AstraZeneca ordered back into the penalty box on ZS-9 after another rejection on manufacturing malfunction

Pascal Soriot

This one will really hurt at AstraZeneca.

Ten months after the pharma giant was sidelined on ZS-9 by manufacturing issues, the team at AstraZeneca is once again being put in the penalty box. The FDA has rejected the hyperkalemia drug — just as it did last May — following an inspection of the manufacturing center.

The agency isn’t looking for any new trials, but AstraZeneca will need to go back to the drawing board to figure out what’s wrong at its manufacturing facility. And that could take until early 2018.

Manufacturing delays are nothing new. Drugmakers were hit with a slew of them in 2016. But the last delay gave AstraZeneca’s competition at Relypsa — bought out by Vifor last summer for $1.53 billion — time to persuade the FDA to remove the black box warning for Veltassa (patiromer). And after analysts had given AstraZeneca a straight shot at dominating the market for hyperkalemia, the pharma giant’s marketing team will now get to twiddle its thumbs as Vifor takes advantage of another stinging delay to consolidate its position.

The last delay was described by AstraZeneca as a “bump in the road.” But this time it has to recover from a black eye the company can ill afford. AstraZeneca badly needed a quick, clear win when it bought ZS Pharma for $2.7 billion in 2015. And that goes double now.

AstraZeneca has made progress with its oncology franchise, most recently picking up big Phase III data for its PARP drug Lynparza. But it has experienced a series of development setbacks under CEO Pascal Soriot as it desperately needs to build revenue with new products.

The Europeans have given AstraZeneca a green light for this drug. But the market they need to make this drug a blockbuster is in the US. And that remains barred this morning.

If the last delay for ZS-9 came at a bad time, this one was even worse. This is no time for AstraZeneca to look hapless at fielding big new drugs. And the penalty box is no place for its marketing group.

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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
Marketing Associate - Demand Generation
Catalytic Data Science Charleston, SC
Associate Principal, Life Sciences Partnerships
Flatiron Health New York City or San Francisco

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