Amgen to Highlight New Evolocumab (AMG 145) Data at Upcoming American Heart Association Scientific Sessions 2013

 Amgen to Highlight New Evolocumab (AMG 145) Data at Upcoming American Heart
                     Association Scientific Sessions 2013

First Long-Term Data of a PCSK9 Inhibitor to be Featured in Clinical Science:
Special Reports Session

PR Newswire

THOUSAND OAKS, Calif., Nov. 12, 2013

THOUSAND OAKS, Calif., Nov. 12, 2013 /PRNewswire/ --Amgen (NASDAQ: AMGN)
today announced that it will present new data on evolocumab (AMG 145), an
investigational fully human monoclonal antibody that inhibits PCSK9, a protein
that reduces the liver's ability to remove low-density lipoprotein cholesterol
(LDL-C), or "bad" cholesterol, from the blood^1, at the upcoming American
Heart Association (AHA) Scientific Sessions 2013, being held Nov. 16 – 20 in
Dallas.

Data from the Phase 2 OSLER (Open Label Study of Long TERm Evaluation Against
LDL-C Trial) study, which evaluates the safety, tolerability and sustained
efficacy of long-term administration of evolocumab and standard of care in
more than 1,100 patients with high cholesterol, will be featured during a
Clinical Science: Special Reports session on Tuesday, Nov. 19, at 4:51 p.m.
CST.

"The Phase 2 OSLER study provides the first long-term 52-week data for a PCSK9
inhibitor in diverse patient populations with high cholesterol," said Sean E.
Harper, M.D., executive vice president of Research and Development at Amgen.
"We hope the data we are accumulating from our Phase 3 clinical program for
evolocumab will help advance care for patients who struggle to control high
cholesterol and have an urgent unmet need."

Additionally, Amgen will highlight findings from long-term open-label data
accumulated from patients in GAUSS (Goal Achievement after Utilizing an
anti-PCSK9 antibody in Statin intolerant Subjects) and MENDEL (Monoclonal
Antibody Against PCSK9 to Reduce Elevated LDL-C in Patients Currently Not
Receiving Drug Therapy For Easing Lipid Levels), two Phase 2 studies that
evaluated evolocumab in patients with hyperlipidemia who cannot tolerate
statins and as a stand-alone treatment, respectively.

Data presented on evolocumab will include:

  oRandomized Comparison of the Safety, Tolerability, and Efficacy of
    Long-Term Administration of AMG 145 Versus Standard of Care in 1104
    Patients: 52-Week Results from the OSLER Study
    CS.03, Clinical Science: Special Reports, Tuesday, Nov. 19, 4:51 - 5:01
    p.m. CST (Ballrooms C1 & C2)
  oEfficacy and Safety of Long-Term Treatment with AMG 145 Monotherapy
    Abstract 12191, Abstract Poster Session, Tuesday, Nov. 19, 3 - 4:30 p.m.
    CST (Hall F, Core 2, Poster Board: 2010)
  oEfficacy and Tolerability of Long-Term Treatment With AMG 145 in Patients
    With Statin Intolerance
    Abstract 12621, Abstract Poster Session, Tuesday, Nov. 19, 3 - 4:30 p.m.
    CST (Hall F, Core 2, Poster Board: 2009)

Amgen will also  host a webcast investor meeting at AHA on Tuesday, Nov. 19,
at 7 p.m. CST. Sean E. Harper, M.D., executive vice president of Research and
Development at Amgen, along with members of Amgen's clinical development team
and clinical investigators, will participate at the investor meeting to
discuss data being presented at AHA.

Live audio of the investor meeting will be simultaneously broadcast over the
Internet and will be available to members of the news media, investors and the
general public.

The webcast of the conference, as with other selected presentations regarding
developments in Amgen's business given by management at certain investor and
medical conferences, can be found on Amgen's website, www.amgen.com, under
Investors. Information regarding presentation times, webcast availability and
webcast links are noted on Amgen's Investor Relations Events Calendar. The
webcast will be archived and available for replay for at least 90 days after
the event.

About Evolocumab (AMG 145)
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.^2 Evolocumab, being
developed by Amgen scientists, is designed to bind to PCSK9 and inhibit PCSK9
binding to LDL receptors on the liver's 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

Amgen has obtained the issuance of two U.S. patents related to evolocumab: USP
8,030,457 and USP 8,563,698. These patents will expire in 2029 but some
extension period may be available, subject to certain regulatory conditions
and statutory provisions for patent term extension. 

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,
including the FOURIER (Further Cardiovascular OUtcomes Research with PCSK9
Inhibition in Subjects with Elevated Risk) study, which will assess whether
treatment with evolocumab compared to placebo reduces recurrent cardiovascular
events in approximately 22,500 patients with cardiovascular disease.

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

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
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uncertainties and risk factors related to our business. Unless otherwise
noted, Amgen is providing this information as of Nov. 12, 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
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CONTACT: Amgen
Ashleigh Koss, 805-313-6151 (media)
Arvind Sood, 805-447-1060 (investors)

References
1. Amgen Data on File, Investigator Brochure.
2. Abifadel M, et al. Mutations in PCSK9 cause autosomal dominant
hypercholesterolemia. Nat Genet 2003;34:154-156.

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SOURCE Amgen

Website: http://www.amgen.com
 
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