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The Readout Damian Garde & Meghana Keshavan

Is $3 billion even a lot of money?

What's the right way to give drugs away? And when is biotech hype justified?

We discuss all that and more on the latest episode of “The Readout LOUD,” STAT’s biotech podcast. First, our colleague Andrew Joseph joins us to discuss Novartis's lottery system for a life-saving gene therapy and how it's affecting families. Then, we discuss pediatrician Priscilla Chan, who is married to Facebook founder Mark Zuckerberg, and her efforts to change the course of human health. Finally, health care investor Les Funtleyder joins us for a chat about the current and future state of his line of work.

You can listen to the episode here. To listen to future episodes, be sure to sign up on Apple Podcasts, Stitcher, Spotify, or wherever you get your podcasts.

An old bull-bear debate is finally settled

Back in the early 2010s, the biotech corner of Twitter was fighting about weight loss. Arena Pharmaceuticals was moving toward approval with a drug called Belviq. Bulls contended the drug was a blockbuster in the making. Bears argued that its ties to tumor growth in rats would doom its prospects.

Cut to yesterday, and Belviq is getting pulled from shelves. The Japanese drug maker Eisai, which acquired Belviq from Arena in 2017, agreed to withdraw the drug from the U.S. market after the FDA expressed concerns about an increased occurrence of cancer reported in people who used the product, STAT’s Adam Feuerstein reports. A large post-marketing study found that more patients who took Belviq developed cancer than those on placebo.

Belviq never made much commercial noise in its eight years on the market. Sales added up to just $41 million in the first nine months of last year.

Read more.

Could an approved drug be a coronavirus treatment?

The ongoing outbreak of a novel coronavirus has drug companies racing to develop vaccines, test antiviral pills, and discover anti-infectious antibodies. But what if there’s a workable therapy already sitting on pharmacy shelves?

To answer that question, a group of Michigan State University researchers took a look at SARS, an older coronavirus with strong genetic similarities to the novel one. The two viruses share almost identical proteases, which are enzymes used for viral replication. And there's already a reliable 3-D model of the SARS protease, so the researchers scrubbed a database on the activity of about 1,500 FDA-approved drugs, loaded the results into modeling software, and virtually tested whether each therapy might bind to it and thus treat infection.

The results, uploaded to a preprint server and not yet peer-reviewed, isolated three promising candidates: the cancer drugs Velcade and Iclusig, and the insomnia treatment flurazepam. The next step would be testing these drugs in animal models of the novel coronavirus to see whether the simulation was onto something.

Celgene’s merger drama isn’t over yet

The biotech stalwart that was Celgene got metabolized by Bristol-Myers Squibb last year, but the pair’s negotiation produced a lottery ticket that remains very much alive in 2020.

Under that deal, every share of Celgene entitled its owner to a $9 payout if three of the company’s drugs win FDA approval on a certain timeframe. This week, the FDA granted priority review to one of them, the CAR-T therapy JCAR017, which means it's likely to meet its end-of-year approval deadline. Another, the multiple sclerosis treatment ozanimod, is up for approval next month, and Bristol-Myers is apparently confident enough to preemptively launch a website.

And yet those lottery tickets, which can be freely traded, are currently valued at just $3.67 apiece, suggesting the market assigns about a 40% probability of success. That might come down to the third drug in the arrangement, a Bluebird Bio-partnered CAR-T called bb2121. In order for the $9 to pay out, bb2121 needs to win approval by March 31, 2021. That means Bristol-Myers would need to submit it to the FDA by this summer at the latest, or Celgene’s former shareholders will be hanging onto worthless paper.

More reads

  • Coronavirus outbreak begins to disrupt booming China drug trials. (Reuters)
  • Coronavirus-drug development becomes a top focus at Gilead. (Wall Street Journal)
  • As opioid crisis intensified, many family doctors liked promotional pitches. (STAT Plus)

Thanks for reading! Until tomorrow,

Friday, February 14, 2020

STAT

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