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.

The US pharma giant Eli Lilly will be increasing its financial commitment to a manufacturing site in Ireland.

According to a release from Ireland’s Industrial Development Agency (IDA) on Monday, Lilly will be investing another $500 million in its manufacturing facility in Limerick, Ireland — bringing the total investment into the facility to approximately $1 billion.

In January of last year, Lilly announced it was placing a $446 million investment into the site to expand active pharmaceutical ingredient and monoclonal antibody production.

DC District Court Judge Christopher Cooper today granted Vanda Pharma’s request to require the FDA to disclose more info on the complete response letter for its sleep disorder drug Hetlioz.

The melatonin receptor agonist is approved by the FDA to treat non-24-hour sleep-wake disorder, a circadian rhythm disorder. But in 2018 Vanda filed a supplemental application to market Hetlioz as a treatment for jet lag, which the FDA rejected in August 2019, with few details on what Vanda needed to correct course, according to the company.