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Fujifilm Starts Build-out for Massive NC Plant, the Latest Piece of Its Multibillion-dollar CDMO Expansion Effort Feedzy

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Earlier this month, when Fujifilm Diosynth broke ground in North Carolina on a facility destined to become its showcase, the occasion was more about the company than the plant.

While the $2 billion complex will eventually house 725 employees and is billed as the largest end-to-end biologics production plant in the world, it’s just one of several investments Tokyo-based Fujifilm has undertaken in its campaign to build CDMO capacity.

“We’re spending this much is because we need this much capability to support our partners with the projects they’ve got,” said Fujifilm Diosynth CEO Martin Meeson.

Such is the ready market these days for manufacturers like Diosynth. Even before the pandemic, the market was flooded with too many projects and not enough CDMOs. Now the backlog is even more pronounced.

“One of the things that we did learn from the pandemic is that there is probably a little more demand out there,” Meeson said. “We already had all of this demand that had nothing to do with COVID and now you’ve kind of built that on top of that.”

These are invigorating days for Diosynth as it considers its future as a major CDMO player. The status change is a result of a spending spree by its parent company.

In June 2020, Fujifilm pledged a $928 million investment at Diosynth’s site in Hillerod, Denmark, to double its cell culture manufacturing capacity and add drug product manufacturing. Just a year earlier, Fujifilm acquired the site from Biogen for $890 million.

This past June, Fujifilm committed $850 million to its subsidiary to increase manufacturing capacity for biologics such as gene therapies and vaccines. As part of the effort, Fujifilm is emphasizing viral vector manufacturing. A year ago, only one of Diosynth’s sites–in College Station, Texas–had the capability. But now there are three as Watertown, Massachusetts, and Teeside, England, have joined the party.

RELATED: Fujifilm socks $2B into new U.S. site as its global CDMO ambitions take shape

Diosynth’s planned mega-plant is in Holly Springs, in the Raleigh-Durham Research Triangle. Due for completion in 2025, it will churn out antibodies and other therapeutics. Diosynth won’t do anything particularly new at the site; it will just be able to do it at a larger scale and handle products from start to finish.

With eight 20,000-liter bioreactors–and the capacity to add 24 more–Diosynth will manufacture large-scale, cell culture bulk substance. It also will perform automated fill-finish, assembly, packaging and labeling.

Why Holly Springs? Messon was quick to point to the support of local jurisdictions. Wake County and Holly Springs have provided a combined $90 million in incentives, on top of $33.5 million from the state, said the Triangle Business Journal. The lucrative package is in anticipation of the tax revenue and commerce boost provided by a plant that will pay an average annual salary of more than $95,000.

Still, Holly Springs couldn’t match the offer Diosynth received to locate the plant in Texas, which was reportedly $300 million. But the deciding factor, according to the report, was the speed with which the company could bring the project online in North Carolina.

RELATED: Fujifilm triples down on viral vector manufacturing with new $40M Boston site

After all, time is of the essence in the current CDMO landscape, as customers are waiting to be served. Meeson said that during the third quarter, Diosynth’s five sites handled some 150 projects. Many more await in the coming years.

“We can see the expansion of the pipelines that we’re bringing in today,” Meeson said. “We’re tech transferring products in. We’re talking to our partners about their future pipelines. We can really see that that demand will continue to grow. We are trying to make it so we can match the supply with our capability.”

Original Post: fiercepharma.com

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You Say Trintellix, I Say Brintellix: Why a Drug Name in the US Won’t Always Translate Across the Pond Feedzy

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As a British citizen living in England but writing on American drug names, I’m in a perfect position to know that many drugs approved in Europe and the U.K. can have very different names from those in the U.S.

Why is that? Well, to find out, Fierce Pharma Marketing sat down with Scott Piergrossi, president of creative at the Brand Institute, a company that has helped name some of the world’s biggest drugs. He’s not explaining the reasoning behind any drug name changes mentioned in this piece, but offering up insight into why different regions may need tweaks–or complete rethinks–in branding for the same drug.

Often, the change in name can be very minor. Let’s take Amgen’s new non-small cell lung cancer drug as an example: In the U.S., the FDA approved the drug as Lumakras, but in in Europe, its counterparts at the European Medicines Agency approved the med as Lumykras earlier this month.

