Fu­ji­film to build $188M man­u­fac­tur­ing plant in North Car­oli­na’s re­search tri­an­gle

As the Japan­ese con­glom­er­ate Fu­ji­film con­tin­ues to in­vest heav­i­ly in its CD­MO arm, one of its man­u­fac­tur­ing di­vi­sions is tee­ing up a ma­jor in­vest­ment.

Fu­ji­film Irvine Sci­en­tif­ic an­nounced on Tues­day that par­ent Fu­ji­film is mak­ing a $188 mil­lion in­vest­ment to build a cell cul­ture me­dia man­u­fac­tur­ing site in the Re­search Tri­an­gle Park in North Car­oli­na. The new site will mark Fu­ji­film Irvine’s fifth man­u­fac­tur­ing site glob­al­ly and its sec­ond in the US.

The 250,000-square-foot site will sit on 64 acres in the re­search park and pro­duce dry pow­der and liq­uid me­dia, with the ca­pac­i­ty to man­u­fac­ture 800,000 kilo­grams per year of dry pow­der and 3.3 mil­lion liters per year of liq­uid me­dia. The site will al­so have a ca­pac­i­ty of 40,000 liters per day of wa­ter for in­jec­tion.

Both the land de­vel­op­ment and con­struc­tion are slat­ed to start in 2023, with pro­duc­tion start­ing in 2025. The com­pa­ny will al­so look to hire around 100 work­ers for the site.

Yu­ta­ka Ya­m­aguchi

“The cell cul­ture me­dia that will be man­u­fac­tured at this new site in North Car­oli­na will help en­sure a steady sup­ply of raw ma­te­ri­als for bi­o­log­ics, cell and gene ther­a­pies, and oth­er key med­i­cines that are es­sen­tial to hu­man health. The ad­di­tion­al pro­duc­tion ca­pac­i­ty will en­sure we meet the pro­ject­ed de­mand for cell cul­ture me­dia from our cus­tomers world­wide,” said Yu­ta­ka Ya­m­aguchi, Fu­ji­film Irvine Sci­en­tif­ic’s CEO, in a state­ment.

Fu­ji­film Irvine is build­ing a sec­ond US site due to “rapid growth” over the past decade and a pre­dict­ed uptick in de­mand for cell cul­ture me­dia to sup­port more “ad­vanced ther­a­pies.” The Re­search Tri­an­gle Park was se­lect­ed be­cause it’s an “ide­al lo­ca­tion” that can pro­vide sup­ply chain se­cu­ri­ty and a good jump­ing-off point to de­liv­er to its cus­tomers in the re­gion.

Fu­ji­film en­ters an ex­treme­ly hot area for wider biotech and phar­ma man­u­fac­tur­ing. Com­pa­nies such as KBI, Chi­nese cell ther­a­py com­pa­ny CARs­gen and En­zy­vant have all plant­ed their flags and set up man­u­fac­tur­ing op­er­a­tions in the park in the past few years.

Last year Eli Lil­ly an­nounced it was adding the eighth site to its net­work of man­u­fac­tur­ing plants in the US, in­vest­ing $470 mil­lion to be­gin pro­duc­tion of in­jectable prod­ucts and de­liv­ery de­vices in the Re­search Tri­an­gle Park.

Fu­ji­film’s CD­MO, Fu­ji­film Diosynth, is en­gag­ing in sev­er­al projects in the re­gion, as last year it an­nounced it will ex­pand its Bio­Process In­no­va­tion Cen­ter at the Re­search Tri­an­gle Park and dou­ble its ex­ist­ing lab­o­ra­to­ry foot­print in the Tar Heel State, as well as add an­oth­er 145 jobs to the site by 2024 and 89,000 square feet.

Last Oc­to­ber, Fu­ji­film Diosynth broke ground on a $2 bil­lion project on a site to man­u­fac­ture cell cul­tures for bulk drug sub­stances in near­by Hol­ly Springs, NC. That site will have eight 20,000-liter biore­ac­tors, and the po­ten­tial to add an­oth­er 24 in the fu­ture, based on mar­ket de­mand.

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.

Tim Pearson, Carrick Therapeutics CEO

Pfiz­er backs $60M in­fu­sion in­to Car­rick, teams up on breast can­cer treat­ment

In a big week for Carrick Therapeutics, the company announced $60 million in funding for its lead breast cancer drug and development of a second program, as well as a collaboration with Pfizer for combo development.

The $35 million from Pfizer comes with an agreement under which Pfizer will support Carrick’s Phase II study of samuraciclib in combination with Pfizer’s Faslodex for advanced breast cancer. Along with the investment, Adam Schayowitz, vice president and development head of breast cancer, colorectal cancer and melanoma at Pfizer global product development, will join Carrick’s scientific advisory board.

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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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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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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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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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Thomas Gad, Y-mAbs Therapeutics founder and interim CEO

FDA re­jects Y-mAbs’ neu­rob­las­toma drug af­ter tak­ing is­sue with clin­i­cal tri­al de­sign

Uncertainty about clinical trial evidence has led the FDA to hand down a complete response letter for Y-mAbs’ neuroblastoma drug, casting a cloud on the future of a candidate that had gone through a long development journey in a rare pediatric cancer.

Y-mAbs said it’s disappointed “but not surprised” given that the agency’s oncology drug advisory committee had voted 16-0 against its drug’s approval a few weeks ago.

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