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Results From Phase 3 FRAME Study of Romosozumab Evaluate Fracture Risk Reduction in Women With Postmenopausal Osteoporosis
THOUSAND OAKS, Calif. (Sept. 7, 2016) – Amgen (NASDAQ:AMGN) today announced that it will present data from multiple studies for its investigational agent romosozumab at the Annual Meeting of the American Society for Bone and Mineral Research (ASBMR) in Atlanta on Sept. 16-19, 2016. At the congress, Amgen will highlight a diverse set of data across its osteoporosis clinical programs, as well as real-world data that provide important insights on living with osteoporosis and underscore the Company’s commitment to pioneering novel treatment options that can help reduce fracture risk.
“As a leader in bone biology, Amgen is committed to translating innovative science into treatments that make a difference in the lives of people,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “The breadth and depth of clinical and real-world data we’re presenting at ASBMR demonstrates our commitment to finding potential options for patients with osteoporosis. We look forward to sharing detailed data from our Phase 3 FRAME study of romosozumab.”
The romosozumab FRAME abstract, “Fracture Risk Reduction With Romosozumab: Results of the Phase 3 FRAME Study (FRActure study in postmenopausal woMen with ostEoporosis),” has been awarded the 2016 ASBMR Most Outstanding Clinical Abstract Award, which is given to the lead investigator of the highest ranking abstract submitted to a clinical category for presentation at the ASBMR Annual Meeting. Lead author Dr. Felicia Cosman, medical director of the Clinical Research Center at Helen Hayes Hospital, professor of Medicine at Columbia University College of Physicians and Surgeons in New York, will be presented with the award on Sunday, Sept. 18.
Osteoporosis disease-state study presentations will provide key insights on unmet needs among patients at high risk for fracture.
Romosozumab is being co-developed by Amgen and UCB.
SELECTED ABSTRACTS OF INTEREST
Romosozumab Oral Presentation
Romosozumab Pre-clinical Oral Presentation
Romosozumab Abstract of Interest
Osteoporosis Disease State Abstracts of Interest
Amgen Webcast Investor Call
Amgen will host a webcast call for the investment community on Monday, Sept. 19, 2016, at 11:30 a.m. ET. Sean E. Harper, M.D., executive vice president of Research and Development at Amgen, along with members of Amgen's clinical development team and clinical investigators, will participate in the call to discuss Amgen's clinical data presented at ASBMR, including the romosozumab Phase 3 study (FRAME).
Live audio of the investor call will be simultaneously broadcast over the Internet and will be available to members of the news media, investors and the general public.
The webcast, as with other selected presentations regarding developments in Amgen's business given by management at certain investor and medical conferences, can be found on Amgen's website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen's Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.
Osteoporosis affects many women after menopause as their ability to form new bone cannot counter balance the rate at which bone is being removed.1,2 This bone loss leads to weakened bones over time, increasing the potential for a break.3
It is estimated that one in three women over the age of 50 will experience an osteoporotic fracture.4,5 Patients who experience an osteoporosis-related fracture are twice as likely to experience a future fracture.6
The World Health Organization has officially declared osteoporosis a public health crisis,7,8 and the International Osteoporosis Foundation urges governments worldwide to make osteoporosis a healthcare priority.9
Romosozumab is an investigational bone-forming agent and is not approved by any regulatory authority for the treatment of osteoporosis. It is designed to work by inhibiting the protein sclerostin, and has a dual effect on bone, both increasing bone formation and decreasing bone breakdown. Romosozumab is being studied for its potential to reduce the risk of fractures in an extensive global Phase 3 program. This program includes two large fracture trials comparing romosozumab to either placebo or active comparator in more than 10,000 postmenopausal women with osteoporosis. Amgen and UCB are co-developing romosozumab.
About the Amgen and UCB Collaboration
Since 2004, Amgen and UCB have been working together under a collaboration and license agreement to research, develop and market antibody products targeting the sclerostin protein. As part of this agreement, the two companies continue to collaborate on the development of romosozumab for the treatment of osteoporosis. This gene-to-drug project demonstrates how Amgen and UCB are joining forces to turn genetic discoveries into new medicine, turning conceptual science into a reality. If approved, Amgen will lead romosozumab commercialization in the United states, Canada, Mexico and Japan, and UCB will lead commercialization in all EU member countries, as well as Switzerland, Norway, Australia and New Zealand.
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 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.
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CONTACT: Amgen, Thousand Oaks
Kristen Davis, 805-447-3008 (media)
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