Friday, February 9, 2018

The Readout by Damian Garde & Meghana Keshavan

Welcome to The Readout, where we keep you on top of the latest in biotech. For more in-depth coverage of biopharma, subscribe to STAT Plus. And get a load of us on LinkedIn. On Twitter: @damiangarde@megkesh, and @statnews.

Biotech is now flat for 2018


Did you enjoy the 2018 biotech boom?

The XBI biotech index began the year at an unassuming $87, only to rocket up to an all-time high in a matter of weeks, with high-dollar buyouts galore and an overwhelming sense that drugs were just super good now.

Those were the days. Last night, XBI closed right back home at $87, like the previous month's honeymoon never even happened. Stocks, man.

Regeneron’s state of the union

A few years ago, the conventional wisdom was that Regeneron Pharmaceuticals was sitting on two sure-fire blockbusters: a treatment for high cholesterol and another with the potential to treat a handful of allergic diseases.

But things didn’t exactly shake out that way. The cholesterol drug has struggled mightily to bring in revenue, and the other treatment, approved for eczema, is facing a now-familiar problem for new therapies: It’s really hard to get prescriptions filled.

And so Thursday’s quarterly earnings call provided a glimpse at the new normal for Regeneron. On the eczema drug, ever-quotable CEO Leonard Schleifer sounded frustrated about the barriers to patient access, suggesting that "perhaps we should start a hashtag: #deniedRx." And on cholesterol, all Schleifer could do was point out that a great, big, important clinical trial is slated to read out next month, and the results will determine whether Regeneron’s drug will be ever be a profitable product.

On the horizon is yet more uncertainty. Regeneron’s next big idea is a pain treatment that promises to relieve agony without the risk of addiction, thereby reducing the need for opioids. It’s part of a whole class of medicines that look like they work in clinical trials, but an alarming rate of joint problems have dogged the whole group. Regeneron believes it has found a way around the safety issues, but just like in cholesterol, it’s impossible to say until Phase 3 trials read out later this year.

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Consider the lab mouse

How do you know when it is in pain? A mouse fears a scientist, because a scientist looks like a predator. And that makes it difficult for a scientist to know how the mouse is feeling — and whether it's responding to an investigational pain drug. And that makes it hard to develop pain drugs.

That's why Boston Children’s Hospital neurobiologist David Roberson invented the PalmReader, as STAT's Megan Thielking reports. Instead of hovering over his mice and freaking them out, Roberson uses his technology to capture their footprints and measure their behavior. Free from the prying eyes of predators, a mouse in pain scurries differently than one simply going about its day, and Roberson can keep tabs on every pattering paw with an eye on whether a given drug is doing its job.

Read more.

How much is too much for CAR-T?

Drug-pricing crusader David Mitchell did some math and concluded Novartis could price its blood cancer CAR-T Kymriah at $160,000 and still make a healthy profit. Kymriah’s actual price is $475,000. To Mitchell, this means Novartis is a greedy pharma profiteer bankrupting the U.S. health care system. Novartis disputes Mitchell’s math and his conclusion. 

This argument is misdirected and counterproductive, says Baird biotech analyst Brian Skorney. His point: Attacking life-saving drugs like Kymriah or Gilead Sciences’ hepatitis C cure Sovaldi for their high cost will cause fewer of them to be developed in the future. If that happens, no one benefits. Instead, critics should focus on drugs that barely work but still generate billions of dollars in revenue, mainly because no one pays attention.

“When a drug like Avastin does $6 billion per year to primarily give prettier CT scans, attacking Kymriah just carries no weight with me,” he says.

More reads

  • He calls animal testing ‘taxpayer-funded torture.’ He got the FDA to listen. (STAT)
  • Maryland sues Insys to enforce subpoena in opioid probe. (Reuters)
  • In latest blow to Teva, CGRP migraine med could be delayed while rivals race toward the finish line. (Endpoints)
  • Optogenetics 2.0: Brain control goes wireless via light, sound, or a drug. (STAT)

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Thanks for reading! Until tomorrow,


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