Sanofi gets more buyout blues

Sanofi’s recent acquisitions have hardly been blazing successes. Now its $3.7bn purchase of Principia, which was already on shaky ground, is looking even more questionable. Today the group disclosed that the main focus of that acquisition, the oral BTK inhibitor tolebrutinib, has been placed on partial clinical hold after cases of drug-induced liver injury in its phase 3 trials. Sanofi put a brave face on the news, saying most patients with this issue had predisposing factors, and that last month the study was revised to exclude these subjects; enrolment under the revised protocol continues outside the US. SVB Securities analysts believe that most recruitment was already happening ex-US, and that a late-2023 readout in relapsing multiple sclerosis could yet be possible. Still, the latest development is another black mark against Sanofi’s deal-making nous. As well as a failure with another Principia BTK inhibitor, rilzabrutinib, the company has seen lacklustre data with SAR444245, the IL-2 it gained from Synthorx, and discontinued development of the unmodified mRNA vaccine it picked up with the $3.2bn purchase of Translate Bio. This is hardly the track record you might expect from what has been one of the most acquisitive big pharmas of recent times.

Looking shakier: what Sanofi got from Principia
Project Indication(s) Trial details 2028e sales ($m)
Tolebrutinib (SAR442168) Relapsing MS Ph3 Gemini 1 & Gemini 2 vs Aubagio, end Sep/Aug 2023 791
Primary progressive MS Ph3 Perseus vs placebo, ends Aug 2024
Secondary progressive MS Ph3 Hercules vs placebo, ends Aug 2024
Myasthenia gravis Ph3 Ursa vs placebo, ends Nov 2024
Rilzabrutinib (PRN1008) Pemphigus Ph3 Pegasus failed Sep 2021 210
Immune thrombocytopenia Ph3 Luna3 ends Oct 2023
Chronic spontaneous urticaria Ph2 Rilescu ends Jan 2023
IG4-related diseases Ph2 ends Feb 2023
Atopic dermatitis  Ph2 ends Apr 2023
Warm autoimmune haemolytic anaemia Ph2 ends Jul 2023
Asthma Ph2 ends Sep 2023
SAR444727 (PRN473) Atopic dermatitis  Ph2 ends Feb 2023 -
Source: Evaluate Pharma & clinicaltrials.gov.

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