Christopher Anzalone, Arrowhead Pharmaceuticals CEO
Arrowhead Pharmaceuticals has purchased 13 acres of land in Wisconsin’s Verona Technology Park and will build a 140,000-square-foot drug manufacturing facility.
The company will spend between $200 million and $250 million to build out the facilities, and the site is expected to create another 250 jobs for the region. Construction starts in Q1. Arrowhead already has operations in Madison, WI, about 10 miles away.
‘This investment reaffirms our commitment to the Wisconsin biotech ecosystem,’ CEO Christopher Anzalone said in a statement. ‘Arrowhead’s pipeline of what we believe are industry leading investigational RNAi medicines continues to expand rapidly. The new Arrowhead campus will allow us to support our growing pipeline and positions us well to advance the manufacturing process, including at commercial scale, of our TRiM-enabled drug candidates.’
The lab and office space is expected to be finished in Q1 2023, and the manufacturing site will be done by Q4 2023, if all goes according to plan.
The companies lead candidate is a drug developed in partnership with Takeda targeting alpha-1 liver disease, which is currently in Phase II trials. Its hepatitis B drug has been licensed out to J&J, and a Phase II drug for cardiovascular disease has been licensed to Amgen. Its focus is on diseases with a genetic basis with the overproduction of proteins, and its RNAi tech allows the company to pursue diseases that aren’t draggable by small molecules or biologics. RNAi inhibits specific genes, and RNAi-based therapeutics benefit from the natural pathway of gene silencing.
Its pipeline also targets gout, Covid-19, renal cell carcinoma, and COPD. Arrowhead has licensed or partnered with J&J for four candidates, including two that are being developed for an undisclosed liver disease.
In November, the company entered a license agreement with GSK for ARO-HSD. Arrowhead picked up $120 million upfront for its NASH treatment, and in exchange, GSK will receive an exclusive license for the drug everywhere except China.
In 2016, the company was forced to scrap its entire clinical pipeline, following deaths in a non-human primate toxicology study. The company was hit with a similar issue in July, when it paused the Phase I/II trial of RNAi cystic fibrosis drug ARO-ENaC after a study in rats showed lung inflammation signals.
CALQUENCE is a registered trademark of the AstraZeneca group of companies.
At the 2021 American Society of Hematology (ASH) Annual Meeting & Exposition, blood cancer researchers from around the world gathered virtually to discuss the progress that has been made in the field of hematology. Over the past decade, that progress has been tremendous. We’ve seen not only breakthrough approaches to care, but also significant improvement upon existing novel treatments and exploring combinations within those medicines.1 These advances have transformed expectations of what a blood cancer diagnosis now means for patients. While we’ve come a long way, I believe the most exciting scientific discovery is yet to come, and that future advances will truly transform patient care.
The FDA on Thursday authorized another new pill to treat the Omicron variant, this time from Merck.
While Pfizer’s antiviral may prove to be more effective, and Merck’s pill has left some scientists questioning the dangers behind its mechanism of action, molnupiravir will be another weapon in the armamentarium of Covid-19 treatments for the US in a time of need, as two mAb treatments from Regeneron and Eli Lilly are no longer effective against Omicron, and as supplies of a third mAb from Vir/GlaxoSmithKline are very limited.
It’s time for our holiday break here at Endpoints News, and like a lot of you, we’ve been prepping for 2022.
Anyone who’s spent some time in industry can tell you the past decade has shoved the drug-hunting field into the forefront of the world’s view of things, garnering tens of billions in investment as new technologies look to change the landscape of R&D. And anyone who qualifies for first-in-class and best-in-class can clean up.
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Khurem Farooq, Gyroscope CEO
Christmas is coming early for Gyroscope.
In its latest gene therapy gambit, Novartis is paying $800 million upfront to acquire the Syncona-backed biotech, with another $700 million reserved for milestones.
Novartis has been diving deep into retinal disorders, and Gyroscope’s lead candidate adds a potential one-time treatment for geographic atrophy — a leading cause of blindness — to the pipeline.
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Mohan Rao, Expression Therapeutics CEO
Expression Therapeutics’ new cell and viral vector manufacturing site is up and running in Cincinnati.
The 43,000 square-foot site will provide end-to-end R&D capabilities and both early phase- and commercial-scale manufacturing of lentiviral and adeno-associated viral vectors. The site will have a mix of 30-180 liter runs in cell stacks and up to 1,000 liter runs in bioreactors, with the capability to manufacture up to 100 products per year. It also gives the necessary infrastructure to fulfill its ex vivo cell processing, and recombinant protein production needs.
Vas Narasimhan, Novartis CEO (Simon Dawson/Bloomberg via Getty Images)
The centerpiece of Novartis’s $9.7 billion buyout of the Medicines Company can finally go to market.
Branded Leqvio, the small interfering RNA therapy long known as inclisiran is the first and only FDA-approved treatment to reduce LDL-C, i.e. bad cholesterol, with just two maintenance doses a year after an initial dose and another one at three months.
Touting a ‘revolutionary approach,’ Novartis CEO Vas Narasimhan noted that the approval ‘creates new possibilities for how healthcare systems can impact cardiovascular disease, a defining public health challenge of our time.’ The label covers both atherosclerotic cardiovascular disease and heterozygous familial hypercholesterolemia.
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Alzheimer’s disease researchers along with medical professors from Harvard and Johns Hopkins issued a formal statement Monday asking the FDA to quickly pull Biogen’s Aduhelm from the market.
‘An accelerated withdrawal would mitigate some of the harm of its unwarranted accelerated approval,’ they wrote to FDA, explaining how Aduhelm ‘did not meet the FDA’s own criteria for accelerated approval based on surrogate markers because amyloid plaque does not correlate well with symptoms, severity of disease or progression.’
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Novavax said Wednesday that initial data suggest its Covid-19 vaccine demonstrated ‘broad cross-reactivity against Omicron and other circulating variants’ after two doses — though neutralization was around 4-fold lower against Omicron compared to the original strain.
As a result, the company says it’s working on an Omicron-specific vaccine and plans to launch clinical studies in the first quarter of 2022.
Bob Baloh, Novartis Head of Neuroscience at NIBR (via Cedars-Sinai)
Even after agreeing to sell off $20 billion in shares back to Roche in November, Novartis got a bit more from its crosstown rival — successfully getting ahold of Roche’s head of neuro and rare disease R&D for themselves.
NIBR president Jay Bradner — a well-known name here at Endpoints — announced Bob Baloh’s appointment on Twitter. Baloh will be running NIBR’s neuroscience division.
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https://endpts.com/arrowhead-adds-newest-facility-to-its-midwest-hub-in-rnai-drug-production-push/
