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Wednesday, March 15, 2017

The Readout by Damian Garde & Meghana Keshavan

Welcome to The Readout, where we keep you on top of the latest in biotech. For more in-depth coverage of biopharma, subscribe to STAT Plus. On Twitter: @damiangarde@megkesh, and @statnews.

Amgen’s date with destiny

We’re about to find out whether Amgen’s much-discussed cholesterol drug has any hope of reaping the billions in sales once widely expected.

The data come out Friday morning at the American College of Cardiology Conference in Washington, D.C., and we've got a cheat sheet for you on STAT Plus. 

The gist: The study is designed to track how well Amgen’s drug, Repatha, can reduce heart attack, stroke, cardiovascular death, and other bad outcomes. The consensus among Wall Street analysts is that it will do 20 percent better than placebo. Anything below that is bad for Amgen, while anything above could reshape the whole PCSK9 landscape.

Here’s more on what the forthcoming data mean for Sanofi, Regeneron, and Eli Lilly.

The PARP wars heat up

AstraZeneca unveiled some stellar data yesterday for its ovarian cancer drug Lynparza — bringing the PARP wars to a head.

Massachusetts-based Tesaro showed impressive ovarian cancer data of its own last year, with progression-free survival of 21 months, compared to just 5.5 months with placebo. 

AstraZeneca's reported PFS was 19 months. It might, however, actually be better than that: A blinded independent review of the same data showed a PFS of 30 months. Dr. Richard Penson, an associate professor at Harvard Medical School and investigator in the Lynparza trial, said the independent figure is likely the more accurate — which would give AstraZeneca an edge over Tesaro. Another advantage for AstraZeneca: Lynparza is already approved for certain ovarian cancer patients. Tesaro's drug is still awaiting a decision from the FDA.

Tesaro stock dropped 11 percent on the news. Clovis Oncology, another company with an approved PARP inhibitor, rose 10 percent as investors bet on higher sales across the category.

The madness continues

Don't forget to vote in the second round of STAT Madness, in which biomedical innovations go head to head for the (figurative) championship belt.

The matchups include a novel centrifuge going up against synthetic beta cells, a CRISPR off switch facing an immunotherapy cocktail, and traceable neurons vying with drug-eluting gum. Vote here.

‘The idea that … you have to do drug discovery is really a fallacy’

That’s a 2015 quote from Brent Saunders, CEO of Allergan, which just spent $90 million to partner on gene editing therapies that are yet to be tested on humans. 

Granted, Allergan is not going to be doing any discovery work in the deal, but buying into unproven technology is quite a reversal for Saunders, who has long been averse to risky R&D and once laid out a vision in which Allergan wouldn’t jump into anything until it had demonstrated promise in human trials.

It would appear that his oft-tweeted commitment to boldness now extends to CRISPR.

Noted

More reads

  • Stung by surging prices, hospital pharmacies cut back on pricey drugs. (STAT Plus)
  • Emma Walmsley, GlaxoSmithKline's first female CEO, will earn significantly less than her predecessor. (Bloomberg)
  • FDA panel rebukes a powerful opioid that was reformulated to curb abuse. (STAT Plus)
  • Atyr taps ancient gene family for new patent haul. (STAT Plus)

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Thanks for reading! Until tomorrow,

Damian & Meghana

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