Amgen Announces Presentation Of Research Reinforcing The Long-Term Safety And Efficacy Of Repatha® (Evolocumab) In High-Risk Patients At AHA Scientific Sessions 2018

THOUSAND OAKS, Calif., Nov. 5, 2018 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the presentation of 10 scientific research abstracts, including the final report of the OSLER-1 study, evaluating the long-term safety and efficacy of Repatha^® (evolocumab) in patients with hypercholesterolemia for up to five years. Additional abstracts to be presented include a sub-analysis of the Repatha cardiovascular outcomes study (FOURIER), investigating the effects of triglycerides on cardiovascular risk in patients with established cardiovascular disease, and an evaluation of the utilization of lipid-lowering therapies in patients at high risk for cardiovascular events in a real-world setting. These analyses will be presented at the upcoming American Heart Association (AHA) Scientific Sessions 2018 in Chicago, Nov. 10-12, and follow the Company's recent announcement that Repatha is now available in the U.S. at a 60 percent reduced list price.

"Despite recent advances in the secondary prevention of cardiovascular events, including heart attack and stroke, many patients with cardiovascular disease do not meet, and may not even be aware of, their recommended low-density lipoprotein cholesterol (LDL-C) goals, putting them at increased risk for cardiovascular events," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "The data that will be presented at AHA contributes to the growing body of compelling clinical evidence on the role for Repatha among high-risk patients for whom statins and other traditional therapies are not enough. Our recent announcement to make Repatha available at a reduced list price should address concerns over out-of-pocket costs, which have been a barrier to its use and help make sure that every patient who needs Repatha gets it."

The OSLER-1 study data to be presented at AHA 18 forms part of the PROFICIO (Program to Reduce LDL-C and cardiovascular Outcomes Following Inhibition of PCSK9 In different pOpulations) scientific research program. PROFICIO is evaluating Repatha in 32 clinical trials to date, with a combined enrollment of approximately 37,800 patients.¹  

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. To ensure patients benefit from this lower list price, all stakeholders must be engaged – from healthcare professionals to payers to plans and to government agencies. Any patients or physicians who need help understanding how recent changes impact them or their patients can contact our team at RepathaReady^® (1-844-REPATHA).

A list of Amgen-sponsored abstracts at AHA Scientific Sessions 2018 can be found online and below:

Late-Breaking Digital Poster

• A Randomized Double-Blind Placebo-Controlled Study Characterizing the Effects of Proprotein Convertase Subtilisin/Kexin Type 9 Inhibition on Arterial Wall Inflammation in Patients With Elevated Lipoprotein(a) (ANITSCHKOW)
  Saturday, Nov. 10, 7:30-7:45 a.m. CST, S102d

Oral Presentation

• OSLER-1 5-year final analysis
  Monday, Nov. 12, 9:45-9:55 a.m. CST, S105abc

Poster Sessions

• Cardiovascular Event Rates Among Patients With Peripheral Arterial Disease in a United States Administrative Insurance Claims Database
  Saturday, Nov. 10, 11:30-12:45 p.m. CST, Zone 1, Science and Technology Hall, Sa1139
• Risk of Cardiovascular Events Among Persons Living with HIV in the Current Era
  Saturday, Nov. 10, 12:55-1 p.m. CST, Moderated Posters 1, Science and Technology Hall, SaMDP2
• Atherosclerotic Cardiovascular Diseases and Low-Density Lipoprotein Cholesterol Management in Alberta, Canada
  Saturday, Nov. 10, 2:15-3:30 p.m. CST, Zone 1, Science and Technology Hall, Sa1173
• What Do U.S. Physicians Think About Lipid-Lowering Therapy and the Guidelines? Results From a National Survey in the Getting to an Improved Understanding of Low-Density Lipoprotein Cholesterol and Dyslipidemia Management (GOULD) Registry
  Sunday, Nov. 11, 10:30-11:45 a.m. CST, Zone 1, Science and Technology Hall, Su1266
• What Is the Clinical Profile of ASCVD Patients With Elevated Baseline LDL-C? 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
  Sunday, Nov. 11, 10:30-11:45 a.m. CST, Zone 1, Science and Technology Hall, Su1290
• The Association Between Time-Averaged Cumulative Low-Density Lipoprotein Cholesterol and Cognitive Function
  Sunday, Nov. 11, 2-3:15 p.m. CST, Zone 1, Science and Technology Hall, Su1111
• GOULD Patient Perceptions about Lipid-Lowering Therapy and Treatment Goals: Insights From a Survey of Patients With Established ASCVD Participating in the Getting to an Improved Understanding of Low-Density Lipoprotein Cholesterol and Dyslipidemia Management (GOULD) Registry
  Sunday, Nov. 11, 3:55-4 p.m. CST, Moderated Posters 1, Science and Technology Hall, SuMDP61
• FOURIER Prognostic Value of Elevated Triglycerides in Atherosclerotic Disease
  Monday, Nov. 12, 10:30-11:45 a.m., Zone 1, Science and Technology Hall, Mo1028

OSLER-1 Study Design
Open Label Study of Long Term Evaluation Against LDL-C 1 (OSLER-1) is an open-label extension study with Repatha, a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor. The study is being conducted across 192 sites in 18 countries.

Patients were eligible for participation in OSLER-1 provided that they did not discontinue treatment due to a treatment-related serious adverse event (SAE) during their qualifying Phase 2 study or require unblinded lipid measurements and/or adjustment of background lipid therapy during the first 12 weeks of OSLER-1. During the first year, patients were randomized 2:1 to Repatha 420 mg monthly in addition to standard of care (SOC) or SOC alone. After year one, all patients continuing in the study received Repatha 420 mg monthly in addition to SOC for the remaining 4 years of the study. Lipid parameters, safety and tolerability were assessed every 12 weeks.

The primary objective of the study is to evaluate the long-term safety and tolerability of Repatha. The secondary objective is to evaluate LDL-C reductions with Repatha over an extended period of time.

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.

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.²

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 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.³ 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. 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.

CONTACT: Amgen, Thousand Oaks
Kristen Davis, 805-447-3008 (Media)
Kristen Neese, 805-313-8267 (Media)
Arvind Sood, 805-447-1060 (Investors)

References

1. Data on file, Amgen; 2018.
2. Repatha Prescribing Information; Amgen, Thousand Oaks, CA, 2018.
3. World Health Organization. Cardiovascular diseases (CVDs) fact sheet. http://www.who.int/mediacentre/factsheets/fs317/en/. Accessed September 29, 2018.

SOURCE Amgen

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