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New Data From Amgen To Be Presented At ACC.19 Continues To Build Evidence For Repatha® (evolocumab) Across Multiple Patient Populations

Results From TAUSSIG Study Reinforce Repatha's Safety and Efficacy in Patients With Genetic Risk of High Cholesterol
Several Real-World Evidence Studies Highlight Continued Unmet Need and Suboptimal Treatment of High-Risk Cardiovascular Disease Patients

THOUSAND OAKS, Calif., March 6, 2019 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the presentation of nine cardiovascular scientific research abstracts, including safety and efficacy results from the largest and longest open label study of homozygous familial hypercholesterolemia (HoFH) patients (TAUSSIG),as well as a sub-analysis from the Repatha® (evolocumab) cardiovascular outcomes study (FOURIER). Additional abstracts to be presented include real-world evidence (RWE) findings from the GOULD registry demonstrating suboptimal care for high-risk cardiovascular disease (CVD) patients.2,3 These analyses will be featured at the American College of Cardiology's 68th Annual Scientific Session (ACC.19) in New Orleans, March 16-18, 2019.

"The findings we are presenting at ACC.19 further reinforce the growing body of evidence demonstrating how Repatha can safely and effectively lower LDL-C levels in a wide range of patients, such as those with atherosclerotic disease or who have a genetic risk of high cholesterol," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "With a robust scientific research program that encompasses more than 30 clinical studies and the GOULD observational registry examining the impact of cardiovascular disease in real world care settings, we remain committed to harnessing cutting-edge science to advance our knowledge of CVD."

The FOURIER and TAUSSIG study findings to be presented at ACC.19 are part of Amgen's PROFICIO (Program to Reduce LDL-C and cardiovascular Outcomes Following Inhibition of PCSK9 In different pOpulations) program. This program of clinical studies investigates the impact of Repatha on LDL-C and CVD across multiple populations. To date, the PROFICIO program consists of 36 trials including over 38,000 patients.4

In addition to Amgen's commitment to advancing the science of the management of LDL-C and cardiovascular risk, the Company is equally committed to ensuring patients who need Repatha can get it. Amgen recently made the innovative biologic available at a list price of $5,850 per year, a 60 percent reduction, to improve affordability for patients, especially for Medicare patients.

Two additional poster presentations focused on heart failure will also be presented by Amgen. This includes a study examining changes in the causes and timing of hospital readmissions after heart failure hospitalizations, and a poster including data on patients with atrial fibrillation and heart failure from the phase 2 COSMIC-HF (Chronic Oral Study of Myosin activation to Increase Contractility in Heart Failure) study of the novel investigational medicine omecamtiv mecarbil, which was conducted by Amgen in collaboration with Cytokinetics.

A list of Amgen-sponsored abstracts at ACC.19 can be found online and below:

Moderated Poster Theaters (Poster Hall F):

  • Impact of Early Statin Titration on Subsequent Cardiovascular Events – Estimates from Swedish Population-based Registry Data
    Cardiovascular Disease Prevention: Insights From Large Registries, Sunday, March 17, 12:45 - 12:55 p.m. CT
  • Long-Term Evolocumab Treatment in Homozygous and Severe Heterozygous Familial Hypercholesterolemia: The TAUSSIG Trial 
    Advances in Cardiovascular Therapeutics, Monday, March 18, 10:15 - 10:25 a.m. CT
  • Lipoprotein(a) Protein Concentration and Apolipoprotein(a) Kringle IV Isoforms Among Black US Adults With and Without PCSK9 Loss-of-Function Variants
    Novel Risk Markers and Cardiovascular Disease Events, Monday, March 18, 1 - 1:10 p.m. CT
  • Effect of Omecamtiv Mecarbil in Patients With Atrial Fibrillation and Heart Failure With Reduced Ejection Fraction: Results From COSMIC-HF
    Heart Failure and Cardiomyopathies: Latest Discoveries in Basic, Translational and Clinical Science, Monday, March 18, 1 - 1:10 p.m. CT

Poster Sessions (Poster Hall F):

