3rd Jun 2024 09:08
(Alliance News) - GSK PLC on Monday said it will appeal a US court ruling that it should face jury trials relating to cases concerning the heartburn drug, Zantac.
On Friday, a Delaware judge allowed more than 70,000 lawsuits over the discontinued drug to go forward to trial, ruling that expert witnesses can testify in court that the drug may cause cancer.
Shares in GSK fell 9.4% in response to 1,600.50 pence in London on Monday. The wider FTSE 100 index was up 0.2%.
But the London-based pharmaceutical manufacturer said the decision by the state court contradicts the federal court's multi-district litigation ruling under the same legal standard, which dismissed all cases alleging five cancer types, in December 2022.
"Scientific consensus is that there is no consistent or reliable evidence that ranitidine increases the risk of any cancer, and GSK will continue to vigorously defend itself against all claims," the company said in a statement.
Zantac was a heartburn drug that was pulled off the market in 2020 at the request of the US Food & Drug Administration, after low levels of a "probable carcinogen" were found in samples. The carcinogen, known as NDMA, is not harmful in very small amounts. However, tests showed that there were excessive quantities of NDMA in ranitidine, otherwise known as Zantac. Multiple litigations have followed.
GSK pointed out the litigation in Delaware remains at an early stage, and the ruling, under the Daubert standard, relates only to the question of whether the methodology used by plaintiffs' experts is sufficiently reliable to allow them to present their evidence at trial.
"The ruling does not mean that the court agrees with plaintiffs' experts' scientific conclusions, and it does not determine liability," GSK noted.
GSK said it would continue to "vigorously" defend itself against all claims and manage this litigation in the best interests of shareholders.
GSK said its capital allocation priorities remain unchanged, and the ruling has no impact on the company's investment plans for growth.
In May, the Illinois state court dismissed a separate case relating to Zantac.
On Monday, GSK also announced positive results which showed a Blenrep combination reduced the risk of disease progression or death by nearly 50% versus standard of care combination in relapsed/refractory multiple myeloma.
GSK said the Dreamm-8 phase III trial showed statistically significant and clinically meaningful improvement in primary endpoint of progression-free survival.
GSK pointed out the results were similar to the results seen in the DREAMM-7 phase III head-to-head trial.
Hesham Abdullah, global head of Oncology R&D, said: "With the robust results from the Dreamm-8 phase III head-to-head trial, we now have consistent data from two phase III trials supporting the potential for Blenrep combinations to redefine the treatment of multiple myeloma at or after first relapse. This is exciting news given the high unmet need for new and efficacious combinations once patients relapse or stop responding to initial treatments. We continue to share data and discuss our path forward with regulators."
By Jeremy Cutler, Alliance News reporter
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