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HEALTH CANADA APPROVES AMGEN’S REPATHA® (EVOLOCUMAB) TO REDUCE THE RISK OF CARDIOVASCULAR EVENTS IN ADULTS WITH ATHEROSCLEROTIC CARDIOVASCULAR DISEASE

New Indication Supports Amgen’s Commitment to Reduce the Risk of Recurrent Cardiovascular Events Faced by Heart Attack and Stroke Survivors

MISSISSAUGA, ON (June 19, 2018) – Today Amgen Canada announced that Health Canada has now indicated Repatha as an adjunct to diet and standard of care therapy (including moderate- to high-intensity statin therapy alone or in combination with other lipid-lowering therapy), to reduce the risk of myocardial infarction, stroke, and coronary revascularization in adult patients with atherosclerotic cardiovascular disease.1

Of all the modifiable risk factors for heart attack and stroke, lowering high low-density lipoprotein cholesterol (LDL-C) is one of the most important and impactful.2,3 Yet, even among patients currently taking a lipid-lowering therapy, many patients still have high LDL-C levels and remain at risk for cardiovascular events. Patients with a previous history of cardiovascular events are at an increased risk of subsequent events, especially in the first year.4 Repatha has been demonstrated to effectively lower “bad cholesterol” or LDL-C for high-risk patients who suffer from a combination of high LDL-C and cardiovascular disease, and who continue to struggle with lowering their LDL-C levels despite statin therapy.

“Heart disease is the second leading cause of death among Canadians and is one of the main reasons for hospitalizations and disability in Canada,”5 said Ponda Motsepe-Ditshego, Executive Medical Director at Amgen Canada. “We are pleased that Health Canada reviewed and included the Repatha cardiovascular outcomes study (FOURIER) data in the product indication. This updated indication provides a new option for physicians to prevent cardiovascular events in patients who have elevated levels of cholesterol, despite being treated optimally with  other lipid-lowering therapies, and who may benefit from Repatha’s ability to reduce heart attacks and strokes by lowering LDL cholesterol.”

In the Repatha cardiovascular outcomes study (FOURIER), Repatha reduced the risk of heart attack by 27 per cent, the risk of stroke by 21 per cent, and the risk of coronary revascularization by 22 per cent.6

"Despite advances and efforts over over the past 25 years, many of our high-risk patients are still not at recommended Canadian guideline targets (DYSIS),"7 said Dr. Lawrence Leiter, Canadian Lead Investigator for the Repatha cardiovascular outcomes study (FOURIER) trial and Director of the Lipid Clinic at St. Michael’s Hospital in Toronto. “With this additional clinical evidence, physicians and their appropriate patients now have another effective option to help further lower the LDL ("bad") cholesterol and reduce the risk of heart attacks and strokes.”

Health Canada previously indicated Repatha as an adjunct to diet and maximally tolerated statin therapy in adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (CVD), who require additional lowering of LDL-C; and as an adjunct to diet and other LDL-lowering therapies in adults and adolescent patients aged 12 years and over with homozygous familial hypercholesterolemia (HoFH), who require additional lowering of LDL-C.1

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, was designed to evaluate whether treatment with Repatha in combination with statin therapy compared to placebo plus statin therapy reduces cardiovascular events. The primary endpoint was the time to cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization. The key secondary endpoint was the time to cardiovascular death, myocardial infarction or stroke.

Eligible patients with high cholesterol (LDL-C ≥1.8 mmol/L or non-high-density lipoprotein cholesterol [non-HDL-C] ≥2.6 mmol/L) and clinically evident atherosclerotic cardiovascular disease at more than 1,200 study locations around the world, including Canada, were randomized to receive Repatha subcutaneous 140 mg every two weeks or 420 mg monthly plus optimized statin dose; or placebo subcutaneous every two weeks or monthly plus effective statin dose. Effective 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)1

Repatha (evolocumab) is a fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9). Repatha binds selectively and with high affinity to PCSK9, and inhibits circulating PCSK9 from binding to the LDLR on the liver cell surface, thus preventing PCSK9-mediated LDLR degradation therefore increasing the number of LDLR available to clear LDL, thereby lowering serum LDL-C levels.

Repatha is indicated as an adjunct to diet and standard of care therapy (including moderate- to high-intensity statin therapy alone or in combination with other lipid-lowering therapy), to reduce the risk of myocardial infarction, stroke, and coronary revascularization in adult patients with atherosclerotic cardiovascular disease.

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.8 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 Canada Inc.

With main operations located in Mississauga, Ont.’s vibrant biomedical cluster, and its research facility in Burnaby, B.C., Amgen Canada has been an important contributor to advancements in science and innovation in Canada since 1991. 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 expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. To learn more about Amgen Canada, visit www.amgen.ca.

Forward-Looking Statements
This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen Inc. and its subsidiaries. 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 Inc., including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and 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. 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 (including products of our wholly-owned subsidiaries) 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. 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 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 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. Discovery or identification of new product candidates cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate will be successful and become a commercial product. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. 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. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all. We are increasingly dependent on information technology systems, infrastructure and data security. 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.

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CONTACT: 
Natasha Bond
Amgen Canada
Ph: 905-285-3007
natashab@amgen.com

References

  1. Repatha Product Monograph. June 5, 2018.
  2. How To Prevent and Control Coronary Heart Disease Risk Factors. Accessed April 10, 2018.
  3. Kuklina, EV. Centers for Disease Control and Prevention. Vital signs: prevalence, treatment, and control of high levels of low-density lipoprotein cholesterol. United States, 1999–2002 and 2005–2008. MMWR. 2011;60(4):109–14.
  4. Bhatt DL, et al. JAMA.  2010;304:1350-7.
  5. Government of Canada. Heart disease – heart health. https://www.canada.ca/en/public-health/services/diseases/heart-disease-heart-health.html. Accessed June 8 2018
  6. Sabatine MS, Giugliano RP, Keech AC, et al, for the FOURIER Steering Committee and Investigators. N Engl J Med. Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease. 2017;376:1713-22.
  7. Cannon CP, et al. N Engl J Med. 2015;372:2387-2397.
  8. World Health Organization. Cardiovascular diseases (CVDs) fact sheet. http://www.who.int/mediacentre/factsheets/fs317/en/. Accessed October 30, 2017.