  • The Hospital Readmissions Reduction Program and Changes in the Causes and Timing of Readmissions After Heart Failure Hospitalizations
    Heart Failure and Cardiomyopathies: Clinical 1, Saturday, March 16, 10 - 10:45 a.m. CT
  • Identification and Characterization of the High CV Risk Patient with Multiple Events
    Acute and Stable Ischemic Heart Disease: Clinical 4, Sunday, March 17, 3:45 - 4:30 p.m. CT
  • Efficacy and Safety of Long-term Evolocumab Use in Asian versus Other Subjects: the FOURIER trial
    Acute and Stable Ischemic Heart Disease: Therapy 4, Sunday, March 17, 3:45 - 4:30 p.m. CT
  • Lipid-Lowering Therapy in Different Regions of the United States: Insights from Getting to an Improved Understanding of Low-Density Lipoprotein Cholesterol and Dyslipidemia Management (GOULD): A Registry of High Cardiovascular Risk Patients in the United States
    Prevention: Clinical 4, Sunday, March 17, 3:45 - 4:30 p.m. CT
  • Intensity of Lipid Lowering Therapy Among Patients with Polyvascular Disease: Insights from the GOULD Registry     
    Acute and Stable Ischemic Heart Disease: Therapy 5, Monday, March 18, 9:45 - 10:30 a.m. CT

TAUSSIG Study Design
The open label TAUSSIG (Trial Assessing Long Term USe of PCSK9 Inhibition in Subjects WIth Genetic LDL Disorders) study is designed to evaluate the long-term safety and lipid-lowering efficacy of Repatha in patients with homozygous familial hypercholesterolemia (HoFH) or severe heterozygous FH (HeFH). The primary endpoint was incidence of treatment emergent adverse events, and the secondary endpoints were changes in LDL-C and other lipids.

Eligible patients with FH were given subcutaneous evolocumab 420 mg monthly or 420 mg every 2 weeks if on lipoprotein apheresis. After 12 weeks, those not on apheresis could be uptitrated to 420 mg administered every 2 weeks.

Repatha Cardiovascular Outcomes (FOURIER) Study Design
FOURIER (Further cardiovascular OUtcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk), 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.

GOULD Study Design
Getting to an ImprOved Understanding of Low-Density Lipoprotein and Dyslipidemia Management (GOULD) Registry is a multicenter, observational registry of atherosclerotic cardiovascular disease (ASCVD) patients, to describe LDL-C treatment patterns in the U.S. and track them over time. This registry and subsequent analysis sought to better understand the adaptability of lipid management guidelines for patients with ASCVD.

From December 2016 to April 2018, interactive phone surveys with the lead physicians from each of the 120 U.S. centers participating in the registry (one physician from each center) and patients (N=5,006) were conducted. Patients with ASCVD receiving any pharmacological lipid-lowering therapy were eligible for enrollment in one of three cohorts: 1) currently receiving a PCSK9i antibody, 2) no PCSK9i and LDL-C 70-99 mg/dL, and 3) no PCSK9i and LDL-C ≥ 100 mg/dL. Patients underwent a one-year retrospective chart review, followed by chart reviews and interviews every six months for two years.

About Repatha® (evolocumab)
Repatha 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.5 

Repatha is approved in more than 60 countries, including the U.S., Japan, Canada and in all 28 countries that are members of the European Union. Applications in other countries are pending.

Important U.S. Product Information

Repatha is a PCSK9 (proprotein convertase subtilisin kexin type 9) inhibitor antibody indicated:

  • to reduce the risk of myocardial infarction, stroke, and coronary revascularization in adults with established cardiovascular disease.
  • as an adjunct to diet, alone or in combination with other lipid-lowering therapies (e.g., statins, ezetimibe), for treatment of adults with primary hyperlipidemia (including heterozygous familial hypercholesterolemia [HeFH]) to reduce low-density lipoprotein cholesterol (LDL-C).
  • as an adjunct to diet and other LDL-lowering therapies (e.g., statins, ezetimibe, LDL apheresis) in patients with homozygous familial hypercholesterolemia (HoFH) who require additional lowering of LDL-C.