RELATED: Surprise! Amgen’s hot KRAS drug seals early FDA approval, winning a shot against ‘undruggable’ cancer

You’ll see this U.S.-Europe divide a lot with drug names–but why? Piergrossi explains that changing a single letter can often provide enough differentiation to satisfy regulatory requirements, which can be different in the U.S. and Europe, “such as changing a vowel to a y, or adding/removing a letter or two.” Just as we see with Lumakras/Lumykras.

Another key reason an agency might reject a name is if they think the name is overly promotional–what the FDA refers to as “misbranding,” such as making misrepresentations about safety or efficacy. Hence, you don’t have antivirals called KillsCOVIDNoSideEffects.

Some examples can seem obvious, but Piergrossi explains there can be more subtle and subjective naming differences that create misleading suggestions in a name.

Take the FDA-approved osteoporosis drug Boniva. In Europe and elsewhere, the drug is sold under the brand name Bonviva. “The latter perhaps suggesting ‘good life’ more so than the former,” Piergrossi says, though he adds that extracting meaning from an invented name, in his experience, is “highly subjective.”

RELATED: Brintellix? Nope, Trintellix. Takeda rebrands to end name confusion

There’s also the rare example of a change mandated after the agency has approved a drug and its name. We saw this with Trintellix, an antidepressant from Takeda and Lundbeck. That’s its newer name: Originally approved as Brintellix, the drug had to change–per the FDA–given that name’s similarity to AstraZeneca’s anti-blood-clotting therapy, Brilinta. Prescribers were actually confusing the two brands, triggering medication errors. Brintellix still bears that name in Europe and elsewhere.

Sometimes, it just comes down to regional preferences at a company. Global pharmas have global teams working on product marketing and name development. “A regional team might prefer one spelling versus another, assuming they are given the latitude to make those decisions, so the name is modified accordingly,” said Piergrossi.

Original Article: fiercepharma.com

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GlaxoSmithKline Rushes to Accelerate COVID-19 Antibody Output Amid Omicron-driven Demand Feedzy

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GlaxoSmithKline and Vir Biotechnology are rushing to speed up production of their COVID-19 therapy, now that they’re the only companies with an antibody that appears to be truly effective against omicron.

The FDA on Dec. 30 cleared a Samsung Biologics site as a second manufacturing facility to make GSK and Vir’s Xevudy (sotrovimab), a GSK spokesperson told Fierce Pharma.

Along with adding the new facility, GSK and Vir worked with external partners to secure additional batches of drug substance to support supply this year, the spokesperson said via email.

GSK had been planning to commission a new production facility to scale up production and establish a second manufacturing site amid pandemic uncertainty, the spokesperson said. But omicron’s emergence suddenly pushed the acceleration button.

GSK and Vir recently found that sotrovimab retains its strength against omicron in cell cultures, while lab data showed that Eli Lilly’s antibody combo of bamlanivimab and etesevimab and Regeneron’s REGEN-COV cocktail are unlikely to be able to tackle the new variant.

That means, among the three FDA-authorized antibody drugs to treat infected patients, only sotrovimab is still powerful enough to fight omicron. AstraZeneca’s Evusheld is authorized as a prevention method for immuno-compromised people.

RELATED: GlaxoSmithKline and Vir’s sotrovimab stands up to omicron despite other COVID antibodies falling short

After those lab tests, the U.S. government in December temporarily halted distribution of Lilly’s and Regeneron’s offerings. Although the two products are now shipping again, their ability to fight the now-dominant omicron remains questionable.

Demand naturally started to shift to Xevudy. Last week, the Biden administration signed a deal to buy 600,000 additional doses for distribution this quarter.

“We were on the phone with the U.S. government immediately, sharing the data, discussing what was possible from a supply perspective,” said Bart Murray, who leads GSK’s COVID operation in the U.S., as quoted by The Wall Street Journal.

Other countries have also been snagging supplies of Xevudy. A few days ago, Canada signed on for 20,000 doses. GSK also has agreements with Japan, U.K., Singapore, Australia and others. All told,

GSK and Vir have said they expect to manufacture about 2 million doses globally in the first half of 2022.

