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The Readout Damian Garde & Meghana Keshavan

Inside Regeneron’s race to treat the latest outbreak

Last week, Regeneron Pharmaceuticals got a package of coronavirus, and scientists cleared their calendars.

The company is among a handful of drug and vaccine makers racing to help with 2019-nCoV, the pandemic virus that has killed more than 400 people since spreading from China. Over the last few days, Regeneron’s scientists have been sprinting through the drug development process, tapping the technology behind Eylea and Dupixent in hopes of coming up with an antibody that might halt 2019-nCoV.

The last time Regeneron broke the glass on its pandemic-response system, it had a human-ready treatment for Ebola in 10 months. But the latest outbreak’s uncertain future could render a treatment unnecessary by the time it’s ready for use. And even if the novel coronavirus persists, the unpredictability of drug development could leave Regeneron with nothing to show for its efforts.

Read more.

The feds are cracking down on biosimilar-blocking

Depending on whom you ask, it may be too soon to say whether biosimilars will make a big dent in U.S. health care spending. But it’s far easier to say that any moves by the biopharma industry to impede wider use of biosimilars won’t help matters.

With that in mind, the Food and Drug Administration and the Federal Trade Commission said this week that they would take a number of steps to ensure that companies seeking to sell biosimilars have a chance to compete for U.S. patients.

Among them, according to STAT’s Ed Silverman, is addressing any false or misleading statements that misrepresent the safety or effectiveness of biosimilars and examining patent settlements that may delay biosimilar product launches. 

Read more.

A biotech barometer is going public

We don’t talk much about contract research organizations, the Amazon Web Services of drug development, but a planned IPO shines a light on their barometric importance.

This week, CRO giant PPD is expected to raise $1.5 billion in a public offering that would value it at roughly $9 billion. Baked into that valuation is the assumption that pharma companies are going to spend more and more on science and that biotech startups are going to keep proliferating thanks to, as PPD puts it, “a robust funding environment, both public and private.”

That makes PPD’s IPO interesting to watch. Buying stock in a major CRO is a bit like buying into a biopharma index fund. If investors agree with PPD that the industry is ascendant, this should be a successful offering. If sentiment is waning ahead of a contentious election, however, PPD might bear the brunt.

Gilead’s Kite buyout looks a little worse

Investors have long since soured on Gilead Sciences’ $12 billion acquisition of Kite Pharma. Now the company’s balance sheet is starting to do the same.

Yesterday, the company revealed that it wrote down an $800 million impairment charge related to its Kite buyout. That follows an $820 million charge in 2018 that stemmed from the abandonment of a Kite treatment for multiple myeloma.

Meanwhile, Yescarta, the only approved product involved in the Kite deal, has stalled. Sales of the CAR-T cancer therapy have now been flat for three straight quarters, lending credence to the bearish analysts who wonder whether Gilead will eventually write down the entire merger.

More reads

  • Step aside CRISPR, RNA editing is taking off (Nature)
  • Shoddy coronavirus studies are going viral and stoking panic. (Buzzfeed)
  • Biotech firm’s former CEO convicted of fraud, money laundering. (CBS News)
Correction: Yesterday's subject line misspelled the "Andreessen" in Andreessen Horowitz.

Thanks for reading! Until tomorrow,

Wednesday, February 5, 2020

STAT

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