The safety and effectiveness of Repatha have not been established in pediatric patients with HoFH who are younger than 13 years old or in pediatric patients with primary hyperlipidemia or HeFH.

Important U.S. Safety Information

Contraindication: Repatha is contraindicated in patients with a history of a serious hypersensitivity reaction to Repatha. Serious hypersensitivity reactions including angioedema have occurred in patients treated with Repatha.

Allergic reactions: Hypersensitivity reactions (e.g. angioedema, rash, urticaria) have been reported in patients treated with Repatha, including some that led to discontinuation of therapy. If signs or symptoms of serious allergic reactions occur, discontinue treatment with Repatha, treat according to the standard of care, and monitor until signs and symptoms resolve.

Adverse reactions: The most common adverse reactions (>5% of patients treated with Repatha and occurring more frequently than placebo) were: nasopharyngitis, upper respiratory tract infection, influenza, back pain, and injection site reactions. 

From a pool of the 52-week trial and seven 12-week trials: Local injection site reactions occurred in 3.2% and 3.0% of Repatha-treated and placebo-treated patients, respectively. The most common injection site reactions were erythema, pain, and bruising.

Allergic reactions occurred in 5.1% and 4.7% of Repatha-treated and placebo-treated patients, respectively. The most common allergic reactions were rash (1.0% versus 0.5% for Repatha and placebo, respectively), eczema (0.4% versus 0.2%), erythema (0.4% versus 0.2%), and urticaria (0.4% versus 0.1%).

The most common adverse reactions in the Cardiovascular Outcomes Trial (>5% of patients treated with Repatha and occurring more frequently than placebo) were: diabetes mellitus (8.8% Repatha, 8.2% placebo), nasopharyngitis (7.8% Repatha, 7.4% placebo), and upper respiratory tract infection (5.1% Repatha, 4.8% placebo).    

Among the 16,676 patients without diabetes mellitus at baseline, the incidence of new-onset diabetes mellitus during the trial was 8.1% in patients assigned to Repatha compared with 7.7% in those assigned to placebo.  

Homozygous Familial Hypercholesterolemia (HoFH): The adverse reactions that occurred in at least two patients treated with Repatha and more frequently than placebo were: upper respiratory tract infection, influenza, gastroenteritis, and nasopharyngitis.

Immunogenicity: Repatha is a human monoclonal antibody. As with all therapeutic proteins, there is a potential for immunogenicity with Repatha. 

Please contact Amgen Medinfo at 800-77-AMGEN (800-772-6436) or 844-REPATHA (844-737-2842) regarding Repatha® availability or find more information, including full Prescribing Information, at www.amgen.com and www.Repatha.com.

About Omecamtiv Mecarbil 
Omecamtiv mecarbil is a novel, selective cardiac myosin activator that binds to the catalytic domain of myosin. Preclinical research has shown that cardiac myosin activators increase cardiac contractility without affecting intracellular myocyte calcium concentrations or myocardial oxygen consumption.6-8 Cardiac myosin is the cytoskeletal motor protein in the cardiac muscle cell that is directly responsible for converting chemical energy into the mechanical force resulting in cardiac contraction. Omecamtiv mecarbil is being developed for the potential treatment of heart failure with reduced ejection fraction (HFrEF) under a collaboration between Amgen and Cytokinetics, with funding and strategic support from Servier.

Omecamtiv mecarbil is the subject of a comprehensive Phase 3 clinical trials program comprised of GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure), a large, Phase 3 global cardiovascular outcomes study, and METEORIC-HF (Multicenter Exercise Tolerance Evaluation of Omecamtiv Mecarbil Related to Increased Contractility in Heart Failure), a Phase 3, randomized, placebo-controlled, double-blind, parallel group, multicenter clinical trial designed to evaluate the effect of treatment with omecamtiv mecarbil compared to placebo on exercise capacity as determined by cardiopulmonary exercise testing (CPET) following 20 weeks of treatment. COSMIC-HF (Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure) was a double-blind, randomized, placebo-controlled, multicenter, Phase 2 trial designed to evaluate an oral formulation of omecamtiv mecarbil in chronic heart failure patients with reduced ejection fraction.9

