Amgen Announces Positive Top-Line Results From Phase 3 MENDEL-2 Trial Of Evolocumab (AMG 145) In Patients With High Cholesterol

   Amgen Announces Positive Top-Line Results From Phase 3 MENDEL-2 Trial Of
            Evolocumab (AMG 145) In Patients With High Cholesterol

Study Meets Co-Primary Endpoints of LDL Cholesterol Reduction

PR Newswire

THOUSAND OAKS, Calif., Dec. 17, 2013

THOUSAND OAKS, Calif., Dec. 17, 2013 /PRNewswire/ --Amgen (NASDAQ:AMGN) today
announced that the Phase 3 MENDEL-2 (Monoclonal Antibody Against PCSK9 to
Reduce Elevated LDL-C in Subjects Currently Not Receiving Drug Therapy for
Easing Lipid Levels-2) trial with evolocumab met its co-primary endpoints: the
percent reduction from baseline in low-density lipoprotein cholesterol (LDL-C)
at week 12 and the mean percent reduction from baseline in LDL-C at weeks 10
and 12. The mean percent reductions in LDL-C, or "bad" cholesterol, compared
to placebo and ezetimibe were consistent with results observed in the MENDEL
Phase 2 study.

Evolocumab is an investigational fully human monoclonal antibody that inhibits
proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces
the liver's ability to remove LDL-C from the blood.^1

The MENDEL-2 trial evaluated safety, tolerability and efficacy of evolocumab
in 614 patients with high cholesterol (LDL-C ≥ 100 mg/dL and < 190 mg/dL) who
were not receiving lipid-lowering therapy. Patients were randomized to one of
six treatment groups to compare two dosing regimens of evolocumab (140 mg
every two weeks or 420 mg monthly) with placebo and ezetimibe (10 mg daily).

Safety was balanced across treatment groups. The most common (>2 percent in
evolocumab combined group) adverse events (AEs) were headache, diarrhea,
nausea and urinary tract infection.

"Data from the MENDEL-2 monotherapy study in more than 600 patients provide
the first of Phase 3 results from our comprehensive development program for
evolocumab," said Sean E. Harper, M.D., executive vice president of Research
and Development at Amgen. "The positive results we have seen with two distinct
dosing options suggest that evolocumab may offer a promising approach to treat
patients with high cholesterol."

Details of the MENDEL-2 study results will be submitted to a future medical
conference and for publication.

According to the Centers for Disease Control and Prevention, more than 71
million American adults have high LDL-C.^2 Elevated LDL-C is recognized as a
major risk factor for cardiovascular disease.^3-4

MENDEL-2 Study Design

MENDEL-2 (Monoclonal Antibody Against PCSK9 to Reduce Elevated LDL-C in
Patients Currently Not Receiving Drug Therapy For Easing Lipid Levels-2) is a
Phase 3 randomized, multi-center, double-blind, double-dummy, stratified,
placebo and ezetimibe-controlled parallel group study designed to evaluate the
efficacy and safety of evolocumab in 614 hyperlipidemic patients with a
10-year Framingham risk score of 10 percent or less who were not receiving
lipid-lowering therapy. Patients were randomized to one of six treatment
groups to compare two dosing regimens of evolocumab (140 mg every two weeks or
420 mg monthly) with placebo and ezetimibe (10 mg daily). The co-primary
endpoints were the percent reduction from baseline in LDL-C at week 12 and the
mean percent reduction from baseline in LDL-C at weeks 10 and 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 cholesterol (non-HDL-C), apolipoprotein B (ApoB), total
cholesterol (TC)/HDL-C, ApoB/apolipoprotein A1 (ApoA1) ratio, lipoprotein(a),
triglycerides, HDL-C and very LDL-C (VLDL-C).

About PROFICIO: The Evolocumab Clinical Trial Program

PROFICIO, which stands for the Program to Reduce LDL-C and Cardiovascular
Outcomes Following Inhibition of PCSK9 In Different POpulations, is a large
and comprehensive clinical trial program evaluating evolocumab. Phase 3
clinical trials for evolocumab are currently underway and build upon the Phase
2 studies.

The Phase 3 program includes 13 trials, with a combined planned enrollment of
more than 28,000 patients. The Phase 3 studies will evaluate evolocumab
administered every two weeks and monthly in multiple patient populations,
including in combination with statins in patients with hyperlipidemia
(LAPLACE-2), in patients with hyperlipidemia who cannot tolerate statins
(GAUSS-2), as a stand-alone treatment in patients with hyperlipidemia
(MENDEL-2), and in patients whose elevated cholesterol is caused by genetic
disorders called heterozygous (RUTHERFORD-2) and homozygous (TESLA and
TAUSSIG) familial hypercholesterolemia.

Five studies of evolocumab will provide long-term safety and efficacy data.
These include FOURIER (Further Cardiovascular OUtcomes Research with PCSK9
Inhibition in Subjects with Elevated Risk), which will assess whether
treatment with evolocumab in combination with statin therapy compared to
placebo and statin therapy reduces recurrent cardiovascular events in
approximately 22,500 patients with cardiovascular disease, and GLAGOV (GLobal
Assessment of Plaque ReGression with a PCSK9 AntibOdy as Measured by
IntraVascular Ultrasound), which will determine the effect of evolocumab on
coronary atherosclerosis in approximately 950 patients undergoing cardiac

Additional information about clinical trials of evolocumab can be found at

About Evolocumab

Evolocumab is a fully human monoclonal antibody that inhibits proprotein
convertase subtilisin/kexin type 9 (PCSK9).^1 PCSK9 is a protein that targets
LDL receptors for degradation and thereby reduces the liver's ability to
remove LDL-C, or "bad" cholesterol, from the blood.^5 Evolocumab, being
developed by Amgen scientists, is designed to bind to PCSK9 and inhibit PCSK9
from binding to LDL receptors on the liver surface. In the absence of PCSK9,
there are more LDL receptors on the surface of the liver to remove LDL-C from
the blood.^1

About Amgen

Amgen is committed to unlocking the potential of biology for patients
suffering from serious illnesses by discovering, developing, manufacturing and
delivering innovative human therapeutics. This approach begins by using tools
like advanced human genetics to unravel the complexities of disease and
understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its biologics
manufacturing expertise to strive for solutions that improve health outcomes
and dramatically improve people's lives. A biotechnology pioneer since 1980,
Amgen has grown to be the world's largest independent biotechnology company,
has reached millions of patients around the world and is developing a pipeline
of medicines with breakaway potential.

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Forward-Looking Statements

This news release contains forward-looking statements that are based on
management's current expectations and beliefs and are subject to a number of
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Ashleigh Koss: 805-313-6151 (media)
Arvind Sood: 805-447-1060 (investors)


1.Amgen Data on File, Investigator Brochure.
2.CDC Morbidity and Mortality Weekly Report. Vital Signs: Prevalence,
    Treatment, and Control of High Levels of Low-Density Lipoprotein
    Cholesterol --- United States, 1999--2002 and 2005-2008. February 4, 2011.
    Available at:
    Accessed November 2013.
3.American Heart Association (2012). Why cholesterol matters.
    Accessed November 2013.
4.World Health Organization. Global status report on noncommunicable
    diseases 2010. Geneva, 2011.
5.Abifadel M, et al. Mutations in PCSK9 cause autosomal dominant
    hypercholesterolemia. Nat Genet 2003;34:154-156.



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