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The Readout Damian Garde & Meghana Keshavan

Survey: Most U.S. physicians disagree with Aduhelm approval

A majority of U.S. physicians disagree with the FDA’s decision to approve Aduhelm, Biogen’s polarizing treatment for Alzheimer’s disease, according to a new survey from STAT and Medscape.

As STAT’s Ed Silverman reports, the survey of 197 primary care physicians and neurologists found that a clear majority had no plans to prescribe the treatment. Nearly two-thirds reported that they find the trial data to be unclear about benefits and risks of the drug. Only 47% of the neurologists and just 34% of the primary care docs said they had enough information to make a prescribing decision.

The survey, conducted between June 14 and June 23, follows a sustained backlash against the FDA, which ignored expert advice and its own regulatory standards to approve Aduhelm. 

Read more.

Switzerland’s biggest drug makers have spent 16 years fighting over $210 million

Novartis and Roche, companies with a combined market value of nearly $700 billion, have spent years fighting over a sum less than one one-thousandth of that, and now the dispute is in federal court.

As Reuters reports, the issue goes back to 2005, when Chiron, later acquired by Novartis, signed a deal with Genentech, eventually bought by Roche. According to Novartis, after merging with Chiron in 2006, it honored the original agreement and made regular licensing payments to Genentech. Eventually, Novartis discovered that it was overpaying, and now the company's lawyers contend “Genentech was aware or should have been aware that Novartis had overpaid,” and they're demanding restitution.

Those years of allegedly ill-gotten gains amount to $210 million. For reference, Novartis made more than $12 billion in revenue in the last quarter, which works out to about $1 billion per week and implies that the company could recoup its entire 16-year shortfall in the course of about a day and a half.

At least one biotech SPAC is making people money

The blank-check boom may be on its way out, with returns on SPACs badly underperforming the S&P 500 as of last month. But one recent SPAC target, Cerevel Therapeutics, had the sort of day that might keep hope alive in biotech.

In a small, early-stage trial enrolling patients with dementia, two separate doses of Cerevel’s lead drug demonstrated a significant improvement in symptoms compared to placebo. It’s early yet for the drug, called CVL-231, but the combination of efficacy and no safety issues suggested the treatment might have a promising future. And it more than doubled Cerevel’s share price.

In investor terms, that means anyone who paid $10 for a share of the SPAC that eventually merged with Cerevel is looking at a three-fold return. The average 2020 blank-check firm is trading roughly flat in 2021, but Cerevel stands out as the kind of outlier that might convince investors to keep betting on SPACs.

Investors still love a platform company

Biogen, the company launching what could be the biggest pharmaceutical product in history, is currently worth about $52 billion. Moderna, whose sole approved medicine is a Covid-19 vaccine, hit an all-time-high valuation of $94 billion yesterday. 

On paper, Biogen’s Aduhelm, which carries a $56,000-a-year list price and is approved for all 6 million Americans with Alzheimer’s disease, is the more valuable product. It’s dosed once a month in perpetuity, and patients are already clamoring for access to it. Moderna’s vaccine, by contrast, is given twice, costs about $15 per shot, and may see its demand plummet in 2022.

But what Moderna has that Biogen does not is a platform. Moderna’s single commercial coup invites investors to think more fondly of the company’s pipeline of mRNA vaccines and treatments, thus inflating the market value. They’re all different medicines with different odds of success, but they all use similar technology. Biogen doesn’t get the same benefit. The company’s biggest hits — Tecfidera, Spinraza, and potentially Aduhelm — were all in-licensed from other firms, meaning there’s unlikely to be a halo effect, even if Biogen’s treatment for Alzheimer’s disease shatters industry records.

More reads

  • ‘This is not enough’: Walmart’s plan to sell another private label insulin is met with skepticism. (STAT+)
  • What mRNA is good for, and what it maybe isn’t. (In the Pipeline)
  • STAT+ Conversations: A conversation about in vivo gene editing to treat rare disease. (STAT+)

Thanks for reading! Until tomorrow,

Wednesday, June 30, 2021

STAT

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