Fujifilm outlays whopping $850M for its Diosynth CMDO wing, looking to rapidly scale cell culture production

Fujifilm Diosynth Biotechnologies is on a spending spree and not stopping yet.

The Japanese firm is adding manufacturing capability at its core CDMO wing by pumping $850 million into locations in the US and UK, it said in a release.

Gene therapy capacity in the UK will increase 10-fold, cell culture capacity will be tripled and microbial fermentation output will be doubled at the 5,000-liter facility. In the US, cell culture production for recombinant vaccines will double. These two expansions will start in 2023.

Teiichi Goto

There’s been a booming growth in the CDMO space in the past two years, and that market is expected to continue to expand, Fujifilm Diosynth said, because of the demand for gene therapy, antibodies and vaccines, including the Covid-19 vaccine.

“Fujifilm will never stop in its relentless pursuit to develop new technologies and provide the necessary manufacturing capacity to meet the needs of our customers and accelerate the growth of its Bio CDMO business,” president Teiichi Goto said in a statement.

The exact location of the US investment will be disclosed in the future, “after evaluation work is completed,” a spokesperson for Fujifilm said Tuesday.

The investment brings the total amount of money Fujifilm has invested into its CDMO wing to $5.5 billion in the last 10 years, the company said.

At the start of the year, the Japanese company doubled down on its Massachusetts location, locking in $76 million in funding for a 40,000 square-foot site in Watertown, MA, that features eight cleanrooms and cell and viral vector capabilities. That center is set to open in 2022. That project is in addition to the $40 million viral vector and advanced therapy facility it is opening in the greater Boston area.

And in March, Fujifilm Diosynth hopped aboard the train to North Carolina, with a $2 billion plant that few facilities have matched in dollar amount. Holly Springs, within the Research Triangle area outside of Raleigh, will be the host of 725 new jobs by 2028 and be operational by spring 2025, if all goes according to plan. It will have eight 20,000-liter bioreactors and the potential to add up to 24 more of the same size, depending on the demand. The site also will feature commercial-scale, automated fill-finish and assembly, packaging and labeling services.

On a smaller scale, the company has expanded a viral-vector plant in Texas that first opened in 2014 with $120 million in additions.

Adaptive Design Methods Offer Rapid, Seamless Transition Between Study Phases in Rare Cancer Trials

Rare cancers account for 22 percent of cancer diagnoses worldwide, yet there is no universally accepted definition for a “rare” cancer. Moreover, with the evolution of genomics and associated changes in categorizing tumors, some common cancers are now characterized into groups of rare cancers, each with a unique implication for patient management and therapy.

Adaptive designs, which allow for prospectively planned modifications to study design based on accumulating data from subjects in the trial, can be used to optimize rare oncology trials (see Figure 1). Adaptive design studies may include multiple cohorts and multiple tumor types. In addition, numerous adaptation methods may be used in a single trial and may facilitate a more rapid, seamless transition between study phases.

Marianne De Backer (L) and Jeff Hatfield

Bayer nabs star biotech Vividion with a $2B buyout and an ‘arms-length’ pact, pulling a partner out of the IPO conga line

Vividion is canceling that IPO it filed. Instead of following the industry-wide migration to Nasdaq, the biotech that has captured considerable attention for its still-preclinical work finding cryptic pockets to bind to on proteins is going to work for Bayer now.

The pharma giant is putting out word today that it has bought out Vividion for $1.5 billion in cash and another half-billion dollars in milestones.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 113,500+ biopharma pros reading Endpoints daily — and it's free.

Josh Hoffman, outgoing Zymergen CEO (Zymergen)

UPDATED: Synbio unicorn Zymergen jettisons founding CEO, cuts guidance as customers report lead product doesn't work

Zymergen, just months off a $500 million IPO that put the synthetic bio firm in rarified air, has now ejected its founding CEO and downgraded its revenue forecasts after customers reported its lead film product doesn’t work as advertised, the company said Tuesday afternoon.

CEO Josh Hoffman will leave his role and sacrifice his board seat immediately in favor of Jay Flatley, the former CEO of Illumina who will take the lead role on an interim basis as the company conducts a search for its next leader.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 113,500+ biopharma pros reading Endpoints daily — and it's free.

