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PCSK9 Battleground Hits The Court, Not The Market, After Amgen Sues

This article was originally published in The Pink Sheet Daily

Executive Summary

A month after filing a BLA for its cholesterol-lowering PCSK9 inhibitor, Amgen sues partners Sanofi and Regeneron claiming infringement of three patents that describe monoclonal antibodies to PCSK9.

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PCSK9 Meets PRV: Regeneron’s $70 Mil. Bid To Catch Up To Amgen

Regeneron and its partner Sanofi have become the first biopharma companies to buy a Priority Review Voucher. The $67 million price is a nice bonus for the seller, BioMarin, but probably not the start of a big new market for PRVs.

How Much Is A Priority Review Worth? $67.5 Million, Sanofi/Regeneron Say

Companies’ decision to purchase and redeem BioMarin’s priority review voucher for their PCSK9 inhibitor alirocumab sets the first public benchmark for a voucher’s value and shows the potential advantages to be gained for sponsors in a race to market.

Sanofi/Regeneron’s PCSK9 Inhibitor Gets Reassuring CV Data – And A Priority Review Voucher

Alirocumab was associated with lower rate of major cardiovascular events compared to placebo in post-hoc, interim Phase III analysis – boosting chances for FDA approval in 2015. The firm is taking no chances on review period, purchasing a priority review voucher from BioMarin.

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