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(Alliance News) - Pfizer Inc late Thursday said it has "significant defences" against Zantac litigation, while Haleon PLC revealed it is "not a party" to any claims.
Fears about the heartburn treatment have hit the pharma stocks.
Pfizer shares closed 3.3% lower at USD48.29 each in New York on Thursday. The stock slipped a further 0.1% after hours. Recent GSK PLC spin-off Haleon suffered a 6.2% slide to 262.30 pence in London on Thursday. GSK itself lost 8.1% to 1,430.03p.
Pfizer said it sold Zantac products between 1998 and 2006. By the time there was a withdrawal of Zantac products from the market in 2019 and 2020, Pfizer had already stopped selling it, the company explained.
Zantac was withdrawn after the US Food & Drug Administration in 2019 warned that the product contained levels of NDMA, a probable human carcinogen - a substance which has been linked to cancer.
"Pfizer has significant defences to this litigation and there are significant legal and factual issues that remain to be addressed by the courts," it said.
"Pfizer also has substantial indemnification claims against others, which have been acknowledged by several manufacturers in their disclosures. As a result, we believe at this time that the outcome of the litigation is not likely to be material to Pfizer."
Haleon said it is not aware of any material developments in relation to Zantac since the start of June. The spin-off of Haleon from GSK was completed in mid-July; the consumer healthcare business previously had been run as a joint venture with Pfizer, which owned just under a third.
Haleon said that it is "not primarily liable" for any over-the-counter or prescription claims involving Zantac.
However, it cautioned it may need to eventually compensate both GSK and Pfizer should the duo come into the legal cross-hairs.
Also on Thursday, Sanofi SA and GSK issued statements on Zantac.
Ranitidine, sold under the name Zantac, was offered over-the-counter in the US by French drugmaker Sanofi and was originally manufactured by GSK.
In late 2019, Sanofi recalled the over-the-counter treatment in the US and Canada over possible contamination fears. By April 2020, the FDA had ordered the drug and all its generics be withdrawn from drug store shelves.
Sanofi said that as of August 1, it was aware of 2,850 personal injury plaintiffs in the US. When factoring in additional Zantac cases that do not include Sanofi, this number rises to 3,450.
Sanofi noted that there are other potential personal injury claimants who, in lieu of filing a court case, have instead joined a registry of "unfiled" claims.
"Over time, the number of unfiled claims alleging either Rx and/or OTC use and implicating a variety of defendants in these actions has exceeded 150,000 – a significant number of these claims, however, do not implicate Sanofi," it said.
GSK, meanwhile, said it has been named as a defendant in around 3,000 filed personal injury cases in US federal and state court and "numerous" unfiled claims. Class actions have also been filed, it said.
Outside the US, there are "several class actions and in excess of 100 personal injury cases" pending against GSK in Canada, along with a class action in Israel.
Sanofi closed down 3.3% to EUR84.75 in Paris on Thursday.
By Eric Cunha; ericcunha@alliancenews.com
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