Sanofi drops two more programmes in R&D clear-out
Sanofi chief executive Belén Garijo.
Shortly after terminating one late-stage R&D programme, Sanofi has confirmed two others are being abandoned as part of a revamp under new chief executive Belén Garijo.
Anti-OX40L antibody amlitelimab was discarded as a treatment for atopic dermatitis last week, and today – during its second-quarter financial update – Sanofi confirmed that it would be joined on the scrap heap by anti-IL33 antibody itepekimab and TNF inhibitor balinatunfib.
Regeneron-partnered itepekimab was in two phase 3 trials in chronic obstructive pulmonary disease (COPD), AERIFY 1 and 2, which read out last year. While the drug achieved its primary objective in AERIFY 1, achieving a statistically significant reduction in moderate or severe COPD exacerbations, that was not replicated in AERIFY 2.
Taking into account that data, along with "changes in the competitive landscape" for COPD – which may be a reference to the recent positive results in a trio of studies involving AstraZeneca's rival IL-33 inhibitor tozorakimab – Sanofi said it had decided with Regeneron to stop development in COPD, as well as follow-up indication chronic rhinosinusitis.
Oral, small-molecule TNF inhibitor balinatunfib (formerly SAR441566), meanwhile – developed by Sanofi in collaboration with UCB – was in a pair of phase 2 trials in Crohn's disease and ulcerative colitis.
It had been held up as a key prospect in Sanofi's immunology and inflammation (I&I) pipeline, but the company has now revealed that interim results from the studies "did not meet the internal efficacy expectations on clinical endpoints and/or the primary endpoint of clinical remission."
The trio of discontinued development programmes has blown a hole in Sanofi's I&I pipeline as it prepares for the potential loss of patent protection for premier cash-generator Dupixent (dupilumab) – which saw its second-quarter sales rise 38% to €5.2 billion (round $6 billion) – in the early 2030s. For context, Sanofi's total sales in the quarter rose 16% to €11.6 billion.
Dupixent sales are now expected to reach around €25 billion in 2030, it said, which will be topped up by "approximately €10 billion" from newer launch products, said Garijo, who rejoined Sanofi as CEO three months ago from the same role at Merck KGaA.
"My first months as CEO have focused on assessing the challenges facing Sanofi and working on an accelerated transformation roadmap that leverages our commercial strengths and focuses on the need for R&D and pipeline improvements," said Garijo.
"We have taken the first decisive steps on pipeline prioritisation," she added, noting that Dupixent's continued strength will support "continued pipeline enhancement and external growth opportunities in the years ahead."
