OREANDA-NEWS. March 22, 2016. Amgen (NASDAQ:AMGN) today announced that it will present 19 abstracts related to its cardiovascular portfolio, including new detailed data  evaluating Repatha® (evolocumab) in patients with high cholesterol who cannot tolerate statins, at the American College of Cardiology's 65th Annual Scientific Session (ACC.16) in Chicago, April 2-4, 2016. Repatha is a human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver's ability to remove low-density lipoprotein cholesterol (LDL-C), or "bad" cholesterol, from the blood.1

"We look forward to sharing a broad range of data at ACC that advances our scientific understanding of Repatha and its role in treating high LDL cholesterol, including new data evaluating Repatha in statin-intolerant patients," said

Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "We continue to grow the clinical body of evidence for Repatha, and the results from the GAUSS-3 study provide additional data for patients who are unable to tolerate effective doses of statins and need to further lower their LDL cholesterol."

Among the abstracts being presented are a Late-Breaking Clinical Trial presentation of the Phase 3 GAUSS-3 (Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-3) trial in patients with high cholesterol who cannot tolerate statins, and an oral presentation examining the safety of very low LDL-C levels in patients taking Repatha. A global health economics study exploring LDL-C values among patients with a high risk of cardiovascular disease on lipid-lowering therapy in a real-world population will also be presented.

Additionally, data from Amgen's Center for Observational Research will be presented, including a moderated poster presentation on the association between statin intolerance and recurrent hospital admissions for coronary heart disease. A global health economics study analyzing cost comparisons across heart failure patients with reduced and preserved ejection fractions will also be presented.

Data to be presented at ACC.16 include:

Repatha

Late-Breaking and Oral Presentations

  • Comparison of PCSK9 Inhibitor Evolocumab Versus Ezetimibe in Statin-intolerant Patients: The Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects 3 (GAUSS-3) Trial
    Abstract 404-10, Late-Breaking Clinical Trial Session, Sunday, April 3, 8:15-8:25 a.m. CT (Main Tent, North Hall B1)
  • Safety of Very Low LDL-C Levels With Evolocumab: An Analysis of 5942 Patients From Phase 2 and 3 and Open-Label Extension Studies
    Abstract 913-06, Oral Session, Monday, April 4, 8:30-8:42 a.m. CT (Room S404)

Poster Presentations

  • Effect of Evolocumab on Low-Density Lipoprotein Particles
    Abstract 1156-368, Poster Session, Saturday, April 2, 3:45-4:30 p.m. CT (Poster Area, South Hall A1)
  • Effect of Evolocumab on Remnant Lipoprotein Particles
    Abstract 1191-396, Poster Session, Sunday, April 3, 9:45-10:30 a.m. CT (Poster Area, South Hall A1)
  • The OSLER-2 Study: Patients' Preferences and Compliance With Biweekly or Monthly Dosing During Treatment of Hypercholesterolemia With Evolocumab
    Abstract 1236-387, Poster Session, Sunday, April 3, 3:45-4:30 p.m. CT (Poster Area, South Hall A1)
  • Reduction in Lipoprotein (a) With Evolocumab: Elucidation of the Role of the LDL Receptor From Clinical Trials and In-Vitro Models
    Abstract 1293M-01, Moderated Poster Session, Monday, April 4, 12:30-12:40 p.m. CT (Prevention Moderated Poster Theater, South Hall A1)
  • A Pooled Safety Analysis of Over 6000 Patients From Double-Blind and Open-Label Extension Studies With Evolocumab
    Abstract 1293M-07, Moderated Poster Session, Monday, April 4, 1:15-1:25 p.m. CT (Prevention Moderated Poster Theater, South Hall A1)
  • PCSK9 Inhibition-Mediated Reduction in Triglyceride With Evolocumab Is Related to Baseline Triglyceride Levels: An Analysis From 1791 Patients
    Abstract 1293M-09, Moderated Poster Session, Monday, April 4, 1:30-1:40 p.m. CT (Prevention Moderated Poster Theater, South Hall A1)

Observational Research

  • Intensive Medical Management and Outcomes Following Myocardial Infarction
    Abstract 1120-391, Poster Session, Saturday, April 2, 10-10:45 a.m. CT (Poster Area, South Hall A1)
  • Statin Use and Titration Patterns in the Year Following a Type II Diabetes Mellitus Diagnosis in Medicare Beneficiaries
    Abstract 1120-392, Poster Session, Saturday, April 2, 10-10:45 a.m. CT (Poster Area, South Hall A1)
  • Statin Intolerance Is Associated With Increased Risk for Recurrent Coronary Heart Disease Hospitalizations
    Abstract 1131M-03, Moderated Poster Session, Saturday, April 2, 10:15-10:25 a.m. CT (Prevention Moderated Poster Theater, South Hall A1)
  • Statin Use and Dose by Low-Density Lipoprotein Cholesterol Level in a Commercially Insured Population of Secondary Prevention Patients
    Abstract 1191-385, Poster Session, Sunday, April 3, 9:45-10:30 a.m. CT (Poster Area, South Hall A1)
  • Long-Term Statin Use Following Re-Initiation Among Medicare Beneficiaries With Coronary Heart Disease
    Abstract 1202M-01, Moderated Poster Session, Sunday, April 3, 9:45-9:55 a.m. CT (Prevention Moderated Poster Theater, South Hall A1)
  • Underutilization of Statin Therapy After a Cardiovascular Event or Diabetes Diagnosis in Three Real-World Data Systems
    Abstract 1236-369, Poster Session, Sunday, April 3, 3:45-4:30 p.m. CT (Poster Area, South Hall A1)
  • Factors Associated With Statin Re-Initiation in Medicare Beneficiaries: A Case-Crossover Study
    Abstract 1236-389, Poster Session, Sunday, April 3, 3:45-4:30 p.m. CT (Poster Area, South Hall A1)
  • Statin Use and Titration Patterns in the First Year Following a Cardiovascular Event in Medicare Beneficiaries
    Abstract 1236-394, Poster Session, Sunday, April 3, 3:45-4:30 p.m. CT (Poster Area, South Hall A1)

