Journal of the American Medical Association Publishes AMG 145 Phase 2 GAUSS Study Showing Significant Reductions In LDL

 Journal of the American Medical Association Publishes AMG 145 Phase 2 GAUSS
 Study Showing Significant Reductions In LDL Cholesterol In Statin-Intolerant

AMG 145 Reduced LDL Cholesterol by up to 51 Percent in a Difficult-to-Treat

Data Simultaneously Presented 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 positive results from the AMG 145 Phase 2 GAUSS study, in patients
with high cholesterol who cannot tolerate statins. Reductions of up to 51
percent were observed in low density lipoprotein cholesterol (LDL-C), or "bad"
cholesterol, with AMG 145 and 63 percent with the combination of AMG 145 and
ezetimibe, compared to 15 percent with ezetimibe alone. 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 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 percent in
the AMG 145 350 mg group; 51 percent in the AMG 145 420 mg group; 63 percent
in the AMG 145 420 mg/ezetimibe 10 mg group; and 15 percent in the
placebo/ezetimibe 10 mg group. The reduction in LDL-C with all doses of AMG
145 was significantly greater than that observed with ezetimibe alone

LDL-C is recognized as a major contributor of risk for cardiovascular
disease.[i] Despite the availability of various treatments for lowering LDL-C,
it is estimated that in two-thirds of treated high-risk patients, LDL-C is not
well controlled.[ii], [iii] While statins are effective, it is estimated that
5 to 15 percent of patients cannot tolerate statins, primarily due to
muscle-related side effects.[iv]

"Close to a million people in the USA alone who are treated with statins
cannot tolerate them, or the dosesneeded for effective cholesterol control.
These patients who are at risk for heart disease or recurrent heart attacks
have few effective alternatives," said Evan Stein, M.D., Ph.D., director of
the Metabolic and Atherosclerosis Research Center in Cincinnati. "In the GAUSS
study, AMG 145 significantly reduced LDL or 'bad' cholesterol in these
patients with previous muscle problems on statins."

Other Efficacy Results
AMG 145 also showed reductions in total cholesterol, non-HDL-C, ApoB, and the
ratios of total cholesterol/HDL-C and ApoB/ApoA1. In this trial, lipoprotein
(a), or Lp(a), was reduced by 20 to 26 percent with AMG 145 and 29 percent
with the combination of AMG 145 and ezetimibe (all p<0.01 to p<0.001 versus
the ezetimibe alone group). AMG 145 alone or with ezetimibe increased HDL-C
modestly, from 6 percent to 12 percent, compared with a 1 percent decrease
with ezetimibe alone (p<0.001). Increases were also seen in ApoA1, with all
groups treated with AMG 145 showing greater responses than those treated with
ezetimibe alone (p<0.05 or p<0.01). Small, non-significant reductions in
triglycerides and very low-density lipoprotein cholesterol (VLDL-C) were seen
with AMG 145 compared with ezetimibe alone. Free PCSK9 levels at week 12
declined by up to 48 percent from baseline with AMG 145 and by 2 percent with
ezetimibe alone.

The most common adverse events (AEs) for AMG 145 in this trial were myalgia,
nasopharyngitis, nausea and fatigue.

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

GAUSS Study Design
The GAUSS study (Goal Achievement after Utilizing an anti-PCSK9 antibody in
Statin intolerant Subjects) was a 12-week, randomized, double-blind, placebo-
and ezetimibe-controlled study to assess the efficacy, safety and tolerability
of AMG 145 in 160 patients ages 18 to 75 years who could not tolerate
effective statin doses due to muscle-related side effects. Patients were
randomized to five groups: AMG 145 given subcutaneously (SC) at three doses:
280 mg, 350 mg and 420 mg; AMG 145 420 mg SC plus daily ezetimibe 10 mg; or
placebo SC and daily ezetimibe 10 mg. Dosing was every four weeks in all
groups.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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in the fight against cancer, kidney disease, rheumatoid arthritis, bone
disease and other serious illnesses. With a deep and broad pipeline of
potential new medicines,Amgenremains committed to advancing science to
dramatically improve people's lives. For more information, visit
www.amgen.comand follow us on

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CONTACT: Amgen, Thousand Oaks
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Arvind Sood: 805-447-1060 (investors)


[i] American Heart Association. (2012). Why Cholesterol Matters. Retrieved
September 17, 2012, from
[ii] AHA 201 Update Online. Page 119. Accessed
November 2012.
[iii] Dyslipidaemia. The Lancet, 362 (9385):
[iv] Fernandez G, Spatz ES, Jablecki C, Phillips PS. "Statin myopathy: a
common dilemma not reflected in clinical trials." Cleve Clin J Med.


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