Af­ter years of Zan­tac heart­burn med­ica­tion le­gal ac­tion, French phar­ma Sanofi is see­ing a res­o­lu­tion to at least some of the lit­i­ga­tion.

In Q4 guid­ance re­leased Wednes­day, Sanofi said it ex­pects the oblig­a­tions and in­dem­ni­fi­ca­tion rights be­ing dis­put­ed through ar­bi­tra­tion with Boehringer In­gel­heim will be re­solved this year, with ear­li­est at the end of Q1. Sanofi bought Zan­tac from Boehringer in 2017.

The ar­bi­tra­tion case it­self, ac­cord­ing to an an­a­lyst re­port from Bar­clays in Au­gust of 2022, was ini­ti­at­ed by Boehringer In­gel­heim against Sanofi as it seeks com­pen­sa­tion for loss­es it could in­cur as a re­sult of Zan­tac lit­i­ga­tion in the US. Sanofi is dis­put­ing the claim and has brought up sev­er­al coun­ter­claims. The dis­pute al­so has roots in the in­dem­ni­fi­ca­tion oblig­a­tions agreed up­on be­tween both com­pa­nies as part of a swap be­tween Sanofi’s an­i­mal health sec­tor for Boehringer In­gel­heim’s con­sumer health care busi­ness.

As for fu­ture Zan­tac lit­i­ga­tion, Emi­ly Field, the head of Eu­ro­pean Phar­ma­ceu­ti­cals eq­ui­ty re­search for Bar­clays, said in an email to End­points News that it should not have an im­pact.

Field said:

It would just as­sert who would owe any li­a­bil­i­ties in the event of a judg­ment against the de­fen­dants – i.e. as a hy­po­thet­i­cal ex­am­ple, if BI pre­vails here and Sanofi has to­tal­ly in­dem­ni­fied BI against li­a­bil­i­ty, if a plain­tiff bought OTC Zan­tac in 2016 and the ju­ry ruled against BI, Sanofi would then owe the mon­e­tary judg­ment.

Field al­so told End­points that since GSK was sell­ing the over-the-counter prod­uct, what goes on be­tween Sanofi and Boehringer In­gel­heim should im­pact any cas­es where the plain­tiffs bought OTC Zan­tac.

In an­oth­er an­a­lyst re­port for Bar­clays in Oc­to­ber, Field said that this ar­bi­tra­tion case is a “black box” and is dif­fi­cult to de­ter­mine if any award will be giv­en. Still, where Sanofi is con­cerned, the award could pro­vide some de­gree of clar­i­ty on Sanofi’s share of any fu­ture set­tle­ment or li­a­bil­i­ty, al­though Bar­clays doesn’t ex­pect the de­ci­sion to pro­vide com­plete cer­tain­ty.

“Le­gal ex­perts we have worked with pre­vi­ous­ly have not­ed that ar­bi­tra­tors have his­tor­i­cal­ly of­ten met some­where in the “mid­dle of the road” rather than award­ing an en­tire ar­bi­tra­tion award to one par­ty. How­ev­er, re­cent ar­bi­tra­tions we’ve seen in our space have in fact award­ed en­tire ar­bi­tra­tions awards to one par­ty,” the re­port said.

Field al­so told End­points that it’s hard to know the range of out­comes but giv­en that the ar­bi­tra­tion could some­how quan­ti­fy the li­a­bil­i­ty that may be faced by Sanofi, in­vestors have been view­ing it as a po­ten­tial­ly pos­i­tive cat­a­lyst.

“What’s been so hard about this sit­u­a­tion all along is that there are two un­known vari­ables: what the to­tal li­a­bil­i­ty pie could be … and then, of that pie, who owes what?” Field said.

Sanofi has been in­volved in some le­gal ac­tions con­cern­ing the drug out­side of its ar­bi­tra­tion with Boehringer In­gel­heim, in­clud­ing a re­cent­ly set­tled case in the state of Cal­i­for­nia. In that case, Sanofi wrote in the Wednes­day re­lease that it set­tled “not be­cause it be­lieves these claims have any mer­it, but rather to avoid the ex­pense and dis­trac­tion of a tri­al in Cal­i­for­nia.”

“Sanofi re­mains con­fi­dent in its le­gal de­fens­es and was pleased with the fed­er­al Mul­ti-Dis­trict Lit­i­ga­tion (MDL) court’s de­ter­mi­na­tion in ear­ly De­cem­ber that there is in­suf­fi­cient ev­i­dence that ran­i­ti­dine can cause plain­tiffs’ al­leged can­cers. This rul­ing sig­nif­i­cant­ly de­creased the scope of the lit­i­ga­tion and sub­stan­ti­ates Sanofi’s sci­en­tif­ic de­fens­es to the claims be­ing as­sert­ed,” Sanofi’s guid­ance said.

While the amount of re­spon­si­bil­i­ty that Sanofi will have is still up in the air, a Sanofi spokesper­son said in an email to End­points that there is no “re­li­able ev­i­dence” that Zan­tac caus­es any of the al­leged in­juries un­der re­al-world con­di­tions.

“Sanofi re­mains ful­ly con­fi­dent in its de­fens­es,” the spokesper­son said.

The Zan­tac brand has faced lit­i­ga­tion in sev­er­al as­pects af­ter a test­ing lab­o­ra­to­ry, Val­isure, filed a cit­i­zen pe­ti­tion in 2019 call­ing for the re­call of all ran­i­ti­dine prod­ucts due to high lev­els of ND­MA, which can cause can­cer.

Since the re­quest­ed re­call of Zan­tac in 2020 by the FDA, some le­gal cas­es have been dis­missed, but GSK still has sev­er­al more cas­es to con­tend with.

President Joe Biden made clear in his “finish the job” State of the Union address last night that one of those jobs to be finished is insulin prices.

Biden’s push again to tackle insulin prices, after Republicans rebuffed the idea last summer and just after Biden won Medicare drug price negotiations/caps via the Inflation Reduction Act, shows how heavily he’s leaning into this work.

Six weeks into his new role at the helm of Teva Pharmaceutical, Richard Francis said it’s time to “get back to growth,” starting with a good look at the company’s priorities.

The chief executive has kicked off a strategic review, he announced during Teva’s quarterly call, which will continue over the next several months and produce results sometime in the middle of 2023. That means some pipeline cuts may be in store, he told Endpoints News, while declining to offer much more detail.

We now know where Roche’s ex-pharma chief Bill Anderson is going.

German pharma giant Bayer announced Wednesday that Anderson will be taking on the role as CEO, less than six weeks after Anderson stepped down from his perch at Roche as head of the group’s pharmaceutical division.

Roche announced back in December that Anderson would depart on Dec. 31 to “pursue opportunities outside of Roche.” His replacement, Genentech vet and Roche’s current head of global product strategy, Teresa Graham, will start her role in March.

As talk of AI this-and-that gobbles up headline after headline, one Big Pharma is losing its AI leader as she transitions to another drug giant: Iya Khalil will trade in her hat as Novartis’ go-to expert and leader in the space for Merck as VP and head of data, AI and genome sciences next week.

After nearly three years leading the artificial intelligence team at Novartis — as Big Pharma and biotechs alike latch onto the ripening AI-for-drug-discovery mode of operation — Khalil will switch employers to head up a similar post at Merck, where she’ll work out of Cambridge, MA beginning Feb. 13, the company tells Endpoints News.