LDL Cholesterol is a Key Risk Factor for Cardiovascular Disease, which Remains Singapore’s Leading Killer
Amgen's Breakthrough Treatment Will Help Patients Significantly Reduce LDL Cholesterol Levels
Singapore (July 3, 2017) – Amgen (NASDAQ:AMGN) today announced the availability of Repatha® (evolocumab), the first PCSK9 inhibitor for lowering high cholesterol, in Singapore.
Repatha® is a new class of drugs called proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors. It is a fully human monoclonal antibody that inhibits PCSK9 from binding to low-density lipoprotein (LDL) receptors. In the liver, this interaction enables our bodies to have more LDL receptors available to remove low-density lipoprotein cholesterol (LDL-C), or “bad” cholesterol, from the blood.1
Elevated LDL-C is recognized as a major risk factor for cardiovascular disease (CVD).2,3 CVDs, such as heart disease and stroke, are Singapore’s leading cause of death, accounting for 1 in every 3 deaths in 2015.4 CVDs also result in steep direct and indirect costs for patients. The average medical cost for an acute stroke is over S$22,000, which is the equivalent of almost two months of an average Singaporean family’s income.5
“While available treatments for other diseases are advancing in leaps and bounds, there hasn’t been much movement to address high cholesterol since the development of statin therapy in the late 1980s,” said Dr. Peter Yan Chee Hong, Consultant Cardiologist at Gleneagles Medical Centre. “Repatha® provides a new treatment option for patients who experience side effects while on statin therapy or remain unable to control their cholesterol levels.”
The key strategy to prevent heart disease is to improve the management of dyslipidemia.6 High elevated LDL-C, is the most common form of dyslipidemia, which leads to abnormally high levels of cholesterol and/or fats in their blood.7,8 Management of abnormal LDL-C is both extremely important and challenging.9
Data from clinical trials demonstrated that Repatha® resulted in up to 77% additional LDL-C reduction in patients receiving background statin therapy.10
“This is the first significant innovation in 30 years for cholesterol management, and we look forward to seeing how it will impact patient lives and help combat the rising burden of CVD,” said Raphael Ho, General Manager of Amgen Singapore. “Amgen has been growing its CVD research competency for more than a decade and we are committed to continue building a robust portfolio that addresses many of the unmet needs in high risk patients across Singapore.”
Approved by the Health Sciences Authority, the cholesterol-lowering drug Repatha® is indicated for: 11
Amgen Cardiovascular
Repatha® underlines the growing importance of using human genetics to address diseases such as CVD and heart disease – which have a large impact on our society as a whole, if left untreated.
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.
Amgen’s research into CVD, 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 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.
###
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. 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
About Repatha® (evolocumab)
Repatha® (evolocumab) is a fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9).10 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.1 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.3
Repatha® is a prescription only medicine in Singapore. Please read the full Prescribing Information prior to administration and full prescribing information is available upon request.
About Familial Hypercholesterolemia (FH)
FH is an inherited condition caused by genetic mutations which lead to high levels of LDL-C at an early age,12 and it is estimated that many people with FH (heterozygous and homozygous forms) are undiagnosed.13
Patients can have either one of two types of FH.12 Heterozygous FH is the more common type of FH and occurs in approximately one in 200 to 500 people.13 It can cause LDL-C levels twice as high as normal (e.g., >190 mg/dL or >4.9 mmol/L).14 Individuals with HeFH have one altered copy of a cholesterol-regulating gene.14 Homozygous FH is the rare, more severe form, occurring in approximately one in a million individuals.15 It can cause LDL-C levels more than six times as high as normal (e.g., 650-1,000 mg/dL or 16.8-25.9 mmol/L).13 An individual with HoFH has two altered copies of the same cholesterol-regulating genes (one from each parent).12
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 November, 2016, 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.
In addition, sales of our products are affected by the reimbursement policies imposed by third-party payors, 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 as well as U.S. legislation affecting pharmaceutical pricing and reimbursement. Government and others' regulations and reimbursement policies may affect the development, usage and pricing of our products. In addition, we compete with other companies with respect to some of our marketed products as well as for the discovery and development of new products. We believe that some of our newer products, product candidates or new indications for existing products, may face competition when and as they are approved and marketed. Our products may compete against products that have lower prices, established reimbursement, superior performance, are easier to administer, or that are otherwise competitive with our products. In addition, 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 and there can be no guarantee of our ability to obtain or maintain patent protection for our products or product candidates. We cannot guarantee that we will be able to produce commercially successful products or maintain the commercial success of our existing products. Our stock price may be affected by actual or perceived market opportunity, competitive position, and success or failure of our products or product candidates. Further, 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 integrate the operations of companies we have acquired may not be successful. We may experience difficulties, delays or unexpected costs and not achieve anticipated benefits and savings from our recently announced restructuring plan. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or their ability to pay a dividend or repurchase our common stock.
Media Contacts
Amgen, JAPAC
Seok Lin Hong, shong01@amgen.com
Edelman, Singapore
Ashley Lau, ashley.lau@edelman.com
References