Amgen And Lazarex Cancer Foundation Team Up To Allow More Diversity In Clinical Trials

THOUSAND OAKS, Calif. and SAN FRANCISCO, Dec. 10, 2018 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and the Lazarex Cancer Foundation, a non-profit organization focused on improving patient access to cancer clinical trials, today announced that they have teamed up to support more equitable access to clinical trials for cancer patients in the U.S. Through a corporate donation, Amgen has contributed $2 million to Lazarex's IMPACT (IMproving Patient Access to Cancer Clinical Trials) program, which is focused on improving patient enrollment, retention, minority participation and equitable access in oncology trials.

IMPACT aspires to create a new standard in clinical trial outreach allowing all cancer patients, regardless of their ability to pay for travel and other expenses, to participate in clinical trials evaluating new cancer treatment options. It also recognizes that higher enrollment in clinical trials overall may contribute to potential development of new cancer treatments and support participation of diverse patient populations.

"Clinical trials are critical to advancing new oncology treatments and can also serve as a lifeline for cancer patients who may only have a few options left," said Robert A. Bradway, chairman and chief executive officer at Amgen. "We are pleased to support the Lazarex Cancer Foundation's efforts to create more equitable access to clinical trials for cancer patients and improve minority participation in clinical trials, regardless of their circumstances."

According to Representation of Minorities and Women in Oncology Clinical Trials between the years of 2003 and 2016, 83 percent of 55,689 clinical trial enrollees were white, 6 percent were African-American, 5.3 percent were Asian, 2.6 percent were Hispanic, and 2.4 percent were classified as "other." ¹ 

"We commend Amgen's decision to join forces with Lazarex to support access to enrollment in clinical trial to diverse patients," said Dana Dornsife, founder of Lazarex Cancer Foundation. "Thanks to Amgen's support of IMPACT, we can optimize the resources we have and get all stakeholders working to provide more opportunities to patients and more opportunities for therapeutic advancement."

IMPACT recently concluded a three-year pilot study at Massachusetts General Hospital and Harvard University. During that time, it demonstrated a 29 percent increase in overall patient enrollment and doubled minority participation. IMPACT is presently launching at the University of California, San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center and the University of Southern California (USC) Norris Comprehensive Cancer Center with plans for further expansion in 2019. A study published in Cancer in 2014 found that only two percent of clinical trials run by the National Cancer Institute focus on any racial or minority population as their primary emphasis.²

About Amgen's Commitment to Oncology
Amgen Oncology is committed to helping patients take on some of the toughest cancers, such as those that have been resistant to drugs, those that progress rapidly through the body and those where limited treatment options exist. Amgen's supportive care treatments help patients combat certain side effects of strong chemotherapy, and our targeted medicines and immunotherapies focus on more than a dozen different malignancies, ranging from blood cancers to solid tumors. With decades of experience providing therapies for cancer patients, Amgen continues to grow its portfolio of innovative and biosimilar oncology medicines.

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.

About Lazarex Cancer Foundation
Lazarex Cancer Foundation is committed to improving the outcome of cancer care, giving hope, dignity and life to advanced stage cancer patients and the medically underserved by providing assistance with costs for FDA clinical trial participation, identification of clinical trial options, community outreach and engagement. We provide resources for cancer patients who have been told they have no other options, but who are not yet done with their journey in life and refuse to give up.

For more information, visit www.lazarex.org

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 its 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 Amgen project. Amgen's results may be affected by its 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 its products and global economic conditions. In addition, sales of Amgen's 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, Amgen's research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Amgen or others could identify safety, side effects or manufacturing problems with its products, including its devices, after they are on the market. Amgen's business may be impacted by government investigations, litigation and product liability claims. In addition, Amgen's business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. While Amgen routinely obtains patents for its products and technology, the protection offered by its patents and patent applications may be challenged, invalidated or circumvented by its competitors, or Amgen may fail to prevail in present and future intellectual property litigation. Amgen performs a substantial amount of its commercial manufacturing activities at a few key facilities, including in Puerto Rico, and also depends on third parties for a portion of its manufacturing activities, and limits on supply may constrain sales of certain of its current products and product candidate development. In addition, Amgen competes with other companies with respect to many of its 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 Amgen's products are supplied by sole third-party suppliers. Certain of Amgen's distributors, customers and payers have substantial purchasing leverage in their dealings with Amgen. The discovery of significant problems with a product similar to one of Amgen's products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on its business and results of operations. Amgen's efforts to acquire other companies or products and to integrate the operations of companies Amgen has acquired may not be successful. A breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of Amgen's systems and Amgen's data. Amgen's stock price may be volatile and may be affected by a number of events. Amgen's business performance could affect or limit the ability of the Amgen Board of Directors to declare a dividend or its ability to pay a dividend or repurchase its common stock. Amgen may not be able to access the capital and credit markets on terms that are favorable to it, or at all.

The scientific information discussed in this news release related to Amgen's product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration, and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates. Further, the scientific information discussed in this news release relating to new indications for Amgen's products is preliminary and investigative and is not part of the labeling approved by the U.S. Food and Drug Administration for the products. The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses.

CONTACT: Amgen, Thousand Oaks
Andrea Fassacesia, 805-590-2575 (media)
Trish Hawkins, 805-447-5631 (media)

CONTACT: Lazarex Cancer Foundation, San Francisco
Laura Evans Manatos, [email protected], 301-379-6028

References
1. Duma, N et al. "Representation of Minorities and Women in Oncology Clinical Trials: Review of the Past 14 Years". Journal of Oncology Practice.2018 14:1. e1-e10
2. Chen, MS et al. "Twenty Years Post-NIH Revitalization Act: Renewing the Case for Enhancing Minority Participation in Cancer Clinical Trials". Cancer. 2014 April 1; 120(0 7): 1091–1096. doi:10.1002/cncr.28575.

SOURCE Amgen

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