Plus de 2.000 plaintes visant le Zantac de Sanofi ont été déposées aux Etats-Unis avec un premier procès prévu pour le 22 août, suivi par une procédure collective en septembre.

Sanofi accumulates setbacks between legal proceedings and abandoned projects



The difficulties accumulate at Sanofi. Last disappointment to date for the French group, the judgment, last Wednesday, of the clinical development program of amcenestrant, oral treatment of certain breast cancers which presented a strong commercial potential. The laboratory has, in fact, not achieved the expected results in a clinical trial in which it was used as an adjuvant, according to a preliminary analysis. 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 »said the pharmaceutical group in its press release, adding that all other studies of amcenestrant, especially in the treatment of early stage breast cancer »will be stopped adds Sanofi.

2,000 complaints against Zantac filed in the United States

A decision that aggravated the losses caused a few days earlier by the prospect of legal proceedings against Zantac in the United States. A report from Canadian and American health authorities established in 2019 that certain drugs containing ranitidine, including Zantac, may contain low levels of NDMA, a substance classified as a probable carcinogen by the World Health Organization, which had led to product recalls in the United States and Canada.

More than 2,000 complaints against Zantac have been filed in the United States with a first trial scheduled for August 22, followed by a class action in September. We do not believe that the elements available make it a new glyphosate but it is very possible that we arrive at compensations which would amount to billions of dollars. », according to Deutsche Bank analysts in a note on GSK and Sanofi, in reference to Monsanto’s glyphosate herbicide scandal, owned by Bayer. Indeed, other laboratories, including GSK and Novartis, recalled or interrupted the distribution of their versions of the drug.

GSK and Sanofi have however reaffirmed the safety of this medicine »according to the words of the French pharmaceutical group. GSK, independent cancer researchers »but also the American and European drug authorities have been looking into the issue since 2019 and all concluded that there is no evidence of a causal link » between ranitidine and cancer, for its part, assured GSK in a press release.

Displayed optimism

A defense that has not prevented Sanofi’s share price from falling by 14% since August 10, to the chagrin of its general manager, Paul Hudson, who is in charge of relaunching it and simplifying the activities of the pharmaceutical group. by refocusing them on vaccines, immunology, rare diseases and oncology. These setbacks therefore increase the pressure on the one who will begin his fourth year at the head of the company next month. Because if the Sanofi title has climbed 5% since the start of his mandate, he is underperforming the European health sector index, against a backdrop of concerns about the reduction of his portfolio of potentially promising drugs.

Jean-Baptiste de Chatillon, financial director of Sanofi, which employs 100,000 people worldwide, including 25,000 in France, wants to believe in a future rebound in the action due to the incredible disconnect between the company’s fundamentals and its valuation », as he explained last Wednesday to Reuters. He notably cited the drug candidates still under development as well as the strong financial performance of Dupixent, Sanofi’s flagship treatment for eczema and asthma. Sanofi’s financial results have, in fact, been boosted by this drug, whose sales have increased by more than 40% during the first half. For 2022, the group anticipates Dupixant sales of up to 13 billion euros. Growth will again be fueled by very strong assets ahead »assured Jean-Baptiste de Chatillon, referring to a drug project against hemophilia and a potential new treatment for childhood respiratory infections.

But for Markus Manns, portfolio manager at Union Investment, based in Germany, and who owns Sanofi shares, this optimism seems misplaced after the failure of amcenestrant. This is a huge setback and the remaining portfolio is very thin compared to companies like Roche ROG.S or AstraZeneca AZN.L. It’s unfortunate if Sanofi does not accept this », did he declare. According to him, the Dupixent allows Sanofi to buy time, as its key patents are not likely to expire before 2032.

Step up efforts

Especially since the French, more than ever under pressure to relaunch his drug portfolio, suffered serious major setbacks in the race for the vaccine against COVID-19, to the benefit of those of its competitors, BioNTech-Pfizer and the Moderna. Following this rout, the French government had moreover announced a massive reinvestment plan for Sanofi in France, because we have to move forward ». Not to mention the discovery of several cases of liver damage that led this year to the cessation of recruitment for clinical trials of tolebrutinib, an experimental treatment for certain forms of multiple sclerosis and myasthenia gravis.

Sanofi: the failure of the anti-Covid vaccine has clouded neither its results nor its dividend

Despite the halt to two of the company’s most important development projects, Union Investment’s Markus Manns believes signals from management about increased efforts or agreements to improve drug prospects would have been welcome. welcomed. For their part, analysts at SVB Securities, who lowered their price target on Sanofi but maintained their recommendation at “ outperformance”, see this double whammy as ” negative for sentiment about business (research and development) productivity and for revenue growth prospects”.

(with agencies)