Regeneron
Pharmaceuticals Inc. and partner Sanofi
have become the first companies to report Phase II proof-of-concept data that
validate blocking PCSK9 as a strategy for lowering LDL-C in patients not
controlled on standard statin therapy. The companies hope to cement their
first-mover status by moving into Phase III by mid-2012.
Despite the success of statins,
the need for new ways to lower LDL-C has never been greater, according to
Regeneron EVP and CSO George Yancopoulos. "Statins lower cholesterol by
40-50% when taken by intensive dosing regimens, but there are still millions of
people not reaching their cholesterol goal who are thus left at high cardiovascular
risk," he said.