Zymergen co-founders Zach Serber, Josh Hoffman, and Jed Dean (Zymergen via website)

Zymergen's sudden implosion shocked biotech. A lingering loan could make things even worse

As former synbio unicorn Zymergen picks up the pieces from its spectacular implosion Tuesday, an outstanding loan from Perceptive Advisors — the only blue-chip biotech crossover investor to touch Zymergen’s fundraising efforts — could make the situation worse, according to public documents.

In December 2019, more than a year before Zymergen filed for what would eventually become a $500 million IPO, the “biofacturing” firm signed a $100 million credit facility with Perceptive to help supplement the nearly $700 million the company had raised across four VC rounds.

Amgen adds new NC plant to the list as part of $1B manufacturing expansion plans stateside

What can $1 billion buy? If you’re Amgen, it’s good for two manufacturing facilities in the US.

The California-based drug giant will invest close to $550 million in a drug substance plant in Holly Springs, NC, adding itself to an ever-growing list of biotech companies that have decided to call North Carolina home, and marking its second drug manufacturing announcement in a little more than a month.

Biogen, Eisai are pushing for another accelerated Alzheimer's OK — this time for BAN2401

Now that the door at the FDA has been opened wide for Alzheimer’s drugs that can demonstrate a reduction in amyloid, Biogen and its partners at Eisai are pushing for a quick OK on the next drug to follow in the controversial path of aducanumab.

In a presentation to analysts, Eisai neurology chief Ivan Cheung outlined some bullish expectations for their newly-approved treatment and set the stage for what he believes will be a fast follow for BAN2401 (lecanemab) — after a dry spell in new drug development that’s lasted close to 20 years.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 113,500+ biopharma pros reading Endpoints daily — and it's free.

Jeffrey Bluestone, Sonoma CEO (Photo credit: Steve Babuljak)

Jeff Bluestone just raised $265M to develop curative cell therapies. We asked him how

Jeff Bluestone had some big goals in mind when he decided to make a switch from a decades-long career in academia and non-profit research to a biotech startup CEO. And now — 18 months after the $40 million launch party — he has a whole lot more money on hand to pay for the considerable amount of work ahead at Sonoma Biotherapeutics.

This morning Bluestone is taking the wraps off a $265 million B round after boosting the core syndicate of A-list investors he started with. Even by today’s standards, that sum dwarfs the kind of $100 million-plus megarounds that have become standard fare in biotech over the last 2 years.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Paul Hudson, Sanofi CEO (Eric Piermont/AFP via Getty Images)

UPDATED: Sanofi buys mRNA player Translate Bio for $3.2B. And the price fits a popular range for biotech M&A

Sanofi CEO Paul Hudson is dead serious about his intention to vault directly into contention for the future of mRNA vaccines.

A year after paying Translate Bio $TBIO a whopping $425 million in an upfront and equity payment to help guide the pharma giant to the promised land of mRNA vaccines, Sanofi closed the deal with a buyout early Tuesday, spending $38 a share in a $3.2 billion buyout.

Translate’s stock $TBIO soared after the market closed Monday when Reuters reported the first word of the acquisition just hours ahead of the formal announcement. The wire service, though, didn’t have a price to report in its scoop, and investors chased the stock up 78% in the wild ride that followed. Once the price was announced, gains shriveled to 29% ahead of the bell.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 113,500+ biopharma pros reading Endpoints daily — and it's free.

Matt Gline (L) and Pete Salzmann

UPDATED: Roivant bumps stake in Immunovant with a $200M deal. But with M&A off the table, shares crater

Roivant has worked out a deal to pick up a chunk of stock in its majority-owned sub Immunovant $IMVT, but the stock buy falls far short of its much-discussed thoughts about buying out all of the 43% of shares it doesn’t already own.

Roivant, which recently inked a SPAC move to the market at a $7 billion-plus valuation, has forged a deal to boost its ownership in Immunovant by 6.3 points, ending with 63.8% of the biotech’s stock following a $200 million injection. That cash will bolster Immunovant’s cash reserves, giving it a $600 million war chest to fund a slate of late-stage studies for its big drug: the anti-FcRn antibody IMVT-1401.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 113,500+ biopharma pros reading Endpoints daily — and it's free.