Fu­ji­film Diosynth breaks ground on a $1.6B ex­pan­sion project in Den­mark

As Fu­ji­film has been in­vest­ing heav­i­ly in its CD­MO arm for over a year, one of its ma­jor projects is now get­ting off the ground.

The Japan­ese man­u­fac­tur­er an­nounced that it has bro­ken ground on an ex­pan­sion project at its site in the city of Hillerød, Den­mark. The ex­pan­sion, which was first an­nounced in June, is part of a $1.6 bil­lion project to ex­pand the cell cul­ture pro­duc­tion ca­pa­bil­i­ties in Den­mark and at an­oth­er fa­cil­i­ty in Texas.

While the ex­pan­sion in Den­mark has Fu­ji­film look­ing to cre­ate 450 jobs and boost the size of the fa­cil­i­ty, the com­pa­ny was mum on the size of the ex­pan­sion. End­points News did reach out to Fu­ji­film Diosynth for fur­ther de­tails and will up­date the sto­ry ac­cord­ing­ly.

The com­pa­ny did re­veal in a state­ment that the build­out will ac­com­mo­date eight new 20,000-liter biore­ac­tors and two down­stream pro­cess­ing units. When the project is com­plet­ed in 2026, the site will have 20 biore­ac­tors for drug sub­stance man­u­fac­tur­ing. The ad­di­tion of these biore­ac­tors will al­so make the site one of the largest CD­MO fa­cil­i­ties in Eu­rope.

The site will al­so fea­ture en­vi­ron­men­tal­ly friend­ly mea­sures such as a net-ze­ro car­bon tar­get, wa­ter con­ser­va­tion and re­new­able en­er­gy, among oth­er green push­es.

As for Fu­ji­film’s ex­pan­sion in Texas, no up­date on that project has been pro­vid­ed, but in Ju­ly the com­pa­ny an­nounced that the project will in­clude an in­vest­ment to ex­pand cell cul­ture man­u­fac­tur­ing. Fu­ji­film plans to make use of its Sym­phonX and MaruX man­u­fac­tur­ing plat­forms to al­low for con­tin­u­ous pro­cess­ing.

The Den­mark ex­pan­sion is not the on­ly move that Fu­ji­film is mak­ing where the price tag is jump­ing be­yond 10 fig­ures. Last year, the com­pa­ny set­tled on build­ing a $2 bil­lion plant in Hol­ly Springs, NC to pro­duce cell cul­tures.

Fu­ji­film al­so said last year that it was mak­ing an $850 mil­lion in­vest­ment in­to gene ther­a­py man­u­fac­tur­ing at sites in the US and the UK, with those projects slat­ed to be com­plete in 2023.

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Casey McPherson shows his daughters Rose (left) and Weston around Everlum Bio, a lab that he co-founded to spark a treatment for Rose and others with ultra-rare conditions. (Ilana Panich-Linsman)

Fa­ther starts lab af­ter in­tel­lec­tu­al prop­er­ty is­sues stymie rare dis­ease drug de­vel­op­ment

Under bright lab lights, Casey McPherson holds his 6-year-old daughter, Rose. His free hand directs Rose’s gaze toward a computer screen with potential clues in treating her one-of-a kind genetic condition.

Gray specks on the screen show her cells that scientists reprogrammed with the goal of zeroing in on a custom medicine. McPherson co-founded the lab, Everlum Bio, to spark a treatment for Rose — and others like her. A regarded singer-songwriter, McPherson never imagined going into drug development.

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Take­da to pull key hy­poparathy­roidism drug from the mar­ket en­tire­ly by end of 2024 af­ter years of man­u­fac­tur­ing woes

Takeda on Tuesday morning made an announcement that almost 3,000 people with the rare disease known as hypoparathyroidism were fearing.

Due to unresolved supply issues and manufacturing woes, Takeda said it will cut its losses and discontinue its hypoparathyroidism drug, known as Natpara (parathyroid hormone), halting all manufacturing of the drug by the end of 2024.

