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The Readout Damian Garde

The (possible) return of Vioxx


The pain drug Vioxx has become shorthand for the occasional dangers of pharmaceutical science. But now, 15 years after the drug’s recall, one company is convinced Vioxx deserves another shot as a treatment for a rare and painful disease.

The firm is called Tremeau Pharmaceuticals, and it’s plotting to study the now-generic Vioxx as a treatment for hemophilic arthropathy, a symptom of hemophilia that results in joint pain, inflammation, and damage.

Doctors recall comfortably prescribing Vioxx off-label to treat hemophilic arthropathy back before the recall. But it’s a particularly rare disease, affecting just a fraction of the roughly 20,000 Americans with hemophilia. And it’s unclear whether Tremeau has the financial might to get its reclamation project over the finish line.

Read more.

Everything you need to know about biotech VC


Perhaps you’re an entrepreneur baffled as to which VCs to pitch. Maybe you’re an investor curious about what your competitors are up to. Or maybe you need a deep dive into the whole bio-capitalist morass that consumes Cambridge and Silicon Valley alike.

It is with you in mind that we crafted “The STAT user’s guide to venture capital in biotech,” a 140-page report with profiles of more than 50 VC firms, interviews with key people, and granular information on just how money works in drug development.

You can buy it here, and you can look forward to future reports from STAT, including a breakdown of biopharma’s stakes in the coming election and an in-depth look at the science behind gene therapy. If you're a subscriber, you can enjoy a 20% discount. Email us at subscribers@statnews.com

Regeneron’s ocular future: Either 'solid' or a 'hot mess'


Yesterday, Novartis won FDA approval for a drug that will challenge Regeneron Pharmaceuticals’ blockbuster Eylea. But just how vigorous that challenge will be depends on whom you ask.

Here are some facts: The Novartis drug, Beovu, is now approved to treat age-related macular degeneration, the very indication that turned Eylea into Regeneron’s greatest commercial success to date. With that approval came the disclosure that Beovu led to four times as much eye inflammation as placebo, and that information will be on the drug’s label, a problem Eylea does not have.

To Baird analyst Brian Skorney, that makes the Beovu label look "meh,” with efficacy similar to Eylea but “marginally worse” safety. PiperJaffray analyst Christopher Raymond took things a step further, declaring Novartis’s label “a hot mess,” arguing that the safety issue “renders Beovu as little more than an also-ran.”

On the other hand, SVB Leerink’s Geoffrey Porges called the label “solid” and figures that Beovu will gradually eat into Eylea’s revenue. And Cowen’s Yaron Werber, citing a survey of retinal surgeons, said the majority believe Novartis’s therapy is simply superior to Regeneron’s, which would mean Eylea sales are likely to decline at a much faster rate than other analysts expect.

BIO’s regime change


After 15 years running biotech’s largest lobbying group, BIO CEO Jim Greenwood will make this election cycle his last.

The former Republican congressman is stepping down at the end of 2020, after which he’ll “help transition a new leader to represent the industry globally and to defend innovation from domestic political attacks,” according to a BIO statement yesterday.

The announcement comes as BIO endures a presidential election in which its industry has been consistently assailed by the incumbent President Trump and each of the most popular Democratic candidates to challenge him come November. It is, as Greenwood noted in a canned quote, “a critical moment for our industry,” which is presumably why he “vowed to keep fighting against short-sighted political attacks in his final 15 months as BIO’s leader.”

More reads

  • ICER says price hikes on 7 drugs were made without proof of new benefits, costing the U.S. $5.1 billion. (STAT Plus)
  • ICER’s concern for patients: Where’s the beef? (STAT)
  • Soylent co-founder seeks to raise biotech venture capital fund. (Wall Street Journal)

Thanks for reading! Until tomorrow,

Wednesday, October 9, 2019

STAT

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