The never ending Biogen Alzheimer’s drug saga delivers yet another twist

First off, I have a request: We’re looking for nominations for Fortune‘s latest 40 Under 40 list, our annual roundup of the top business, government, cultural, and other up-and-coming stars beneath the age of 40. If you happen to have any suggestions for those who fit the bill in the health care space, please submit your suggestions here. And do it soon because the deadline for nominations is July 19!

On to the week’s news. And today in particular was a doozy for the biopharma sector. The dramatic show stealer is, yet again, Biogen and its highly-scrutinized Alzheimer’s medication Aduhelm. And in the latest twist, the biotech giant is voluntarily agreeing to a so-called “label change” for who should be prescribed this pioneering medication that would actually reduce its market reach.

Now, why might a company go along with that? It’s still a little fuzzy whether or not the Food and Drug Administration (FDA) itself initiated the process or if it was at the behest of Biogen, though the end result remains the same: the FDA originally granted a widespread approval to Aduhelm, also called aducanumab, for Alzheimer’s disease patients in the U.S. despite the heavy disapproval of its own independent advisers, and now Biogen, in conjunction with the regulator, is pulling back on that blanket language and recommending the drug be focused on those with mild Alzheimer’s disease be the main targets for the therapy.

Biogen says the decision was meant to boost confidence in its product by prioritizing the patient population which made up its clinical studies leading to aducanumab’s controversial approval. That may be the case. But there’s also been a political firestorm brewing around the FDA’s relationship with the biopharma industry, including what some critics such as California’s Rep. Katie Porter have called an inappropriately cozy dynamic between the regulator and those it regulates. The label change could serve as an olive branch of sorts to the fiercest Aduhelm skeptics.

What it means for the drug’s future is far from clear. Investors certainly paid no mind on Thursday, with Biogen’s stock price rising 3.9% in daily trading despite the announcement. That could be a signal that they believe the move was just enough to take some heat off the company and the FDA while still giving the drug giant the chance to reap billions in annual revenues given the size of the Alzheimer’s treatment market and Aduhelm’s $56,000 list price tag.

A more open question is whether physicians’ concerns will be quelled. A recent Medscape survey found that nearly 90% of doctors and neurologists disagreed or strongly disagreed with the FDA’s approval decision since there’s still scant evidence that the drug is effective in slowing down mental decline in these patients. Many in the poll said they wouldn’t even prescribe Aduhelm to patients without more concrete information. And that could make for an awkward medical dynamic between care providers and patients’ families who are seeking out just a bit of therapeutic hope in a space that’s traditionally been littered with failure.

Read on for the day’s news, and see you again next Thursday. And once again, send over your 40 Under 40 nominations here.

Sy Mukherjee
sy.mukherjee@fortune.com
@the_sy_guy

DIGITAL HEALTH

Can Moderna leverage mRNA to tame the flu? Moderna was already working on a bigger and better flu vaccine before its explosive (and early) entry into the COVID vaccine market. Now, the company has begun administering the experimental mRNA-based treatment in actual human volunteers. We'll have to wait and see how those studies go, but consider this: The reason the seasonal flu vaccine can have dismal efficacy rates is that it presents a guessing game for the biopharma industry. Which strain will be prevalent come flu season? And based on those assumptions, the production challenges of traditional flu vaccines necessitates development many months ahead of the jab's deployment. That doesn't always work out. But with mRNA technology (and the similar promise it holds for addressing genetic mutations in the coronavirus and creating booster shots down the line), the process might be far more malleable and agile in addressing the actual flu strain going around in a given year. (The Verge)

Eli Lilly, Verge Genomics team up on $25 million ALS deal. Drug giant Eli Lilly and upstart biotech Verge Genomics have reached a deal worth $25 million in upfront cash (with the potential for hundreds of millions more for Verge later on should the partnership bear fruit) to identify new targets for treating ALS, the muscle-wasting genetic disorder also known as Lou Gehrig's disease. As the name spells out, Verge Genomics is a, well, genomics company, and it has an artificial intelligence-powered platform for identifying promising drug targets based on the genetic quirks of a disease. (FierceBiotech)

INDICATIONS

Pfizer, BioNTech plot out their booster shot campaign. The update on boosters has finally arrived: "Pfizer and BioNTech have seen encouraging data in the ongoing booster trial of a third dose of the current BNT162b2 vaccine," the companies said in a statement on Thursday. They're specifically working on a booster shot tailored towards the rapidly spreading Delta variant wreaking havoc across the globe and say a third dose of the existing shot may have to be taken by even fully vaccinated Americans within 6 to 12 months of their original vaccination to maximize immune protection. But an updated version of the jab targeting the Delta variant is in development and could go into clinical trials before the end of summer.

THE BIG PICTURE

The Tokyo Olympics won't have any fans present. There's not a whole lot to add here. A slow-rolling debacle with the Olympics has culminated in a total retreat from the dream of spectators physically being in Tokyo to watch the Olympics. The rationale was driven by the rapid spread of the COVID Delta variant globally and early, recent outbreaks in Tokyo, and the Japanese government's wish to avoid being a springboard for another wave of infections in its own nation and across the globe with an influx of party-ready fans. The would-be revelers probably aren't too pleased by the sudden cancelation mere weeks ahead of the games.

REQUIRED READING

Delta variant forces companies to grapple with mandatory vaccinations, by Jessica Mathews

Apple has approved an app to buy weed, by Chris Morris

Goldman Sachs thinks Ethereum could overtake Bitcoin, by Marco Quiroz-Gutierrez