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Amgen Announces Positive Top-Line Results From 52-Week Phase 3 DESCARTES Study Of Evolocumab (AMG 145) In Patients With High

Amgen Announces Positive Top-Line Results From 52-Week Phase 3 DESCARTES Study
          Of Evolocumab (AMG 145) In Patients With High Cholesterol

Study Meets Primary Endpoint of LDL Cholesterol Reduction

PR Newswire

THOUSAND OAKS, Calif., Dec. 19, 2013

THOUSAND OAKS, Calif., Dec. 19, 2013 /PRNewswire/ --Amgen (NASDAQ:AMGN) today
announced that the Phase 3 DESCARTES (Durable Effect of PCSK9 Antibody
CompARed wiTh PlacEbo Study) study evaluating the long-term 52-week safety and
efficacy of evolocumab for the treatment of high cholesterol met its primary
endpoint of percent reduction from baseline in low-density lipoprotein
cholesterol (LDL-C) at week 52. The mean percent reduction in LDL-C, or "bad"
cholesterol, was consistent with the results observed in the 52-week analysis
of the Phase 2 OSLER (Open Label Study of Long TERm Evaluation Against LDL-C)
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 DESCARTES study evaluated safety, tolerability and efficacy in 901
patients with high LDL-C and a range of cardiovascular risk. Background
lipid-lowering therapy was optimized to one of four treatment groups (diet
alone; diet plus atorvastatin 10 mg; diet plus atorvastatin 80 mg; and diet
plus atorvastatin 80 mg plus ezetimibe 10 mg) for individual patients based on
their LDL-C and cardiovascular risk. Patients with a fasting LDL-C ≥ 75 mg/dL
were then randomized to receive monthly subcutaneous evolocumab 420 mg or
placebo in combination with background lipid-lowering therapy.

Evolocumab significantly reduced LDL-C, as measured by the accepted standard,
preparative ultracentrifugation, from baseline at week 52 compared to
placebo. LDL-C reduction at week 12 was consistent with the long-term
efficacy at week 52.

Safety was balanced across treatment groups. The most common adverse events (>
5 percent in evolocumab) were nasopharyngitis, upper respiratory tract
infection, influenza and back pain.

"Datafrom thePhase 3DESCARTES studyof evolocumabaddtothe promising
safety and efficacydatawerecentlysawin theMENDEL-2 study
and52-weekPhase 2OSLERstudy," saidSean E. Harper, M.D., executive vice
president of Research and Development at Amgen. "These datacontributeto the
growing body of research suggesting that evolocumab may offer a new treatment
option forpatients with dyslipidemia."

Details of the DESCARTES 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

DESCARTES Study Design
DESCARTES (Durable Effect of PCSK9 Antibody CompARed wiTh PlacEbo Study) is a
Phase 3 randomized, multicenter, double-blind, placebo-controlled study
designed to evaluate the long-term (52-week) safety, tolerability and efficacy
of evolocumab in patients with hyperlipidemia at risk for cardiovascular
disease. Background lipid-lowering therapy was optimized to one of four
treatment groups (diet alone; diet plus atorvastatin 10 mg; diet plus
atorvastatin 80 mg; and diet plus atorvastatin 80 mg plus ezetimibe 10 mg) for
individual patients based on their LDL-C and cardiovascular risk according to
the National Cholesterol Education Program Adult Treatment Panel (NCEP ATP)
III risk categories. After optimization, patients were maintained on therapy
for at least four weeks. A total of 901 patients with a fasting LDL-C ≥ 75
mg/dL were then randomized and received monthly subcutaneous evolocumab 420 mg
or placebo in combination with background lipid-lowering therapy.

The primary endpoint was percent change from baseline in LDL-C, measured by
the accepted standard, preparative ultracentrifugation, after 52 weeks of
treatment. Secondary efficacy endpoints included the percent change from
baseline in LDL-C and LDL-C response (LDL-C <70 mg/dL [1.8 mmol/L]) at week
52, percent change from baseline in LDL-C and total cholesterol (TC) at week
12, and percent change from baseline at week 52 in TC, non-high-density
lipoprotein cholesterol (non-HDL-C), apolipoprotein B (ApoB), TC/HDL-C ratio,
ApoB/apolipoprotein A1 (ApoA1) ratio, lipoprotein(a), triglycerides, HDL-C and
very low density lipoprotein cholesterol (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, DESCARTES (Durable
Effect of PCSK9 Antibody CompARed wiTh PlacEbo Study) in patients with
hyperlipidemia at risk for 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
catheterization.

