PCSK9 Battleground Hits The Court, Not The Market, After Amgen Sues
This article was originally published in The Pink Sheet Daily
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.
You may also be interested in...
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.
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.
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.