Fu­ji­film's CD­MO arm plots mas­sive $2B plant in the US for broad range of ther­a­peu­tics

Buoyed by in­ter­est from ma­jor Covid-19 vac­cine mak­ers for its vi­ral-vec­tor ca­pa­bil­i­ties, Fu­ji­film’s CD­MO arm has looked to rapid­ly build its US foot­print to meet de­mand. Now, just days af­ter un­veil­ing plans for a new HQ in the Boston area, Fu­ji­film is putting down a mas­sive down pay­ment on an­oth­er US site.

Fu­ji­film will spend $2 bil­lion by 2025 to build a large-scale cell cul­ture pro­duc­tion plant near one of its ex­ist­ing fa­cil­i­ties as the Japan­ese CD­MO looks to ex­pand and scale its US foot­print. The newest plant will help boost Fu­ji­film Diosynth Biotech­nolo­gies’ cu­mu­la­tive growth by 20% by March 2026, the com­pa­ny said.

Fu­ji­film said in a press re­lease Thurs­day that the fa­cil­i­ty will be built as an ex­ten­sion of an ex­ist­ing US site, but didn’t pro­vide fur­ther de­tails. Grant­ed, that doesn’t leave too many op­tions, as Diosynth Biotech­nolo­gies cur­rent­ly op­er­ates on­ly in Col­lege Sta­tion, Texas, and Mor­risville, North Car­oli­na.

On Tues­day, the con­glom­er­ate an­nounced a new head­quar­ters in the bustling Boston area, which will be­gin lim­it­ed vi­ral-vec­tor man­u­fac­tur­ing op­er­a­tions lat­er this year be­fore it’s ful­ly op­er­a­tional in 2023.

A com­pa­ny spokesper­son told End­points News in an email Thurs­day that no fur­ther de­ci­sions have been made on where ex­act­ly the site will be.

Re­gard­less, it sig­ni­fies a marked ex­pan­sion for Fu­ji­film, which has sought since 2017 to in­crease its foot­print in the bio­phar­ma man­u­fac­tur­ing realm. That year, the spot­light was on ex­pand­ing mon­o­clon­al an­ti­body fa­cil­i­ties, and in 2018, the con­glom­er­ate ven­tured to re­gen­er­a­tive med­i­cine by buy­ing two com­pa­nies spe­cial­iz­ing in cell-cul­ture me­dia. More re­cent ex­pan­sions, in­clud­ing Tues­day’s, in­di­cate a more gen­er­al fo­cus on meet­ing un­met med­ical needs.

Ken­ji Sukeno

With the new site sched­uled to be­gin op­er­a­tions in the spring of 2025, the CD­MO will have a drug sub­stance pro­duc­tion line ca­pac­i­ty of eight 20,000-liter biore­ac­tors for mam­malian cells, a ful­ly au­to­mat­ed fill-fin­ish sys­tem, and a pack­ag­ing line for as­sem­bling sy­ringes and au­to­mat­ic-pack­ag­ing equip­ment.

“The Unit­ed States is the world’s biggest mar­ket for bio­phar­ma­ceu­ti­cals,” Fu­ji­film Pres­i­dent Ken­ji Sukeno said in a state­ment. “I am pleased that through this large in­vest­ment in the U.S.A we are able to sup­port the de­vel­op­ment and man­u­fac­tur­ing of new drugs that can help ful­fill un­met med­ical needs.”

Mar­tin Mee­son

Fu­ji­film Diosynth Biotech­nolo­gies CEO Mar­tin Mee­son said the newest fa­cil­i­ty will house the ca­pac­i­ty to turn out a broad range of ther­a­pies in the com­ing years.

“We are lever­ag­ing our strengths in process de­vel­op­ment and man­u­fac­tur­ing for a wide range of bio­phar­ma­ceu­ti­cals such as an­ti­bod­ies, re­com­bi­nant pro­teins, gene ther­a­pies and vac­cines,” he said.

Fu­ji­film said it’s set a tar­get of $2 bil­lion by its fis­cal year end­ing in March 2025 for its fa­cil­i­ties in Col­lege Sta­tion and Teesside, UK. By the fol­low­ing year, it ex­pects the afore­men­tioned 20% growth rate to kick in.

5AM Ven­tures: Fu­el­ing the Next Gen­er­a­tion of In­no­va­tors

By RBC Capital Markets
With Andy Schwab, Co-Founder and Managing Partner at 5AM Ventures

Key Points

Prescription Digital Therapeutics, cell therapy technologies, and in silico medicines will be a vital part of future treatment modalities.
Unlocking the potential of the microbiome could be the missing link to better disease diagnosis.
Growing links between academia, industry, and venture capital are spinning out more innovative biotech companies.
Biotech is now seen by investors as a growth space as well as a safe haven, fuelling the recent IPO boom.

