Moderna plots mRNA vaccine factory in Australia that can churn out 100M doses per year

Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

Just two months af­ter Mod­er­na an­nounced plans to build a $500 mil­lion mR­NA vac­cine fac­to­ry in Africa, the biotech gi­ant agreed ‘in prin­ci­ple’ yes­ter­day on a new mR­NA vac­cine man­u­fac­tur­ing fa­cil­i­ty — but in­stead of look­ing in the US, Eu­rope or Africa again, Mod­er­na is go­ing to the land down un­der.

While the deal is not set in stone, Mod­er­na said that the biotech and the Aus­tralian gov­ern­ment are com­mit­ted to fi­nal­iz­ing the agree­ment. As for the fi­nan­cial as­pects of the deal, they have not been pub­licly dis­closed.

Aus­tralian PM Scott Mor­ri­son an­nounced the deal to re­porters, say­ing that the plant, which will be built in Vic­to­ria state in the south­east part of the coun­try, is ex­pect­ed to pro­duce up to 100 mil­lion mR­NA vac­cine dos­es every year once it be­gins op­er­a­tions in 2024.

‘By ad­vanc­ing with this new part­ner­ship, we are build­ing … our sov­er­eign ca­pa­bil­i­ty to man­u­fac­ture these vac­cines here in Aus­tralia,’ Mor­ri­son told re­porters.

This is the sec­ond ma­jor deal in re­cent mem­o­ry for biotech man­u­fac­tur­ing in the Asia Pa­cif­ic re­gion — BioN­Tech had reached an agree­ment to build a man­u­fac­tur­ing fa­cil­i­ty in Sin­ga­pore back in May that would have an es­ti­mat­ed an­nu­al ca­pac­i­ty of sev­er­al hun­dred mil­lion dos­es of its mR­NA vac­cines once it be­comes op­er­a­tional some­time in 2023.

And Mod­er­na still has work to do in oth­er parts of the world on the man­u­fac­tur­ing front, af­ter the biotech gi­ant an­nounced back in Oc­to­ber that it would in­vest half a bil­lion dol­lars in­to a man­u­fac­tur­ing fa­cil­i­ty in Africa, mak­ing up to 500 mil­lion dos­es a year. To date, the lo­ca­tion for the yet-re­al­ized fac­to­ry has not been de­ter­mined — al­though it has been nar­rowed down to one of three to five coun­tries, ac­cord­ing to Mod­er­na CEO Stéphane Ban­cel back in mid-Oc­to­ber.

Ac­cord­ing to Mod­er­na, the col­lab­o­ra­tion would pro­vide Aus­tralians with ac­cess to a do­mes­ti­cal­ly man­u­fac­tured port­fo­lio of mR­NA vac­cines against res­pi­ra­to­ry virus­es, in­clud­ing Covid-19, sea­son­al in­fluen­za, res­pi­ra­to­ry syn­cy­tial virus (RSV) and po­ten­tial oth­er vac­cines pend­ing li­cen­sure.

Sensor-based technology for clinical trial data collection represents the latest medical paradigm shift. There are more than 700 clinical studies involving wearable devices currently underway in the United States. A study from Intel IT projects their inclusion in clinical trials will surge to 70% by 2025.

Apps, biosensors and patient-centered technologies increase visibility of comprehensive patient data. Pharma leaders anticipate the benefits of wearables to include better data (58%), faster results (33%) and lower trial costs (10%).

When Bristol Myers Squibb celebrated the approval of ozanimod — branded Zeposia — in ulcerative colitis earlier this year, the company touted the first gastrointestinal indication for an S1P receptor modulator.

Now Pfizer wants to give the pharma rival a run for its money.

Pfizer is dropping $6.7 billion to acquire Arena Pharmaceuticals, whose lead drug, etrasimod, targets the sphingosine 1-phosphate receptor.

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A Boston-based provider of lab space is tripling its footprint with the addition of a West Coast campus.

SmartLabs, a company with labs in three different neighborhoods in the Boston area, will open a new research and manufacturing center that will be located in the heart of the South San Francisco biotech corridor. The site will support end-to-end drug development and include 500L manufacturing bioreactors that can support allogeneic and autologous cell therapies.

As the investments in cell and gene therapy manufacturing continue to grow across the world, Cincinnati Children’s Hospital and CTI Clinical Trial & Consulting Services have entered a $100 million agreement to produce clinical material locally.

The joint venture enables the hospital to work on its Translational Core Laboratory, which manufactures and tests services for cell and gene therapy trials. This will help address the global gene and cell therapy shortage and prevent the lack of capacity from getting in the way of new development. About 15 C&G therapy products have been approved by regulatory agencies across the globe, and a study from the Alliance for Regenerative Medicine predicts another 10 to 20 per year by 2025.

Rob Califf, the famous cardiologist from Duke University, is likely to return to the top of the FDA, this time under the Biden administration.

At his confirmation hearing Tuesday, Democrats and Republicans on the Senate health committee offered their support for Califf, with Chair Patty Murray (D-WA) stressing the need for an experienced leader, like Califf, who can ensure that science comes first.

Aamir Malik, Pfizer chief business innovation officer

Pfizer made a big splash in the M&A space Monday, announcing a $6.7 billion buyout of Arena Pharmaceuticals to chase Bristol Myers Squibb in the S1P race. But company execs suggested the company isn’t finished bringing on new assets.

In an investor call outlining the Arena acquisition, chief business innovation officer Aamir Malik took a moment to discuss Pfizer’s growth plans going forward. The strategy was made up of three pillars: advancing the internal pipeline, continuing to pursue outside opportunities and exploring the combination of technology and data to ‘accelerate’ growth.

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The drastic difference in efficacy for Merck’s Covid-19 pill between interim and final analyses — from a 50% relative reduction in hospitalizations and deaths at the interim to just 30% in the final results — had some worrying that the Pfizer pill’s early success for adults at high risk of hospitalization might also be more muted in the final results.

But that wasn’t the case early Tuesday as Pfizer said that final data available from the more than 2,200 high-risk patients enrolled in its trial confirmed prior results showing Paxlovid reduced the risk of hospitalization or death by 89% (within three days of symptom onset) and 88% (within five days of symptom onset) compared to placebo. The company added:

Roche/Genentech CMO Levi Garraway

Breakthroughs in drug development have begun to unlock the potential of antibody-drug conjugates, therapies designed to better target proteins on tumor cells. Genentech’s Polivy has become an early winner in blood cancer, and now the drugmaker is revealing promising results in getting into patients even sooner.

A combination of Roche’s Polivy, an ADC targeting the CD79b protein on tumor cells, with Rituxan and the chemotherapy regimen R-CHOP cut the risk of disease progression or death over Rituxan-chemo alone by 27% in patients with first-line diffuse large B cell lymphoma, according to late-breaking data presented Tuesday at #ASH21.

Sanofi head of development Dietmar Berger

Sanofi’s fitusiran has had a rough road in hemophilia, weathering clinical holds and program halts tied to its lingering safety woes. Now, the drug is nearing the finish line with late-stage data in hand, but will those same safety concerns slam the brakes on the program despite its deliriously effective results?

Fitusiran, an RNAi drug designed to silence the gene that overproduces a protein responsible for clotting suppression, significantly reduced the annualized rate of bleeding over on-demand factor therapy in hemophilia A/B patients without preexisting factor inhibitors in the blood, according to late-breaking data presented Tuesday at #ASH21.
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