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The Readout Damian Garde

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Who’s the best CEO in biotech?



Courtesy of STAT’s Adam Feuerstein, you now have your annual chance to vote on that very question. 

There’s an entrepreneur who convinced the FDA to grant a pioneering approval, an industry lifer who engineered a turnaround at a struggling giant, the architect of a years-long success story in precision medicine, and a true believer who found himself vindicated by a huge clinical trial.

Make your choices now, and don’t worry: You’ll get the chance to weigh in on biotech’s worst CEOs later this week.

Moderna’s worst isn’t over, readers say

Yesterday, we asked readers whether Moderna would reach its $23-a-share IPO price by the beginning of next year, and the results were less than enthusiastic.

Roughly 86 percent of respondents said Moderna would stay in the red through the holidays, maintaining a valuation more than $1 billion below the one it carried as a private company. The other 14 percent sees a rally in the cards.

It’s easy to see where the majority is coming from. Biotech sentiment is heavily driven by catalytic events, whether in the form of clinical trials or FDA approvals, and Moderna’s pipeline of mid-stage vaccines and preclinical drugs looks unlikely to produce any news, good or bad, in the near term.

That said, for whatever it’s worth, no less than Jim Cramer is preaching patience. In the next few weeks, Moderna will get the chance to make its case to sell-side analysts, and if the resulting reports are bullish — as they almost certainly will be — the stock could rally, Cramer said on TV.

"These speculative biotechs are a lot like Giancarlo Stanton,” he added. “When he steps up to the plate, he's likely to either strike out or hit a home run.”

Stanton hit for .266 last season, and Moderna was down another 4 percent yesterday.

The anti-Mylan pulls a Mylan

Back in 2016, a company called Kaleo won some positive press coverage when it introduced an alternative to EpiPen, the epinephrine autoinjector whose price Mylan had repeatedly hiked. Now Kaleo is in a situation Mylan would find familiar: Selling a generic version of its own product to address pricing outrage.

As STAT’s Lev Facher reports, Kaleo has promised to sell an authorized generic of its brand-name naloxone injector at a retail price of $178 for two doses. The branded version, called Evzio, goes for $4,100, a price Kaleo raised from just $575.

It’s nearly identical to what Mylan did in the wake of 2016’s EpiPen outrage. First Mylan tried explaining the complexities of the supply chain and blaming middlemen — as Kaleo did — and then it relented and introduced a generic at roughly half the cost of its branded product.

Read more.

What would be a sufficient explanation for price hikes?

Sen. Tammy Baldwin has questions for Pfizer over its defer-to-appease approach to price increases, marking the latest congressional inquiry into the drug business that seems destined to provide boring answers.

As STAT’s Ed Silverman reports, Baldwin is asking about Pfizer’s decision to pause some planned price hikes over the summer, at the height of President Trump’s anti-pharma rhetoric, and then unpause them in time for the new year. She wants data on the price increases and an explanation on why Pfizer is doing them.

But what could that possibly yield? Most major drug companies raise prices at the start of the year as a rule — Pfizer's Ian Read literally called it “business as normal” — making it unclear how the company's explanation might illuminate the issue or how Baldwin’s attention might serve as a deterrent to the next CEO in Read’s position.

More reads

  • Lawsuit alleges NIH, FDA let clinical trial sponsors off the hook. (STAT Plus)
  • Clive Meanwell gives way to new CEO as activist investor Alex Denner shakes up The Medicines Company. (Endpoints)
  • Tumor-specific antigens from way out there. (In the Pipeline)
  • Lessons from the biggest pharma drug launches of all time. (Forbes)

Thanks for reading! Until tomorrow,


Wednesday, December 12, 2018


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