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The Readout

Can AbbVie’s new drug meet Wall Street’s expectations?

Yesterday, an AbbVie drug called elagolix won FDA approval to treat pain related to endometriosis, ending some mild but persistent speculation that it would get rejected for safety reasons. But the FDA’s final label limits just how long women can take the treatment, which could imperil the multibillion-dollar sales Wall Street has already penciled in.

The approval says elagolix can only be taken for up to two years at the low dose and a maximum of just six months at the high dose. For women with moderate kidney problems, the label is even more restrictive. 

That could be problematic for the drug’s long-term future. AbbVie intends to market it for both endometriosis and uterine fibroids, which are lifelong conditions for most women who have them. The FDA-mandated short duration of therapy could be a major limitation in the eyes of prescribing physicians — and it could make Wall Street’s projection of $1.5 billion in annual revenue unattainable.

Let's talk about Alzheimer's

We’re hours away from finally learning just how positive those “positive” data are on Biogen and Eisai’s BAN2401, a treatment for Alzheimer’s disease. The companies will present their results today at 4:30 p.m. ET, and we’ll have the details up on the STAT homepage shortly thereafter.

But, this being a big deal and all, we wanted to do something different and give readers a chance to consult an expert. So we asked Dr. Howard Fillit, chief science officer of the Alzheimer's Drug Discovery Foundation, to get on the phone and field some questions.

Tomorrow, at 10 a.m. ET, we’re hosting a call for STAT Plus subscribers on which we’ll ask Fillit for his take on the BAN2401 results, their scientific implications, and what they mean for the drug industry's efforts to finally craft a disease-modifying therapy for Alzheimer's. If you're a subscriber, you can sign up here and submit your questions in advance. If you'd like to subscribe, sign up here.

When big drug makers aren't just about drugs

Major pharmaceutical companies are beginning to bet that doctors might someday prescribe a smartphone application for depression, insomnia, heart disease and type 2 diabetes. 

Sanofi's and Merck's venture funds have both invested in digital therapeutics companies, and Novartis' Sandoz division will be partnering with another to bring their FDA-cleared app for substance abuse to market.

Digital therapeutics companies are similar to many other drug companies. They've got pipelines. They're running pivotal clinical trials on their lead candidates. Many have their data evaluated by the FDA. And though no prescriptions have been filled yet—or even written—the CEO of one company told STAT's Kate Sheridan that he hopes his company's app will have a price tag that reflects its value, "just like a drug." 

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Gene therapy's great. How do we pay for it?

The idea of a one-time shot that literally cures a debilitating disease is no longer the stuff of science fiction. And, in keeping with that, figuring out how society should deal with its attendant one-time cost is no longer an economic thought experiment.

But that's starting to change, according to Dr. Robert Dubois, the executive vice president and chief science officer of the National Pharmaceutical Council. Writing in STAT, Dubois points out that the powers that be have begun to wrap their heads around the complex concept of paying a large up-front payment for a therapy with lifetime effects.

One idea is giving insurers that pay for cures a depreciating, tradeable “HealthCoin” that has a value commensurate with the cost of the treatment. If a cured patient switches health plans, the new insurer would purchase the remaining value of the HealthCoin from the initial insurer, offsetting the up-front cost. Others borrow ideas from the housing market, creating annuities that spread the cost of therapy out over a number of years.

Read more.

How to spot red flags when you hear about blockchain in health care

In the past year, hundreds of millions of dollars have flowed into projects using blockchain in biomedicine and other areas of health care. But, uh, how do you tell if these projects are any good?

To try to figure that out, Andy Coravos of the startup Elektra Labs and Noah Zimmerman of Mount Sinai's Icahn School of Medicine launched a database tracking all sorts of metrics, from fundraising to function. In a new First Opinion piece, they point to a few things they look for in analyzing these much-hyped digital ledgers. Among the giveaways that a blockchain might be suspect: Explanatory white papers that don't provide technical backing. And no publicly available code base.

Read more.

More reads

  • Biogen rare-disease drug bounces back with strong sales in the second quarter. (STAT)
  • For scientists racing to cure Alzheimer’s, the math is getting ugly (New York Times)
  • How the fleece vest became the new corporate uniform. (Wall Street Journal)

Thanks for reading! Until tomorrow,


Wednesday, July 25, 2018


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