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AMGEN PRESENTS NEW CARDIOVASCULAR RESEARCH AT AHA 2023

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AMGEN PRESENTS NEW CARDIOVASCULAR RESEARCH AT AHA 2023

New Repatha® (evolocumab) Data Show No Decline in Cognitive Function Associated With Very Low Levels of LDL-C

Olpasiran Research Provides Further Insights Into Cardiovascular Risks Associated With Elevated Lp(a)

THOUSAND OAKS, Calif. (Nov. 10, 2023) – Amgen (NASDAQ:AMGN) today announced new data reinforcing the safety and efficacy of Repatha® (evolocumab) from the FOURIER Open Label Extension (OLE) [FOURIER-OLE] trial at the American Heart Association (AHA) Scientific Sessions 2023 in Philadelphia. These presentations will focus on the reduction of a known cardiovascular disease (CVD) risk factor, LDL “bad” cholesterol (LDL-C). Amgen will also present new research from the Phase 2 OCEAN(a)-DOSE study of its investigational small interfering RNA (siRNA) olpasiran that will focus on a primarily genetically determined and presumed independent CVD risk factor, lipoprotein(a) [Lp(a)].1,2,3,4,5

Repatha Data Reinforces Benefits of Low LDL-C

Data from the EBBINGHAUS sub-study of the FOURIER-OLE is the first to evaluate the impact of long-term lowering of LDL-C on cognitive function following administration of Repatha in adult patients with atherosclerotic cardiovascular disease (ASCVD). The data showed patients treated with Repatha did not experience any apparent cognitive decline following a median achieved LDL-C of 34 mg/dL through a median follow-up period of 5.1 years.

“Cardiovascular disease is a leading public health crisis in the United States. Amgen remains steadfast in our commitment to reduce the risk of heart attack and stroke, starting with lowering levels of LDL-C, one of the most modifiable risk factors,” said Paul Burton, senior vice president and chief medical officer at Amgen. “Repatha continues to be an effective option in helping people with cardiovascular disease manage their LDL-C, and this FOURIER-OLE data further demonstrates that long-term lowering of LDL-C levels come with no decline in cognitive function.”

An additional analysis combining FOURIER and FOURIER-OLE data for 152 OLE participants originally randomized to receive Repatha showed that long-term treatment with this medication had no significant impact on measures of executive function, working and episodic memory, and psychomotor speed over time as compared to baseline. No new safety signals were identified in the analyses.

“The neurocognitive data highlighting long-term use of evolocumab is highly encouraging for the cardiovascular community,” said Robert Giugliano, M.D., S.M., Senior Investigator, TIMI Study Group, Staff Physician, Cardiovascular Medicine, Brigham and Women’s Hospital, Professor of Medicine, Harvard Medical School, and FOURIER-OLE investigator. “In addition to reiterating the neurocognitive safety of evolocumab, this study provides reassuring information for patients and clinicians that sustained very low levels of LDL-C over the long-term does not increase cognitive impairment.”

Olpasiran Research on Risks Associated with Elevated Lp(a)

Amgen also shared new research from the OCEAN(a)-DOSE study on Lp(a) involving its investigational olpasiran. Evidence suggests that elevated Lp(a) contributes to cardiovascular events, including heart attack, stroke and peripheral arterial disease.3,4 Data will be presented on the intraindividual variability in serial Lp(a) concentration among placebo-treated patients in the OCEAN(a)-DOSE trial. Additional research presented at AHA will include Mass General Brigham Lp(a) registry data on whether the association between Lp(a) and major adverse cardiovascular events (MACE) differs based on baseline ASCVD status. This research investigates the threshold for defining Lp(a) in patients both with and without ASCVD.

For more information on the Amgen abstracts, see below.

