Ther­mo Fish­er will drop a whop­ping $600M in­to its man­u­fac­tur­ing sup­ply chain as Covid-19 work ramps up

With Covid-19 con­tract work grow­ing at a rapid clip, the biggest CD­MOs are tak­ing the op­por­tu­ni­ty — and a wind­fall of cash — to carve out big­ger foot­prints. At Ther­mo Fish­er Sci­en­tif­ic, the time’s nev­er been bet­ter for a far­sight­ed glob­al ex­pan­sion that will great­ly ex­pand its man­u­fac­tur­ing ca­pac­i­ty and add re­dun­dan­cy to the sup­ply chain.

Ther­mo will pump $600 mil­lion in­to its glob­al man­u­fac­tur­ing net­work as part of a move to ramp up its short-term Covid-19 work and more than dou­ble its ca­pac­i­ty for the fu­ture, the Mass­a­chu­setts firm said Wednes­day.

Tar­get­ing 11 sites spread through­out the Amer­i­c­as, Eu­rope and Asia, Ther­mo ex­pects to add 1,500 em­ploy­ees to its glob­al work­force in or­der to ex­pand its bio­pro­cess­ing ca­pac­i­ty for sin­gle-use tech, cell cul­ture me­dia and pu­rifi­ca­tion. The ex­pan­sions are set to be com­plet­ed by 2022.

Ther­mo’s grow­ing foot­print will in­clude:

  • Adding ca­pac­i­ty for sin­gle-use tech at lo­ca­tions in Lo­gan, Utah; Millers­burg, Penn­syl­va­nia; Cram­ling­ton, UK.; Sin­ga­pore; and Suzhou, Chi­na.  An ad­di­tion­al in­vest­ment at Ther­mo’s San­ta Clara, Cal­i­for­nia site will ex­pand bio­pro­cess­ing equip­ment and au­toma­tion ca­pac­i­ty.
  • Ex­pand­ing the com­pa­ny’s POROS resin man­u­fac­tur­ing site in Bed­ford, Mass­a­chu­setts. and open a new 85,000-square-foot man­u­fac­tur­ing fa­cil­i­ty in Chelms­ford, Mass­a­chu­setts. Those sites will “re­in­force” Ther­mo’s pu­rifi­ca­tion sup­ply chain and add ex­per­tise in vac­cines and gene ther­a­pies, the com­pa­ny said.
  • Ex­pand­ing cell cul­ture me­dia ca­pac­i­ty at sites in Grand Is­land, New York; Mi­a­mi, Flori­da; and Inchin­nan, Scot­land.

“These in­vest­ments add sig­nif­i­cant ca­pac­i­ty and re­gion­al re­dun­dan­cy to fur­ther bol­ster sup­ply chains and help us bet­ter sup­port cus­tomers as they ac­cel­er­ate the com­mer­cial­iza­tion of life­sav­ing ther­a­pies and vac­cines,” Ther­mo Fish­er ex­ec­u­tive VP Michel La­garde said in a state­ment.

Sim­i­lar to the oth­er big play­ers in the CD­MO space amid a red-hot mar­ket for Covid-19 con­tract work, Ther­mo has been plac­ing big down pay­ments on ex­pand­ing its tech in vac­cines.

In Jan­u­ary, the com­pa­ny shelled out $878 mil­lion to ac­quire Henogen SA, No­vasep’s vi­ral vec­tor man­u­fac­tur­ing busi­ness, which com­pris­es two Bel­gian lo­ca­tions in Sen­effe and Gos­selies and of­fers more than 75,000 square feet of clin­i­cal and com­mer­cial man­u­fac­tur­ing ca­pac­i­ty. No­vasep comes with 400 em­ploy­ees and an­nu­al rev­enue of $95 mil­lion. In a state­ment at the time, La­garde said the ad­di­tion of Eu­ro­pean man­u­fac­tur­ing ca­pac­i­ty would com­ple­ment Ther­mo’s four CD­MO sites in the US.

Back in De­cem­ber, Ther­mo launched a par­al­lel glob­al ex­pan­sion for its vac­cine of­fer­ings, an­nounc­ing plans to beef up its fa­cil­i­ties in Greenville, North Car­oli­na; Fer­enti­no and Mon­za, Italy; and Swin­don, Eng­land.

Though not work­ing on the scale of oth­er ma­jor CD­MOs like Catal­ent, Ther­mo did ice a deal in Sep­tem­ber to pro­duce In­ovio’s Covid-19 vac­cine (INO-4800) be­gin­ning this year. Al­so on the Covid front, Ther­mo in May en­tered in­to a deal with Cal­i­for­nia-based Hu­mani­gen to help scale up man­u­fac­tur­ing of the biotech’s lenzilum­ab, a clin­i­cal-stage can­di­date for cy­tokine storms that the com­pa­ny is test­ing in pa­tients with more se­vere cas­es of the res­pi­ra­to­ry virus. In Sep­tem­ber, Ther­mo Fish­er agreed to a deal with the US gov­ern­ment to pro­duce the vi­ral trans­port me­dia tubes need­ed to trans­port Covid-19 test sam­ples.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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J. Kelly Ganjei, AmplifyBio CEO and president

Af­ter pri­vate and state in­vest­ment, Am­pli­fy­Bio plans to ex­pand to an­oth­er Colum­bus, OH lo­ca­tion

An Ohio-based biotech spinout is garnering even more investment and space even after only being around for about a year.

