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Amgen HIGHLIGHTS LANDMARK REPATHA (EVOLOCUMAB) cardiovascular outcomes study amongst data TO BE PRESENTED at acc.17

THOUSAND OAKS, Calif. (March 6, 2017) – Amgen (NASDAQ:AMGN) today announced that detailed results of the Repatha (evolocumab) cardiovascular outcomes trial will be presented, as well as new data from across the cardiovascular portfolio, at the American College of Cardiology 66th Annual Scientific Session (ACC.17) in Washington, D.C., March 17-19, 2017.

Detailed results from the Repatha cardiovascular outcomes trial (FOURIER) will be featured as a late-breaking oral presentation on Friday, March 17 at 9 a.m. ET. A second late-breaking oral presentation, the Repatha cognitive function trial (EBBINGHAUS), will be presented on Saturday, March 18 at 9 a.m. ET. Live audio and video of the presentations will be webcast over the internet simultaneously with the presentations. Amgen announced in February that FOURIER met its primary composite endpoint and key secondary composite endpoint and EBBINGHAUS met its primary endpoint.

“As cardiovascular disease remains the leading health burden in the world, we sought to answer whether adding Repatha would provide further risk reduction for patients who are already well-treated with statins,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “The data from this large cardiovascular outcomes trial will provide a new understanding of the role that Repatha plays in the lives of the millions of people living with uncontrolled high cholesterol.”

Additionally, data from two separate analyses will explore prescription rejection rates and access barriers for PCSK9 inhibitors, including a comparison of the patient characteristics amongst those approved and denied access.

Harper continued, “As we prepare to share our outcomes data with the cardiovascular community, patients continue to face unacceptable barriers to getting the additional LDL lowering that Repatha can provide, despite their physician’s treatment recommendations."

  • Primary Results of the Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk (FOURIER) Trial
  • Abstract 400-14, Opening Session and the Joint American College of Cardiology and Journal of American College of Cardiology Late-Breaking Clinical Trials Featuring the Simon Dack Lecture, Friday, March 17, 9 – 9:12 a.m. ET
  • Primary Results of EBBINGHAUS, a Cognitive Study of Patients Enrolled in the FOURIER Trial
  • Abstract 404-16, Joint American College of Cardiology/Journal of the American Medical Association Late-Breaking Clinical Trials, Saturday, March 18, 9 – 9:10 a.m. ET
  • Impact of Evolocumab Therapy in Patients With Discordance Between LDL-C and LDL-P
  • Abstract 1106-065, Advances in Cholesterol Measurement and Management, Friday, March 17, 10 – 10:45 a.m. ET

Observational Research

  • Observed Versus Predicted Cardiovascular Event Rates in Primary Prevention Diabetic Patients Receiving High-Intensity Statins in the United Kingdom
  • Abstract 1277-048, Diabetes and Other Issues in Cardiovascular Prevention, Sunday, March 19, 9:45 – 10:30 a.m. ET
  • Comparison of the Use of Cardiovascular Risk Equations by Health Technology Assessment Bodies and Clinical Guidelines
  • Abstract 1277-070, Diabetes and Other Issues in Cardiovascular Prevention, Sunday, March 19, 9:45 – 10:30 a.m. ET
  • Corlanor® (ivabradine)Observational ResearchSerial Assessment of Heart Rate and Beta Blocker Use in Chronic Heart Failure Patients With Reduced Ejection Fraction in a Large Integrated Healthcare Network
    Abstract 1123-273, Making Progress in Understanding Heart Failure, Friday, March 17, 10 – 10:45 a.m. ET
    • Genetics of Heart Rate Observational Study (GenHRate)

    Abstract 1226M-03, Put Your Codon! Genetic Insights Into Heart Failure, Saturday, March 18, 12:30 – 12:40 p.m. ET

    Omecamtiv Mecarbil
    Clinical
    The Cardiac Myosin Activator, Omecamtiv Mecarbil, Improves Left Ventricular Myocardial Deformation in Chronic Heart Failure (COSMIC-HF)
    Abstract 1248-244, Heart Failure and Cardiomyopathies: What Next When All Else Is Failing?, Saturday, March 18, 3:45 – 4:30 p.m. ET

    Amgen Webcast Investor Meeting
    Amgen will host a webcast investor meeting at ACC.17 on Friday, March 17, 2017, at noon ET. 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 Amgen's cardiovascular program and data presented at ACC.17.
    Live audio of the conference call will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public. The webcast, as with other selected presentations regarding developments in Amgen's business given at certain investor and medical conferences, can be accessed 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.

