Press Release Details

THOUSAND OAKS, Calif., Nov. 12, 2014 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that it will present 13 abstracts at the upcoming American Heart Association (AHA) Scientific Sessions 2014 being held Nov. 15-19 in Chicago, including data from studies evaluating evolocumab, 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 low-density lipoprotein cholesterol (LDL-C), or "bad" cholesterol, from the blood.¹

"We will be sharing diverse data exploring the potential clinical utility of evolocumab at this year's AHA Scientific Sessions, including multiple new analyses that examine longer-term treatment with evolocumab, the effect on different lipid parameters and the efficacy of two dosing regimens," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "The medical community is keenly aware of the significant unmet need for many patients with high cholesterol, and we are continuing to work with regulatory agencies on the global filing packages we have submitted, including in the U.S. and EU."

Several of the abstracts are from the large and comprehensive evolocumab clinical trial program, PROFICIO (Program to Reduce LDL-C and Cardiovascular Outcomes Following Inhibition of PCSK9 In Different POpulations).

Data to be presented at the AHA Scientific Sessions 2014 include:

Clinical Development

• Long-Term Reduction in Lipoprotein (a) With the PCSK9 Monoclonal Antibody Evolocumab (AMG 145): A Pooled Analysis of 3278 Patients in Phase 2, 3, and Open Label Extension Studies
  Abstract 15743, Abstract Poster Session, Monday, Nov. 17, 9:30-11 a.m. CST (South Hall A2 – Core 2)
  
  
• Evaluation of the Relationship Between Evolocumab 140 mg Every Two Weeks and 420 mg Monthly Dosing Regimens
  Abstract 16270, Abstract Poster Session, Monday, Nov. 17, 9:30-11 a.m. CST (South Hall A2 – Core 2)
  
  
• Effects of Evolocumab Treatment on Serum Adrenal and Gonadal Hormone Levels: Results from the 52-week, Phase 3, Double-blind, Randomized, Placebo-controlled DESCARTES Study
  Abstract 17005, Abstract Poster Session, Monday, Nov. 17, 9:30-11 a.m. CST (South Hall A2 – Core 2)
  
  
• Trial Assessing Long-Term Use of PCSK9 Inhibition in Patients with Genetic LDL Disorders (TAUSSIG): Efficacy and Safety in Patients with Homozygous Familial Hypercholesterolemia Receiving Lipid Apheresis
  Abstract 17016, Abstract Poster Session, Tuesday, Nov. 18, 9:30-11 a.m. CST (South Hall A2 – Core 2)
  
  
• The Diagnosis of Heterozygous Familial Hypercholesterolemia: Genotype versus Phenotype
  Abstract 17368, Abstract Poster Session, Tuesday, Nov. 18, 9:30-11 a.m. CST (South Hall A2 – Core 2)
  
  
• Impact of Baseline PCSK9 Levels on the Efficacy of Evolocumab, a Monoclonal Antibody Against PCSK9
  Abstract 16196, Abstract Poster Session, Tuesday, Nov. 18, 3-4:30 p.m. CST (South Hall A2 – Core 2)
  
  
• Safety and Tolerability of Very Low LDL-C Levels in Patients Treated with 52 Weeks of Evolocumab (AMG 145)
  Abstract 16865, Abstract Poster Session, Tuesday, Nov. 18, 3-4:30 p.m. CST (South Hall A2 – Core 2)

Early Development

• Statin-Induced Myopathy is Mediated by Isoprenoid Depletion and is Independent of Serum Cholesterol Levels
  Abstract 13907, Abstract Poster Session, Sunday, Nov. 16, 9:30-11 a.m. CST (South Hall A2 – Core 2)
  
  
• Effects of Evolocumab (AMG 145) as a Monotherapy or in Combination with Statins on Lipoprotein Particles and Subclasses
  Abstract 16955, Abstract Poster Session, Wednesday, Nov. 19, 9:30-11 a.m. CST (South Hall A2 – Core 7)

