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The Readout Damian Garde & Meghana Keshavan

Does AstraZeneca’s Covid-19 vaccine really prevent transmission?

The latest clinical results on AstraZeneca’s Covid-19 vaccine offered a seductive number: A single dose reduced positive test results by 67%, a finding widely interpreted as the first evidence that a vaccine could prevent transmission of the virus.

But the data don’t support such a conclusion.

As STAT’s Matthew Herper and Helen Branswell report, AstraZeneca’s actual claim is that one dose of the vaccine resulted in fewer people carrying the virus, not fewer cases of Covid-19 transmission. To read it otherwise requires an unjustified leap in logic, experts said. 

“The study showed a decrease in [viral] shedding, not ‘transmission,’” said Carlos del Rio, a professor of infectious diseases at the Emory University School of Medicine. “The bottom line is, no, one cannot draw a conclusion or straight line.”

Read more.

GW Pharma went from a biotech curiosity to blockbuster buyout target

Back in 2013, GW Pharmaceuticals and its quest to develop an FDA-approved medicine derived from marijuana were regarded with skepticism, as the company’s roughly $300 million market value could attest. Now, the British firm is set to be sold for $7.2 billion, a testament to its scientific success and changing attitudes toward cannabinoid research.

As STAT’s Adam Feuerstein reports, Jazz Pharmaceuticals agreed to buy GW for $220 per American Depositary Share, which represents a 50% premium to the stock’s previous close. The transaction involves a mix of cash and Jazz stock.

The principal allure is Epidiolex, a cannabinoid-based medicine approved in the U.S. and Europe to treat three severe types of epilepsy in children. The drug, which in 2018 became the first cannabidiol-based treatment to win FDA approval, brought in $526 million in 2020 and is expected to reach $714 million this year, according to analysts’ consensus forecast.

Read more.

Biogen’s business has an aducanumab-sized hole in it

Much has been said about the riches that await Biogen if the FDA approves the Alzheimer’s disease treatment aducanumab, a sure-bet blockbuster that would be in immediate worldwide demand. But yesterday’s earnings report offered a glimpse of Biogen’s future if the drug doesn’t come through, one with dwindling product revenue and an uncertain pipeline.

Biogen’s fourth-quarter sales fell 22% compared to the same period last year, the effects of generic competition for its top-selling product, the multiple sclerosis treatment Tecfidera. U.S. sales of Biogen’s most recent success story, the spinal muscular atrophy treatment Spinraza, dropped by 34% over the same period of time, reflecting increased competition from Novartis and Roche.

Neither trend seems likely to improve over time, and Biogen’s late-stage pipeline, headlined by a treatment for depression partnered with Sage Therapeutics, is by no means guaranteed to succeed. All of this will be lost to history if, as Biogen’s leaders seem to expect, the FDA approves aducanumab and it becomes a historically lucrative product. But if things don’t break the company’s way, 2021 could force Biogen to rethink its strategy.

There’s another mRNA bakeoff afoot

There’s something of a scientific consensus that the pace of mutations to the SARS-CoV-2 virus will demand second- and even third-generation vaccines in the years to come. And more than a few experts believe the speed of mRNA technology makes it an ideal tool for developing them quickly. But is the wisest move to cook up a vaccine for each new viral variant, or to develop a sort of omnibus injection that might protect against many?

GlaxoSmithKline, which just aligned itself with the mRNA-focused biotech CureVac, is betting on the latter approach. Under a partnership agreement, GSK will help CureVac manufacture its in-development vaccine for the original strain of SARS-CoV-2 and work alongside the company to develop a multivalent successor, one that would protect against several strains of the virus.

GSK's strategy comes in contrast to that of Moderna, which plans to follow its successful mRNA vaccine with strain-specific booster shots. Time will tell which approach proves the wiser, and the path ahead will depend not only on the results of clinical trials but also the decisions of global regulators, who will need to decide just how much evidence is necessary to prove that a follow-on vaccine is safe and effective enough for authorization.

More reads

  • Apple Watch can help track Parkinson’s disease symptoms, research shows. (STAT)
  • Novo Nordisk's long-term chief scientific officer Thomsen retires, becomes its foundation chief. (FierceBiotech)
  • Vaxart shares plunge 60% on concern that lackluster antibody response will hinder effectiveness of oral Covid vaccine. (CNBC)
  • Biotech scandal drags on as the feds only score partial victory against execs charged with cooking the books. (Endpoints)

Thanks for reading! Until tomorrow,

Thursday, February 4, 2021

STAT

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