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The Readout Damian Garde & Meghana Keshavan

Spoiler: Today's newsletter is mostly focused on the FDA's momentous decision to approve Biogen's Alzheimer's disease treatment Aduhelm. If, after all this, you're in the market for more analysis of the implications for biotech, science, and policy, join STAT's Matthew Herper and Damian Garde at 1 p.m. for a live, interactive event discussing all things Aduhelm. Sign up here.

Payday for Biogen

One might say yesterday was a good day for Biogen. A very, very good day.

The Food and Drug Administration’s approval of its Alzheimer’s drug — by no means a foregone conclusion — came with a surprising twist: The agency endorsed the therapy’s use for anyone with Alzheimer’s, not just those with early-stage disease, the only population enrolled in the company’s clinical trials.

Combine that with the sticker price for Aduhelm, $56,000 per year for the average patient, and Biogen is now sitting on what may be the most lucrative product in pharmaceutical history. That said, the price could set up problems — both political and regulatory — down the line.

Read more.

The rollercoaster of participating in Aduhelm trials

Few people have felt the ups and downs in the Aduhelm saga as profoundly and personally as volunteers in the clinical trials and their caregivers. And with the therapy's approval Monday, those participants said they were feeling a mix of emotions: joy at the news, but also unease about some of the open questions about access to the therapy long term. They were also still grappling with the fact that, whatever milestone the Alzheimer's community hit when the FDA gave the therapy the green light, Aduhelm at best only slowed the progression of the neurodegenerative disease. 

“As I reflect on all this work and time — and all these needles and these blood draws and these MRIs — I’m delighted that I’m a part of it and have helped move the field forward, but I’m also cognizant that we have so much more to do,” one trial participant, Phil Gutis, 59, told STAT's Andrew Joseph. “We moved the needle, but this is not a dance-around-the-Christmas-tree moment.”

Read more.

Battle over Shkreli’s future is delayed

A vote to determine Martin Shkreli’s future in his own company has been postponed.

As STAT reported last week, Phoenixus, formerly known as Turing Pharmaceuticals, was set to hold an emergency shareholder meeting yesterday to elect a new slate of directors. If a scheme devised by a pharmaceutical turnaround artist and one of Shkreli’s former acolytes succeeded, Shkreli would be out, and the company would move toward unwinding the 4,000% price hike on its drug, Daraprim, that gained the “pharma bro” national infamy.

In a brief note to shareholders, however, the company said that “due to new information received by the board,” the meeting has been delayed. “Additional information,” it said, “will be forthcoming.”

Biogen’s fortune made it rain on Wall Street



As Biogen’s stock price soared on that surprise FDA approval, investors bid up the shares of would-be rivals big and small — even when the connection to Aduhelm was tenuous at best.

The biggest beneficiary was Eli Lilly, which rose about 12% and added more than $20 billion to its market value. And that makes sense. Lilly’s most advanced treatment for Alzheimer’s disease targets amyloid plaques in the brain. Biogen’s drug just won approval based on its ability to clear those plaques. It follows logic that Lilly’s therapy is now that much likelier to win approval, and such an approval might come earlier than expected.

But the day’s other big winners are a bit more of a stretch. Alector, a biotech company developing immunotherapies for Alzheimer’s, rose about 8%, joined by Anavex Life Sciences, Cassava Sciences, and Athira Pharma, none of which target amyloid to treat the disease.

Read more.

More reads

  • 'The price is bewildering’: The cost of Biogen’s Alzheimer’s drug may lead payers to erect roadblocks. (STAT+)
  • Moderna seeks European approval for Covid-19 vaccine's use in teens. (Reuters)
  • Apple announces new features to share health data with doctors, track trends over time. (STAT)
  • Novo’s Wegovy approved after superior weight-loss impact shown. (Bloomberg)

Thanks for reading! Until tomorrow,

Tuesday, June 8, 2021

STAT

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