ics, the CD­MO arm of the Ko­re­an con­glom­er­ate, an­nounced that it has of­fi­cial­ly signed a land pur­chase agree­ment with the In­cheon Free Eco­nom­ic Zone to sup­port the build-out of its sec­ond bio cam­pus, dubbed Bio Cam­pus II. Sam­sung stat­ed that the 3.8 mil­lion square foot land pur­chase is val­ued at about $324 mil­lion. The land, which is lo­cat­ed with­in the Song­do In­dus­tri­al Clus­ter, will be 30% larg­er than the com­pa­ny's cur­rent cam­pus.

Bio Cam­pus II is al­so de­signed to sup­port fur­ther ex­pan­sion of large-scale man­u­fac­tur­ing ca­pac­i­ty along with a plant and an in­no­va­tion fa­cil­i­ty.

In an in­ter­view with Sam­sung Bi­o­log­ics CEO John Rim at #BIO22, the new cam­pus will be ad­ja­cent to their cur­rent 60-acre cam­pus in Song­do, South Ko­rea. Rim said the cur­rent cam­pus is ful­ly oc­cu­pied and needs ex­pan­sion. Rim ex­pects the site be ful­ly staffed with­in the next decade.

Ac­cord­ing to a re­port from the Ko­re­an news site, Yon­hap News Agency, the com­pa­ny is plan­ning to add 400 new jobs fol­low­ing con­struc­tion, with a to­tal of 4,000 ad­di­tion­al jobs added by 2032.

“Through con­tin­u­ous in­vest­ment, we will main­tain our po­si­tion as the best-in-class CD­MO part­ner, ful­ly equipped with the world's largest man­u­fac­tur­ing ca­pac­i­ty and pro­vide di­verse ser­vice of­fer­ings to our clients to ad­dress new emerg­ing dis­eases and save lives of pa­tients world­wide,” Rim said in a state­ment.

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European Commissioner for Health Stella Kyriakides (Francisco Seco/Pool via AP Images)
8
by Paul Schloesser

The EU is back for more dos­es of mon­key­pox vac­cines af­ter see­ing thou­sands of more cas­es.

The Eu­ro­pean Com­mis­sion an­nounced Mon­day that it reached a deal with Bavar­i­an Nordic to buy an ad­di­tion­al 54,000 dos­es of the biotech's mon­key­pox vac­cine af­ter a sub­stan­tial in­crease in mon­key­pox cas­es in the con­ti­nent.

This or­der and oth­ers pushed Bavar­i­an Nordic on Mon­day to al­so re­up its 2022 rev­enue guid­ance, which is now ex­pect­ed to be be­tween $368 mil­lion and $396 mil­lion (pre­vi­ous­ly it was es­ti­mat­ed to be be­tween $314 mil­lion and $341 mil­lion).

Eu­ro­pean Com­mis­sion­er Stel­la Kyr­i­akides ex­pressed con­cern in a state­ment over in­creas­ing cas­es of mon­key­pox in the EU, not­ing that there are now more than 7,000 cas­es — about a 50% in­crease over last week. There are cur­rent­ly more than 12,500 con­firmed cas­es of mon­key­pox world­wide, ac­cord­ing to a CDC track­er — tripling the 4,000 mark reached the last week of June.

"We have now se­cured over 160,000 dos­es of vac­cines to re­spond prompt­ly to the pro­gres­sion of the spread of this virus," Kyr­i­akides said in a state­ment.

De­liv­ery of these vac­cine dos­es will be done through the rest of 2022 to all EU mem­ber states, plus Nor­way and Ice­land, the Eu­ro­pean Com­mis­sion said in a state­ment.

This comes just a few weeks af­ter the Eu­ro­pean Com­mis­sion reached an ini­tial deal with Bavar­i­an Nordic for 110,000 dos­es of Jyn­neos, the US-li­censed ver­sion of Bavar­i­an Nordic’s Im­vanex. Im­vanex is cur­rent­ly on­ly au­tho­rized in the EU to pre­vent small­pox in adults, but on­ly “un­der ex­cep­tion­al cir­cum­stances" due to dif­fi­cul­ties gen­er­at­ing ef­fi­ca­cy da­ta.

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Khloé Kardashian is back again to promote Biohaven migraine med Nurtec ODT in its newest TV and digital campaign (courtesy Biohaven)
9
by Beth Snyder Bulik

Re­al­i­ty star, busi­ness­woman and brand boss Khloé Kar­dashi­an is back on TV for Bio­haven’s mi­graine brand Nurtec ODT. The mega-in­flu­encer is lead­ing the charge for Bio­haven’s con­sol­i­dat­ed “All in One” mar­ket­ing strat­e­gy and mes­sage.

The new 15- and 30-sec­ond Kar­dashi­an TV ads, along with re­vamped mar­ket­ing across the Nurtec TV and dig­i­tal port­fo­lio of re­al pa­tient am­bas­sadors, in­cludes its lat­est brand­ing el­e­ment — a white pill with “All in One” across the top and “Treat & pre­vent” on the bot­tom. Nurtec ODT was first ap­proved in Feb­ru­ary 2020 to treat acute on­set of mi­graine, and nabbed a sec­ond in­di­ca­tion as a pre­ven­ta­tive in May 2021.

“The first thing we did when we launched was just get peo­ple aware about this new mech­a­nism that works for acute,” Bio­haven CEO Vlad Coric said. “Then we got the pre­ven­tion and the fo­cus was on rais­ing pre­ven­tion aware­ness. Now the next stage is to high­light the one pill that does both.”

Kar­dashi­an sports a more se­ri­ous busi­ness look in the new ad, de­part­ing from her last Nurtec TV ad ap­pear­ance as a mom on the couch with her daugh­ter, and opens the ad say­ing, “There’s noth­ing glam­orous about mi­graines.”

