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Amgen Announces New Data Highlighting Global Trends In Hip Fracture Incidence And Treatment

Real-World Data Reinforces Hip Fracture as a Significant Public Health Issue Globally, With Low Use of Pharmacologic Interventions

Results Presented as a Late-Breaking Abstract at the American Society for Bone and Mineral Research 2021 Annual Meeting (ASBMR)

Amgen Logo. (PRNewsFoto/Amgen) (PRNewsFoto/)

News provided by

Amgen

Oct 04, 2021, 16:00 ET

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THOUSAND OAKS, Calif., Oct. 4, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced results from real-world data in Asia, Europe, Oceania, and North and South America on the temporal trends in hip fracture incidence, and in post-fracture pharmacological treatment intervention. The study, presented as a late-breaking abstract at the American Society for Bone and Mineral Research 2021 Annual Meeting (ASBMR), is titled "Hip Fractures: Initial Report of Trends in Incidence, Treatment, and Mortality In Multiple Countries Using a Common Analytical Platform." The results of the study reveal that hip fracture remains a significant public health issue across the globe, and that the effects of aging populations and suboptimal pharmacological treatment may contribute to an increasing burden of osteoporosis.i 

"Hip fractures represent a major public health crisis, but previously available reports on incidence are based on decades old data for some regions," said Darryl Sleep, M.D., senior vice president of Global Medical and chief medical officer at Amgen. "We are excited to present the latest global data on hip fractures, which uses a unified methodology that makes it possible to provide updated incidence, as well as valuable insights on the risk factors and next steps in the treatment of osteoporosis."

This study, led by the University of Hong Kong, was funded by Amgen and includes Amgen authors. This initial report, inclusive of years 2005 and 2018, is based on thirteen data sources from Australia, Canada, Germany, Hong Kong, Italy, the Netherlands, New Zealand, South Korea, Spain, Taiwan, United Kingdom, and two systems (Medicare and Optum's de–identified Clinformatics® Data Mart Database) from the United States.i The change in age-standardized hip fracture incidence varied from -2.1% to +2.3% per year across all data sources (HK, -2.1%; UK, -1.3%; TW, -1.8%; IT, -1.4%; Spain, -1.1%; USM, -1.1%; Canada, -0.9%; NZ, -0.8%; USO, -0.2%; AU, +0.2%; GE, +0.8%; SK, +0.8%; NL, +2.3%); those data sources with full population coverage show the absolute number of hip fractures per year has increased. Post-fracture care with pharmacological treatment within 12 months after fracture ranged from 11.5% to 50.3% across the globe, with recent annual trends notably decreasing in some health care systems (e.g. United States Medicare).i

"This study examined patients over 50 years old who were hospitalized due to a hip fracture. Although hip fracture incidence has been stabilized or reduced in many countries in recent years, this reduction is insufficient to offset the increase of hip fractures as the global population ages," said lead investigator, Chor-Wing Sing, PhD, Department of Pharmacology and Pharmacy, Li Ka Shing Faculty of Medicine, The University of Hong Kong. "The current results also show low post-hip fracture treatment rates, which suggest that prevention efforts following hip fractures can be improved. Such efforts are critical, given that following a hip fracture, postmenopausal women are 2.5 times more likely to break another bone." ii

About Osteoporosis-related Fractures
Worldwide, one in three women and one in five men over the age of 50, will suffer a fracture due to osteoporosis.iii Similarly, in the U.S. one in two women over the age of 50 will experience a fracture in her remaining lifetime due to osteoporosis.iv Breaking a bone can be a life-altering event that can lead to pain, loss of mobility and a change in lifestyle.v

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 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., Kyowa-Kirin Co., Ltd., or any collaboration to manufacture therapeutic antibodies against COVID-19), the performance of Otezla (apremilast) (including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion), or the Five Prime Therapeutics, Inc. 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 such as the ongoing COVID-19 pandemic on our business, outcomes, progress, or effects relating to studies of Otezla as a potential treatment for COVID-19, 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. An outbreak of disease or similar public health threat, such as COVID-19, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse effect on the supply of materials for our manufacturing activities, the distribution of our products, the commercialization of our product candidates, and our clinical trial operations, and any such events may have a material adverse effect on our product development, product sales, business and results of operations. 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 collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to support the products or technology 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. Global economic conditions may magnify certain risks that affect our business. 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
Michael Strapazon, 805-313-5553 (Media)
Megan Fox, 805-447-1423 (Media)
Arvind Sood, 805-447-1060 (Investors)

i Sing C, Lin T, Bartholomew S, et al. Hip Fractures: Initial Report of Trends in Incidence, Treatment, and Mortality In Multiple Countries Using a Common Analytical Platform. Abstract presented at: American Society for Bone and Mineral Research Annual Meeting, October 1-4, 2021; San Diego, California.
ii Klotzbuecher CM, Ross, PD, Landsman, PB, et al. Patients with Prior Fractures Have an Increased Risk of Future Fractures: A Summary of the Literature and Statistical Synthesis. JBMR. 2010; 15:4, 721-739.
iii International Osteoporosis Foundation. Facts and Statistics. https://www.iofbonehealth.org/facts-statistics. Accessed September 7, 2021.
iv National Osteoporosis Foundation. Osteoporosis Fast Facts. https://cdn.nof.org/wp-content/uploads/2015/12/Osteoporosis-Fast-Facts.pdf. Accessed September 17, 2021.
v Cosman F, De beur SJ, Leboff MS, et al. Clinician's Guide to Prevention and Treatment of Osteoporosis. Osteoporos Int. 2014;25(10):2359-2381.

SOURCE Amgen

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