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(Alliance News) - GSK PLC said on Tuesday the first scheduled trial in its Zantac case has been voluntarily dismissed.
GSK, among others, has come under pressure that heartburn treatment Zantac causes cancer. Its consumer healthcare spin-off Haleon PLC is implicated, as is French firm Sanofi SA and US firm Pfizer Inc.
The pharma firm noted it did not pay anything in exchange for the voluntary dismissal.
"GSK welcomes this outcome and believes the dismissal of Joseph Bayer's case is the correct result. The overwhelming weight of the scientific evidence supports the conclusion that there is no increased cancer risk associated with the use of ranitidine. GSK will continue to vigorously defend itself against all claims alleging otherwise," it added.
Moving forward, GSK noted cases where it is named, a trial in California is currently scheduled to begin February 13 and a trial is currently scheduled to begin in Madison County, Illinois in February 2023.
Zantac was withdrawn after the US Food & Drug Administration in 2019 warned that the product contained levels of NDMA, a probable human carcinogen - a substance which has been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.
While the worries were not new, it particularly grabbed investor attention last week. In its listing prospectus, Haleon actually mentioned Zantac litigation. It noted GSK and Pfizer, its former owners, were named as a defendant in roughly 2,150 US "personal injury lawsuits involving Zantac".
On Tuesday, GSK put this number at about 3,000.
Haleon on Thursday said it was 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.
Pfizer 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.
Ranitidine, sold under the brand Zantac, was originally manufactured by GSK, and French pharmaceutical firm Sanofi bought the rights to branded over-the-counter US sales back in 2017.
In a statement on Tuesday, GSK said US and European regulators have undertaken "extensive" reviews of the drug since it was taken off the shelves in 2019.
"Based on these investigations and experiments, GSK, the FDA, and the EMA have all independently concluded that there is no evidence of a causal association between ranitidine therapy and the development of cancer in patients," it said.
GSK added: "Since the issue concerning the presence of NDMA in ranitidine arose in 2019, the scientific community has actively focused on understanding whether there is a link between ranitidine and cancer. There have been 11 epidemiological studies conducted in that time looking at human data regarding the use of ranitidine, with the resulting scientific consensus, that the totality of the reliable evidence does not support that ranitidine increases the risk of any type of cancer."
Shares in GSK closed 1.4% higher in London on Tuesday at 1,425.75 pence. Haleon gained 0.1% to 266.98p, while Sanofi added 1.7% in Paris to EUR86.59. Pfizer was up 0.2% in New York at USD49.87.
By Paul McGowan; paulmcgowan@alliancenews.com
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