All eyes on Dupixent decision in COPD as Sanofi suffers further pipeline setbacks

25 Apr 2024
firstwordpharma.com
Phase 2Phase 3Financial StatementClinical Trial FailureDrug Approval
Sanofi said Thursday that Dupixent remains on track to record sales of around €13 billion this year after posting strong growth in the first quarter ahead of an expected expansion into chronic obstructive pulmonary disease. Revenue from Dupixent jumped 22.4% in the three-month period to €2.8 billion.
The performance of Dupixent, along with Beyfortus (€182 million) and Altuviiio (€122 million), helped the company top expectations, with overall sales rising 2.4% to €10.5 billion, ahead of forecasts of €10.3 billion. However, net income plunged 43.2% to €1.1 billion.
Sanofi reiterated its expectation that earnings this year will decrease by a low single-digit percentage at constant currencies. CEO Paul Hudson has braced investors for a period of slower growth over the next few years as the company directs resources into its drug-development, betting on 12 pipeline medicines including amlitelimab, frexalimab and tolebrutinib that it says have blockbuster potential.
​​Pipeline setbacks
However, Sanofi’s ambitions for frexalimab took a hit on Thursday after the company disclosed that development in Sjögren’s syndrome has been halted. Results from a Phase II trial failed to meet the “necessary efficacy outcomes” to continue to work in this indication, the drugmaker said, noting that Phase III studies of the anti-CD40L antibody in relapsing multiple sclerosis and secondary-progressive multiple sclerosis will continue, as well as mid-stage development in type 1 diabetes and systemic lupus erythematosus.
Sanofi also disclosed Thursday that the Phase III AMETHIST trial of the GCS inhibitor venglustat for the treatment of GM2 gangliosidosis was discontinued based on “the absence of positive trends” for clinical endpoints. The company also confirmed the discontinuation of the RIPK1 inhibitorRIPK1 inhibitor oditrasertib -  announced by partner Denali Therapeutics in February – in amyotrophic lateral sclerosis.
More to come.
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