In a rare misfire, Regeneron scraps its RSV drug after a PhIII failure

George Yancopoulos,

In a rare Phase III failure, Regeneron says its late-stage antibody for RSV — suptavumab (REGN2222) — flopped in a major study which enrolled more than a thousand healthy pre-term infants.

There won’t be a second act for this drug. Regeneron $REGN is scrapping the drug, once held up as one of its top Phase III prospects, and moving on.

Although researchers were able to tease out evidence of efficacy in one subgroup, they say the drug failed to significantly reduce the number of medically-attended RSV infections.

Regeneron R&D chief George D. Yancopoulos, the best paid chief scientist in the industry in one of the best antibody shops in the world, wasted little time in saying goodbye. He noted: “Regeneron has a robust pipeline across many serious diseases, and we look forward to important data readouts from other programs in the coming weeks and months.”

Sanofi $SNY had been allied with Regeneron on this program, but later bowed out and recently signed on to partner with AstraZeneca. Back in March the French pharma giant agreed to pay €120 million upfront and up to €495 million more in development and sales milestones to buy into the program. The two Big Pharmas are splitting R&D costs for MEDI8897, with AstraZeneca in charge of manufacturing and Sanofi Pasteur taking control of the commercialization work — provided it goes through to an approval.

After a slate of new drug approvals, including Dupixent, Sanofi and Regeneron are ending their broad-based antibody alliance at the end of this year, though Sanofi will remain on board for their immuno-oncology alliance as Sanofi focuses more on in-house R&D.

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Sr. Manager, Regulatory Affairs, CMC
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