Things are just not going Sanofi’s way. Late last week, just a couple of days before Pfizer scooped out Medivation after slamming the French pharma’s bid to the sidelines, Sanofi had to concede that its application for a Lantus-plus-lixisenatide combo has been delayed. The FDA now plans to make a decision in November so it can take extra time to consider the fresh data it demanded to see.
Sanofi’s loss is Novo’s gain. The Danish pharma company looks to be on the inside track at the FDA after winning a unanimous vote at an agency panel review for Xultophy, its rival combination of Tresiba with its GLP-1 blockbuster Victoza.
Novo’s advantage came after Sanofi splurged $245 million on a priority review voucher—acquired from Retrophin—just so it could win this race. And while Sanofi’s FDA panel voted 12 to 2 in favor of an approval, regulators weren’t quite satisfied by the package submitted for an OK.
Analysts have also begun betting that Novo’s Xultophy could wind up with a much broader label. Combined with evidence of reduced cardio risks, that could set up a big win for Novo, which some expect could have a product worth $5 billion a year. For Sanofi, that would mean settling for a distant second-place finish at a time its diabetes franchise overall has been suffering from declining revenue.
All that, plus the miss on Medivation, can only add further pressure on Biogen CEO Olivier Danos to pull off a high-profile acquisition, which won’t come cheap. Some speculate that its focus could now turn to BioMarin, a rare disease drug manufacturer and developer with some late-stage products that have attracted considerable attention.
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