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The Readout Damian Garde & Meghana Keshavan

The off-the-books meeting that set Aduhelm’s approval in motion

Back in 2019, weeks after Biogen had announced the failure of aducanumab, the company embarked on Project Onyx, a behind-the-scenes effort to resuscitate its closely watched treatment for Alzheimer’s disease. And in May of that year, Biogen’s top scientist had an off-the-books meeting with a powerful FDA official, forming an alliance that would help the drug get approved two years later.

That meeting is among the previously unreported details in a sweeping new STAT story, which charts the 16-year odyssey from discovery to approval of Aduhelm, a seemingly unlikely and undoubtedly far-reaching FDA decision. It is also the story of how Biogen was pulled from the brink by the agency's decision, but only after the company was buffeted by a boom-and-bust business cycle, a gyrating stock price, corporate infighting, and a years-long struggle for what Biogen knew could be its defining project.

Read more.

Gilead may have a leg up in a CAR-T contest

New data from Gilead Sciences suggest the company’s CAR-T cancer therapy was better than the standard of care for patients who’d already been through one round of treatment.

As STAT’s Ed Silverman reports, Gilead’s Yescarta met its primary endpoint of preventing the return of large B-cell lymphoma better than standard treatment, which includes chemotherapy and a stem cell transplant. The news comes about three weeks after Bristol Myers Squibb described similar results for its CAR-T therapy, but without disclosing any data. 

Yescarta’s success in lymphoma is a victory for CAR-T, which has largely been used as a last option. It’s also a partial vindication for Gilead, whose $12 billion acquisition of the CAR-T company Kite Pharma in 2017 was less than pleasing to investors. 

Read more.

Sanofi is betting big on mRNA

If the Covid-19 pandemic functioned as a sort of vaccine bake-off, mRNA came out ahead of the older, established technologies that seemed to have a scientific head start. And now Sanofi, well-versed in those established vaccine technologies, is playing catch-up in mRNA.

The French company said today that it will spend about €400 million a year on a dedicated mRNA vaccine business, spread across sites in Lyon, France, and Cambridge, Mass. Sanofi is calling it the mRNA Center of Excellence, and it will employ roughly 400 people in R&D, chemistry, manufacturing, and technology. The company expects to have at least six mRNA vaccines in the clinic by 2025.

The move follows a major setback in Sanofi’s effort to develop a vaccine for Covid-19 using the same technology employed by its annual flu vaccine. In December, the company discovered a formulation problem that delayed the vaccine’s development. Last month, Sanofi reported positive Phase 2 data, but given the availability of other vaccines, the best-case scenario for the company’s shot would be use as a booster.

The Celgene lottery ticket isn’t dead yet

Among last year’s stranger biotech subplots was the question of whether former Celgene shareholders would get a $6.4 billion payment from Bristol Myers Squibb. In the end, they did not. But thanks to a class-action lawsuit, those shareholders could end up with at least a fraction of that cash.

The lawsuit, filed earlier this month, claims Bristol’s executives deliberately delayed the development of key Celgene drugs whose timely approval would have triggered the payment to shareholders. Whether that can be proved in court is debatable, but, as Mizuho analyst Salim Syed pointed out in a note to investors, there’s precedent for a big drug company settling to avoid the headache.

Syed cites a similar lottery ticket created by Sanofi’s 2011 acquisition of Genzyme. When the payment didn’t materialize, shareholders filed suit, and Sanofi eventually settled for about 45% of the total. Applied to the Celgene case, that would work out to about $2.9 billion. And, as Syed points out, Celgene shareholders are represented by the same trustee who brought the suit against Sanofi.

More reads

  • Biotech firms on the shoulders of giants. (C&EN)
  • Roche's neuromyelitis optica drug Enspryng wins EU approval. (Reuters)
  • Experts debate the value of digital coaching for type 2 diabetes. (STAT+)
  • There's only one drug for postpartum depression. Why does Kaiser Permanente make it so hard to get? (KQED)

Thanks for reading! Until tomorrow,

Tuesday, June 29, 2021

STAT

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