Friday Five – The Pharma Week in Review (18 June 2021)

We break down five of the week’s key pharma news stories.

CureVac comes up short

New data opens up potential role for COVID-19 antibody therapies

  • The UK-run RECOVERY study has identified yet another compelling treatment option for patients with COVID-19.
  • It showed that the addition of Regeneron Pharmaceuticals' antibody cocktail REGEN-COV to usual care reduced the risk of death by 20% in patients hospitalised with severe COVID-19 who had not mounted a natural antibody response on their own against SARS-CoV-2.
  • These data are the first to demonstrate that a treatment that fights SARS-CoV-2 directly reduces mortality.
  • The results are also important as they show REGEN-COV can help patients already in hospital. The antibody cocktail is approved in the US to prevent hospitalisation resulting from COVID-19, but challenges have persisted in identifying those patients best suited to being treated at that stage of disease progression.

Questions remain over potential role of new depression therapy

  • Sage Therapeutics and its development partner Biogen announced top-line Phase III results for the investigational depression treatment zuranolone this week, confirming the drug met its primary endpoint in the WATERFALL study.
  • Questions were immediately asked, however, as to whether these results are clinically meaningful and, if supportive of regulatory approval, will be compelling enough to see physicians reach for zuranolone as a new treatment option.
  • We have a snap-poll in field (targeting psychiatrists) to gain further insight on this issue.

 Aduhelm approval glosses over Biogen's questionable investments

  • Biogen paid Sage $875 million upfront to gain co-development rights to zuranolone and another drug for essential tremor late last year. A move that was widely seen as the company hedging its bets against the FDA choosing not to approve its Alzheimer's disease treatment Aduhelm.
  • That outcome did not materialise, with the FDA announcing with much controversy a decision to approve Aduhelm last week.

See – FirstImpact Results – How do 50 US neurologists plan to use Aduhelm?

  • Some will argue that less than compelling data for zuranolone will only add to the fortuitous nature of the FDA's decision from Biogen's perspective. More so as the company was also forced to concede this week that the gene therapy assets it acquired by purchasing Nightstar Therapeutics for $800 million in 2019 are now essentially worthless.
  • Biogen also confirmed on Wednesday that another Alzheimer's treatment it is working on missed its primary endpoint in a Phase II study, meaning that many of its eggs are in an Aduhelm-shaped basket.

GSK boards the TIGIT train, but can it get upgraded?

  • GlaxoSmithKline investors are gearing up for the company's capital markets day on June 23 with CEO Emma Walmsley reportedly under pressure from activist shareholders.
  • Ahead of that event, GlaxoSmithKline announced another pricey looking deal this week designed to further evolve its pharmaceutical business into one characterised by innovative and specialist medicines.
  • The drugmaker agreed to pay $650 million upfront to in-license co-development rights for iTeos Therapeutics' anti-TIGIT monoclonal antibody EOS-448, in a deal that could rise in value to over $2 billion.
  • A key selling point put forward by both companies is GlaxoSmithKline's clutch of investigational drugs that target other known CD226 checkpoints, which could be complimentary to EOS-448.
  • One counter argument is that the TIGIT field is already crowded with some illustrious competitors to boot. GlaxoSmithKline's efforts to revamp its oncology game have so far fallen somewhat short.   

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