Game on: Amgen sues Sanofi, Regeneron over PCSK9 cholesterol drug patent
- On Friday, Amgen filed a patent infringement suit in the U.S. District Court of Delaware against Sanofi and Regeneron, seeking to block the latter companies' novel cholesterol drug, the PCSK9 inhibitor alirocumab, from coming to market. Amgen's own PCSK9 inhibitor is evolocumab.
- PCSK9 inhibitors are an entirely new class of cholesterol medications that are expected to produce blockbuster sales and foster a potential $10 billion market.
- Amgen filed its application for evolocumab in August, while Sanofi/Regeneron paid $67.5 million for FDA permission to fast-track the review process for its own PCSK9 inhibitor this past summer. That would give both the competing cholesterol drugs a possible launch date in mid-2015.
Amgen is claiming that Sanofi and Regeneron have violated three Amgen patents for this novel new cholesterol drug class, which has been shown to greatly reduce LDL cholesterol in clinical trials. If successful, Amgen's suit would bar Sanofi and Regeneron from manufacturing or marketing alirocumab.
The lawsuit shouldn't come as too much of a surprise, since the companies have long been jockeying for the first-to-market advantage for this potentially blockbuster new drug class. It should be noted that Pfizer has its own PCSK9 inhibitor, bococizumab, currently in phase III trials.