Sanofi forges new $8bn pact with Regeneron

Sanofi's long-running R&D alliance with Regeneron has gone up a gear with a partnership – worth up to $8 billion – that spans four new medicines.

The two companies' collaboration track record – which goes back two decades – has already delivered the goods with Dupixent (dupilumab), an IL-4 and IL-13-targeting antibody that made almost $18 billion last year across a lengthening list of immunology and inflammation (I&I) indications.

The expanded alliance builds on this I&I heritage and is headed by REGN20423, a long-acting IL-13 inhibitor in phase 1 for atopic dermatitis, along with a long-acting IL-4xIL-13 bispecific and two other long-acting antibodies, directed at IL-4 and IL-4 receptor alpha, that are in preclinical development.

Under the terms of the deal, Regeneron is in line for $1 billion upfront, with another $7 billion on offer if the four drugs reach the market and deliver as hoped. US-based Regeneron also gets an option on including Sanofi's IL-13 and TSLP-targeting drug, lunsekimig, in the collaboration if it passes muster in an ongoing phase 3 programme in chronic obstructive pulmonary disease (COPD).

It's the first major play for Sanofi under its new chief executive, Belén Garijo, who took over the reins of the French pharma group in April and has since started a clear-out and rebuilding of its R&D pipeline, with the help of new R&D chief Paulo Fontoura.

The changes at the top of Sanofi came amid investor disquiet about a big increase in R&D spending in recent years, coupled with late-stage programme failures that blew some holes in its product pipeline.

"This is a deliberate first step in igniting Sanofi's innovation engine," said Garijo of the revised Regeneron terms, which reverse what has been viewed as a distancing in the relationship between the two companies in recent years, exacerbated by litigation between them over Dupixent sales data transparency that has now been settled.

"Our longstanding alliance with Regeneron has transformed the treatment landscape for millions of patients living with diseases driven by type 2 inflammation and created one of the world's leading immunology businesses," she added.

"By deepening our collaboration, we will make rapid progress in creating the next generation of meaningful therapies for patients with immune-mediated diseases, while contributing to Sanofi's long-term future."

As with Dupixent and other earlier drugs in the alliance, the two companies will share development and commercialisation costs and split future profits from any emerging products 50:50 on a global basis.

Other drugs brought to market by the two partners include IL-6 inhibitor Kevzara (sarilumab) for rheumatoid arthritis, cholesterol-lowering PCSK9 inhibitor Praluent (alirocumab), and PD-1 inhibitor Libtayo (cemiplimab) for cancer.

Not all their collaborations have ended successfully, however. IL-33 itepekimab was dropped from development for COPD after disappointing phase 3 results, while Sanofi handed back rights to a long-acting GLP-1 receptor agonist for cardiometabolic disorders, efpeglenatide, citing changing pipeline priorities.

"By combining Regeneron's world-class scientific discovery and antibody development expertise with Sanofi's global capabilities and reach, we hope to once again deliver the next wave of innovation in immunology," commented George Yancopoulos, Regeneron's president and chief scientific officer.