Additional information about clinical trials of evolocumab can be found at
www.clinicaltrials.gov.

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.

For more information, visit www.amgen.com and follow us on
www.twitter.com/amgen.

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
risks, uncertainties and assumptions that could cause actual results to differ
materially from those described. All statements, other than statements of
historical fact, are statements that could be deemed forward-looking
statements, including estimates of revenues, operating margins, capital
expenditures, cash, other financial metrics, expected legal, arbitration,
political, regulatory or clinical results or practices, customer and
prescriber patterns or practices, reimbursement activities and outcomes and
other such estimates and results. Forward-looking statements involve
significant risks and uncertainties, including those discussed below and more
fully described in the Securities and Exchange Commission (SEC) reports filed
by Amgen, including Amgen's most recent annual report on Form 10-K and any
subsequent periodic reports on Form 10-Q and Form 8-K. Please refer to Amgen's
most recent Forms 10-K, 10-Q and 8-K for additional information on the
uncertainties and risk factors related to our business. Unless otherwise
noted, Amgen is providing this information as of Dec. 19, 2013 and expressly
disclaims any duty to update information contained in this news release.

No forward-looking statement can be guaranteed and actual results may differ
materially from those we project. Discovery or identification of new product
candidates or development of new indications for existing products cannot be
guaranteed and movement from concept to product is uncertain; consequently,
there can be no guarantee that any particular product candidate or development
of a new indication for an existing product will be successful and become a
commercial product. Further, preclinical results do not guarantee safe and
effective performance of product candidates in humans. The complexity of the
human body cannot be perfectly, or sometimes, even adequately modeled by
computer or cell culture systems or animal models. The length of time that it
takes for us to complete clinical trials and obtain regulatory approval for
product marketing has in the past varied and we expect similar variability in
the future. We develop product candidates internally and through licensing
collaborations, partnerships and joint ventures. Product candidates that are
derived from relationships may be subject to disputes between the parties or
may prove to be not as effective or as safe as we may have believed at the
time of entering into such relationship. Also, we or others could identify
safety, side effects or manufacturing problems with our products after they
are on the market. Our business may be impacted by government investigations,
litigation and products liability claims. We depend on third parties for a
significant portion of our manufacturing capacity for the supply of certain of
our current and future products and limits on supply may constrain sales of
certain of our current products and product candidate development.

In addition, sales of our products are affected by the reimbursement policies
imposed by third-party payors, including governments, private insurance plans
and managed care providers and may be affected by regulatory, clinical and
guideline developments and domestic and international trends toward managed
care and healthcare cost containment as well as U.S. legislation affecting
pharmaceutical pricing and reimbursement. Government and others' regulations
and reimbursement policies may affect the development, usage and pricing of
our products. In addition, we compete with other companies with respect to
some of our marketed products as well as for the discovery and development of
new products. We believe that some of our newer products, product candidates
or new indications for existing products, may face competition when and as
they are approved and marketed. Our products may compete against products that
have lower prices, established reimbursement, superior performance, are easier
to administer, or that are otherwise competitive with our products. In
addition, while we routinely obtain patents for our products and technology,
the protection offered by our patents and patent applications may be
challenged, invalidated or circumvented by our competitors and there can be no
guarantee of our ability to obtain or maintain patent protection for our
products or product candidates. We cannot guarantee that we will be able to
produce commercially successful products or maintain the commercial success of
our existing products. Our stock price may be affected by actual or perceived
market opportunity, competitive position, and success or failure of our
products or product candidates. Further, the discovery of significant problems
with a product similar to one of our products that implicate an entire class
of products could have a material adverse effect on sales of the affected
products and on our business and results of operations.

The scientific information discussed in this news release related to our
product candidates is preliminary and investigative. Such product candidates
are not approved by the U.S. Food and Drug Administration (FDA), and no
conclusions can or should be drawn regarding the safety or effectiveness of
the product candidates.

CONTACT: Amgen
Ashleigh Koss: 805-313-6151 (media)
Arvind Sood: 805-447-1060 (investors)

References
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:
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6004a5.htm?s_cid=mm6004a5_w.
Accessed November 2013.
3. American Heart Association (2012). Why cholesterol matters.
http://www.heart.org/HEARTORG/Conditions/Cholesterol/WhyCholesterolMatters/Why-Cholesterol-Matters_UCM_001212_Article.jsp.
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.

(Logo: http://photos.prnewswire.com/prnh/20081015/AMGENLOGO)

SOURCE Amgen

Website: http://www.amgen.com
 
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