About Amgen in the Cardiovascular Therapeutic Area
Building on more than three decades of experience in developing biotechnology medicines for patients with serious illnesses, Amgen is dedicated to addressing important scientific questions to advance care and improve the lives of patients with cardiovascular disease, the leading cause of morbidity and mortality worldwide.10 Amgen's research into cardiovascular disease, and potential treatment options, is part of a growing competency at Amgen that utilizes human genetics to identify and validate certain drug targets. Through its own research and development efforts, as well as partnerships, Amgen is building a robust cardiovascular portfolio consisting of several approved and investigational molecules in an effort to address a number of today's important unmet patient needs, such as high cholesterol and heart failure.

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 the current expectations and beliefs of Amgen. 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 reports filed by Amgen, including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on  Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

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. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints we have selected. 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, including our devices, after they are on the market.

Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions. In addition, sales of our products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, 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. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. Further, 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, or we may fail to prevail in present and future intellectual property litigation. We perform a substantial amount of our commercial manufacturing activities at a few key facilities, including in Puerto Rico, and also depend on third parties for a portion of our manufacturing activities, and limits on supply may constrain sales of certain of our current products and product candidate development. We rely on collaborations with third parties for the development of some of our product candidates and for the commercialization and sales of some of our commercial products. In addition, we compete with other companies with respect to many of our marketed products as well as for the discovery and development of new products. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. Certain of our distributors, customers and payers have substantial purchasing leverage in their dealings with us. 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. Our efforts to acquire other companies or products and to integrate the operations of companies we have acquired may not be successful. A breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of our systems and our data. Our stock price is volatile and may be affected by a number of events. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all.

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, and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates. Further, the scientific information discussed in this news release relating to new indications for our products is preliminary and investigative and is not part of the labeling approved by the U.S. Food and Drug Administration for the products. The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses.

CONTACT: Amgen, Thousand Oaks
Kristen Davis, 805-447-3008 (Media)
Jessica Akopyan, 805-447-0974 (Media)
Arvind Sood, 805-447-1060 (Investors)

References   

1 Santos, R., et al. Long-Term Evolocumab Treatment in Homozygous and Severe Heterozygous Familial Hypercholesterolemia: The TAUSSIG Trial. To be presented at ACC Scientific Sessions, Abstract Number 20110271 (2019). 
2 Ballantyne, C., et al. Lipid-Lowering Therapy in Different Regions of the United States: Insights From Getting to an ImprOved Understanding of High Cardiovascular Risk Patients in the United States. To be presented at ACC Scientific Sessions, Abstract Number 20150230, (2019). 
3 Peterson, B.E., et al. Intensity of Lipid Lowering Therapy Among Patients with Polyvascular Disease: Insights from Getting to an ImprOved Understanding of Low-Density Lipoprotein Cholesterol and Dyslipidemia Management (GOULD): A Registry of High Cardiovascular Risk Patients in the United States. To be presented at ACC Scientific Sessions, Abstract Number 20150230, (2019). 
4 Data on File, Amgen; 2018
5 Repatha Prescribing Information (Amgen Thousand Oaks, CA, 2018).
6 Planelles-Herrero VJ, Hartman JJ, Robert-Paganin J. et al. Mechanistic and structural basis for activation of cardiac myosin force production by omecamtiv mecarbil. Nat Commun. 2017;8:190.
7 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: 522-27.
8 Malik FI, Hartman JJ, Elias KA, Morgan BP, Rodriguez H, Brejc K, Anderson RL, Sueoka SH, Lee KH, Finer JT, Sakowicz R. Cardiac myosin activation: a potential therapeutic approach for systolic heart failure. Science. 2011 Mar 18;331(6023):1439-43.
9 Teerlink, John R et al. Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure (COSMIC-HF): a phase 2, pharmacokinetic, randomised, placebo-controlled trial. Lancet 2016; 388: 2895 – 2903).
10 WHO, W.H.O. Cardiovascular diseases (CVDs) fact sheet.

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