Amgen sues to block Sanofi and Regeneron at the PCSK9 goal line

Amgen R&D Chief Sean Harper

Sanofi ($SNY) and Regeneron ($REGN) have cut to the front of the line in the race to develop a new class of cardio drugs, but now rival Amgen ($AMGN) has made a chess move of its own, filing a patent-infringement lawsuit designed to block its rivals from reaching what's expected to be a blockbuster market.

Amgen's lawsuit claims that Sanofi and Regeneron stepped on its intellectual property in crafting an antibody that blocks the protein PCSK9, thereby helping the body clear LDL cholesterol from the blood. The three patents in question apply to antibodies to PCSK9, including Amgen own evolocumab, and the lawsuit seeks to prevent the manufacture, use and sale of Sanofi and Regeneron's similar alirocumab.

Sanofi didn't respond to a request for comment Friday morning.

The lawsuit is the latest development in an increasingly contentious race between the companies, which are angling for first place in a potential $10 billion market for new cholesterol-lowering drugs. Amgen has long led the way, filing evolocumab for approval in August with eyes on a 2015 launch.

But Sanofi and Regeneron made things interesting over the summer when they paid $67.5 million for an FDA voucher that will cut alirocumab's review time down from 10 months to 6 months. The two plan to submit their treatment by year's end, which would put both drugs up for approval next June.

Bringing up the rear in the PCSK9 race is Pfizer ($PFE), which is in the midst of a sweeping Phase III program to demonstrate that its bococizumab can significantly slash rates of bad cholesterol.

- read the statement

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