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Amgen Joins With Community Oncology Networks For New Research Collaboration

Amgen Community Oncology Research Collaborators (ACORC) Will Work to Expand Clinical Trial Access to Cancer Patients Treated Outside of Academic Centers

First Members Include US Oncology Research and TRIO-US With UCLA

THOUSAND OAKS, Calif., May 28, 2019 /PRNewswire/ -- Amgen (AMGN), along with leading community oncology networks, today announced the launch of Amgen Community Oncology Research Collaborators (ACORC), a new initiative to enhance access by community centers to innovative oncology clinical research. Fewer than one in 20 adult cancer patients in the U.S. have participated in a clinical trial.1 The collaboration will allow Amgen to significantly expand its clinical research footprint to more than 200 patient care sites across the U.S. and help community centers reach more than 900,000 new patients each year with investigational medicines.

"About 80 percent of cancer patients across the U.S. are treated outside of an academic institute by a community oncologist, making it critical to expand clinical trials to include patients in the community setting,2" said Darryl Sleep, M.D., senior vice president of Global Medical and chief medical officer at Amgen. "Community oncologists are on the frontline and have significant insights that are instrumental in informing cancer research and clinical trials. By leveraging our collective expertise, Amgen hopes to expand our clinical research footprint to bring innovative trials to community centers as quickly as possible."

US Oncology Research and Translational Research In Oncology-US, Inc. (TRIO-US) and its joint work with the University of California, Los Angeles (UCLA) Clinical Research Unit have signed on as the first ACORC participants, with plans to include additional networks in 2019. This collaboration will provide community oncologists the opportunity to have their patients participate in clinical trials of investigational agents from Amgen's pipeline — including bispecific T cell engager (BiTE®) antibody constructs and novel small molecules. In addition, the collaboration will offer the opportunity to generate data through real-world evidence studies on currently available oncology products.

"US Oncology Research allows community-based oncologists to participate in clinical research studies at more than 155 locations across the country," said Michael Seiden, M.D., Ph.D., president, The US Oncology Network. "This collaboration will help include more patients in research designed to evaluate innovative investigational molecules. In turn, we look forward to sharing insights from these trials to help the development of new oncology medicines."

"We're excited to sign on as an ACORC participant to provide our physicians access to studies of new and potentially transformative investigational targets," said John Glaspy, M.D., M.P.H., TRIO director and member of the UCLA Jonsson Comprehensive Cancer Center. "With roots in Southern California, we look forward to working with our neighbors at Amgen now and into the future as we look to provide the best options to people living with cancer."

About Amgen Oncology
Amgen Oncology is searching for and finding answers to incredibly complex questions that will advance care and improve lives for cancer patients and their families. Our research drives us to understand the disease in the context of the patient's life – not just their cancer journey – so they can take control of their lives.

For the last four decades, we have been dedicated to discovering the firsts that matter in oncology and to finding ways to reduce the burden of cancer. Building on our heritage, Amgen continues to advance the largest pipeline in the Company's history, moving with great speed to advance those innovations for the patients who need them.

At Amgen, we are driven by our commitment to transform the lives of cancer patients and keep them at the center of everything we do.   

For more information, follow us on www.twitter.com/amgenoncology.

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 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 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. 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
Kristen Davis, 805-447-3008 (Media)
Trish Hawkins, 805-447-5631 (Media)
Arvind Sood, 805-447-1060 (Investors)

References

  1. American Cancer Society. The Basics of Clinical Trials. Available at: https://www.cancer.org/treatment/treatments-and-side-effects/clinical-trials/what-you-need-to-know/clinical-trial-basics.html. Accessed on May 3, 2019.
  2. Amgen Data on File.

 

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