Who Wants to Finish Shkreli's Noble Drug-Pricing Scheme With Me?

In some ways, the less said about the new AARP report, the better.

I’m going to do the passive-aggressive thing and not link to it, but the short version is that AARP put out a report showing the way that the drugs with the highest Medicare spend have seen their list prices grow over their lifecycle.

But not only does the report not account for rebates, it doesn’t even mention the lack of net prices as a caveat.

In other words, it’s both useless and inflammatory.

But the fact that the story, though it got some pickup, didn’t get more coverage is probably a good sign. So a shout out to all of those reporters who got pitched by AARP, maybe even attended their press briefing, and decided to take a pass.

OK, last Shkreli bit for a while:

I was all over last week’s the story that, a decade ago, Martin Shkreli had big plans to buy a competitor to Acthar Gel, get it approved, and then massively undercut Acthar’s price as an elaborate scheme to tank the price of Acthar’s manufacturer.

But I had one unanswered question: what ever happened to that competitor, a compound called Synacthen Depot? Turns out, it had quite an arc:

• In 2013, Acthar’s manufacturer, Questcor, bought Synacthen Depot from Novartis for $135 million, outbidding Shkreli and at least two other companies. Questcor then just sat on the new compound.

• In 2014, Questcor got bought by Mallinckrodt for $5.6 billion.

• In January 2017, Mallinckrodt settled with the Federal Trade Commission over charges that the company “violated the antitrust laws when Questcor acquired the rights to a drug that threatened its monopoly in the U.S. market.” The settlement included a $100 million fine and a requirement that Mallinckrodt divest Synacthen Depot.

• In July 2017, Synacthen Depot was licensed to West Therapeutic Development, a subsidiary of an Irish company called Slán Medicinal Holdings.

• In November 2017, West/Slán flipped the rights to Depomed.

• In 2018, Depomed changed its name to Assertio.

• In December 2018, Assertio filed for FDA approval of the compound, which they were calling cosyntropin depot. To do the math, that was less than an 18-month turnaround from when the rights were wrested from Mallinckrodt. The FDA filing, however, was for a narrow indication.

• In October, 2019, Assertio said the FDA had rejected the drug because “certain pharmacodynamic parameters were not adequately achieved.”

• In February 2020, Asserio formally announced that they were giving up, and they gave the medicine back to Slán.

What does that all mean? Well, for one, it sounds like if you want to pick up where Shkreli left off, you could probably license the rights to cosyntropin depot for a lot less than $135 million.

So how about it? Who is game to finish Shkreli’s work? Martin himself can’t do that, because he’s barred for life from dabbing in biopharma. But maybe one of you is up for the challenge.

If you are, I’ll give you PR help for free.

(In all seriousness, there’s probably a reason the drug is functionally dead. You have a regulatory rejection to work around, and Mallinckrodt has spent a decade digging a clinical and regulatory moat around Acthar. But I’m still rooting for a Don Quixote-type to pick this back up, just for the lolz.)

• Anyone here have the skinny on a former BMS guy named Daniel Heider? He’s running the CMS office dedicated to “negotiation” under the IRA. (Pink Sheet just covered, probably based on page 38 of this org chart, and I noticed that NPR had his name in this story from late last month.) That’s probably the most fascinating job in all of health policy, and I’m curious as h*ck to see what happens next.

• There is a new bispecific antibody for myeloma from Janssen -- Talvey -- and it has a price: $45,000 a month, with a typical duration of treatment of six to eight months.

• Axios gave a broad overview of 340B this morning. Probably nothing news to you all, but a nice wrap, nonetheless.

• On the subject of 340B, Endpoints noted litigation in Louisiana over requirements that drugmakers ship to all contract pharmacies. I’ve mentioned the PhRMA lawsuit, but -- per Endpoints -- there’s an AstraZeneca suit, too.

• I talked yesterday about a STAT op-ed about Mark Cuban and PBMs, and NPC’s John O’Brien wrote a LinkedIn piece about that op-ed that was a good deal more thoughtful than my analysis. (“This is a dumb op-ed,” was my not-very-nuanced take.)