The First PCSK9 Inhibitor Approved in Hong Kong for the Lowering of High Cholesterol

HONG KONG, Dec. 6, 2016 /PRNewswire/ -- Amgen today announced the availability of the first PCSK9 inhibitor for high cholesterol in Hong Kong. Approved by the Hong Kong Department of Health, the cholesterol-lowering drug evolocumab is indicated for use as an adjunct to diet and statin therapy for the treatment of adults with familial hypercholesterolemia (FH) including heterozygous FH (HeFH) and homozygous FH (HoFH), or clinical atherosclerotic cardiovascular disease (CVD), who require additional lowering of low density lipoprotein cholesterol (LDL-C)1.

Evolocumab is a 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.2­  

In Hong Kong, CVD or heart disease is the third leading cause of death.3 Every year, heart disease accounts for 13.2% of all deaths.4 One strategy to prevent heart disease is to improve the management of dyslipidemia.5  High cholesterol, particularly elevated LDL-C, is the most common form of dyslipidemia, which is an abnormality of cholesterol and/or fats in the blood.6,7 Elevated LDL-C is recognized as a major risk factor for CVD.8,9

Management of abnormal LDL-C is a challenge.10 A Hong Kong study found 24% of patients do not achieve target levels of LDL-C (< 2.6 mmol/L) despite statin treatment.11 Data from clinical trials demonstrated that evolocumab resulted in up to 77% additional LDL-C reduction in patients receiving background statin therapy, which is expected to reduce their risk of experiencing heart disease and a stroke.12

Amgen Cardiovascular

This new treatment option underlines the growing importance of utilizing human genetics to address diseases such as CVD and heart disease -- both of which have a large impact on our society as a whole, if left untreated.

"At Amgen, we believe in a 'biology first' approach through the use of cutting-edge science and technology to study the subtlest biological mechanisms in search of therapies that will improve the lives of those who suffer from diseases. With the introduction of evolocumab in Hong Kong,  we are excited that there is a new treatment option for patients who have elevated levels of cholesterol, despite using other lipid-lowering therapies," said Dr Victoria Elegant, Vice President Regional Medical for Amgen's Japan Asia Pacific region.

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.18

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 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.

AboutFamilial hypercholesterolemia

Familial hypercholesterolemia (FH) is an inherited condition caused by genetic mutations which lead to high levels of LDL-C at an early age,13 and it is estimated that many people with FH (heterozygous and homozygous forms) are undiagnosed.14 

Patients can have either one of two types of FH.13 Heterozygous FH is the more common type of FH and occurs in approximately one in 200 to 500 people.14 It can cause LDL-C levels twice as high as normal (e.g., >190 mg/dL or >4.9 mmol/L).15 Individuals with HeFH have one altered copy of a cholesterol-regulating gene.15 Homozygous FH is the rare, more severe form, occurring in approximately one in a million individuals.16 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).14 An individual with HoFH has two altered copies of the same cholesterol-regulating genes (one from each parent).13

About evolocumab

Evolocumab is a fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9).2 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.17 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.2

Repatha® (evolocumab) is a prescription only medicine in Hong Kong. Please read the full Prescribing Information prior to administration and full prescribing information is available upon request.

Media contact

Seok Lin Hong, Amgen at shong01@amgen.com, tel: (852)2843-1114

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 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.

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.

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References

1.

Repatha Full Prescribing Information. Amgen, January 2016, Hong Kong. HKPI20150007.

2.

Amgen Data on File, Investigator Brochure.

3.

Number of Dealths by Leading Causes of Deaths, 2001-2015, Centre for Health Prevention .

4.

Lee, K.K., et al., Cholesterol goal attainment in patients with coronary heart disease and elevated coronary risk: results of the Hong Kong hospital audit study. Value Health, 2008. 11 Suppl 1: p. S91-8.

5.

Chung, J.S., et al., Clinical and economic impact of clinical pharmacy service on hyperlipidemic management in Hong Kong. J Cardiovasc Pharmacol Ther, 2011. 16(1): p. 43-52.

6.

World Health Organization. Quantifying Selected Major Risks to Health. In: The World Health Report 2002 - Reducing Risks, Promoting Healthy Life. Chapter 4: Geneva: World.

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Merck Manuals website. http://www.merckmanuals.com/professional/endocrine_and_metabolic_disorders/lipid_disorders/dyslipidemia.html. Accessed May 2015.

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American Heart Association (2012). Why Cholesterol Matters. http://www.heart.org/HEARTORG/Conditions/Cholesterol/WhyCholesterolMatters/Why-Cholesterol-Matters_UCM_001212_Article.jsp. Accessed May 2015.

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World Health Organization. Global Status Report on Noncommunicable Diseases 2010. Geneva, 2011.

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Ambegaonkar, B., et al., Attainment of normal lipid levels among patients on lipid-modifying therapy in Hong Kong. Adv Ther, 2012. 29(5): p. 427-41.

11.

Ambegaonkar, B., et al., Attainment of normal lipid levels among patients on lipid-modifying therapy in Hong Kong. Adv Ther, 2012. 29(5): p. 437.

12.

Amgen Data on File.

13.

National Human Genome Research Institute. Learning About Familial Hypercholesterolemia. http://www.genome.gov/25520184. Accessed May 2015.

14.

Nordestgaard BG, Chapman MJ, Humphries SE, et al. Familial Hypercholesterolaemia is Underdiagnosed and Undertreated in the General Population: Guidance for Clinicians to Prevent Coronary Heart Disease. Eur Heart J. 2013;34:3478-3490.

15.

Hopkins PN, Toth PP, Ballantyne CM, et al. Familial Hypercholesterolemias: Prevalence, Genetics, Diagnosis and Screening Recommendations From the National Lipid Association Expert Panel on Familial Hypercholesterolemia. J Clin Lipid. 2011:5(3S):S9-S17.

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Daniels SR, Samuel SG, de Ferranti SD. Pediatric Aspects of Familial Hypercholesterolemias: Recommendations from the National Lipid Association Expert Panel on Familial Hypercholesterolemia. J Clin Lipid. 2011:5(3S):S30-S37.

17.

Abifadel M, Varret M, Rabes JP, et al. Mutations in PCSK9 Cause Autosomal Dominant Hypercholesterolemia. Nat Genet. 2003;34:154-156.

18.

World Health Organization. Cardiovascular diseases (CVDs) fact sheet. http://www.who.int/mediacentre/factsheets/fs317/en/. Accessed May 2015.

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