Covid-19 roundup: Moderna enlists Catalent as manufacturing partner, securing fill-finish capacity for the first 100M doses
With Phase III trials now outlined, locking in a network of production partners appears to be top of mind for the leading Covid-19 vaccine developers. In the latest move, Moderna has named Catalent a collaborator for the large-scale, commercial fill-finish manufacturing of its mRNA-based candidate.
Catalent — which has signed deals with AstraZeneca, J&J and Arcturus — will provide vial filling and packaging capacity for an initial 100 million doses intended to supply the US market starting the third quarter of this year. Additional staffing at its Bloomington, Indiana site will be deployed to guarantee round-the-clock, 24/7 operations.
Moderna might yet sign up for more, but the arrangements for those hundreds of millions of doses are still under negotiations.
The CRO is also helping with the Phase III program, offering clinical supply services from the facilities in Philadelphia such as packaging and labeling, as well as storage and distribution.
“We appreciate this collaboration with Catalent and the flexibility of their team to deliver critical fill-finish capacity for mRNA-1273 at unprecedented speed,” Juan Andres, Moderna’s chief technical operations and quality officer, said in a statement highlighting the race with time.
The Cambridge, MA-based biotech operates its own manufacturing facility in Norwood, MA, a key advantage it’s constantly boasted. At the same time, it’s recently begun tech transfer to Lonza as part of a billion-dose pact structured for the long haul.
Knee deep in the effort to deliver a vaccine candidate at warp speed, Catalent is also utilizing sites in Madison, WI and Anagni, Italy to scale up manufacturing for other partners.
NIH may have ownership of Moderna’s vaccine. So what?
As an approval for Moderna’s Covid-19 vaccine seems increasingly likely and imminent, consumer advocates are shining a spotlight on the NIH’s role in inventing it, laying ground for future arguments for the government to make it a free or low-cost public good.
Citing a material transfer agreement between the NIH and Moderna on mRNA coronavirus vaccine candidates and patent application disclosures uncovered by Public Citizen, Axios reported that the federal agency may co-own mRNA-1273. And if they do, Public Citizen argued, they could more broadly license the vaccine (assuming clinical success) to manufacturers whether Moderna agrees with it or not.
Not that the NIH might be particularly keen to exercise these powers. Francis Collins, the director, was quoted in an Economic Club interview in May saying his agency does have “some particular stake in the intellectual property.” But he added: “Talking to the companies, I don’t hear any of them say they think this [vaccine] is a money-maker. I think they want to recoup their costs and maybe make a tiny percentage of increase of profit over that, like single digits percentage-wise, but that’s it. Nobody sees this as a way to make billions of dollars.”
ICER updates pricing models, adding new considerations on Gilead’s pricing of remdesivir
Almost two months after ICER first offered two different pricing models serving as bookends to the discussion on how much Gilead should charge for remdesivir, the pricing watchdog has updated its calculations. Perhaps most importantly, the group incorporated a new scenario that can significantly reduce the price benchmark even under the more generous model.
Several things have happened since ICER published its initial guidelines: Generic producers in Bangladesh and India have announced their prices; Gilead revealed more about their R&D investment and plan; and British researchers came up with “striking” — though preliminary — data suggesting that a common steroid, dexamethasone, can help severe Covid-19 patients. The NIH also posted the full dataset for the randomized, controlled remdesivir trial. All of these developments fed into the new models.
Whereas Gilead could’ve charged $10 for a 10-day course under the previous cost-recovery model, ICER now says they would need to price higher to simply recoup the marginal cost of making the drug.
ICER’s updated cost-recovery benchmark price range for a full course of remdesivir is $10 to $600 if only considering the marginal cost of producing the treatment, and $1,010 to $1,600 if also considering the manufacturer’s forecasted 2020 clinical development expenses related to the treatment.
The $1,000 for each course of treatment sold was based on the assumption that Gilead would sell around 1 million courses to cover $1 billion in R&D spending.
Determining the cost-effectiveness threshold, on the other hand, was more complex. Under old assumptions adjusted to new details from the NIH’s ACTT1 numbers, Gilead could reasonably charge $4,580 to $5,080 per treatment course. If you factor in dexamethasone, the range falls immediately to $2,520 to $2,800. And if you get really strict and assume no mortality benefit — something remdesivir didn’t demonstrate at statistical significance — it drops to $310.
All of these, as usual, are meant to spur discussions, ICER president Steven Pearson said.
“Reaction to our initial ICER-COVID analyses confirms policymakers are eager to weigh and debate multiple approaches to pricing in a pandemic,” he said in a statement. “As with all drug pricing decisions, policy makers should weigh potential other benefits of treatment and broader contextual considerations as important in framing the results of cost-recovery and cost-effectiveness analyses. Future updates to our report will continue to assess the evolving clinical landscape, including emerging peer-reviewed data on remdesivir, dexamethasone, and other emerging therapies.”
Vaxart aims at 1 billion doses of oral vaccine with latest MOU
And it’s not only the big players. Vaxart, the South San Francisco-based developer of oral vaccines, said it’s reached a tentative deal with a partner that can enable production of a billion or more doses of its Covid-19 vaccine candidate.
Attwill Medical Solutions would begin preparing the resources and equipment needed for freeze-drying, tableting and enteric coating under a formal agreement.
It would join a group of CDMO partners, including KindredBio and Emergent BioSolutions, that have committed to making the recombinant protein vaccine.
“We believe our oral vaccines, generated on our proven platform, have the potential to offer superior protection against airborne viruses such as SARS-CoV-2 by triggering both mucosal and systemic immunity while being administered by a room temperature-stable tablet, an enormous logistical advantage in large vaccination campaigns,” Andrei Floroiu, who’s recently tapped as CEO to replace Wouter Latour, said in a statement.
A Phase I study of the Covid-19 candidate can begin as early as this summer. While it’s had years of experience with coronavirus, norovirus, flu, respiratory syncytial virus and the human papillomavirus, though, Vaxart has yet to get a product across the finish line in its decades of existence.
EMA officially recommends remdesivir for conditional approval
As the US continues to debate the price for remdesivir — which currently claims the only emergency use authorization for a Covid-19 treatment — the EU has followed suit to recommend it for conditional authorization in the EU.
The antiviral developed by Gilead is the first Covid-19 drug to receive this recommendation, according to a statement. Japan and Singapore have both greenlighted it.
Regulators from the EMA said their decision was mainly based on data from the NIAID ACTT-1 study and supported by other studies. Having begun assessing data on April 30 even before an application was filed, they noted the review happened in “an exceptionally short timeframe.”
Taking into consideration the available data, the Agency considered that the balance of benefits and risks had been shown to be positive in patients with pneumonia requiring supplemental oxygen; i.e., the patients with severe disease. Remdesivir is given by infusion (drip) into a vein and its use is limited to healthcare facilities in which patients can be monitored closely; liver and kidney function should be monitored before and during treatment, as appropriate. Treatment should start with a 200-mg infusion on the first day, followed by one 100-mg infusion a day for at least 4 days and no more than 9 days.
It is now up to the European Commission to grant a formal decision, which is expected in the coming week.
Gilead has yet to announce prices for anywhere in the world, although Indian generic makers have said they will sell their versions between roughly $66 and $80.
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