Sanofi: new marked drop, the bad news accumulates











Photo credit © Sanofi Corporate


(Boursier.com) — Sanofi once again weighs on the trend (-3.5% to 83.5 euros) in Paris after announcing the end of its clinical development program for amcenestrant, an oral treatment for certain breast cancers. An independent data monitoring committee found that, compared to the control group, amcenestrant in combination with palbociclib did not reach the pre-specified threshold for continued treatment and therefore recommended stopping the trial . The company will continue to evaluate data from the trial and plans to communicate its results to the scientific community soon. All other studies of amcenestrant, particularly in the treatment of early-stage breast cancer (AMEERA-6), will be stopped, Sanofi said.

The laboratory had already been heavily heckled on the stock market last week, weighed down by several headwinds, and in particular fears of legal proceedings linked to Zantac in the United States. This heartburn treatment was taken off the market from 2019 after a potential risk from a potentially carcinogenic impurity emerged. Zantac, originally launched by GSK, has been marketed by several companies since its exclusive patent expired in the late 1990s, including Sanofi, Pfizer and Boehringer Ingelheim.

More than 2,000 complaints involving Zantac have been filed in the United States according to analysts and the first trial is due to open at the end of the month. In a statement released last week, Sanofi said it “acted responsibly at all times…The plaintiffs’ claims in this litigation are not scientifically substantiated. There is no reliable evidence that Zantac causes the one of the alleged illnesses under real-world conditions, and Sanofi remains fully confident in its legal defenses. Given the strength of our case and the uncertainty of future proceedings, no litigation provision has been established.”

For Bernstein (‘outperforming’), today’s news is “actually all about communication”, saying Sanofi management remained bullish on the drug even after it failed in a phase 2 trial this year. The analyst explains that management’s argument for maintaining a positive view was “correct”, but adds that it was “clearly” not the case… “Following the recent negative update for tolebrutinib, investors will rightly question management’s comments and their approach to pipeline communication.” The broker points out that the stock “may struggle to perform in the short term” due to the flow of negative news regarding both the R&D pipeline and the Zantac-related litigation.

Credit Suisse sees him as “a major unpleasant surprise” for the group, the molecule having been presented as one of the most promising in its portfolio in oncology.


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