Sanofi stops the development of amcenestrant, the title drops

(updated with analyst commentary § 5-6, share price §1)

PARIS, Aug 17 (Reuters) – Sanofi shares opened lower on the Paris Stock Exchange on Wednesday, falling 1.14% at the start of the session after the announcement of the end of the clinical development program for amcenestrant, an oral treatment for certain breast cancers that failed to achieve 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 discontinuation of trial”, specifies the pharmaceutical group in its press release.

“All other studies devoted to amcenestrant, in particular in the treatment of early-stage breast cancer”, will be stopped, adds Sanofi.

Sanofi had already announced in March that amcenestrant administered as monotherapy did not improve progression-free survival in patients with metastatic or advanced ER+/HER2- type breast cancer ( estrogen receptor positive/human epidermal growth factor receptor 2 negative).

This announcement constitutes a new setback for Sanofi, already far behind in the race for vaccines at the start of the COVID-19 pandemic and which was forced to abandon the development of its messenger RNA (mRNA) vaccine last September in a already amply filled market.

For Credit Suisse analyst Jo Walton, this failure represents a “significant disappointment”, insofar as amcenestrant, a flagship molecule in Sanofi’s pipeline which was in the final stages of development, could have potentially supported the group’s growth at from 2025 in addition to its star drug, Dupixent (a fully human monoclonal antibody used in the treatment of several inflammatory diseases such as asthma or atopic dermatitis).

(Written by Myriam Rivet, with contributions from Tassilo Hummel, editing by Tangi Salaün and Kate Entringer)

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