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.

John Hood [file photo]

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UP­DAT­ED: Sci­en­tist-CEO ac­cused of im­prop­er­ly us­ing con­fi­den­tial in­fo from uni­corn Alec­tor

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On June 18, 2019, we initiated a confidential arbitration proceeding against Dr. Asa Abeliovich, our former consulting co-founder, related to alleged breaches of his consulting agreement and the improper use of our confidential information that he learned during the course of rendering services to us as our consulting Chief Scientific Officer/Chief Innovation Officer. We are in the early stage of this arbitration proceeding and are unable to assess or provide any assurances regarding its possible outcome.

There’s no explicit word in the filing on what kind of confidential info was involved, but the proceeding got started 2 days ahead of Abeliovich’s IPO.

Abeliovich, formerly a tenured associate professor at Columbia, is a top scientist in the field of neurodegeneration, which is where Alector is targeted. More recently, he’s also helped start up Prevail Therapeutics as the CEO, which raised $125 million in an IPO. And there he’s planning on working on new gene therapies that target genetically defined subpopulations of Parkinson’s disease. Followup programs target Gaucher disease, frontotemporal dementia and synucleinopathies.

But this time Abeliovich is the CEO rather than a founding scientist. And some of their pipeline overlaps with Alector’s.

Abeliovich and Prevail, though, aren’t taking this one lying down.

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CEO Pascal Soriot via Getty Images

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