Alirocumab, Sanofi (with Regeneron)

Drug: Alirocumab
Company: Sanofi (with Regeneron)
Phase: Phase III
Class: Anti-proprotein convertase subtilisin-like kexin type 9 (PCSK9) Mab
2020 sales: $1.05 billion
Net present value: $2.95 billion

Just when it started to look like Amgen was going to beat Sanofi ($SNY) and its close development partner Regeneron ($REGN) with its leading PCSK9 candidate by a country mile, the pair came up with a full house of data from 9 late-stage studies. The data in late July created a foundation for a regulatory submission at the FDA before the end of the year, coming soon after Amgen's ($AMGN) planned third-quarter filing. Then Sanofi and Regeneron pulled a rabbit out of their hat, buying a priority review voucher from BioMarin that will cut four months off the process, and eliminating Amgen's lead. If they are both approved, you can expect to see a big marketing showdown among a large patient group that includes people at risk of a cardio event or whose cholesterol levels remain stubbornly resistant to the cheap commercially available therapies already on the market. EvaluatePharma expects this to be a near draw between Amgen and Sanofi, which in particular needs to see some new approvals after experiencing setbacks for its own in-house pipeline work.

For more:
Sanofi, Regeneron pay $67M for a shortcut in the blockbuster PCSK9 race with Amgen
Sanofi, Regeneron prep their PCSK9 cardio contender for FDA review after PhIII sweep
Sanofi, Regeneron add positive PhIII data on key RA drug

Alirocumab, Sanofi (with Regeneron)
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