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The Readout Damian Garde & Meghana Keshavan

Welcome to the age of mRNA

Moderna’s news that its Covid-19 vaccine showed dramatic efficacy in an early look at pivotal data offers both a relief for the globe and a vindication of the company’s underlying technology.

Like the Pfizer vaccine that moved markets last week, Moderna's relies on messenger RNA to protect people from Covid-19. And, like its counterpart at Pfizer, Moderna’s medicine was more than 90% effective at doing so in the first glimpse of Phase 3 data. Each is expected to be deployed in the coming weeks.

Outside of its implications for the global pandemic, the tandem success of Moderna and Pfizer’s vaccines is a major affirmation of the promise of mRNA, a medical technology that has advanced in fits and starts for three decades. If these results hold up, mRNA could become a new vanguard in vaccines, and it might finally prove its worth as a treatment for scores of diseases.

Read more.

Speaking of Covid-19 vaccines

They appear to be just months away from widespread availability, which is good. But with cases rising around the country, the prospect of a vaccine makes it that much more important to be vigilant over the holidays, according to Caitlin Rivers, assistant professor at Johns Hopkins Bloomberg School of Public Health

“There are very severe, widespread outbreaks across the U.S., and we have not seen signs of those slowing down," Rivers said yesterday during the STAT Summit. “The light is at the end of the tunnel. We will be getting a vaccine in the coming months. We just need to see this through to the end.”

We’ll be talking a lot more about Covid-19 vaccines today, starting with an interview with the NIH’s Anthony Fauci and followed by a one-on-conversation with Pfizer CEO Albert Bourla. You can still sign up to tune in here.

Celgene’s $7 billion lottery ticket might be kaput

Celgene shareholders’ quest for a deferred profit may have been permanently derailed yesterday, when an FDA decision imperiled what would be a $7 billion payout from Bristol Myers Squibb.

The news is that the FDA didn’t approve liso-cel, a CAR-T cancer treatment previously owned by Celgene, because the agency hasn’t yet inspected a manufacturing facility at which it's produced. That doesn’t mean the FDA will never approve liso-cel, but in order for former Celgene investors to get paid, the agency would need to do so by the end of the year. A quick look at the calendar would suggest that’s unlikely.

Under the terms of Bristol Myers Squibb’s acquisition of Celgene, every share of Celgene conferred a tradable lottery ticket that would turn into $9 in cash if three drugs got approved on a specific timeframe and be worth nothing if even one slipped. The apparent delay to liso-cel sent the lottery ticket’s market price down to about $1, its lowest valuation on record, suggesting investors are less than optimistic it will pan out.

Moderna is bigger than Biogen now

At least as measured by market value. Moderna, which has no approved products, crossed the $39 billion mark thanks to yesterday’s Covid-19 vaccine data. Biogen, one of biotech’s famed four horsemen, has been on the decline since last week and now trades below its younger neighbor in Cambridge, Mass.

The two companies are on opposite sides of the drug industry’s biggest stories in 2020. Moderna, at the vanguard of companies developing vaccines for Covid-19, has seen its share price quintuple. Biogen, whose hopes of finally winning FDA approval for the Alzheimer’s disease treatment aducanumab seem to be slipping away, has oscillated throughout the year before plummeting 30% in a week.

There’s still time for those sliding doors to reverse. Biogen’s odds with aducanumab seem long in light of a startlingly negative panel review, but there’s no guaranteeing the FDA doesn’t approve the drug anyway. And Moderna is benefitting from a first-mover advantage in Covid-19, but with more than a dozen vaccines moving through late-stage development, the commercial landscape could evolve to leave the company left with diminishing returns.

More reads

  • EU eyes Covid-19 vaccine deal with Moderna at less than $25 per dose, says source. (Reuters)
  • Retrophin no more: Shkreli's legacy disappears as former company becomes Travere Therapeutics. (Endpoints)
  • ‘They’ve been following the science’: How the Covid-19 pandemic has been curtailed in Cherokee Nation. (STAT)

Thanks for reading! Until tomorrow,

Tuesday, November 17, 2020

STAT

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