Fu­ji­film con­tin­ues CD­MO ex­pan­sion, break­ing ground on $435M UK site

Fu­ji­film’s CD­MO arm, Fu­ji­film Diosynth, has been on a roll this month as the com­pa­ny has re­cent­ly bro­ken ground on a ma­jor project in Eu­rope and it ap­pears to be keep­ing up the mo­men­tum.

Fu­ji­film Diosynth an­nounced that it has kicked off an ex­pan­sion project for its mi­cro­bial man­u­fac­tur­ing fa­cil­i­ty at its cam­pus in the town of Billing­ham, UK, in the north­east of Eng­land.

The 20,000 square-foot, £400 mil­lion ($435 mil­lion) ex­pan­sion will add clean rooms, pu­rifi­ca­tion suites and a pack­ing area along with more space for the man­u­fac­tur­ing it­self.

Ac­cord­ing to Fu­ji­film Diosynth, the project is slat­ed to be com­plet­ed at the end of next year or the be­gin­ning of 2024 and will boost the man­u­fac­tur­ing ca­pac­i­ty by 70%. Once com­plet­ed, it will al­so look to cre­ate around 350 jobs.

When the ex­pan­sion was an­nounced last year, the site was ex­pect­ed to fea­ture four 2,000L biore­ac­tors and two 500L sin­gle-use biore­ac­tors to make mon­o­clon­al and nov­el an­ti­body treat­ments in a cell cul­ture fa­cil­i­ty.

Paul Found

“Through in­no­va­tion and the uti­liza­tion of high-through­put tech­nolo­gies, we con­tin­u­al­ly strive to in­crease our renowned mi­cro­bial process de­vel­op­ment ser­vices to com­ple­ment our ex­ten­sive man­u­fac­tur­ing ex­pe­ri­ence,” Paul Found, the COO of the UK site, said in a state­ment.

This comes as Fu­ji­film Diosynth kicked off the con­struc­tion for a $1.6 bil­lion ex­pan­sion project at the com­pa­ny’s site in Den­mark to in­crease cell cul­ture pro­duc­tion as well as to boost ca­pa­bil­i­ties at a fa­cil­i­ty in Texas. The com­pa­ny is al­so look­ing to make an in­vest­ment of $850 mil­lion to­tal across its sites in the US and the UK.

Fu­ji­film’s Billing­ham fa­cil­i­ty has al­so been a key play­er in Covid-19 vac­cine pro­duc­tion, serv­ing as No­vavax’s con­tract part­ner in pro­duc­ing the anti­gen com­po­nent for its vac­cine.

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.

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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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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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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Bi­par­ti­san law­mak­ers pres­sure FDA on com­mon chemother­a­pies now in short­age

The US House of Representatives has turned a sharp eye to drug shortages over the past few months, with hearings and new caucuses to try and dampen the situation, but another bipartisan letter sent yesterday to FDA aims to keep the pressure up on cancer drug shortages.

Reps. Debbie Dingell (D-MI) and Tim Walberg (R-MI) penned the letter to FDA Commissioner Rob Califf, expressing concerns around the shortages of two commonly used chemotherapies used to treat cancer, known as cisplatin and carboplatin, which are used for lung, gynecologic and breast cancers, as well as methotrexate, which is used in treating other forms of cancer.

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Touchlight opens its new manufacturing facility in a newly-renovated Victorian-era building. (Credit: Touchlight)

DNA man­u­fac­tur­er Touch­light ex­pands its cam­pus to Vic­to­ri­an-era wa­ter­works build­ing

The manufacturing spaces for any type of DNA work may bring up images of a large, windowless, warehouse-type building, or a more modern facade donned with glass, but one manufacturer is converting an old Victorian-style building into a new manufacturing site.

Touchlight, a UK-based producer of a proprietary enzymatic DNA product it calls “doggybone DNA,” or dbDNA, which has a schematic structure that’s linear and double-stranded, giving the appearance of a dog bone, has opened the doors to a redeveloped and expanded manufacturing facility that is housed within a former Victorian-era waterworks building on the River Thames in the Borough of Hampton in West London. According to a release, the expanded facility has tripled Touchlight’s manufacturing output and can produce more than 8 kg of DNA product a year.

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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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