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The Readout Damian Garde & Meghana Keshavan

Biden gets on board with waiving pharma patents

After months of internal debate, the U.S. announced yesterday it would lend its support to a proposal that would temporarily waive intellectual property rights for Covid-19 vaccines with the goal of increasing global production and quelling the pandemic.

As STAT’s Ed Silverman reports, the Biden administration’s embrace of the idea is a reversal of the U.S.’s prior position and runs counter to vehement opposition from the pharmaceutical industry. The proposal arose last year, when South Africa and India asked the World Trade Organization to let countries temporarily infringe pharmaceutical patents and manufacture Covid-19 treatments and vaccines themselves, an idea that fell flat with wealthy nations, including the U.S.

What remains unclear is just how waiving vaccine patents will lead to more vaccines. The drug industry has argued that giving countries instructions for manufacturing a vaccine is useless unless they have the infrastructure and expertise to actually do it, just as reading a recipe is not a stand-in for studying at Le Cordon Bleu.

And it’s a pretty good point. The world is full of factories that can reliably make generic Lipitor, as an example, but there are very few facilities that can precisely place strands of mRNA into nanoparticle envelopes. As a case in point: Moderna promised back in October that it wouldn’t enforce its Covid-19 patents for the duration of the pandemic, and yet no country is manufacturing generic versions of its vaccine.

Read more.

How much money is Moderna going to make?

With the news that Pfizer’s 2021 Covid-19 vaccine revenue will roughly match the gross domestic product of Honduras, the world’s attention turns to Moderna as it reports financial projections for the year ahead.

This morning, at 8 a.m. ET, Moderna will recap its first quarter and, of particular interest, provide an update on just how much money it expects to make on its Covid-19 vaccine this year. The number could be quite high. Last month, Moderna said it planned to ship as many as 1 billion doses in 2021, and it’s been selling them at an average price of $15.50 to $37 per dose. In theory, that adds up to tens of billions of dollars in revenue.

It also underlines an obvious follow-up question: What are they going to do with all that money? Moderna has spoken at length about its pipeline of vaccines, including a potentially lucrative effort to produce an annual flu vaccine. But analysts will likely want to hear more about Moderna’s stable of mRNA-based treatments, which have progressed more slowly but present a tantalizing future for the growing company.

Cel-Sci and the long, long wait for data

It has been one year since the small biotech company Cel-Sci concluded a Phase 3 trial of its investigational cancer treatment. And yet the data remain unknown to the public and, according to Cel-Sci, to the company itself.

That, to STAT’s Adam Feuerstein, strains credulity. Analyzing clinical trial results is a time-consuming process, conceivably taking a couple of months. The fact that Cel-Sci’s third-party analysis has dragged on for 12 suggests, as Feuerstein writes, “it knows the drug failed and is doing everything in its power to delay dissemination of the bad news from the final analysis.”

It’s worth remembering that Cel-Sci’s independent monitors tried to shut the study down twice, and that the FDA once halted the study citing an “unreasonable and significant risk of illness or injury to human subjects.”

Read more.

Aducanumab may only be cost effective at $2,500 a year

That’s according to ICER, the independent nonprofit that measures the value of new medicines, which dug into the data on Biogen’s oft-debated treatment for Alzheimer’s disease and found too much uncertainty to justify a premium price.

As STAT’s Ed Silverman reports, ICER determined that aducanumab would only be cost effective if Biogen charges between $2,500 and $8,300 a year. Analyst projections of the final price of aducanumab have been all over the map, but there’s an informal consensus that it might cost around $50,000 a year. Which is to say ICER is at odds with Wall Street.

The nonprofit’s issue is the same one shared by neurologists, statisticians, and advisers to the FDA: It’s unclear the extent to which aducanumab actually helps people. If the drug had proved to halt neurodegeneration, it would be worth as much as $70,000 a year, Icer concluded. And if you throw out aducanumab’s negative clinical trial and consider only the positive one, it could be cost-effective at $23,100, according to the group. But the sum of the existing evidence makes those prices unthinkable to ICER. (In a statement, Biogen said ICER had failed to account for “the possible holistic value” of aducanumab, pointing to the financial burden Alzheimer’s places on families, caregivers, and society at large.)

Read more.

More reads

  • ‘In their own bubble’: How a cancer center promoted an exclusive experimental drug to attract patients. (STAT)
  • CRISPR’s next frontier: treating common conditions. (Wall Street Journal)
  • Moderna says its Covid vaccine booster works well against variants. (CNBC)
  • Faster approval of complex generics is central to affordable, equitable care. (STAT)

Thanks for reading! Until tomorrow,

Thursday, May 6, 2021

STAT

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