Sanofi prevails in Zantac arbitration initiated by
Boehringer Ingelheim
- Arbitral tribunal dismisses claim
brought by Boehringer Ingelheim (“BI”) against Sanofi for
indemnification of potential liabilities related to the ongoing
Zantac litigation in the U.S. ; decision is final and cannot be
appealed
- Key U.S. federal court ruling in
December 2022 found no reliable evidence that Zantac causes the
alleged injuries, bolstered similar findings by FDA and EMA; tens
of thousands of claimants have abandoned their claims
- Sanofi remains highly confident in
defense of underlying U.S. Zantac litigation as confirmed by
developments over the last 6 months
Paris, June
20, 2023. Sanofi announces that
in an International Chamber of Commerce dispute, the tribunal
dismissed BI’s indemnification claim against Sanofi and confirmed
that Sanofi shall not be liable to indemnify BI for any potential
losses in relation to the ongoing Zantac litigation in the U.S.
This decision is final and non-appealable.
Importantly, Sanofi remains confident that the
defense of the underlying U.S. Zantac litigation is very strong.
There is no reliable scientific evidence that Zantac causes the
alleged injuries in the cases brought against GSK, Pfizer, BI,
Sanofi, and others in the U.S. litigation. The FDA and the European
Medicines Agency have both evaluated the available data and found
no evidence that ranitidine, the active ingredient contained in
Zantac, causes cancer.
This was notably confirmed in December 2022,
when a U.S. federal court assigned to oversee all federal cases in
the United States (“MDL”) ruled that plaintiffs had no reliable
scientific evidence that ranitidine can cause any of the
plaintiffs’ alleged injuries. The thorough ruling substantiated
Sanofi’s scientific defenses demonstrating that there is no
reliable evidence of causation for even those cancer types that
plaintiffs claimed had the strongest evidence. Sanofi believes that
any appeal by plaintiffs of the MDL ruling has a low probability of
success. Tens of thousands of claimants who were once a part of
this MDL litigation chose to abandon their claims or else withdrew
early from the MDL, either filing in state court or not re-filing
at all. These recent events have significantly decreased the
potential scope of the litigation.
Background
Zantac was launched in the United States as a
prescription medication by GSK in 1983 (GSK continued to market the
Rx version until 2017). In 1995, GSK launched an OTC version of its
Zantac 75mg formula. In 1997, generic ranitidine entered the
market. In 1998, Pfizer acquired the OTC rights and in 2004 it
launched a 150mg version of the product as well. In 2006, BI
acquired the U.S. OTC rights for Zantac and in January 2017 Sanofi
acquired those OTC rights.
On September 13, 2019, FDA issued a statement
alerting the public that some ranitidine medicines, including
over-the-counter Zantac, contained a nitrosamine impurity called
N-nitrosodimethylamine (NDMA) at low levels. NDMA is a known
environmental contaminant found in drinking water, soil, and common
foods, including meats, dairy products, and vegetables. People are
routinely exposed to small amounts of NDMA every day. In October
2019, out of an abundance of caution Sanofi issued a voluntary
recall of all ranitidine Zantac OTC products in the U.S. and
Canada.
Since that time, the medical, scientific, and
regulatory communities have extensively evaluated the safety of
Zantac’s active ingredient ranitidine, and the data show there is
no evidence of consumer harm from real-world use of Zantac. Over
time, both FDA and the European Medicines Agency have evaluated the
available data and have also found no evidence that ranitidine
causes cancer.
Regardless of the scientific evidence, within
days of FDA’s September 2019 announcement, purported class actions
and personal injury lawsuits were filed in U.S. courts, alleging
that Zantac caused various cancers. In addition to Sanofi, these
lawsuits named GSK, Pfizer, BI, dozens of generic manufacturers,
retailers and pharmaceutical distributors.
The arbitration dispute arose from contractual
indemnification obligations agreed between Sanofi and BI as part of
the January 2017 swap of Sanofi’s Animal Health business for BI’s
Consumer Health Care business.
There is no evidence of consumer harm from
real-world use of Zantac as a result of any NDMA contamination.
Sanofi stands by the safety of Zantac. Given the
lack of scientific support for plaintiffs’ claims, Sanofi remains
fully confident in its defenses to the litigation. Sanofi acted
responsibly at all times.
About SanofiWe are an innovative global
healthcare company, driven by one purpose: we chase the miracles of
science to improve people’s lives. Our team, across some 100
countries, is dedicated to transforming the practice of medicine by
working to turn the impossible into the possible. We provide
potentially life-changing treatment options and life-saving vaccine
protection to millions of people globally, while putting
sustainability and social responsibility at the center of our
ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY
Media RelationsSandrine
Guendoul | + 33 6 25
09 14 25 | sandrine.guendoul@sanofi.com Evan
Berland | +1 215 432 0234 |
evan.berland@sanofi.comNicolas
Obrist | + 33 6 77 21
27 55 | nicolas.obrist@sanofi.com Victor
Rouault | + 33 6 70
93 71 40 | victor.rouault@sanofi.com
Investor RelationsEva
Schaefer-Jansen | +
33 7 86 80 56 39 | eva.schaefer-jansen@sanofi.com
Arnaud
Delépine | +
33 6 73 69 36 93 |
arnaud.delepine@sanofi.comCorentine
Driancourt | + 33 6
40 56 92 21 | corentine.driancourt@sanofi.comFelix
Lauscher | +
1 908 612 7239 |
felix.lauscher@sanofi.comTarik
Elgoutni| + 1 617 710 3587 |
tarik.elgoutni@sanofi.comNathalie
Pham | + 33 7 85 93
30 17 | nathalie.pham@sanofi.com
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