The shutdown claims its first biotech victim

The drug industry's biggest shutdown fear has come true: The FDA is almost broke, and that's delaying new approvals. Aimmune Therapeutics, which filed its peanut allergy treatment the day before the shutdown, got word last night that the FDA won't consider its application until funding is restored.

And it might not be the last company forced to change plans. As STAT’s Nicholas Florko and Ike Swetlitz report, the FDA has about five weeks of funds left in its drug-review account, money raised from collecting industry fees. The shutdown prevents the FDA from accepting any new money, which means a handful of weighty decisions — on drugs from Johnson & Johnson, Sanofi, and Novartis — could be indefinitely delayed if conditions persist.

And, in pharma, that’s bad for business.

“Folks are freaking out because who knows what’s going to happen,” said Kurt Karst, an attorney at Hyman, Phelps & McNamara. “Publicly traded companies, they’re going to start issuing press releases or investor statements that FDA may not act.”

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The state of biotech’s #SFrexit

There is perhaps nothing more predictable in biotech than the complaints surrounding the J.P. Morgan Healthcare Conference, an annual sojourn to San Francisco that seems to get more crowded, expensive, and problematic each year.

But 2019's incarnation is a bit different. This time, people are actually bailing on the once-requisite trip. Atlas Venture’s Bruce Booth said his firm will no longer be going en masse, a move that won endorsements from longtime conference-goers now convinced that meetings at J.P. Morgan — often rushed, superficial, and replicable by phone — just don’t merit the cost of attendance.

The thing about J.P. Morgan, though, is that it takes place in January, filling a void in the biotech calendar that happens to coincide with people planning what it is they’re going to do all year. If you got rid of the conference, an old lament goes, someone would just invent a new one, and then everyone would complain about that.

What about you? If you work somewhere that ships people to San Francisco each year, is your company planning to send fewer (or none) in 2020?

Yes
No

Is the smallest player in migraine underrated?

Alder Biopharmaceuticals has an injectable drug to prevent migraines, and, in clinical trials, it seems to work pretty well. The problem is that Alder’s treatment is a year away from approval, while the likes of Amgen, Eli Lilly, and Teva are already on the market with similar ones. Alder’s odds of competing don’t look great, which is perhaps why the company’s share price has fallen more than 40 percent since August.

But Leerink analyst Geoffrey Porges believes sentiment might have run afoul of reality. Yes, Alder doesn’t have the resources of, say, Lilly. But the fact that pharma is out doing the legwork of developing the migraine market could benefit Alder if and when it wins approval, he argued. And Alder’s product, which can be administered quarterly, could prove more attractive than the competitors that require more frequent dosing, Porges wrote in a note to investors.

All of that conspires to make Alder look like a potential buyout target, according to Porges, who began that note with “Hello, Biogen.” But as of this moment, with Alder at about $11 a share, that opinion doesn't seem particularly popular.

Mr. Jørgensen goes to Washington

The Democrats who run the House of Representatives have an oft-stated interest in drug prices, which probably means you can expect to see pharma CEOs dragged before congressional committees in the months to come. So, yesterday, we asked readers: Who’s most likely to get the summons first?

The winner, with 30 percent of the vote, was Lars Jørgensen, whose Novo Nordisk has presided over umpteen increases to the list price of insulin. Fractionally behind him was PhRMA CEO Stephen Ubl, whose literal job is to speak for the industry in Washington, followed by Pfizer CEO Ian Read with 24 percent of the vote and Mylan’s Heather Bresch with 16 percent.

The closeness of the vote is perhaps telling of the state of the industry in 2019. Martin Shkreli is in federal prison, and it’s been months since the last public outrage over a single product. Instead, the conversation around the cost of drugs has focused on the metronomic single-digit price increases that have long since become standard procedure in pharma. That makes for a more nuanced discussion, but it also makes it hard to pick a witness.

The shutdown claims its first biotech victim

The state of biotech’s #SFrexit

Only a few more days left to enter STAT Madness!

Is the smallest player in migraine underrated?

Mr. Jørgensen goes to Washington

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