Strong mid-stage results for Amgen's cholesterol drug candidate AMG 145

Global biotech leader Amgen (Nasdaq: AMGN) has announced positive results from the AMG 145 Phase II GAUSS study, in patients with high cholesterol who cannot tolerate statins, such as all-time blockbuster Pfizer’s Lipitor (atorvastatin) which is now off patent in the USA.

Reductions of up to 51% were observed in low density lipoprotein cholesterol (LDL-C), or "bad" cholesterol, with AMG 145 and 63% with the combination of AMG 145 and ezetimibe, compared to 15% with ezetimibe (Merck & Co’s Zetia) alone. The study was published today in Journal of the American Medical Association and simultaneously presented in an oral session at the American Heart Association Scientific Sessions 2012.

At week 12, the mean decrease from baseline in LDL-C, measured by preparative ultracentrifugation, was 41 percent in the AMG 145 280 mg group; 43% in the AMG 145 350 mg group; 51% in the AMG 145 420mg group; 63% in the AMG 145 420mg/ezetimibe 10mg group; and 15% in the placebo/ezetimibe 10mg group. The reduction in LDL-C with all doses of AMG 145 was significantly greater than that observed with ezetimibe alone (p<0.001).