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.

Image courtesy of The Janssen Pharmaceutical Companies of Johnson & Johnson.

Pro­tect­ing the glob­al phar­ma­ceu­ti­cal in­no­va­tion ecosys­tem – what’s at stake?

We are living in a new era of healthcare that is rapidly advancing progress impacting patient outcomes and experiences. We’ve seen a remarkable pace of transformational innovation, applied research, and advanced clinical development over the last decade.

Despite this tremendous progress, there is much more work to be done, and patients are counting on us – now more than ever – to continue that momentum. At the heart of our industry is a focus on developing and delivering medicines for some of the world’s most challenging diseases, including those that have few or no effective treatments today.

Mi­rati’s drug sitra­va­tinib flops PhI­II in com­bo with Op­di­vo for cer­tain lung can­cer

Mirati Therapeutics’ path to a second drug approval will likely have to wait. The San Diego biotech company said Wednesday that its investigational lung cancer drug failed a Phase III trial testing it in combination with Bristol Myers Squibb’s Opdivo.

The drug, sitravatinib, and Opdivo weren’t better than the chemo drug docetaxel at keeping patients alive, Mirati said in a press release. The spectrum-selective kinase inhibitor missed the primary goal of overall survival in patients with second- or third-line advanced non-squamous, non-small cell lung cancer.

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End­points 20(+2) un­der 40, 2023; Bio­phar­ma's high­est-paid CEOs; N-of-1 CRISPR sto­ry goes on af­ter tragedy; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

We will be off Monday in observance of Memorial Day — and when we get back, it will be a straight march to ASCO, BIO and more. Enjoy the (long) weekend!

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Rich Horgan (R) with his late brother, Terry

Rich Hor­gan spear­head­ed a gene ther­a­py for his broth­er. The tri­al end­ed in tragedy, but the work con­tin­ues for more pa­tients

Rich Horgan’s quest to create a custom gene therapy for his brother, Terry, ended in tragedy. But Horgan doesn’t believe it’s the end of the story.

Terry, a 27-year-old patient with Duchenne muscular dystrophy, died last October just eight days after receiving the therapy in a clinical trial in which he was the only participant. The case raised questions about the safety of certain gene therapies and what would happen to other drug programs under a nonprofit that Horgan created, called Cure Rare Disease.

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Bio­phar­ma's 20 high­est-paid CEOs of 2022, each bring­ing in $20M+ pay­days

Even in a down year for much of the biopharma market, 20 CEOs brought in pay packages valued at more than $20 million, an Endpoints News analysis found.

Endpoints collected data on more than 350 CEO compensation packages, covering a wide range of pharma, biotech, and life sciences companies. All told, the 20 largest earners made over $725 million in 2022 — an average package of $36.4 million. Three brought in paydays over $50 million, and one CEO broke the $100 million mark.

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FDA ap­proves Lex­i­con’s heart-fail­ure drug af­ter de­feat in di­a­betes

The FDA on Friday approved Lexicon’s heart failure drug sotagliflozin following a string of setbacks for the pharma company, including an FDA rejection in diabetes and the loss of a development deal with Sanofi.

The dual SGLT1 and SGLT2 inhibitor will be marketed as Inpefa and is a once-daily tablet. It’s been approved to reduce the risk of cardiovascular death and heart failure-related hospitalization or urgent visits in adults with heart failure or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors. The label spans the range of left ventricular ejection fraction, including preserved ejection fraction and reduced ejection fraction, as well as patients with or without diabetes, Lexicon said Friday.

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The 20(+2) un­der 40: Your guide to the next gen­er­a­tion of biotech lead­ers

This year’s list of 20 biotech leaders under the age of 40 includes a huge range of ambitions. Some of our honorees are planning to create the next big drug giant. Others are pushing the bounds of AI. One is working to revolutionize TB testing. All are compelling talents who are still young in age, but already far along in achievement.

And, as in years past, we went over. The 20 are actually 22 because of two double profiles that reflect how important teamwork is in the industry. As one of our honorees, Joe Illingworth of DJS Antibodies, told me in our interview, “It takes a village to raise a biotech.”

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Eu­ro­pean Com­mis­sion to re­ceive few­er Pfiz­er-BioN­Tech vac­cine dos­es un­der amend­ed con­tract

The European Commission has made a few changes to its vaccine contract with Pfizer and BioNTech, reducing the dose volume while extending the delivery timeline to cope with “evolving public health needs.”

The Commission previously struck a contract in May 2021 for 900 million doses, with the option to purchase another 900 million. Of those, 450 million were expected to be delivered in 2023, though an amendment now calls for fewer doses. While neither the Commission nor Pfizer and BioNTech have revealed an exact amount, an unnamed source told Reuters that the amendment reduces the remaining expected doses by about a third.

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EMA rec­om­mends re­vok­ing au­tho­riza­tion of No­var­tis' sick­le cell drug

The European Medicines Agency’s committee for medicinal products for human use (CHMP) on Friday recommended revoking the marketing authorization for Novartis’ treatment for a painful complication related to sickle cell, after a recent study did not confirm its clinical benefit.

CHMP’s review looked at results of the STAND study, finding that Adakveo (crizanlizumab) did not reduce the number of painful crises leading to a healthcare visit, and patients treated with Adakveo had slightly more painful crises on average, with a subsequent healthcare visit, over the first year of treatment, compared with those on placebo.

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