North Carolina governor Roy Cooper, left, elbow bumps with Fujifilm Diosynth Biotechnologies CEO Martin Meeson (Ethan Hyman/The News & Observer via AP Images)

Drum­roll, please: Fu­ji­film Diosynth picks North Car­oli­na as new home for $2B cell-cul­ture su­per­plant

Fu­ji­film made waves ear­li­er this year when it an­nounced a new $2 bil­lion plant for its CD­MO arm — Fu­ji­fulm Diosynth Tech­nolo­gies — that few fa­cil­i­ties have matched in terms of dol­lar fig­ure. The on­ly thing left to de­cide is where ex­act­ly the fa­cil­i­ty would go, and now that mys­tery has been solved.

Fu­ji­film Diosynth Biotech­nolo­gies, the CD­MO arm of Japan’s tech and life sci­ences gi­ant, has se­lect­ed Hol­ly Springs, NC, as the site of its $2 bil­lion cell cul­ture su­per­plant, adding 725 jobs in the area by 2028, the com­pa­ny said Thurs­day.

Fu­ji­film had been search­ing for a home for the plant af­ter an­nounc­ing its in­tent to build back in Jan­u­ary. The com­pa­ny eyed lo­ca­tions with­in shout­ing dis­tance of its ex­ist­ing US sites in Col­lege Sta­tion, TX, and Mor­risville, NC.

Ul­ti­mate­ly, North Car­oli­na won the lot­tery due to its “strong pool of tech­ni­cal tal­ent, lo­cal re­sources and part­ners with the right com­pe­ten­cies, clean en­er­gy re­sources, and sus­tain­abil­i­ty for fu­ture growth,” Fu­ji­film said in a re­lease.

Ren­der­ing of the fu­ture Hol­ly Springs site — via Fu­ji­film

Click on the im­age to see the full-sized ver­sion

The plants will come on­line in spring 2025 and house eight 20,000-liter biore­ac­tors with the po­ten­tial to ex­pand and add a fur­ther 24 biore­ac­tors of the same size “based on mar­ket de­mand,” the com­pa­ny says. The site will al­so in­clude com­mer­cial-scale, au­to­mat­ed fill-fin­ish and as­sem­bly, pack­ag­ing and la­belling ser­vices.

The site will ri­val in size the equal­ly mas­sive $2 bil­lion plant Ko­re­an gi­ant Sam­sung is plan­ning in In­cheon. That fa­cil­i­ty, al­so fo­cused on bi­o­log­ics, will cov­er about 2.5 mil­lion square feet, Sam­sung said back in Sep­tem­ber. It will add 256KL to Sam­sung’s over­all man­u­fac­tur­ing ca­pac­i­ty, bring­ing the com­pa­ny’s to­tal to 620KL.

The Hol­ly Springs plant is on­ly one arm of Fu­ji­film’s state­side ex­pan­sion plans as it boosts it con­tract man­u­fac­tur­ing work for Covid-19 vac­cines, in­clud­ing mak­ing the vi­ral vec­tors that de­liv­er J&J’s one-shot vac­cine.

In Jan­u­ary, the firm an­nounced it would drop $40 mil­lion to es­tab­lish a new head­quar­ters in the greater Boston area, which will al­so func­tion as its third vi­ral-vec­tor man­u­fac­tur­ing site.

The Boston fa­cil­i­ty is set to be­gin process de­vel­op­ment analy­ses and ex­per­i­ments for con­di­tion­ing cell cul­ti­va­tion by the fall of 2021. The ca­pac­i­ty for drug sub­stance man­u­fac­tur­ing in ear­ly-stage clin­i­cal tri­als will come lat­er, in fall 2023, the com­pa­ny said in a press re­lease at the time.

Fu­ji­film has al­so re­cent­ly ex­pand­ed its vi­ral-vec­tor plant in Texas — that fa­cil­i­ty opened in 2014 and has since un­der­gone a $120 mil­lion build­out to fur­ther in­crease man­u­fac­tur­ing ca­pac­i­ty. In Oc­to­ber, the com­pa­ny al­so an­nounced plans for a gene ther­a­py site in the UK, which it said would be op­er­a­tional by this spring.

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Uğur Şahin, BioNTech CEO (Kay Nietfeld/picture-alliance/dpa/AP Images)

De­spite falling Covid-19 sales, BioN­Tech main­tains '22 sales guid­ance

While Pfizer raked in almost $28 billion last quarter, its Covid-19 vaccine partner BioNTech reported a rise in total dose orders but a drop in sales.

The German biotech reported over $3.2 billion in revenue in Q2 on Monday, down from more than $6.7 billion in Q1, in part due to falling Covid sales. While management said last quarter that they anticipated a Covid sales drop — CEO Uğur Şahin said at the time that “the pandemic situation is still very much uncertain” — Q2 sales still missed consensus by 14%.

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Ted Love, Global Blood Therapeutics CEO

Up­dat­ed: Pfiz­er scoops up Glob­al Blood Ther­a­peu­tics and its sick­le cell ther­a­pies for $5.4B

Pfizer is dropping $5.4 billion to acquire Global Blood Therapeutics.

Just ahead of the weekend, word got out that Pfizer was close to clinching a $5 billion buyout — albeit with other potential buyers still at the table. The pharma giant, flush with cash from Covid-19 vaccine sales, apparently got out on top.

The deal immediately swells Pfizer’s previously tiny sickle cell disease portfolio from just a Phase I program to one with an approved drug, Oxbryta, plus a whole pipeline that, if all approved, the company believes could make for a $3 billion franchise at peak.

