Circulation Publishes Results From RUTHERFORD Study Which Showed AMG 145 Significantly Reduced LDL Cholesterol In Patients With

   Circulation Publishes Results From RUTHERFORD Study Which Showed AMG 145
 Significantly Reduced LDL Cholesterol In Patients With Heterozygous Familial

AMG 145 Combination Therapy With Statins Reduced LDL Cholesterol up to 56

Genetic Condition Creates Risk of Aggressive and Premature Cardiovascular

Data Presented Simultaneously at American Heart Association Scientific
Sessions 2012

PR Newswire

THOUSAND OAKS, Calif., Nov. 5, 2012

THOUSAND OAKS, Calif., Nov. 5, 2012 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today
announced that treatment with AMG 145 in combination with statin therapy, with
or without ezetimibe,resulted in a reduction in low density lipoprotein
cholesterol (LDL-C), or "bad" cholesterol, by up to 56 percent in patients
with heterozygous familial hypercholesterolemia (HeFH) in the Phase 2
RUTHERFORD study. AMG 145 is an investigational fully human monoclonal
antibody directed against PCSK9, a protein that reduces the liver's ability to
remove LDL-C from the blood. The study was published today in Circulation and
simultaneously presented in a late-breaking clinical trial session at the
American Heart Association Scientific Sessions 2012.

HeFH is one of the most common genetic disorders, affecting at least one out
of every 500 people worldwide. HeFH causes severe elevations in total
cholesterol and LDL-C, leading to the premature development of cardiovascular
disease and early cardiovascular morbidity and mortality.

In the RUTHERFORD trial, treatment with AMG 145 every four weeks (Q4W)
resulted in a significant LDL-C decrease versus placebo in HeFH patients on
lipid-lowering therapy (statins with or without ezetimibe). At week 12, LDL-C
reduction, measured by preparative ultracentrifugation, was 43 percent and 55
percent with AMG 145 350 mg and 420 mg, respectively, compared to a 1 percent
increase with placebo (p<0.001 for both dose groups). At week 12, treatment
with AMG 145 350 mg and 420 mg Q4W resulted in 70 percent and 89 percent of
patients reaching LDL-C levels of <100 mg/dL and 44 percent and 65 percent
achieving <70 mg/dL, respectively, compared to 2 percent and 0 percent of
placebo subjects, respectively. Favorable reductions in total cholesterol,
non-HDL-C, Lp(a) and ApoB were consistent with the reductions in LDL-C.

"Despite existing therapies and maintaining a healthy lifestyle, patients with
heterozygous familial hypercholesterolemia are prematurely at risk for serious
cardiovascular disease due to the difficulty in reducing their LDL-C levels,"
said Frederick Raal, M.D., Ph.D., Carbohydrate & Lipid Metabolism Research
Unit, Division of Endocrinology & Metabolism, Department of Medicine,
University of the Witwatersrand, Johannesburg. "Data from the RUTHERFORD study
suggests that using AMG 145 as an add-on therapy to statins helped these
high-risk patients achieve LDL-C goals and offers promise for the treatment of

The most common adverse events (AEs) for AMG 145 in this trial were
nasopharyngitis, injection-site reaction and headache.

This study is one of four Phase 2 studies of AMG 145 being presented at the
American Heart Association Scientific Sessions 2012.

RUTHERFORD (RedUction of LDL-C with PCSK9 InhibiTion in HEteRozygous Familial
HyperchOlesteRolemia Disorder Study) was a randomized, double-blind,
placebo-controlled study that evaluated AMG 145, dosed subcutaneously Q4W, in
168 patients with an LDL-C >100 mg/dL who were on a stable dose of statin,
with or without ezetimibe. Patients were randomized to three treatment groups:
AMG 145 at 350 mg, AMG 145 at 420 mg or placebo administered subcutaneously
every four weeks. The primary endpoint was percentage change from baseline in
LDL-C, measured by preparative ultracentrifugation, at week 12.

Webcast Information
Amgen will hold an analyst/investor event on Tuesday, Nov. 6, at 7:00 p.m.
Pacific Standard Time to discuss data presented at the American Heart
Association Scientific Sessions 2012. A webcast of the event can be found on
Amgen's website at, under Investors. The audio webcast will be
archived and available for replay for at least 72 hours.

About AMG 145
AMG 145 is a fully human monoclonal antibody directed against proprotein
convertase subtilisin/kexin type 9 (PCSK9). PCSK9 is a protein that reduces
the liver's ability to remove LDL-C from the blood and thereby causes bad
cholesterol to increase. AMG 145, developed by Amgen scientists, binds to
PCSK9 circulating in the blood and prevents PCSK9 from binding to LDL
receptors in the liver. Without PCSK9 bound to them, the LDL receptors can
take up and remove LDL-C from the blood, recycle and remain available for
binding additional LDL-C. The Amgen Phase 2 program for AMG 145 enrolled more
than 2,000 patients across seven studies to evaluate the effects of AMG 145
across multiple patient populations who may benefit from additional
cholesterol lowering treatment options. The Phase 2 program is evaluating the
treatment of hyperlipidemia with AMG 145 in combination with statins, in
patients with hyperlipidemia who cannot tolerate statins, as a stand-alone
treatment in patients with hyperlipidemia, and in patients whose elevated
cholesterol is caused by genetic disorders called heterozygous and homozygous
familial hypercholesterolemia.

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CONTACT: Amgen, Thousand Oaks
Christine Regan: 805-559-0718 (media)
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