Janet Woodcock (AP Images)

End­points poll: Janet Wood­cock takes the (in­ter­im) helm at the FDA. And a large ma­jor­i­ty of our read­ers want her to stay there

It’s official: Janet Woodcock is now the acting chief of the FDA.

And — according to an Endpoints poll — most industry readers would like her to stay there, although a significant minority is strongly opposed.

To recap: Joe Biden is reportedly choosing between Woodcock and former deputy FDA commissioner Joshua Sharfstein as his nominee for the permanent position. Given their respective track records, the decision is set to determine the agency’s lodestar for years to come.

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What’s next for End­points — and how to sup­port our in­de­pen­dent bio­phar­ma news mis­sion

The firehose of biopharma news is gushing these days.

That’s why broader and deeper is the theme for 2021 at Endpoints. You can expect new coverage outside our core R&D focus, with deeper reporting in some key areas. When John Carroll and I launched Endpoints nearly five years ago, we were wading in waist-high waters. Now we’re a team of 25 full-time staffers (and growing) with plans to cover the flood of biopharma news, Endpoints-style.

Eli Lil­ly's an­ti­body cuts risk of Covid-19 by up to 80% among the most vul­ner­a­ble — but will it have a place next to vac­cines?

Eli Lilly says bamlanivimab lowered the risk of contracting symptomatic Covid-19 in a first-of-its-kind trial involving nursing home residents and staff, paving the way for a new option to protect against the virus.

But how big of an impact it might have, and what role it will play, at a time vaccines are being rolled out to the exact population it is targeting still remains unclear.

Among 965 participants in the study — all of whom tested negative for the coronavirus at baseline — the number of symptomatic cases reported in the bamlanivimab arm was 57% lower than that in the placebo arm (odds ratio 0.43, p=0.00021). In addition to that primary endpoint, all secondary endpoints reached statistical significance.

Michelle McMurry-Heath, BIO CEO (BIO via YouTube)

BIO looks to re­struc­ture, lay­ing off staff amid chal­lenge to the trade org's nor­mal face-to-face style

The biopharma industry, on the whole, had a red-letter year in 2020 amid Covid-19, with fundraising at an all-time high and major players speeding vaccines ahead to approval. But for BIO, the industry’s leading trade organization, the pandemic has prompted a reconsideration of the game plan.

BIO will pivot to digital as the Covid-19 pandemic continues to rage, making “some staff reductions” as it looks to bring its roughly 37,000 in-person meetings each year to the web, the organization said Thursday.

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Covid-19 roundup: Italy won­ders aloud if it can sue Pfiz­er for vac­cine short­falls; US recom­mits to WHO un­der Biden ad­min­is­tra­tion

As reports crop up that deliveries of Pfizer and BioNTech’s Covid-19 vaccine are being unexpectedly cut, Italy wonders if it can take the vaccine developers to court, according to the Wall Street Journal. 

After its shipment for this week was cut by 29%, the Italian government consulted its attorney general about taking legal action, the WSJ reported. Pfizer and BioNTech had warned the EU and Canada last week that their allocations would be reduced as Pfizer upgrades its Belgium factory. What Italy says it doesn’t appreciate, though, is the short notice.

Mike Grey, Plexium chairman (Horizon Therapeutics)

Plex­i­um adds in­dus­try vet Mike Grey to the brain trust with new in­vestor cash fund­ing its pro­tein degra­da­tion play

About 15 months since closing a $28 million Series A, a San Diego protein-degradation upstart returned to the venture well Thursday with an extension of that round and some new hires, including one of the city’s best-connected biotech execs.

Plexium has bagged an additional $35 million in financing, the biotech said, money that will push undisclosed oncology and immuno-oncology programs into the clinic. In addition, longtime industry vet Mike Grey is jumping on as chairman of the board, and two others from Thursday’s leads — Adam Goulburn from Lux Capital and Rob Hopfner from Pivotal BioVentures — joined the board too.

Hal Barron, GSK R&D chief (GSK via YouTube)

Glax­o­SmithK­line's $4B bis­pe­cif­ic can­cer drug al­liance with Mer­ck KGaA hit by big set­back with a PhI­II fail­ure on NSCLC

Close to 2 years ago, GSK’s R&D team eagerly agreed to pay up to $4 billion-plus to ally itself with Merck KGaA on a mid-stage bispecific called bintrafusp alfa, which intrigued them with the combination of a TGF-β trap with the anti-PD-L1 mechanism in one fusion protein.

But today the German pharma company says that their lead study on lung cancer was a bust, as independent monitors said there was no reason to believe that the experimental drug — targeting PD-L1/TGF-Beta — could beat Keytruda.

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Janet Woodcock and Joshua Sharfstein (AP, Images)

Poll: Should Joshua Sharf­stein or Janet Wood­cock lead the FDA from here?

It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years.

As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.