Before the coronavirus global emergency stole the R&D show in biopharma, the leaders in the race to develop new mRNA therapies had a big interest in determining if their tech could ...
A new study points to $6.5B in public support building the scientific foundation of Gilead's remdesivir. Should that be reflected in the price?
By drug R&D standards, Gilead’s move to repurpose remdesivir for Covid-19 and grab an emergency use authorization was a remarkably easy, low-cost layup that required modest efficacy and a clean safety profile from just a small group of patients.
The drug OK also arrived after Gilead had paid much of the freight on getting it positioned to move fast.
In a study by Fred Ledley, director of the Center for Integration of Science and Industry at Bentley University in Waltham, MA, researchers concluded that the NIH had invested only $46.5 million in the research devoted to the drug ahead of the pandemic, a small sum compared to the more than $1 billion Gilead expected to spend getting it out this year, all on top of what it had already cost in R&D expenses.
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Donald and Melania Trump watch the smoke of fireworks from the South Lawn of the White House on July 4, 2020 (via Getty)
Which drug developers offer Trump a quick, game-changing ‘solution’ as the pandemic roars back? Eli Lilly and AbCellera look to break out of the pack
We are unleashing our nation’s scientific brilliance and will likely have a therapeutic and/or vaccine solution long before the end of the year.
— Donald Trump, July 4
Next week administration officials plan to promote a new study they say shows promising results on therapeutics, the officials said. They wouldn’t describe the study in any further detail because, they said, its disclosure would be “market-moving.”
— NBC News, July 3
Something’s cooking. And it’s not just July 4 leftovers involving stale buns and uneaten hot dogs.
Over the long weekend observers picked up signs that the focus in the Trump administration may swiftly shift from the bright spotlight on vaccines being promised this fall, around the time of the election, to include drugs that could possibly keep patients out of the hospital and take the political sting out of the soaring Covid-19 numbers causing embarrassment in states that swiftly reopened — as Trump cheered along.
So far, Gilead has been the chief beneficiary of the drive on drugs, swiftly offering enough early data to get remdesivir an emergency authorization and into the hands of the US government. But their drug, while helpful in cutting stays, is known for a limited, modest effect. And that won’t tamp down on the hurricane of criticism that’s been tearing at the White House, and buffeting the president’s most stalwart core defenders as the economy suffers.
We’ve had positive early-stage vaccine data, most recently from Pfizer and BioNTech, playing catchup on an mRNA race led by Moderna — where every little sign of potential trouble is magnified into a lethal threat, just as every advance excites a frenzy of support. But that race still has months to play out, with more Phase I data due ahead of the mid-stage numbers looming ahead. A vaccine may not be available in large enough quantities until well into 2021, which is still wildly ambitious.
So what about a drug solution?
Trump’s initial support for a panacea focused on hydroxychloroquine. But that fizzled in the face of data underscoring its ineffectiveness — killing trials that aren’t likely to be restarted because of a recent population-based study offering some support. And there are a number of existing drugs being repurposed to see how they help hospitalized patients.
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Positive Covid-19 vaccine data? New mouse study? OWS inclusion? Yep, but somehow, the usual tidbits from Inovio backfire
You don’t go more than 40 years in biotech without ever getting a product to market unless you can learn the art of writing a promotional press release. And Inovio captures the prize in baiting the hook.
Tuesday morning Inovio, which has been struggling to get its Covid-19 vaccine lined up for mass manufacturing, put out a release that touched on virtually every hot button in pandemic PR.
There was, first and foremost, an interim snapshot of efficacy from their Phase I program for INO-4800.
Day one: The disruptor-in-chief at BridgeBio invites Brent Saunders onto the board
Now that Allergan has been swept up into AbbVie following their $63 billion buyout, it’s time for ex-CEO Brent Saunders to kickstart the next chapter of his career. And his new post as an independent board member at BridgeBio looks to be right up his alley.
BridgeBio, led by CEO Neil Kumar, has built up a hub-and-spoke operation involving a variety of subsidiaries on different development paths as the McKinsey vet looked to create a new kind of biopharma company, free of the usual corporate clutter that slows the giants down.
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The FDA backs off a hasty — and damaging — emergency OK for a potentially dangerous Covid-19 drug
The FDA rushed in with an emergency authorization less than 3 months ago to allow anxious, frightened people the opportunity of using two malaria drugs to ward off Covid-19. One of them, hydroxychloroquine, arrived with the repeated endorsement of President Donald Trump — who ended up taking it himself — and various Fox News commentators. But with the evidence of its uselessness for guarding against coronavirus growing, as data on potential safety risks mounted amid a chorus of expert warnings, the agency reversed itself on Monday and revoked the green light.
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Cameron Durrant, Humanigen CEO (Columbia University Technology Ventures via YouTube)
Cameron Durrant hustled his way from the OTC sidelines right into the Covid-19 drug race. Death or glory lies straight ahead
Over the past few months, Covid-19 has gone from being a monolithic threat to one of the biggest overnight boons the biopharma industry has ever seen. And amid all the furor over Moderna’s swelling stock price, plenty of chatter over what new drugs and vaccines will cost and investors’ uninhibited zeal for all things related to pandemic products, it’s been one little biotech’s golden ticket back from the land of the living dead.
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Sanofi CEO Paul Hudson has $23B burning a hole in his pocket. And here are some hints on how he plans to spend that
Sanofi has reaped $11.1 billion after selling off a big chunk of its Regeneron stock at $515 a share. And now everyone on the M&A side of the business is focused on how CEO Paul Hudson plans to spend it.
After getting stung in France for some awkward politicking — suggesting the US was in the front of the line for Sanofi’s vaccines given American financial support for their work, versus little help from European powers — Hudson now has the much more popular task of managing a major cash cache to pull off something in the order of a big bolt-on. Or two.
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Researchers define exactly what they saw in the first positive remdesivir study for Covid-19. But what's that worth to Gilead?
Remdesivir can work in fighting Covid-19, particularly for patients with less severe cases, but this is just a first step in the journey to finding combos that can do the job much better.
That’s the bottom line from Gilead’s randomized study published in the New England Journal of Medicine. Analysts were quick to draw conclusions about how the big biotech could turn this into a profitable advantage — with widespread expectation of considerable pricing restraint on Gilead’s part. Anyone looking for a new mountain of cash to count as the world grapples with the pandemic is likely to come away disappointed.
BARDA offers a tiny startup up to $812M to create a US-based drug manufacturer — and the CEO comes with a price gouging controversy on his résumé
BARDA has tapped a largely unknown startup to ramp up production of a list of drugs that may be at risk of running short in the US. And the deal, which comes with up to $812 million in federal funds, was inked by a CEO who found himself in the middle of an ugly price gouging controversy a few years ago.
The feds’ new partner — called Phlow — won a 4-year “base” contract of $354 million, with another $458 million that’s on the table in potential options to sustain the outfit. That would make it one of the largest awards in BARDA’s history.
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President Donald Trump, left, listens as Moncef Slaoui, a former GlaxoSmithKline executive, speaks about the coronavirus in the Rose Garden of the White House, Friday, May 15, 2020, in Washington. (AP Photo/Alex Brandon)
Moncef Slaoui pivots from Moderna's board to the helm of Project Warp Speed. His task: Overnight success
Moncef Slaoui stepped off Moderna’s board of directors on Friday and pivoted straight into the high profile role heading the Trump administration’s Project Warp Speed, where he’ll be in charge of accelerating Moderna’s — and others — vaccines to a rapid release for a pandemic weary world.
The news became official mid-day Friday after numerous reports earlier that he had been picked off the short list of candidates.
