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Readout @ JPMDamian Garde

Hello again from #JP20. This is your afternoon check-in, live from San Francisco with everything interesting from from Day 2 of biotech's biggest annual conference, where investors are restless and there are no mattresses to be found. Follow STAT's reporters on the ground: @adamfeuerstein, @damiangarde, @rebeccadrobbins@erbrod@pharmalot, and @matthewherper.

Shingrix shines — and stings — for GSK

Conversations with investors about GlaxoSmithKline have changed, the British drug giant’s CEO, Emma Walmsley, told STAT’s Matthew Herper.  These days, she said, investors ask her about the drugs GSK is developing, not its financial maneuvers.

A bright light has been Shingrix, the company's vaccine for shingles, an extremely painful adult infection that's caused by the same virus that triggers chickenpox. Shingrix appears more effective than the previous vaccine, and has become a big seller. Sales last quarter totaled $700 million. “Shingrix has been the best biopharma launch in a decade,” Walmsley said.

It also has side effects — pain for most patients, severe fever for at least a fifth. “It hurts ’cause it works, but it's certainly not slowing down demand,” Walmsley said. GSK works to make sure patients are aware of potential side effects, she said, adding: “It doesn't hurt nearly as much as shingles does.” 

Demand for the vaccine is accelerating, Walmsley noted.

A pivotal moment for NASH nears

Six years ago at JPM, Intercept Pharmaceuticals had investors (and journalists) scrambling to Google to look up the definition of NASH after the surprising and positive results from a mid-stage clinical trial sent the biotech’s stock price soaring. It’s been a long and bumpy road since January 2014, but Intercept’s NASH drug — the biotech industry’s first — is finally on the cusp of a highly anticipated commercial launch later this year.

But first, Intercept needs to secure the NASH drug’s approval. Step one in that process will be an FDA advisory panel tentatively scheduled for April 22.

“It’s difficult from the outside to appreciate this but preparation for these FDA advisory panels is actually more work than the New Drug Application itself,” Intercept CEO Mark Pruzanski said in an interview with STAT’s Adam Feuerstein on Tuesday. “You really need to do deep dives across each and every possible topic that may come up, and of course there is very little visibility on what those topics might be.”

Adam will have more details about Intercept’s NASH drug plans from the Pruzanski interview later today at statnews.com

Biogen isn’t backing down

Back in November, Biogen’s top scientist turned heads around the industry with some strong words about the company’s controversial treatment for Alzheimer’s disease and whether the FDA should approve it. To more than a few outside observers, his comments read like brinkmanship.

At J.P. Morgan, he got the chance to walk them back, and he very much did not do so.

In the cramped breakout room after Biogen’s Monday presentation, Al Sandrock stood by aducanumab, the company’s once-dismissed Alzheimer’s drug. And he again pointed out that, whatever one’s opinion on Biogen’s complicated argument that the drug works, the agency has to consider that every day without an approved therapy means more people getting Alzheimer’s.

“The FDA has to weigh the fact that this is a very serious disease,” Sandrock said. “It’s fatal, and it’s terribly disabling. There are no alternative treatments.” Whether to approve aducanumab will “be a difficult decision for them,” he said. “It always is, it seems. But I think they’ll make the right decision.”

Elsewhere, Eli Lilly outlined its future, Gilead Sciences played some defense, and Sage Therapeutics faced some discordant music. You can read all about it in our Day 1 recap

EQRx is even more ambitious than you thought

One of the biggest stories of the week so far has been the launch of EQRx, a new company from health care veteran Alexis Borisy that aims to develop medicines at lower costs and sell them at lower prices.

The company raised $200 million from a bevy of top tech and biotech investors, but that won’t be nearly enough: It’ll need to raise $2.5 billion to $5 billion to achieve its goals, Borisy said during a panel discussion hosted by STAT last night.

Borisy also said he expects his company’s cost structure to look a lot different than that of a typical generics pharmaceutical company, which might spend 20% on general and administrative expenses, 40% on sales and marketing, and 20% on research and development — and then take 20% as profit. EQRx plans to flip those marketing and R&D percentages.

How? By steering clear of spending big on “frivolous medical marketing studies” and direct-to-consumer TV ads, Borisy said.

More reads

  • After a big stock surge, Patrick Soon-Shiong makes his case to investors (STAT Plus)
  • A forerunner in ‘smart pills’ adopts a new tack as key pharma partnership unravels. (STAT)
  • How Silicon Valley’s elites hatched their multibillion-dollar scheme to cure death. (OneZero)
  • At major San Francisco conference, it’s Mass General Brigham, not Partners. (Boston Globe)

Thanks for reading! More tomorrow.

Tuesday, January 14, 2020

STAT

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