The rivalry among companies developing PCSK9 inhibitors has spilled over into the law courts, with Amgen suing Sanofi and Regeneron for patent infringement.
Amgen and Sanofi/Regeneron have been in a head-to-head race to bring the first PCSK9 inhibitor to market as a treatment for elevated cholesterol, with Amgen nosing into the lead after it filed for approval of its evolocumab drug in the US in the summer.
Sanofi and Regeneron have not yet filed for approval of their alirocumab (REGN727) candidate but closed the gap on Amgen after paying $67.5m to buy a priority review voucher awarded to BioMarin by the FDA that could mean it gets approval within six months of filing.
Amgen’s lawsuit has been filed in the US District Court of Delaware and claims infringement of three US patents – Nos. 8,563,698, 8,829,165, and 8,859,741 – which cover monoclonal antibodies to PCSK9 (proprotein convertase subtilisin/kexin type 9). The US biotech major is seeking an injunction on the “manufacture, use and sale” of alirocumab.
The latter two patents have only been granted by the US Patent and Trademark Office (USPTO) in the last few weeks, perhaps suggesting Amgen was waiting for these to be in force before pursuing its action.
The lawsuit has been filed after Sanofi and Regeneron “recently announced that they have completed phase III clinical trials on alirocumab and intend to pursue regulatory approval to market alirocumab in the US,” said Amgen.
A third PCSK9 inhibitor – Pfizer’s bococizumab (RN316) – has also reported results of phase III trials but is not named in the Delaware suit.
All three PCSK9-targeting antibodies are expected to fulfil a medical unmet need by reducing low-density lipoprotein-cholesterol (LDL-c) in patients who cannot tolerate statins, and according to analysts at GlobalData could capture a 40% share of the $17.5bn acute coronary syndromes market by 2023.
GlobalData predicted last week that Amgen would still beat its rival to market despite the priority review voucher.