Press Release Details

THOUSAND OAKS, Calif., Oct. 24, 2019 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that effective Dec. 31, 2019, Repatha^® (evolocumab), an innovative treatment for patients with high cholesterol and cardiovascular disease proven to reduce heart attacks and strokes, will be distributed exclusively at the 60% lower list price of $5,850 per year and will no longer be available at its original list price.

"One year ago, Amgen announced a commitment to improve patient affordability, particularly for Medicare patients, in order to ensure that every patient who needs Repatha, gets Repatha. The discontinuation of the original list price option is a critical step in delivering on this commitment," said Murdo Gordon, executive vice president of Global Commercial Operations at Amgen.

Amgen introduced the lower list priced option of Repatha in October 2018 to reduce out-of-pocket costs, especially for Medicare patients. To minimize disruption in the supply chain and allow time for payers and pharmacy benefit managers (PBMs) to modify existing contracts, Amgen continued to offer the original list price option of Repatha. Through contracting, Amgen continues to offer all PBMs and health plans equivalent or better net pricing on the lower list price option of Repatha.

"We have seen significant improvements in access and affordability, but not all Medicare patients are benefitting from these improvements because some Medicare Part D plans have not transitioned to the lower list price option of Repatha. Almost half of all Medicare patients who are prescribed Repatha will have an affordable co-pay of less than $50 in 2020, but that means that the other half will still face affordability challenges that need to be addressed. We are discontinuing the original list price option so that payers and Medicare Part D health plans have clarity and can do their part: cover the lower list price option of Repatha to help every patient prescribed Repatha fill their prescription at an affordable, low fixed dollar co-pay," continued Gordon.

A recent observational study sponsored by the Familial Hypercholesterolemia (FH) Foundation published in Circulation: Cardiovascular Quality and Outcomes showed that patients who were unable to get their prescribed PCSK9 inhibitor experienced more cardiovascular (CV) events than patients who received their prescription. Furthermore, women, minorities and individuals with low incomes were more likely to have rejected or unfilled prescriptions.

"Heart disease is a leading public health issue in the U.S. When individuals with established heart disease and FH face obstacles to getting their prescribed lipid-lowering medications, it has devastating effects on their health.  We are pleased that Amgen is taking this additional step to remove barriers that stand in the way of patients getting the care they need," said Katherine A. Wilemon, founder and chief executive officer of the FH Foundation.

Amgen will work with payers, wholesalers and pharmacies to phase out supply of the original list price national drug codes (NDCs) through the remainder of 2019 and to return any remaining inventory of the discontinued NDCs in 2020. 

Burden of Cardiovascular Disease
Cardiovascular disease (CVD) remains one of the most pressing public health issues in the U.S., with someone in the country experiencing a heart attack every 40 seconds.¹ LDL-Cholesterol, also known as bad cholesterol, is one of the most important modifiable risk factors for having a heart attack.^2,3 About seven out of 10 adults in the U.S. with CVD have elevated LDL-C, despite optimal lipid-lowering treatment.⁴ Additionally, 43% of patients who have had a CV event, such as heart attack, will have at least one new event within two years.^5,6 Professional guidelines around the world, including the American Heart Association , the American College of Cardiology  and the European Society of Cardiology call for more intensive reduction of LDL-C.^7,8 The guidelines confirm the lower the LDL-C value, the lower the risk of future CV events for patients with CVD, and recommend intensive lipid-lowering treatment for very high-risk patients.

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.

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. 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 any statements on the outcome, benefits and synergies of the acquisition of Otezla^® (apremilast), including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion, as well as 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. 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. We or others could identify safety, side effects or manufacturing problems with our products, including our devices, 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. If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. government, we could become subject to significant sanctions. 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. We rely on collaborations with third parties for the development of some of our product candidates and for the commercialization and sales of some of our commercial products. 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 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, 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
Jessica Akopyan, 805-447-0974 (media)
Trish Hawkins, 805-447-5631 (media)
Arvind Sood, 805-447-1060 (investors)

References

1. Benjamin EJ, et al. Circulation. 2017;135:e146-e603.
2. Goldstein JL, et al. Arterioscler Thromb Vasc Biol. 2009;29(4):431-438.
3. Yusuf S, et al. Lancet. 2004;364:937-952.
4. Data on File, Amgen; 2018.
5. Data on File, Amgen; 2018.
6. Punekar R, Fox KM, Richhariya A, et al. Burden of first and recurrent cardiovascular events among patients with hyperlipidemia. Clin Cardiol. 2015;38:483-491.
7. Mach F, et al. European Heart Journal. 2019;ehz455.
8. Grundy SM, et al. JACC. 2018; 1-80.

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SOURCE Amgen