The Lancet Publication Of LAPLACE-TIMI 57 And MENDEL Studies Showed AMG 145 Significantly Reduced LDL Cholesterol

 The Lancet Publication Of LAPLACE-TIMI 57 And MENDEL Studies Showed AMG 145
                    Significantly Reduced LDL Cholesterol

LAPLACE-TIMI 57 Showed AMG 145 Reduced LDL Cholesterol up to 66 Percent in
Patients Currently Taking Statins

MENDEL Showed AMG 145 Reduced LDL Cholesterol up to 53 Percent in Patients Not
Taking Statins

Data Presented Simultaneously at American Heart Association Scientific
Sessions 2012

PR Newswire

THOUSAND OAKS, Calif., Nov. 6, 2012

THOUSAND OAKS, Calif., Nov. 6, 2012 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today
announced that results from the LAPLACE-TIMI 57 and MENDEL Phase 2 studies
evaluating AMG 145 in hypercholesterolemic patients with or without statins,
respectively, showed that treatment with AMG 145 resulted in a statistically
significant reduction in low-density lipoprotein (LDL) cholesterol. The two
studies were presented today at the American Heart Association Scientific
Sessions 2012 and simultaneously published in The Lancet.

AMG 145 is an investigational fully human monoclonal antibody directed against
PCSK9, a protein that reduces the liver's ability to remove LDL-C, or "bad"
cholesterol from the blood. LDL-C is 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]

LAPLACE-TIMI 57 Primary Results

  oResults from the LAPLACE-TIMI 57 study showed that all six dose regimens
    of AMG 145 significantly decreased LDL-C, measured by preparative
    ultracentrifugation, from baseline compared to placebo at week 12 in
    patients at risk for cardiovascular disease already on statin therapy
    (p<0.0001).
  oIn these at risk patients, LAPLACE-TIMI 57 showed the addition of AMG 145
    to statin therapy, with or without ezetimibe, achieved significant
    decreases in LDL-C.
  oAt week 12, AMG 145 reduced LDL-C, measured by preparative
    ultracentrifugation, by up to 66 percent when dosed every two weeks (Q2W)
    and up to 50 percent when dosed very four weeks (Q4W), compared to placebo
    (p<0.001 for the highest dose vs. placebo).

       oThe mean reduction in LDL-C versus placebo for AMG 145 dosed Q2W was
         42 percent in the 70 mg group; 60 percent in the 105 mg group; and 66
         percent in the 140 mg group.
       oThe mean reduction in LDL-C versus placebo for AMG 145 dosed Q4W was
         42 percent in the 280 mg group; 50 percent in the 350 mg group; and
         50 percent in the 420 mg group.

  oThe most commonly reported adverse events (AEs) for AMG 145 were
    nasopharyngitis, cough and nausea.

"Statins have been a critical tool in the management of high cholesterol, but
even at high doses, statins do not always achieve the targeted level of LDL
(bad) cholesterol in our high risk patients," said Robert Giugliano, M.D.,
Brigham and Women's Hospital, Cardiovascular Medicine. "The LAPLACE-TIMI 57
study is very relevant in that the addition of AMG 145 to background therapy
with statins resulted in significant reductions in LDL-cholesterol at all the
doses tested."

Efficacy and Safety of a Fully Human Monoclonal Antibody Against PCSK9 as
Monotherapy for Hypercholesterolemia: Results from the MENDEL Study, a Global
Phase 2 Trial of AMG 145

  oMENDEL is the first monotherapy study of a PCSK9-inhibitor, and evaluated
    AMG 145 in patients who were not taking a statin.
  oResults of the study at week 12 demonstrated that AMG 145, dosed Q2W or
    Q4W, significantly reduced LDL-C, measured by preparative
    ultracentrifugation, compared to placebo (p<0.001).
  oAt week 12, treatment with AMG 145 reduced LDL-C, measured by preparative
    ultracentrifugation, by up to 47 percent in the groups dosed Q2W; and up
    to 53 percent from baseline in the groups dosed Q4W, compared to placebo
    (p<0.001 for the highest dose vs. placebo).

       oThe mean decrease in LDL-C from baseline for AMG 145 dosed Q2W was 41
         percent in the 70 mg group; 44 percent in the 105 mg group; and 51
         percent in the 140 mg group compared to four percent for placebo.
       oThe mean decrease in LDL-C from baseline for AMG 145 dosed Q4W was 39
         percent in the 280 mg group; 43 percent in the 350 mg group; and 48
         percent in the 420 mg group compared to five percent increase for
         placebo.

  oThe most commonly reported AEs for AMG 145, were upper respiratory tract
    infection, nasopharyngitis and diarrhea.