Sponsored Research

• PCSK9 is Elevated in HIV+ Patients
  Abstract 17751, Abstract Oral Session, Saturday, Nov. 15, 2:15-2:25 p.m. CST (Room S406A)

Observational Research

• Statin Prescription and Dose Intensity Among Elderly Medicare Beneficiaries, by CV Disease Diagnosis and Prescriber Specialty
  Abstract 15677, Abstract Poster Session, Monday, Nov. 17, 9:30-11 a.m. CST (South Hall A2 – Core 2)
  
  
• Low Density Lipoprotein Cholesterol Response and Statin Persistence among Patients with High Coronary Heart Disease Risk Initiating Treatment
  Abstract 18986, Abstract Poster Session, Monday, Nov. 17, 9:30-11 a.m. CST (South Hall A2 – Core 2)

Health Economics

• Work Absenteeism, Short Term Disability and Related Indirect Costs Associated with Cardiovascular Events and Related Clinical Procedures
  Abstract 13352, Abstract Poster Session, Sunday, Nov. 16, 9:30-11 a.m. CST (South Hall A2 – Core 2)

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.² 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 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 in 22 clinical trials, with a combined planned enrollment of approximately 35,000 patients.

The Phase 3 program includes 16 trials to evaluate evolocumab administered every two weeks and monthly in multiple patient populations, including in combination with statins in patients with hyperlipidemia (LAPLACE-2 and YUKAWA-2); in patients with hyperlipidemia who cannot tolerate statins (GAUSS-2 and GAUSS-3); as a stand-alone treatment in patients with hyperlipidemia (MENDEL-2); in patients whose elevated cholesterol is caused by genetic disorders called heterozygous (RUTHERFORD-2 and TAUSSIG) and homozygous (TESLA and TAUSSIG) familial hypercholesterolemia; the effects of evolocumab on lipoprotein metabolism (FLOREY); and the administration of evolocumab in statin-treated hyperlipidemic patients (THOMAS-1 and THOMAS-2).

Five ongoing studies in the evolocumab Phase 3 program 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 27,500 patients with cardiovascular disease; EBBINGHAUS (Evaluating PCSK9 Binding AntiBody Influence oN CoGnitive HeAlth in High CardiovascUlar Risk Subjects), which will evaluate the effect of evolocumab on cognitive function in a subset of patients enrolled in FOURIER; OSLER-2 (Open Label Study of Long TERm Evaluation Against LDL-C Trial-2) in patients with high cholesterol who completed any of the Phase 3 studies; 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; and TAUSSIG (Trial Assessing Long Term USe of PCSK9 Inhibition in Subjects with Genetic LDL Disorders), which will assess the long-term safety and efficacy of evolocumab on LDL-C in patients with severe familial hypercholesterolemia including patients with homozygous familial hypercholesterolemia. The DESCARTES (Durable Effect of PCSK9 Antibody CompARed wiTh PlacEbo Study) study, a long-term safety and efficacy trial in patients with hyperlipidemia at risk for cardiovascular disease, has been completed, presented and published.

About Amgen's Commitment to Cardiovascular Disease
Amgen is dedicated to addressing important scientific questions in order to advance care and improve the lives of patients with cardiovascular disease. Through its own research and development efforts and innovative partnerships, Amgen has built a robust cardiology pipeline consisting of several 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 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 Nov. 12, 2014, 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.

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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, Thousand Oaks
Kristen Davis: 805-447-3008 (media)
Trish Hawkins: 805-447-5631 (media)
Arvind Sood: 805-447-1060 (investors)

References
1.    Amgen Data on File, Investigator Brochure.
2.    Abifadel M, Varret M, Rabes JP, et al. Mutations in PCSK9 Cause Autosomal Dominant Hypercholesterolemia. Nat Genet. 2003;34:154-156.

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