New year, same Fujifilm Diosynth.
The CDMO giant hit the ground running at full speed this year, announcing it will expand its BioProcess Innovation Center in Research Triangle Park, NC. The move will double its existing laboratory footprint in the Tar Heel State, and add another 145 skilled jobs to the site by 2024. Another 89,000 square feet will be added, which will allow for a more robust commercial process.
The expansion will also support its process characterization programs, and complement operations at its UK facility. It’s expected to be operational by 2024.
‘As leaders in process development, we are delighted to be adding this additional capacity to support our growing pipeline of customers,’ the site’s COO Christine Vannais said in a statement. ‘The cutting-edge laboratory equipment and automation tools, combined with the deep technical expertise of our scientific community will allow us to better serve our partners to rapidly generate and assess data to understand complex molecules, along with the processes used in their manufacture.’
The BIC opened in May 2016 as a three-story, 62,000-square-foot facility for process invention, design and development.
The upgrade is big news for the region as two developers just announced plans for a $1 billion biotech hub in nearby Morrisville, with enough space for both manufacturing and R&D work. That site will have retail space and outdoor recreation areas. No future tenants have been named yet so far. Three weeks ago, the company announced that it would invest another $300 million into its Bryan-College Station, TX facility, a move that will create another 150 jobs. That investment will feature a $1.5 million grant from the Texas Enterprise Fund. The expansion will add 138,000 square feet to the campus and several 500- and 2,000-liter bioreactors.
In the fall, Fujifilm Diosynth dumped $2 billion into a headquarters in North Carolina and another $454 million in its UK supply chain. The project will result in the large-scale cell culture manufacturing of bulk drug substance. The site will have eight 20,000-liter bioreactors, and the potential to add another 24.
CPhI experts predicted in the fall that CMOs will account for four of the top five manufacturing capacities by the year 2025, and nearly half of all capacity will shift to large capacity volume. Fujifilm is right at the top of that list, alongside Lonza, Samsung Biologics and WuXi Biologics.
Their Staying Power Lies in their Patient-Centricity
Decentralized clinical trials (DCTs) were traditionally utilized in an isolated fashion prior to the COVID-19 pandemic. To continue their research within the constraints of the pandemic, sponsors and clinical investigators pivoted to a decentralized model out of necessity. At the onset, regulatory agencies offered some guidance on the digital approaches that are acceptable to ensure DCT approaches are applied in a way that maintains patient safety, as well as data quality and integrity.
Exscientia CEO Andrew Hopkins and Sanofi CEO Paul Hudson
Drug R&D has for years had an abysmal track record of success, with the vast majority of drug candidates never making it to market. The promise of AI to shorten the discovery time for new drugs and up their chances of success has more big drugmakers buying in — and Sanofi is the latest.
Sanofi will pay $100 million upfront with a potential $5.2 billion in downstream milestones for access to up to 15 small molecule drugs from Exscientia, a red-hot UK deep learning company at the forefront of the so-called ‘AI-discovered’ drug R&D movement, the partners said Friday.
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Scott Clarke, Ambagon Therapeutics CEO
The saying goes necessity is the mother of invention — and few areas of drug development are in greater need than oncology. A new startup is now repurposing promising technology to tackle the hardest-to-drug proteins, and a suite of big-name backers are buying in.
Ambagon Therapeutics launched Friday with an $85 million A round and a world-class group of researcher-founders building what are known as ‘molecular glues’ to crack the code on a class of elusive cellular proteins, the biotech said.
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A district court in Texas will likely tie up the FDA’s FOIA office for months, as the court ruled late Thursday that the agency must release all documents related to its review of Pfizer-BioNTech’s Covid-19 vaccine.
The order from district judge Mark Pittman, handed down late Thursday, notes that while the Court recognizes the ‘unduly burdensome’ challenges that this FOIA request may present to the FDA, there also ‘may not be’ a more important issue at the FDA right now than the pandemic, the Pfizer vaccine, getting every American vaccinated, and making sure to the American public that the process was not rushed.
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Aligos Therapeutics took a beating Thursday after reporting it is stopping development on its lead program for chronic hepatitis B.
The biotech’s shares $ALGS closed down 57% and fell into penny stock territory Thursday, following a morning press release saying Aligos’ ALG-010133 program did not prove efficacious at the dose tested in a Phase I study. Additionally, the company concluded that higher doses were also unlikely to be effective, and ultimately decided to axe the candidate altogether.
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Roger Perlmutter, Eikon CEO
Roger Perlmutter hasn’t wasted any time since announcing his supposed retirement from Merck in October 2020. After leaving his perch as one of the most successful R&D chiefs in Big Pharma, he’s now snatching a cool half-billion dollars to develop ‘a battery of innovative tools’ for drug discovery at the young startup Eikon Therapeutics.
Eikon closed on a $517.8 million Series B round on Thursday morning, bringing the Hayward, CA-based company’s total raise to more than $668 million.
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Eric Easom, CEO of AN2 Therapeutics
After starting up with a $12 million Series A in 2019, California outfit AN2 Therapeutics issued its first press release in over 2 years — and its second ever: The ultra-quiet biotech has raised an $80 million Series B and added a pair of directors to boot.
The biotech is headed by several leaders from Anacor, which was bought out by Pfizer in 2016 for about $5.2 billion. Eric Easom, former head of Anacor’s R&D on neglected diseases, is co-founder and CEO. Other Anacor vets include AN2’s chief development officer, CFO and head of biology.
Cytokinetics stumbled a bit with its closely watched lead heart drug over the last year or so, losing two pharma partners after missing a key secondary endpoint in a Phase III study. But things are looking up in 2022, as Royalty Pharma is reaching a little deeper into its wallet to bolster that program and another heart candidate.
Royalty Pharma has agreed to lend up to $300 million to support the potential commercialization of Cytokinetics’ lead candidate, omecamtiv mecarbil, and development of its other heart program, aficamten. The cash will come in five tranches, including an initial tranche of $50 million upon closing and four others upon certain regulatory and clinical milestones. Each tranche has an interest-free and payment-free period of six calendar quarters, followed by 34 calendar quarters of installment re-payments totaling 1.9 times the amount drawn.
In the year-plus since Roger Perlmutter left his post leading Merck’s R&D efforts, the Big Pharma’s new leadership has continued to pursue an aggressive dealmaking strategy. On Friday, Merck enlisted a new partner as the spree shows no signs of slowing down.
Merck signed a pair of collaborations with Absci aiming to bolster its AI research capabilities, the companies announced Friday. The first is a relatively modest deal on Merck’s end — there are no details about the upfront or milestone payments but the duo said it could lead to more.
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