Merck is the latest company to weather bad news in the Alzheimer’s drug race, halting a late-stage trial yesterday in an experimental amyloid-targeting candidate called verubecestat after a data monitoring committee said there was “virtually no chance of finding a positive clinical effect,” Reuters reported. Merck shares got hammered in after-hours trading Tuesday evening and during the early morning rush, but had fully recovered by mid-morning. (The stock is actually at a 52-week high now.)
Who knows? Maybe savvy traders expected the rotten news. After all, Merck simply joins a growing fraternity of pharma and biotech companies that have tried to tackle this insidious disease and failed.
Eli Lilly, of course, went through Job-like setbacks with another drug targeting (in a different way) beta-amyloid, the bits of sticky protein that clump together around nerve cells and which may block signaling in the brain as well as do other damage. In November, the company announced that the results of a Phase III trial of solanezumab “were not what we had hoped for.” Lilly had spent 15 years developing the drug and many experts believed it would be first to the gate in securing an FDA approval for slowing Alzheimer’s progression. (In full disclosure, we at Fortune had predicted—in our ordinarily can’t-miss, fail-safe, never-wrong “Fortune Crystal Ball” for 2016—that “sola” would succeed. It has now joined a scrap heap of other would-be brain-saving blockbusters (and missed Crystal Ball predictions).
The bulk of research scientists working on Alzheimer’s have long believed that a buildup of amyloid “plaques” is central to the disease’s development—and that therefore targeting this protein is the best chance for a cure. But the failure of so many efforts here has made many wonder—or wonder more loudly than ever, I should say—if that age-old thesis is wrong.
It wouldn’t be the first time. See “Galileo, solar system, 1632.”
For anyone who wants to read the best damn feature out there on this debate—and on the epic story of the effort to find a worthy Alzheimer’s drug—I recommend this 2015 Fortune classic by my colleague Erika Fry: “Can Biogen Beat The Memory Thief?”
Here’s Sy with the news below.
Abbott’s glucose monitoring patch for diabetes posts some compelling real world data. A blood sugar monitoring patch which continuously assesses glucose levels appears to be helping diabetes patients maintain better control of their disease – particularly if they use it more frequently. In fact, an examination of a staggering 50,000 people found that diabetes patients who use Abbott’s FreeStyle Libre monitoring device scan their blood sugar levels an average of 16 times per day, or triple the recommended amount of a conventional finger prick blood test. The convenience factor (and lack of a need to draw blood) appears to be driving usage. “There is now substantial evidence from both real-world usage and clinical studies that reaffirms the powerful impact of FreeStyle Libre,” said Jared Watkin, senior vice president of Diabetes Care at Abbott, in a statement. “FreeStyle Libre is changing how diabetes has been managed for decades, with one simple swipe. Most importantly, we’re doing that by empowering patients with the information that they need to take action themselves, helping people living with diabetes live fuller, healthier lives.”
Scientists’ panel backs CRISPR gene editing but urges caution. The National Academy of Sciences and the National Academy of Medicine have published a new report on CRISPR gene-editing that signals a slight shift in the careful approach bioethicists have taken to the groundbreaking new technology. The guidelines, compiled by 22 scientists and ethicists from around the world, state that gene editing procedures which have been proven safe and effective could be used to treat devastating disorders (so long as multiple regulations are in place which restrict the use of such genetic engineering). However, the panel strongly condemned any use of gene editing to make cosmetic enhancements, such as boosting muscle strength in healthy individuals. You can read the report’s highlights here.
Trump’s push to deregulate the FDA is facing skepticism from pharma. President Donald Trump has pitched biopharma CEOs an FDA that will help speed treatments to the market by cutting down on regulatory red tape. But major biotech and pharmaceutical company executives told Reuters that they’re not all that eager for an FDA commissioner who would take a hack-and-slash approach to regulations. The reason? Fear that such a drug approval process would spook insurers into rejecting treatments, effectively making an expedited treatment approval completely moot. “People often argue that the FDA is too restrictive,” says Merck R&D chief Roger Perlmutter. “We have the sense that the balance is pretty right … you have to have a well-characterized risk/benefit profile.” Several rumored candidates for Trump’s FDA commissioner have advocated for extreme changes to the FDA, including allowing drug approvals based solely on proven safety (rather than both safety and efficacy). (Reuters)
THE BIG PICTURE
Humana is pulling out of Obamacare’s marketplaces. With uncertainty swirling around the future of the Affordable Care Act, health insurer Humana has decided to abscond from Obamacare’s individual insurance marketplaces. Humana executives said they believe the health law’s risk pools will continue to be unbalanced and expensive in 2018. The question, of course, is why that’s the case. While it’s likely that insurers underestimated the medical costs of enrollees in the law’s nascent years (leading to massive premium increases), some analyses have suggested that the markets would soon begin to stabilize. But the latest Obamacare enrollment period proved chaotic amid Trump and the GOP Congress’ vows to dismantle the law.
Cigna is rejecting Anthem’s buyout bid. Hot on the heels of yesterday’s announcement that Aetna and Humana are scuttling their proposed merger, insurance giant Cigna has announced that it’s rejecting rival Anthem’s bid and suing the company for more than $13 billion in damages (on top of a hefty $1.85 billion breakup fee). Federal judges had blocked both the Anthem-Cigna and Aetna-Humana deals, leading Anthem to file an appeal of the decision. But Cigna’s decision throws a huge wrench into that process. There have been multiple reports of tensions between Anthem and Cigna over the merger, with Cigna executives claiming that the firm has breached conditions of the original deal. (Fortune)
Welcome to the Era of Great Data Center Consolidation, by Barb Darrow
Intel Says It Will No Longer Sponsor Science Fairs, by Madeline Farber
Blackberry Now Has a 0% Share of the Smartphone Market, by Zamira Rahim
How Apple Stores Were Almost Apple Cyber Cafes, by Don Reisinger
|Produced by Sy Mukherjee|
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