Tribunal rejects Boehringer Ingelheim’s liabilities against Sanofi for Zantac

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Tribunal rejects Boehringer Ingelheim’s liabilities against Sanofi for Zantac

An International Chamber of Commerce arbitration tribunal has dismissed a claim by Boehringer Ingelheim against Sanofi in a dispute over legal responsibilities related to ranitidine-based product Zantac, the French multinational company announced Tuesday.

The legal battle stems from a statement issued by the FDA in 2019 that ranitidine-based products such as Zantac contain N-nitrosodimethylamine (NDMA), a carcinogenic compound. In April 2020, the regulator requested removal of the product from the market.

Since the FDA’s first announcement, multiple lawsuits have been filed by users of Zantac. These lawsuits have been directed against several companies responsible for the manufacture and distribution of the heartburn medication, Sanofi and Boehringer among them. In 2017, Paris-based Sanofi acquired U.S. over-the-counter rights to Zantac, transferred in an exchange agreement with Germany-based Boehringer, which had purchased them in 2006.

According to Sanofi’s statement, Boehringer had claimed indemnification “for any potential losses in relation to the ongoing Zantac litigation in the U.S.” The rejection of these claims by the International Chamber of Commerce tribunal is final and non-appealable, according to Sanofi. In a statement, Boehringer declared that it will not comment further since the arbitration is “subject to confidentiality provisions” and that it has “taken note” of the outcome, Fierce Pharma reported.  

Sanofi’s shares were up more than 3% on Tuesday after announcing its legal victory.

Since 2019, the safety of Zantac has been widely assessed, yet both the FDA and the European Medicine Agency have found no conclusive data showing that the drug causes cancer, according to Sanofi’s press release.

In its removal request, FDA acknowledged that it had not observed “unacceptable levels of NDMA in many of the samples” it tested, but its concern arose from determining that “impurity in some ranitidine products increases over time and when stored at higher than room temperatures.”

In December 2022, a federal judge in Florida ruled that there was no reliable scientific evidence that ranitidine could cause any of the injuries alleged by the plaintiffs, clearing Sanofi, Boehringer and other drugmakers of about 50,000 federal cases.

Following that ruling, Boehringer said in an email to Fierce Pharma that the company appreciated the court’s “detailed analysis” and that it would continue its defense in state courts, where thousands of cases are still pending. Last month, a supreme court in Canada also dismissed cancer claims on ranitidine-based products.

In its Tuesday statement, Sanofi said that it “stands by the safety of Zantac, [and] given the lack of scientific support for plaintiffs’ claims, [the company] remains fully confident in its defenses to the litigation.”

Alejandra Manjarrez is a freelance science writer based in Mexico City. Reach her on her website.

Source: BioSpace