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The Readout Damian Garde & Meghana Keshavan

Looks like remdesivir works, but it's not a 'home run'

The most closely followed drug in the world, Gilead Sciences’ remdesivir, beat placebo at helping patients recover from Covid-19 in an 800-patient study. As STAT’s Matthew Herper and Adam Feuerstein report, that's likely enough to convince the FDA to approve remdesivir for emergency use, and analysts expect a full approval to follow in time.

As former FDA Commissioner Scott Gottlieb put it, “remdesivir isn’t a home run” but it “can be part of a toolbox of drugs and diagnostics that substantially lower our risk heading into the fall.” 

Meantime, STAT's Matthew Herper spoke with Gilead CEO Daniel O'Day about the results, along with criticism of how the clinical trials were run and how the data were released yesterday.

Vertex’s new drug is an instant blockbuster

Trikafta, Vertex Pharmaceuticals’ latest treatment for cystic fibrosis, has made more than $1.3 billion in revenue since winning FDA approval in October, putting it on pace to become one of the fastest drug launches in industry history.

The drug’s remarkably quick uptake led to a 77% increase in quarterly sales for Vertex, and the company raised its 2020 projection by about 6%, to $5.6 billion. Vertex’s stock price, which ticked up after hours yesterday, has risen by more than 50% over the last 12 months.

Trikafta’s instant success sets a strong opening tone for CEO Reshma Kewalramani, who started the job this month. But it also underlines questions about Vertex’s future growth. The majority of U.S. patients eligible for Trikafta are already on it, according to Vertex, and sales of its other CF drugs fell about 28% year over year as patients moved to the new medicine. That means Vertex will need some of its pipeline treatments, largely focused on rare diseases, to come through if it plans on extending its enviable run. 

If we want more antibiotics, the feds should pull more than push

That’s according to the Government Accountability Office, which argued in a new report that the department of Health and Human Services isn’t providing the right incentives to encourage companies to develop much-needed new antibiotics.

As STAT’s Ed Silverman reports, the GAO’s point hinges on the difference between push incentives and pull incentives. The former consist of upfront money meant to spur drug development, which HHS currently provides. Those are all well and good, according to the GAO, but the government needs to supplement them with pull incentives, rewards that pay out after a medicine comes to market.

One idea is a lump-sum payment delivered upon approval, or a voucher for extended patent life that could be sold to another company. Another potential solution is offering to pay a subscription fee for a set number of doses, guaranteeing companies a consistent revenue stream if their medicines prove to work.

Read more.

Maybe the drug industry can win America back over

There was a time, before the opioid crisis and the birth of Martin Shkreli, that the pharmaceutical business was among the nation’s most admired industries. In 1941, when President Roosevelt called for a massive production of penicillin to support the war effort, a small New York chemical company called Pfizer rose to the occasion, eventually making 90% of the drug sent to the front lines.

The coronavirus pandemic presents an opportunity to tilt public perception back toward the positive, according to John LaMattina, Pfizer’s former president of global R&D. 

Writing in STAT, LaMattina points out that the many drug companies researching treatments and vaccines for Covid-19 have been met largely with skepticism and concerns about future price gouging. That’s perhaps unsurprising, considering the industry’s ailing reputation. But if some of those potential medicines work, and if companies ensure access, Big Pharma might be able to win the public back over, just as Pfizer did in the ’40s.

Read more.

GSK’s $5 billion bet is beginning to look wise

Back in 2018, when GlaxoSmithKline traded $5 billion for the cancer drug maker Tesaro, the Wall Street consensus was that the company vastly overpaid. Zejula, part of a class of drugs called PARP inhibitors, lagged behind a competing medicine from AstraZeneca and Merck, and yet GSK asserted again and again that Tesaro’s treatment was going to be useful in more cancers than investors believed.

Yesterday, the company got some absolution as the FDA widened Zejula’s label just two months after accepting GSK’s application. The drug is now the only PARP inhibitor approved as a first-line treatment for women with ovarian cancer, regardless of whether they have BRCA mutations. 

Zejula has a long way to go to catch up to its competitor, but if GSK proves similarly prescient in other ongoing studies, its $5 billion bet may pay off in time.

More reads

  • Diagnostics firm says new Covid-19 test could be used 1 million times a week. (STAT)
  • Trump’s ‘Operation Warp Speed’ aims to rush coronavirus vaccine. (Bloomberg)
  • NIH announces $1.5 billion, ‘Shark Tank’-like initiative to accelerate Covid-19 testing. (STAT)

Thanks for reading! Until tomorrow,

Thursday, April 30, 2020

STAT

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