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Brussels, Belgium, 7th September, 2016, 07:00 – UCB (Euronext Brussels: UCB) and Amgen (NASDAQ: AMGN) today announced that they are presenting Phase 3 data for the 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, additional presentations will also highlight data providing key insights around the long-term burden of fractures and research related to identifying patients at increased risk of fracture.
“We look forward to presenting detailed data from the Phase 3 FRAME study of romosozumab at ASBMR which provide further understanding of the potential role of romosozumab in reducing the risk of fragility fractures,” said Dr Pascale Richetta, Head of Bone and Executive Vice President at UCB. “Fragility fractures are often the first sign of osteoporosis, a disease that remains underdiagnosed and undertreated. In addition, a fracture identifies a patient at high risk of a subsequent fracture and so should signal the need for physician intervention with the aim of helping patients live free from the worry of the next fracture.”
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 selected by the ASBMR scientific committee and given to the lead investigator. 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, September 18.
UCB and Amgen submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for romosozumab in July 2016. Romosozumab is being co-developed by UCB and Amgen.
The following is a guide to the UCB/Amgen sponsored data presentations.
Romosozumab Oral Presentations
Romosozumab Abstracts of Interest
Osteoporosis Abstracts of Interest
About Romosozumab
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, thereby 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 patients with osteoporosis. Romosozumab is being co-developed by UCB and Amgen.
About UCB
UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With more than 7,700 people in approximately 40 countries, the company generated revenue of € 3.9 billion in 2015. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news.
About the UCB and Amgen 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.
Forward looking statements – UCB
This press release contains forward-looking statements based on current plans, estimates and beliefs of management. 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 information, expected legal, political, regulatory or clinical results and other such estimates and results. By their nature, such forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions which could cause actual results to differ materially from those that may be implied by such forward-looking statements contained in this press release. Important factors that could result in such differences include: changes in general economic, business and competitive conditions, the inability to obtain necessary regulatory approvals or to obtain them on acceptable terms, costs associated with research and development, changes in the prospects for products in the pipeline or under development by UCB, effects of future judicial decisions or governmental investigations, product liability claims, challenges to patent protection for products or product candidates, changes in laws or regulations, exchange rate fluctuations, changes or uncertainties in tax laws or the administration of such laws and hiring and retention of its employees. UCB is providing this information as of the date of this press release and expressly disclaims any duty to update any information contained in this press release, either to confirm the actual results or to report a change in its expectations.
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For further Information
France Nivelle, Global Communications, UCB, T +32.2.559.9178, france.nivelle@ucb.com
Scott Fleming, Communications Director, Bone, UCB, T +44.7702 777378, scott.fleming@ucb.com
Laurent Schots, Media Relations, UCB, T+32.2.559.92.64, laurent.schots@ucb.com
Antje Witte, Investor Relations, UCB, T +32.2.559.94.14, antje.witte@ucb.com
Isabelle Ghellynck, Investor Relations, UCB, T +32.2.559.9588, isabelle.ghellynck@ucb.com
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