RELATED: GSK, Vir file for emergency FDA authorization of intramuscular formulation of COVID-19 antibody

Before the new deal, GSK had delivered the 440,000 doses it agreed to supply to the U.S. in 2021. The government is still allocating that supply to healthcare facilities. The company now expects to start shipping the 600,000 doses in February and March, the spokesperson said.

Both Regeneron and Eli Lilly have started developing new antibody treatments that could neutralize omicron.

Meanwhile, China’s Brii Biosciences is seeking an FDA green light for its antibody combo of amubarvimab and romlusevimab, which won Chinese approval in December. The company recently said its cocktail also held up against omicron. The U.S. doesn’t yet have any supply agreement with Brii.

Article: fiercepharma.com

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Fierce JPM Week: Bristol Myers’ Next-gen Autoimmune Med Not Just Another JAK Drug, Exec Says Feedzy

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After a high-profile study turned up safety risks for Pfizer’s JAK inhibitor Xeljanz last year, the FDA put the entire class under a microscope–and it only recently went back to granting new approvals in that class. Bristol Myers Squibb, meanwhile, has a new candidate that the company’s chief medical officer says is safer than the other JAKs.

Speaking during the Fierce JPM Week virtual conference, Bristol’s CMO, Samit Hirawat, said the company’s deucravacitinib is a novel TYK2 inhibitor “with a very specific downstream effect of integrating IL-12, IL-23 and interferon and sparing other cytokines and sparing JAK 1, 2 and 3.”

While Bristol aims to highlight its med’s differences from drugs in the JAK class, TYK2 is known colloquially as JAK4 and is part of the Janus kinase family. That has some industry watchers worried that the FDA may take a tough stance on the candidate amid safety concerns for the larger drug class.

After an FDA submission last year, deucravacitinib is under review to treat moderate to severe plaque psoriasis. The agency’s decision deadline is set for Sept. 10, 2022.

So far in deucravacitinib’s studies, BMS doesn’t “see the hematologic impact that JAK inhibitors do show [and] we don’t see the dysfunction in the liver enzymes that is seen with JAK inhibitors,” Hirawat said during Fierce JPM Week.

Further, “we don’t see dyslipidemia that is shown by JAK inhibitors,” Hirawat added.

Since Xeljanz post-marketing study showed heightened risks of cardiovascular problems and cancer, the FDA has put the entire JAK inhibitor class in a protracted safety review. That process triggered missed approval deadlines for new drug candidates and delayed label expansions for existing meds.

More recently, the FDA started giving new blessings for JAK drugs–but under the condition that they’re used behind old-school TNF inhibitors such as Humira. Pfizer’s new Cibinqo and AbbVie’s Rinvoq recently won eczema approvals, for instance.

RELATED: Bristol Myers Squibb’s next-gen autoimmune med starts high-stakes FDA review amid classwide JAK scrutiny

As for deucravacitinib, Hirawat said the Poetyk PSO-1 and Poetyk PSO-2 studies–plus trials in Japan and China–show that the med is a “first-in-class” medicine, apparently hoping to differentiate the drug from existing meds at the center of the FDA safety review.

When Bristol bought Celgene for $74 billion back in early 2019, the company had to sell the lucrative psoriasis drug Otezla to score antitrust approval for the deal. The company opted to stick with deucravacitinib, which later beat Otezla in the Poetyk studies by helping more patients achieve 75% skin clearance.

These days, Amgen markets Otezla and is generating blockbuster sales from the psoriasis medicine. For its part, Bristol figures deucravacitinib can generate $4 billion at peak.

And deucravacitinib has some other new indications in the works. BMS is “looking forward to seeing the data imminently” for a phase 2 trial in systemic lupus erythematosus, Hirawat said. If that result is “supportive,” BMS will launch a phase 3 program, he said.

RELATED: Bristol Myers Squibb’s deucravacitinib flunks midphase IBD trial, raising questions about potential blockbuster

Meanwhile, the drug didn’t meet proof of concept criteria in inflammatory bowel disease last October, but Hirawat said the company is running two studies with higher doses and is “absolutely” committed in that disease. With those results, the company expects to have more information about potential indications to “pursue in the future,” Hirawat said.

Source: fiercepharma.com

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