She’s pro­mot­ing the new work in me­dia in­ter­views and across her so­cial chan­nels.

Along with celebri­ty Kar­dashi­an, Nurtec “re­al-life” spokes­peo­ple in­clud­ing col­lege stu­dent El­lie and mil­i­tary vet­er­an Greg will al­so be fea­tured in ads run­ning on net­work, ca­ble and con­nect­ed TV and on its web­site and in dig­i­tal and so­cial me­dia with the new con­sol­i­dat­ed mes­sage.

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Canadian Prime Minister Justin Trudeau (Justin Tang/The Canadian Press via AP)
10
by Tyler Patchen

While Covid-19 and mon­key­pox man­u­fac­tur­ers are get­ting more on­tracts, the Cana­di­an gov­ern­ment is still con­cerned with the flu, es­pe­cial­ly as its sea­son will soon be up­on North Amer­i­ca in a few months.

Last Fri­day, GSK an­nounced an agree­ment with the Cana­di­an gov­ern­ment to man­u­fac­ture pan­dem­ic and sea­son­al in­fluen­za vac­cines.

The four-year agree­ment, which ex­tends through March 2026, in­cludes GSK sup­ply­ing as many as 80 mil­lion dos­es of Arepan­rix, an ad­ju­vant­ed pan­dem­ic flu vac­cine, in case there is an in­fluen­za pan­dem­ic. The deal will al­so have GSK pro­duce a min­i­mum of 4 mil­lion dos­es per year of the sea­son­al flu vac­cine Flulaval Tetra. Both vac­cines will be man­u­fac­tured at its 230,000-square-foot fa­cil­i­ty in Sainte-Foy, Que­bec.

The fi­nan­cial terms of the deal were not dis­closed.

Ac­cord­ing to GSK, the agree­ment fol­lows ear­li­er agree­ments be­tween the Cana­di­an gov­ern­ment and GSK. The com­pa­ny has been sup­ply­ing both vac­cines since 2001.

"COVID-19 has shown the world the im­por­tance of im­mu­niza­tion and pan­dem­ic pre­pared­ness. This agree­ment re­serves fu­ture pro­duc­tion and de­liv­ery of pan­dem­ic and sea­son­al in­fluen­za vac­cines al­low­ing for a rapid re­sponse to help pro­tect Cana­di­ans,” said Roger Con­nor, pres­i­dent of GSK Vac­cines.

This deal in Cana­da comes as GSK plans to dis­trib­ute 50 mil­lion dos­es of flu vac­cines in the US in prepa­ra­tion for flu sea­son.

GSK’s fa­cil­i­ty in Que­bec, how­ev­er, did re­ceive a warn­ing let­ter from the FDA in 2014. Ac­cord­ing to Fierce Phar­ma, the let­ter raised con­cerns about is­sues re­lat­ed to cer­tain qual­i­ty con­trol and man­u­fac­tur­ing pro­ce­dures at the fa­cil­i­ty.

Wisconsin Governor Tony Evers (AP Photo/Andy Manis, File)
11
by Tyler Patchen

Mer­ck KGaA’s Mil­li­pore­Sig­ma is again ex­pand­ing its fa­cil­i­ties near Wis­con­sin’s cap­i­tal, now with the fed­er­al gov­ern­ment con­tract in tow.

The com­pa­ny kicked off the ex­pan­sion at its She­boy­gan lo­ca­tion as the com­pa­ny is build­ing its first lat­er­al flow mem­brane pro­duc­tion fa­cil­i­ty in the US. Lat­er­al flow mem­branes are a key com­po­nent in rapid di­ag­nos­tic test kits for a va­ri­ety of ap­pli­ca­tions, in­clud­ing Covid-19 test­ing. Ac­cord­ing to the com­pa­ny, the new fa­cil­i­ty is sup­port­ed by a $136.7 mil­lion con­tract award­ed to Mil­li­pore­Sig­ma from the DOD on be­half of HHS.

The con­tract, which was award­ed last year, will see the com­pa­ny specif­i­cal­ly pro­duce ni­tro­cel­lu­lose mem­brane pro­duc­tion ca­pac­i­ty, which is a key com­po­nent in Covid-19 rapid tests. How­ev­er, the fa­cil­i­ty will al­so serve oth­er in-vit­ro di­ag­nos­tic man­u­fac­tur­ing cus­tomers.

Oth­er fi­nan­cial de­tails or the size of the lo­ca­tion were not dis­closed.

"Our pur­pose is to pos­i­tive­ly im­pact life and health with sci­ence, and to­day's ground-break­ing ex­em­pli­fies this com­mit­ment by adding phys­i­cal ca­pac­i­ty and ex­pand­ing our re­gion­al net­work to meet the grow­ing needs of our cus­tomers and en­sure sup­ply chain se­cu­ri­ty," said Matthias Heinzel, mem­ber of the ex­ec­u­tive board of Mer­ck KGaA, Darm­stadt, Ger­many, and CEO Life Sci­ence.

Ac­cord­ing to Wis­con­sin Gov­er­nor Tony Evers, the ex­pan­sion will al­so cre­ate 60 jobs.

How­ev­er, this is not the first time Mil­li­pore­Sig­ma has ex­pand­ed in She­boy­gan. In 2017, the com­pa­ny ex­pand­ed the lo­ca­tion to 80,000 square feet and re­ceived a tax cred­it of $1.25 mil­lion from the Wis­con­sin Eco­nom­ic De­vel­op­ment Cor­po­ra­tion over three years. That project cost Mil­li­pore­Sig­ma $47 mil­lion ac­cord­ing to the lo­cal news site the She­boy­gan Press.

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