Health Economics

  • Trends in Real-World Treatment Modifications Among High-Cardiovascular Disease Risk Patients With Hyperlipidemia
    Abstract 1156-383, Poster Session, Saturday, April 2, 3:45-4:30 p.m. CT (Poster Area, South Hall A1)
  • Cost Comparison Across Heart Failure Patients With Reduced and Preserved Ejection Fractions: Analyses of Inpatient Decompensated Heart Failure Admissions
    Abstract 1217-064, Poster Session, Sunday, April 3, 3:45-4:30 p.m. CT (Poster Area, South Hall A1)
  • Low Density Lipoprotein Cholesterol (LDL-C) Values Among High Cardiovascular Risk Patients in a Real World Population
    Abstract 1271-392, Poster Session, Monday, April 4, 9:45-10:30 a.m. CT (Poster Area, South Hall A1)

About Repatha® (evolocumab)
Repatha® (evolocumab) is a human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9).1 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.2

GLAGOV, the intravascular ultrasound study, is underway to determine the effect of Repatha on coronary atherosclerosis in approximately 950 patients undergoing cardiac catheterization to test the hypothesis of robust LDL-C reduction leading to a reduction or a change in the build-up of plaque in the arteries. Results from the GLAGOV study are expected in the second half of 2016.

The FOURIER outcomes trial is designed to evaluate whether treatment with Repatha in combination with statin therapy, compared to placebo plus statin therapy, reduces the risk of cardiovascular events in patients with high cholesterol and clinically evident cardiovascular disease, and completed patient enrollment in June 2015. Top-line results from the approximately 27,500-patient event-driven FOURIER study are anticipated in the second half of 2016.

Repatha is approved in the United States, Japan, Canada, Australia, Kuwait, Switzerland and in all 28 countries that are members of the European Union as well as in Norway, Iceland and Liechtenstein. Applications in other countries are pending.

Important U.S. Product Information
Repatha® is indicated as an adjunct to diet and:

  • Maximally tolerated statin therapy for treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD), who require additional lowering of low-density lipoprotein cholesterol (LDL-C)
  • 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 effect of Repatha® on cardiovascular morbidity and mortality has not been determined.

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

The safety and effectiveness of Repatha® have not been established in pediatric patients with primary hyperlipidemia or HeFH.

Important Safety Information

Contraindication: Repatha® is contraindicated in patients with a history of a serious hypersensitivity reaction to Repatha®.

Allergic reactions: Hypersensitivity reactions (e.g. 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 Repatha®-treated patients and more common than placebo) were: nasopharyngitis, upper respiratory tract infection, influenza, back pain, and injection site reactions.

In a 52-week trial, adverse reactions led to discontinuation of treatment in 2.2% of Repatha®-treated patients and 1% of placebo-treated patients. The most common adverse reaction that led to Repatha® treatment discontinuation and occurred at a rate greater than placebo was myalgia (0.3% versus 0% for Repatha® and placebo, respectively).

Adverse 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. The proportions of patients who discontinued treatment due to local injection site reactions in Repatha®-treated patients and placebo-treated patients were 0.1% and 0%, respectively.

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%).

Neurocognitive events were reported in less than or equal to 0.2% in Repatha®-treated and placebo-treated patients.

In a pool of placebo- and active-controlled trials, as well as open-label extension studies that followed them, a total of 1,988 patients treated with Repatha® had at least one LDL-C value <25 mg/dL. Changes to background lipid-altering therapy were not made in response to low LDL-C values, and Repatha® dosing was not modified or interrupted on this basis. Although adverse consequences of very low LDL-C were not identified in these trials, the long-term effects of very low levels of LDL-C induced by Repatha® are unknown.

Musculoskeletal adverse reactions were reported in 14.3% of Repatha®-treated patients and 12.8% of placebo-treated patients. The most common adverse reactions that occurred at a rate greater than placebo were back pain (3.2% versus 2.9% for Repatha® and placebo, respectively), arthralgia (2.3% versus 2.2%), and myalgia (2.0% versus 1.8%).

Homozygous Familial Hypercholesterolemia (HoFH): In 49 patients with homozygous familial hypercholesterolemia studied in a 12-week, double-blind, randomized, placebo-controlled trial, 33 patients received 420 mg of Repatha® subcutaneously once monthly. The adverse reactions that occurred in at least 2 (6.1%) Repatha®-treated patients and more frequently than in placebo-treated patients, included upper respiratory tract infection (9.1% versus 6.3%), influenza (9.1% versus 0%), gastroenteritis (6.1% versus 0%), and nasopharyngitis (6.1% versus 0%).

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 Amgen Cardiovascular
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.3Amgen'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 one of the world's leading independent biotechnology companies, 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.

Amgen Forward-Looking Statements
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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 after they are on the market.

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The scientific information discussed in this news release relating to new indications is preliminary and investigative and is not part of the labeling approved by the U.S. Food and Drug Administration or European Commission 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)

Kristen Neese: 805-313-8267 (media)

Arvind Sood: 805-447-1060 (investors)

References
1.    Amgen Data on File, Investigator Brochure.
2.    Repatha® U.S. Prescribing Information. Amgen.
3.    World Health Organization. Cardiovascular diseases (CVDs) fact sheet. http://www.who.int/mediacentre/factsheets/fs317/en/. Accessed March 2016.