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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

  • Fracture Risk Reduction With Romosozumab: Results of the Phase 3 FRAME Study (FRActure study in postmenopausal woMen with ostEoporosis). Abstract 1096, Oral Presentation, [Sunday], September 18, 09:45. ET
  • Effects of Romosozumab on Remodeling and Bone Strength at the Distal Radius in Ovariectomized Cynomolgus Monkeys. Abstract 1024, Oral Presentation, [Friday] September 16, 15:45. ET

Romosozumab Abstracts of Interest

  • Romosozumab Blocks the Binding of Sclerostin to the Two Key Wnt Signaling Co-receptors, LRP5 and LRP6, but not to LRP4. Abstract MO0300, Poster Presentation, [Monday], September 19, 12:30-14:30. ET

Osteoporosis Abstracts of Interest

  • Estimating the Long-Term Functional Burden of Osteoporosis-Related Fractures, Abstract MO0243, Poster Presentation, [Monday], September 19, 12:30-14:30 ET
  • High Risk of Second Fracture within 1, 2, 5 years after Prior Fracture among Women 65 years or Older, Abstract FR0233, Poster Presentations, [Friday] September 16, 17:30-19:00 ET and Abstract SA0233, Poster Presentation, [Saturday] September 17, 12:30-14:30 ET
  • Prediction of two-year risk of fracture among older US women, Abstract FR0237, Poster Presentations, [Friday] September 16, 17:30-19:00 ET and Abstract SA0237, Poster Presentation, [Saturday] September 17, 12:30-14:30 ET 
  • Predictors of Imminent Risk of Non-Vertebral Fracture in Older Women: The Framingham Osteoporosis Study, Abstract MO0232, Poster Presentation, [Monday], September 19, 12:30-14:30 ET
  • Predictors of Imminent Fracture Risk in Medicare-enrolled Men and Women, Abstract SU0227, Poster Presentation, [Sunday], September 18, 12:30-14:30 ET
  • Characteristics of Patients at High One-year Fracture Risk, Abstract MO0223, [Monday], September 19, 12:30-14:30 ET
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