"In the MENDEL study, AMG 145 monotherapy showed robust reductions in serum
LDL-C with both the Q2W and Q4W dosing regimens in patients with high
cholesterol regardless of sex, age, race or cardiovascular risk factors," said
Michael Koren, M.D., C.P.I. of Jacksonville Center for Clinical Research.
"This study provides support that treatment with AMG 145 may be an alternative
approach for LDL-C reduction in patients who cannot take statins."

These studies are two of four Phase 2 studies of AMG 145 being presented at
the American Heart Association Scientific Sessions 2012.

LAPLACE-TIMI 57 Study Design
LAPLACE-TIMI 57 (LDL-C Assessment with PCSK9 monoclonaL Antibody inhibition
Combined with statin thErapy – Thrombolysis In Myocardial Infarction-57) is a
Phase 2 randomized, double-blind, dose-ranging, placebo-controlled study that
included eight treatment arms to evaluate the efficacy, safety and
tolerability of AMG 145, administered subcutaneously, in 629 patients at risk
for cardiovascular disease with LDL-C > 85 mg/dL when added to a stable dose
of statin with or without ezetimibe. Treatment arms included AMG 145 (70 mg,
105 mg and 140 mg) versus placebo Q2W and AMG 145 (280 mg, 350 mg and 420 mg)
versus placebo Q4W. The primary endpoint of the study was the percent change
from baseline in LDL-C, measured by preparative ultracentrifugation, at week
12. Secondary efficacy endpoints included the absolute change from baseline in
LDL-C at week 12 and the percentage changes from baseline to week 12 in
non-high-density lipoprotein (non-HDL-C), apolipoprotein B (ApoB), total
cholesterol (TC)/HDL-C ratio and ApoB/ApoA1 ratio.

MENDEL Study Design
MENDEL (Monoclonal Antibody Against PCSK9 to Reduce Elevated LDL-C in Patients
Currently Not Receiving Drug Therapy For Easing Lipid Levels) is a Phase 2
randomized, multi-center, double-blind, controlled trial designed to evaluate
the efficacy, safety and tolerability of AMG 145 in 406 patients with low
cardiovascular risk (LDL-C> 100 mg/dL and < 190 mg/dL) who were not receiving
statin therapy. AMG 145 was evaluated across nine treatment groups, including
AMG 145 at 70 mg, 105 mg and 140 mg dosed Q2W compared to placebo Q2W; and AMG
145 at 280 mg, 350 mg and 420 mg dosed Q4W compared to placebo Q4W; or daily
ezetimibe 10 mg. The primary endpoint was percentage change from baseline in
LDL-C, measured by preparative ultracentrifugation, at week 12.Secondary
efficacy endpoints included the absolute change from baseline in LDL-C at week
12 and the percentage changes from baseline at week 12 in non-high-density
lipoprotein (non-HDL-C), apolipoprotein B (ApoB), total cholesterol (TC)/HDL-C
ratio and ApoB/ApoA1 ratio.

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 AHA. A webcast of the event
can be found on Amgen's website at www.amgen.com, 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.

AboutAmgen
Amgendiscovers, develops, manufactures and delivers innovative human
therapeutics. A biotechnology pioneer since 1980,Amgenwas one of the first
companies to realize the new science's promise by bringing safe, effective
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in the fight against cancer, kidney disease, rheumatoid arthritis, bone
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potential new medicines,Amgenremains committed to advancing science to
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www.amgen.comand follow us on www.twitter.com/amgen.

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CONTACT: Amgen, Thousand Oaks
Christine Regan: 805-559-0718 (media)
Ashleigh Koss: 805-559-0746 (media)
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[i] American Heart Association. (2012). Why Cholesterol Matters. Retrieved
September 17, 2012, from
http://www.heart.org/HEARTORG/Conditions/Cholesterol/WhyCholesterolMatters/Why-Cholesterol-Matters_UCM_001212_Article.jsp.
[ii] AHA 2011 Update Online.
http://circ.ahajournals.org/content/123/4/e18.full. Page 119. Accessed
November 2012.
[iii] Dyslipidaemia. The Lancet, 362 (9385):
717–31.doi:10.1016/S0140-6736(03)14234-1.

SOURCE Amgen

Website: http://www.amgen.com
 
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