    Repatha Cardiovascular Outcomes (FOURIER) Study Design
    FOURIER (Further CardiovascularOUtcomesResearch with PCSK9Inhibition in Subjects withElevatedRisk), a multinational Phase 3 randomized, double-blind, placebo-controlled trial, is designed to evaluate whether treatment with Repatha in combination with statin therapy compared to placebo plus statin therapy reduces cardiovascular events. The primary endpoint is the time to cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization. The key secondary endpoint is the time to cardiovascular death, myocardial infarction or stroke.

    Eligible patients with high cholesterol (LDL-C ≥70 mg/dL or non-high-density lipoprotein cholesterol [non-HDL-C] ≥100 mg/dL) and clinically evident atherosclerotic cardiovascular disease at more than 1,300 study locations around the world were randomized to receive Repatha subcutaneous 140 mg every two weeks or 420 mg monthly plus effective statin dose; or placebo subcutaneous every two weeks or monthly plus effective statin dose. Optimized statin therapy was defined as at least atorvastatin 20 mg or equivalent daily with a recommendation for at least atorvastatin 40 mg or equivalent daily where approved. The study was event driven and continued until at least 1,630 patients experienced a key secondary endpoint.

    Repatha Cognitive Function (EBBINGHAUS) Study Design
    EBBINGHAUS (Evaluating PCSK9 Binding antiBody Influence oN coGnitive HeAlth in high cardiovascUlar risk Subjects) is a double-blind, placebo-controlled randomized non-inferiority trial involving approximately 1,900 patients enrolled in the FOURIER outcomes study. The primary endpoint in the study is the Spatial Working Memory strategy index of executive function. Secondary endpoints are working memory, as assessed by the CANTAB Spatial Working Memory (SWM) test between-errors score; memory function, as assessed by the CANTAB Paired Associates Learning (PAL) test; and psychomotor speed, as assessed by the CANTAB Reaction Time (RTI) test.

    About Repatha (evolocumab)
    Repatha (evolocumab) is a human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9). Repatha binds to PCSK9 and inhibits circulating PCSK9 from binding to the low-density lipoprotein (LDL) receptor (LDLR), preventing PCSK9-mediated LDLR degradation and permitting LDLR to recycle back to the liver cell surface. By inhibiting the binding of PCSK9 to LDLR, Repatha increases the number of LDLRs available to clear LDL from the blood, thereby lowering LDL-C levels.1

    Repatha is approved in more than 40 countries, including the U.S.,Japan,Canadaand in all 28 countries that are members of theEuropean Union. Applications in other countries are pending.

    CONTACT: Amgen, Thousand Oaks

    Kristen Davis, 805-447-3008 (Media)

    Kristen Neese, 805-313-8267 (Media)

    Arvind Sood, 805-447-1060 (Investors)

    REFERENCES

    1. Repatha® U.S. Prescribing Information. Amgen.
    2. Corlanor® U.S. Prescribing Information. Amgen.
    3. Malik FI, Hartman JJ, Elias KA, et al. Cardiac myosin activation: a potential therapeutic approach for systolic heart failure.Science. 2011;331(6023):1439-1443.
    4. Shen YT, Malik FI, Zhao X, et al. Improvement of cardiac function by a cardiac myosin activator in conscious dogs with systolic heart failure.Circ Heart Fail. 2010;3(4):522-527.
    5. Malik FI, Morgan BP. Cardiac myosin activation part 1: From concept to clinic.J Mol Cell Cardiol. 2011;51:454-461.
    6. World Health Organization. Cardiovascular diseases (CVDs) fact sheet.http://www.who.int/mediacentre/factsheets/fs317/en/. Accessed February 2017.



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    Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe and effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. To learn more about our pioneering science and our vital medicines, visit www.amgen.se

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