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Sanofi, Regeneron boost Dupixent’s megablockbuster quest with latest trial win

Sanofi and Regeneron rejiggered their longstanding antibody partnership based on underwhelming sales of key drugs in the past. But one thing that won’t change is their collaboration on promising immunology med Dupixent, and positive data in a rare indication could give both drugmakers more reason to stay together.

Dupixent cut patients’ difficulty swallowing by 69% after 24 weeks compared with an improvement of 32% in eosinophilic esophagitis (EoE) patients treated with placebo, according to data from the first segment of a phase 3 trial released Friday. 

In the 81-patient study, those treated with weekly 300-milligram doses of Dupixent also saw a significant reduction in esophageal eosinophil levels––a measure of inflammation––compared with placebo, the drugmakers said in a release. 

Dupixent, an IL-4/IL-13 inhibitor, hopes to become the first approved biologic to treat EoE, which affects around 160,000 U.S. patients each year and is often treated with steroids or esophageal dilation surgery, the companies said. 

Dupixent’s safety profile was similar to past studies, with 86% of patients reporting an adverse effect––mostly injection site reactions––compared with 82% in the placebo arm. One patient discontinued due to joint pain, the companies said. 

Sanofi and Regeneron are running a second segment of the study for a different dosing regimen and expect to present findings from part A at an upcoming medical meeting.

Dupixent has high hopes in EoE after receiving an FDA orphan drug designation in that indication back in 2017.

An eventual FDA nod should give another sales boost to Sanofi and Regeneron, which split revenues from the blockbuster immunology med 50-50 and have dreams of Dupixent becoming a $10 billion-plus behemoth. 

In February, Sanofi CEO Paul Hudson predicted Dupixent could eventually turn in sales of $10.97 billion with a flood of looming launches and more indications in the pipeline. Dupixent hit $2.56 billion in sales in 2019 and turned in 8% growth in the first quarter at $832 million. 

And despite those big growth forecasts, some analysts figure the partners’ sales aims for Dupixent could be on track. In February, SVB Leerink pegged sales of Dupixent at $3.84 billion this year and $10 billion in 2026. That long-term forecast is 10% to 15% higher than the consensus estimate.

Dupixent’s bright future is at the center of the Sanofi and Regeneron antibody partnership that the drugmakers are shaking up only a bit, in contrast to their previous plans.

The partners initially pledged to divvy up rights for their PCSK9 cholesterol drug Praluent and rheumatoid arthritis treatment Kevzara. But with Kevzara now in testing for COVID-19, Sanofi and Regeneron opted only to rework their deal for Praluent.

As part of the new arrangement, Regeneron took over U.S. commercialization rights for Praluent and will receive a royalty from Sanofi on sales abroad. Meanwhile, the 50-50 split on Dupixent will stay the same. 

On Monday, Sanofi said it would sell off most of its $13 billion Regeneron stake, with its partner picking up $5 billion of that. The move will cause “no change” to their ongoing partnership, the companies said. Sanofi will retain around 400,000 shares in Regeneron stock “in support of the ongoing collaboration.”