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FDA commissioner Rob Califf (Tom Williams/CQ Roll Call via AP Images)

With drug pric­ing al­most done, Con­gress looks to wrap up FDA user fee leg­is­la­tion

The Senate won’t return from its summer recess until Sept. 6, but when it does, it officially has 18 business days to finalize the reauthorization of the FDA user fee programs for the next 5 years, or else thousands of drug and biologics reviewers will be laid off and PDUFA dates will vanish in the interim.

FDA commissioner Rob Califf recently sent agency staff a memo explaining how, “Our latest estimates are that we have carryover for PDUFA [Prescription Drug User Fee Act], the user fee funding program that will run out of funding first, to cover only about 5 weeks into the next fiscal year.”

Pascal Soriot, AstraZeneca CEO (David Zorrakino/Europa Press via AP Images)

As­traZeneca and Dai­ichi Sankyo sprint to mar­ket af­ter FDA clears En­her­tu in just two weeks

Regulators didn’t keep AstraZeneca and Daiichi Sankyo waiting long at all for their latest Enhertu approval.

The partners pulled a win on Friday in HER2-low breast cancer patients who’ve already failed on chemotherapy, just two weeks after submitting a supplemental BLA. While this isn’t the FDA’s fastest approval — Bristol Myers Squibb won an OK for its blockbuster checkpoint inhibitor Opdivo in just five days back in March — it comes well ahead of Enhertu’s original Q4 PDUFA date.

David Reese, Amgen R&D chief

UP­DAT­ED: In a fresh dis­ap­point­ment, Am­gen spot­lights a ma­jor safe­ty is­sue with KRAS com­bo

Amgen had hoped that its latest study matching its landmark KRAS G12C drug Lumakras with checkpoint inhibitors would open up its treatment horizons and expand its commercial potential. Instead, the combo spurred safety issues that blunted efficacy and forced the pharma giant to alter course on its treatment strategy, once again disappointing analysts who have been tracking the drug’s faltering sales and limited therapeutic reach.

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GSK and IQVIA launch plat­form of US vac­ci­na­tion da­ta, show­ing drop in adult rates

Throughout the Covid-19 pandemic, the issue of vaccine uptake has been a point of contention, but a new platform from GSK and IQVIA is hoping to shed more light on vaccine data, via new transparency and general awareness.

The two companies have launched Vaccine Track, a platform intended to be used by public health officials, medical professionals and others to strengthen data transparency and display vaccination trends. According to the companies, the platform is intended to aid in increasing vaccine rates and will provide data on trends to assist public health efforts.

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Ab­b­Vie sur­veys emo­tion­al im­pact of chron­ic leukemia con­di­tion, finds 'roller coast­er' of emo­tions

Rare diseases often have more than just physical effects on patients — especially when it comes to chronic conditions. In the case of the rare slow-growing blood cancer chronic lymphocytic leukemia (CLL), AbbVie wanted to try to assess the mental and emotional toll on patients.

So it surveyed more than 300 CLL patients, caregivers and physicians. While each group differed in how they felt — caregivers overwhelmingly (81%) felt positive about their role, for instance — patients described a “roller coaster” of emotions traversing diagnosis to treatment to remission and even relapse for some.

Bernhardt Zeiher, outgoing Astellas CMO (Astellas)

Q&A: Astel­las' re­tir­ing head of de­vel­op­ment re­flects on gene ther­a­py deaths

For anyone who’s been following discussions about the safety alarms surrounding the adeno-associated viruses (AAV) commonly used to deliver gene therapy, Astellas should be a familiar name.

The Japanese pharma — which bought out Audentes Therapeutics near the end of 2019 and later built a gene therapy unit around the acquisition — rocked the field when it reported three patient deaths in a trial testing AT132, the lead program from Audentes designed to treat a rare muscle disease called X-linked myotubular myopathy (XLMTM).

When the company restarted the trial, it adjusted the dose and instituted a battery of other measures to try to prevent the same thing from happening again. But tragically, the first patient to receive the new regimen died just weeks after administration. The therapy remains under clinical hold, and just weeks ago, Astellas flagged another safety-related hold for a separate gene therapy candidate. In the process of investigating the deaths, the company has also taken flak about the way it disclosed information.

Big questions remain — questions that can have big implications about the future of AAV gene therapies.

Bernhardt Zeiher did not imagine any of it when he first joined Astellas as the therapeutic area leader in inflammation, immunology and infectious diseases. But his ascent to chief medical officer and head of development coincided almost exactly with Astellas’ big move into gene therapy, putting him often in the driver’s seat to grapple with the setbacks.

As Zeiher prepares to retire next month after a 12-year tenure — leaving the unfinished tasks to his successor, a seasoned cancer drug developer — he chatted with Endpoints News, in part, to discuss the effort to understand what happened, lessons learned and the criticism along the way.

The transcript has been lightly edited for length and clarity.

Endpoints: I want to also ask you a bit about the gene therapy efforts you’ve been working on. Astellas has really been at the forefront of discovering the safety concerns associated with AAV gene therapy. What’s that been like for you?

Zeiher: Well, I have to admit, it’s been a bit of a roller coaster. We acquired Audentes. Huge amount of enthusiasm. What we saw with AT132 — that was the lead program in XLMTM — was just remarkable efficacy. I mean, kids who went from being on ventilators, not able to eat for themselves, sit up, do things like that, to off ventilators, walking, you know, really — one investigator called it this Lazarus-like effect. It was just really dramatic efficacy. And then to have the safety events that occurred. So they actually occurred within that first year of the acquisition. So we had the three patient deaths. Me and my organization became very, very much involved. In fact, Ed Conner, who had been the chief medical officer, he left after some of the deaths, but I stepped in as the kind of acting chief medical officer, we had another chief medical officer who was involved, and then we had a fourth death, and I became acting again for a period of time.

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