The Readout Damian Garde & Meghana Keshavan

How much data does Moderna need to get a coronavirus vaccine approved?

Moderna Therapeutics’ potential coronavirus vaccine only entered Phase 1 yesterday, but, considering the speed of the program and severity of the pandemic, it’s worth asking: Would the FDA consider approving it before there's proof it protects people?

EvercoreISI analyst Umer Raffat wondered exactly that and went digging through FDA regulations. The agency prefers that vaccines demonstrate protection — preferably in large, placebo-controlled studies — but it reserves the right to approve treatments based on immunological evidence that looks protective. In practice, that has only applied when regulators can be sure that a certain amount of immune activity confers protection. When it comes to coronavirus, no one has any idea.

But the pandemic, which has resulted in more than 180,000 cases around the world, is an unusual case. If the FDA waives its normal requirement, Moderna could file for approval based on the amount of protective antibodies its vaccine produces. And it could win that approval much faster than is currently thought.

Biotech’s peanut allergy debate might be over

Back in early 2018, there were three oft-discussed biotech companies vying to come up with a treatment for kids with peanut allergies. Disappointing data led investors to dismiss one, called AnaptysBio. Another, Aimmune Therapeutics, saw some discouraging side effects with its therapy but managed to convince the FDA to approve it this year. As of this week, DBV Therapeutics, a third, was on its way toward FDA approval with an approach it believes to be superior.

But that might have just gone off the rails. Yesterday, DBV said the FDA canceled a planned advisory meeting after identifying “questions regarding efficacy” when it comes to the company’s product, a skin patch meant to gradually decrease allergy. As it stands, the FDA’s promised decision date of Aug. 5 hasn’t changed, but if DBV has to submit more data, it almost certainly will.

To investors, that signaled the end of DBV’s hopes of competing with Aimmune. The company’s share price fell nearly 60% after hours, while Aimmune’s rose 26%.

There’s a biotech company going public right now

As you might have heard, the S&P 500 is down roughly 30% over the past month. The Dow Jones Industrial Average has fallen about as much in the same period. CNBC has even resurrected its most beloved chyron

To the people who run a biotech company called Keros Therapeutics, this is the time to go public.

As STAT’s Kate Sheridan reports, the company just raised $56 million in a private funding round just this month but apparently needs even more cash to keep things running. Keros, based in Massachusetts, is developing drugs that manipulate a receptor called TGF-beta, a popular target for scientists looking for a way to make immuno-oncology drugs more effective.

Read more

It has been quite the month at CureVac

Back on March 2, CureVac CEO Dan Menichella was at the White House, seated among his counterparts at drug makers big and small, explaining to President Trump how his company planned to develop a vaccine for the novel coronavirus. Nine days later he was out of a job, and then CureVac became party to an international incident. Now his successor is leaving, too.

CureVac disclosed yesterday that Ingmar Hoerr, who took over for Menichella, was taking an indefinite leave “for medical reasons,” adding that the issue is “not caused by coronavirus.” Franz-Werner Haas, the company’s chief operating officer, is now the CEO. Meanwhile, the German company is still working on that vaccine, which uses messenger RNA to generate virus-blocking antibodies. 

Over the weekend, a German newspaper reported that Trump at some point tried to strike a deal with CureVac that would give the U.S. exclusive access to the vaccine, which is yet to be tested in humans. CureVac distanced itself from the story, and the U.S. ambassador to Germany said it was false. But billionaire Dietmar Hopp, who owns about 80% of CureVac, said in an interview with soccer reporters (a long story in its own right) seemed to confirm it, saying that Trump made the offer to CureVac’s management, “who then told me and asked what I thought.”

He thought it was a very bad idea. But whether Hopp's thoughts had anything to do with CureVac’s management upheaval remains unclear.

The pandemic is scrambling pharma’s business model

While dozens of drug companies are racing to develop therapies and vaccines for the novel coronavirus, countless others are struggling with one of its practical effects: It’s hard to run a sales force in a pandemic.

As STAT’s Adam Feuerstein reports, Amgen and Merck have ordered their sales reps to halt all in-person meetings with doctors and hospitals. Amarin, maker of the heart drug Vascepa, instituted a two-week suspension of all face-to-face sales interactions.

Whether this will have an effect on companies’ bottom lines remains to be seen. No one knows when the outbreak might wane, and drugs tend to be must-have goods for consumers, meaning it’s unlikely patients won’t refill prescriptions because of coronavirus. 

Read more.

More reads

  • Regeneron says potential Covid-19 drugs could start human tests this summer. (STAT)
  • Generic ‘identity’ gets lost when companies juggle both generic and brand drugs. (STAT)
  • Biogen staffer fled to China in search of emergency Covid-19 testing, care — and now faces criminal charges. (Endpoints)
  • Global spending on drugs may hit $1.1 trillion by 2024, but the rate of growth is forecast to slow. (STAT Plus)
Correction: In yesterday’s newsletter, we misspelled Covid-19. It has been a long month.

Thanks for reading! Until tomorrow,

Tuesday, March 17, 2020


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