The decision to not re-commercialize Natpara will be a blow to not only the 2,400 people who were awaiting supplies of their reliable injection since 2019, but also the additional nearly 400 people who were accessing the drugs via the company’s Special Use Program as Takeda sought to resolve these manufacturing issues over the past five years.

Benjamine Liu, TrialSpark CEO

Paul Hud­son and Tri­alSpark's mu­tu­al de­sire to speed up de­vel­op­ment con­verges in three-year, six-drug goal

A unicorn startup that originally set out to hasten clinical studies for biopharma partners dug further into its revised path of internal drug development by linking arms with Sanofi in a pact that the biotech’s CEO said originated from the top.

TrialSpark and the Big Pharma on Tuesday committed to in-licensing and/or acquiring six Phase II/Phase III drugs within the next three years.

“I’ve known Paul Hudson for a while and we were discussing the opportunity to really re-imagine a lot of different parts of pharma,” TrialSpark CEO Benjamine Liu told Endpoints News, “and one of the things that we discussed was this opportunity to accelerate the development of new medicines in mutual areas of interest.”

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Al Sandrock, Voyager Therapeutics CEO

Af­ter 12 months of dig­ging, Pfiz­er opts for one of two Voy­ager cap­sids for gene ther­a­py

The path at Voyager Therapeutics keeps winding, and at the 12-month deadline, Pfizer has elected to only move forward with one of two capsids out of the preclinical biotech for the Big Pharma’s AAV gene therapies.

Last October, the Big Pharma and biotech linked arms on a deal that gave Pfizer the ability to hit the gas pedal on two capsids: one for a cardiac target and the other for a rare neurologic disease target.

Marc Dunoyer, Alexion CEO (AstraZeneca via YouTube)

Up­dat­ed: As­traZeneca nabs a small rare dis­ease gene ther­a­py play­er for 667% pre­mi­um

AstraZeneca is kicking off the fourth quarter with a little M&A Monday for a gene editing player recently overcoming a second clinical hold to its only program in human studies.

The Big Pharma and its subsidiary Alexion are buying out little LogicBio for $2.07 per share. That’s good for a massive 667% premium over its Friday closing price, when it headed into the weekend at 27 cents and just weeks after Nasdaq said LogicBio would have to delist, which has been put on hold as the biotech requests a hearing. It’s one of two biotech deals to commence October, alongside the news of Incyte buying a vitiligo-focused biotech.

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Dave Marek, Myovant CEO

My­ovant board balks as ma­jor­i­ty own­er Sum­it­o­mo swoops in with a $2.5B deal to buy them out

Three years after Sumitomo scooped up Roivant’s 46% stake in the publicly traded Myovant $MYOV as part of a 5-company, $3 billion deal, they’re coming back for the whole thing.

But these other investors at Myovant want more than what the Japanese pharma company is currently offering to pay at this stage.

Sumitomo is bidding $22.75 a share for the outstanding stock, which now represents 48% of the company after Sumitomo bumped its ownership since the original deal with Roivant. Myovant, however, created a special committee on the board, and they’re shaking their heads over the offer.

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Astel­las, Pan­th­er­na add or­gan to mR­NA tie-up; Rock­et launch­es sale of six fig­ures worth of stock

Astellas and Pantherna have expanded their November 2021 pact surrounding the latter’s mRNA platform to include a new target organ, the duo announced Tuesday morning, though they did not specify what that target is.

German biotech Pantherna is home to two platform technologies — one that designs mRNAs for non-vaccine therapies and another that designs LNPs. Astellas and Pantherna’s deal appears to mainly revolve around the first platform, which Astellas said it is using to research direct reprogramming, or turning cells from one kind into another without an intermediate stem cell phase.

Andrew Crockett, KalVista CEO

KalVista ends a PhII study ear­ly af­ter pa­tients suf­fer se­vere and life-threat­en­ing side ef­fects

KalVista took a beating Tuesday after announcing it would scrap a Phase II trial for one of its experimental drugs.

The biotech said in an early morning press release that it is terminating the study for KVD824 after multiple patients in every treatment group saw unsafe, elevated levels of certain liver enzymes. By ending the trial now, KalVista hopes to save some money and funnel it toward another study for its lead program, CEO Andrew Crockett said in a statement.