WASHINGTON, D.C. (TheStreet) -- Amgen's (AMGN) investigational cholesterol-lowering compound evolocumab reduces low-density lipoprotein (LDL) cholesterol by 55-66% compared to placebo, according to data from phase III clinical trials presented over the weekend at the annual meeting of the American College of Cardiology (ACC.)
If approved, Amgen's new drug would represent a medical breakthrough because it lowers cholesterol by inhibiting the PCSK9 enzyme, putting it in a different category than conventional statins. Unlike statins, which are pills, the new PCSK9 inhibitors are injected through the skin.
Amgen estimates 5-15% of patients are statin intolerant due to muscle-related side effects. The company's executive medical director, Dr. Scott M. Wasserman, said evolucumab could also be used as a supplement to statins for patients whose LDL cholesterol level remains high.
Barclays equity research estimates the new class of PCSK9 inhibitors could generate $7-8 billion in revenues in 2020 and said first-mover advantage will be critical. A cooperative venture between Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) is developing a competing PCSK9 inhibitor, also in phase III trials. Amgen executives said they believe the evolocumab data presented at this weekend's cardiology meeting puts their drug furthest along in the race to approval.
In all, Amgen presented results from five studies of evolocumab at the ACC meeting this weekend:
-- The 12-week MENDEL-2 study of 614 patients with LDL levels of 100 mg/dL or higher who were not receiving therapy found a 55-57% reduction in LDL levels from baseline compared with placebo and 38-40% reduction compared to those who received the statin supplement ezetimibe.
-- The 52-week DESCARTES study of 901 high-risk patients found a mean reduction in LDL levels of 57% compared to placebo and a 49% reduction in the highest-risk patients who received 80 mg of atorvastatin and 10 mg of ezetimibe.