AmplifyBio, a CRO and R&D biotech, has received a nine-figure investment to expand its facilities to a second location in New Albany, a suburb of the state capital of Columbus.

The company is receiving an investment of around $150 million to establish a new 350,000-square-foot facility. With this investment, the company is also expected to create over 200 new jobs both at its new location and at an existing location in West Jefferson, another Columbus suburb. That location, which has 220,000-square-feet of space for the young biotech, is the headquarters for nonprofit Battelle, which spun out AmplifyBio last year.

Belén Garijo, Merck KGaA CEO (Kevin Wolf/AP Images for EMD Serono)

Mer­ck KGaA pumps €440M in­to ex­pand­ing and con­struct­ing Irish man­u­fac­tur­ing fa­cil­i­ties

The area of Ireland famous for Blarney Castle and its cliffsides along the Atlantic Ocean is seeing Merck KGaA expand its commitment there.

The German drug manufacturer is expanding its membrane and filtration manufacturing capabilities in Ireland. The company will invest approximately €440 million ($470 million) to increase membrane manufacturing capacity in Carrigtwohill, Ireland, and build a new manufacturing facility at Blarney Business Park, in County Cork, Ireland.

Phillip Gomez, SIGA CEO

UP­DAT­ED: On the back of SIGA Tech­nolo­gies' win with the FDA, the mon­key­pox virus sees the com­pa­ny spring­ing to fur­ther ac­tion

As the cases of monkeypox now sit at well over 100 worldwide and have spread to multiple continents, the orders for any type of vaccine against monkeypox are seeing nations and medical bodies looking to get their hands on anything and everything. And now SIGA Technologies seems to be getting in on the action.

According to Euronews, SIGA Technologies, a pharmaceutical company that is focused on providing medical countermeasures to biological and chemical attacks, is now in talks with several European authorities looking to stockpile its antiviral that can counter monkeypox. The drug known as tecovirimat or Tpoxx was approved by the FDA in 2018 as a vaccine for smallpox but was approved by the European Medicines Agency to also act against monkeypox, cowpox and complications from immunization with vaccinia.

Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Phar­ma com­pa­ny con­tin­ues its FDA law­suit spree, this time af­ter agency de­nies fast-track des­ig­na­tion

Vanda Pharmaceuticals is making a name for itself, at least in terms of suing the FDA.

The DC-headquartered firm on Monday filed its latest suit against the agency, with the company raising concerns over the FDA’s failure to grant a fast track designation for Vanda’s potential chronic digestive disorder drug tradipitant, which is a neurokinin 1 receptor antagonist.

Specifically, Vanda said FDA’s “essential point” in its one-page denial letter on the designation pointed to “the lack of necessary safety data,” which was “inconsistent with the criteria for … Fast Track designation.”

Mod­er­na seeks to dis­miss Al­ny­lam suit over Covid-19 vac­cine com­po­nent, claim­ing wrong venue

RNAi therapeutics juggernaut Alnylam Pharmaceuticals made a splash in March when it sued and sought money from both Pfizer and Moderna regarding their use of Alnylam’s biodegradable lipids, which Alnylam claims have been integral to the way both companies’ mRNA-based Covid-19 vaccines work.

But now, Moderna lawyers are firing back, telling the same Delaware district court that Alnylam’s claims can only proceed against the US government in the Court of Federal Claims because of the way the company’s contract is set up with the US government. The US has spent almost $10 billion on Moderna’s Covid-19 vaccine so far.

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Cracks in the fa­cade: Is phar­ma's pan­dem­ic ‘feel good fac­tor’ wan­ing?

The discordant effects of the Covid-19 pandemic on pharma reputation continues. While the overall industry still retains a respectable halo from its Covid-19 quick response and leadership, a new patient group study reveals a different story emerging in the details.

On one hand, US patient advocacy groups rated the industry higher-than-ever overall. More than two-thirds (67%) of groups gave the industry a thumbs up for 2021, a whopping 10 percentage point increase over the year before, according to the PatientView annual study, now in its 9th year.

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Michael Corbo, Pfizer CDO of inflammation & immunology

UP­DAT­ED: Plan­ning ahead for crowd­ed ul­cer­a­tive col­i­tis mar­ket, Pfiz­er spells out PhI­II da­ta on $6.7B Are­na drug

Pfizer has laid out the detailed results behind its boast that etrasimod — the S1P receptor modulator at the center of its $6.7 billion buyout of Arena Pharma — is the winner of the class, potentially leapfrogging an earlier entrant from Bristol Myers Squibb.

Pivotal data from the ELEVATE program in ulcerative colitis — which consists of two Phase III trials, one lasting 52 weeks and the other just 12 weeks — illustrate an “encouraging balance of efficacy and safety,” according to Michael Corbo, chief development officer of inflammation & immunology at Pfizer. The company is presenting the results as a late breaker at Digestive Disease Week.

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Robert Califf (Michael Brochstein/Sipa USA via AP Images)

House Re­pub­li­cans at­tack Chi­na-on­ly da­ta in FDA sub­mis­sions, seek new in­ves­ti­ga­tion in­to re­search in­spec­tions

Three Republican representatives are calling on the FDA to take a closer look at the applications including only clinical data from China.

The letter to FDA commissioner Rob Califf late last week comes as the agency recently rejected Eli Lilly’s anti-PD-1 antibody, which attempted to bring China-only data but ran into a bruising adcomm that may crush the hopes of any other companies looking to bring cheaper follow-ons based only on Chinese data.

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