Abstracts and Presentation Times:

Amgen Sponsored Abstracts

Repatha® (evolocumab)

Abstract #Sa3071, Poster Session, Zone 3, Science and Technology Hall, Level 2, Saturday, Nov. 11 from 3-4:15 p.m. EST

Invited Encore Oral Presentation, Room 121B, Sunday, Nov. 12 from 3:30-3:35 p.m. EST (previously published in Circulation, Feb. 2023)

Abstract #Su3278, Poster Session, Zone 3, Science and Technology Hall, Level 2, Hall A-D, Sunday, Nov. 12 from 3-4:15 p.m. EST

Abstract #Su3242, Poster Session, Zone 3, Science and Technology Hall, Level 2, Sunday, Nov. 12 from 11:30 a.m.-12:45 p.m. EST

Abstract #304, Oral Presentation, Room 204C, Monday, Nov. 13 from 10:30-10:40 a.m. EST

Abstract #Mo3065, Poster Session, Zone 3, Science and Technology Hall, Level 2, Monday, Nov. 13 from 10:30-11:45 a.m. EST

Abstract #Mo3012, Poster Session, Zone 3, Science and Technology Hall, Level 2, Monday, Nov. 13 from 10:30-11:45 a.m. EST

Olpasiran

Abstract #Sa1005, Poster Session, Zone 1, Science and Technology Hall, Level 2, Saturday, Nov. 11 from 11:30 a.m.-12:45 p.m. EST

Abstract #MDP278, Moderated Digital Poster 4, Science and Technology Hall, Level 2, Monday, Nov. 13 from 12:10-12:15 p.m. EST

Investigator-Sponsored Studies (ISS)

Abstract #Su3229, Poster Session, Zone 3, Science and Technology Hall, Level 2, Sunday, Nov. 12 from 3:30-4:45 p.m. EST

Abstract #565, Poster Session, Zone 2, Science and Technology Hall, Level 2, Monday, Nov. 13, 2023 from 9:50-9:55 a.m. EST

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 has been studied for 12 years in 50 clinical trials with over 51,000 patients.

Repatha is approved in more than 75 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.

About Olpasiran

Olpasiran (formerly known as AMG 890) is a small interfering RNA (siRNA) that targets lipoprotein(a), also known as Lp(a). We look forward to studying this treatment further in the Phase 3 clinical trial OCEAN(a)-Outcomes, which is currently recruiting.

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.

Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average and is also part of the Nasdaq-100 index. In 2023, Amgen was named one of "America's Greatest Workplaces" by Newsweek, one of "America's Climate Leaders" by USA Today and one of the "World's Best Companies" by TIME.

For more information, visit Amgen.com and follow us on X (formerly known as Twitter), LinkedIn, Instagram, TikTok, YouTube and Threads.

Repatha® (evolocumab) Important U.S. Product Information

INDICATIONS

Repatha® is indicated:

The safety and effectiveness of Repatha® have not been established in pediatric patients with HeFH or HoFH who are younger than 10 years old or in pediatric patients with other types of hyperlipidemia.

IMPORTANT SAFETY INFORMATION

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. Hypersensitivity reactions occurred in 5.1% and 4.7% of Repatha®-treated and placebo-treated patients, respectively. The most common hypersensitivity 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%).

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 treated with Repatha® compared with 7.7% in patients that received placebo.

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.

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 collaborations, or potential collaborations, with any other company (including BeiGene, Ltd. or Kyowa Kirin Co., Ltd.), the performance of Otezla® (apremilast) (including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion), our acquisitions of Teneobio, Inc., ChemoCentryx, Inc., or Horizon Therapeutics plc (including the prospective performance and outlook of Horizon’s business, performance and opportunities and any potential strategic benefits, synergies or opportunities expected as a result of such acquisition), 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, effects of pandemics or other widespread health problems on our business, outcomes, progress, 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.

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CONTACT: Amgen, Thousand Oaks
Madison Howard, 773-636-4910 (media)
Jessica Akopyan, 805-440-5721 (media)
Justin Claeys, 805-313-9775 (investors)

References:

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Om Amgen

Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe and effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. To learn more about our pioneering science and our vital medicines, visit www.amgen.se

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