Amgen (AMGN) to Highlight 19 Abstracts at ASBMR Meeting

September 7, 2016 4:06 PM EDT

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Amgen (NASDAQ: AMGN) today announced that it will present data from multiple studies for its investigational agent romosozumab and for Prolia® (denosumab) 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, along with new clinical data and real-world research on Prolia."

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.

Prolia presentations will include additional analyses from the three-year FREEDOM trial and its seven-year extension, further characterizing the long-term (up to 10 years) efficacy and safety of Prolia in postmenopausal women with osteoporosis, as well as real-world data showing long-term (two-year) persistence rates for Prolia and other osteoporosis therapies among postmenopausal women.

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

  • Fracture Risk Reduction With Romosozumab: Results of the Phase 3 FRAME Study (FRActure study in postmenopausal woMen with ostEoporosis) Abstract 1096, Oral Presentation, Sunday, Sept. 18, 9:45 a.m.-10 a.m. ET (Sidney Marcus Auditorium – Building A)

Romosozumab Pre-clinical Oral Presentation

  • Effects of Romosozumab on Remodeling and Bone Strength at the Distal Radius in Ovariectomized Cynomolgus MonkeysAbstract 1024, Oral Presentation, Friday, Sept. 16, 3:45 p.m.-4 p.m. ET (Room A411/412)

Romosozumab Abstract of Interest

  • Romosozumab Blocks the Binding of Sclerostin to the Two Key Wnt Signaling Co-receptors, LRP5 and LRP6, but not to LRP4Abstract MO0300, Poster Presentation, Monday, Sept. 19, 12:30 p.m.-2:30 p.m. ET (ASBMR Discovery Hall – Expo Hall A1)

Prolia Late-Breaking Abstract of Interest

  • Effects of Up to 10 Years of Denosumab Treatment on Bone Matrix Mineralization: Results From the FREEDOM ExtensionAbstract LB-1163, Late-Breaking Oral Presentation, Monday, Sept. 19, 11:48 a.m.-noon ET (Room A404/405)

Prolia Oral Presentations

  • Effect of 10 Years of Denosumab Treatment on Bone Histology and Histomorphometry in the FREEDOM Extension StudyAbstract 1005, Oral Presentation, Friday, Sept. 16, 1:45 p.m.-2 p.m. ET (Sidney Marcus Auditorium – Building A)
  • Discontinuation of Denosumab and Associated Fracture Incidence: Analysis From FREEDOM and its ExtensionAbstract 1100, Oral Presentation, Sunday, Sept. 18, 10:45 a.m.-11 a.m. ET (Sidney Marcus Auditorium – Building A)

Prolia Abstracts of Interest

  • The Risk of Subsequent Osteoporotic Fractures Is Decreased in Patients Experiencing Fracture While on Denosumab: Results From the FREEDOM and FREEDOM Extension Studies Abstract FR0288 and SA0288, Plenary Poster, Friday, Sept. 16, 5:30 p.m.-7 p.m. ET and Saturday, Sept. 17, 12:30 p.m.-2:30 p.m. ET (ASBMR Discovery Hall – Expo Hall A1)
  • Denosumab Treatment for 10 Years in Postmenopausal Women With Osteoporosis Was Associated With Substantially Lower Fracture Incidence Relative to Their Baseline FRAX-Predicted Probability Abstract FR0289 and SA0289, Plenary Poster, Friday, Sept. 16, 5:30 p.m.-7 p.m. ET and Saturday, Sept. 17, 12:30 p.m.-2:30 p.m. ET (ASBMR Discovery Hall – Expo Hall A1)
  • Fracture Risk After Discontinuation of Denosumab Abstract FR0294 and SA0294, Plenary Poster, Friday, Sept. 16, 5:30 p.m.-7 p.m. ET and Saturday, Sept. 17, 12:30 p.m.-2:30 p.m. ET (ASBMR Discovery Hall – Expo Hall A1)
  • Bone Microarchitecture After Discontinuation of Denosumab in Postmenopausal Women With Low Bone Mass Abstract SU0285, Poster Presentation, Sunday, Sept. 18, 12:30 p.m.-2:30 p.m. ET (ASBMR Discovery Hall – Expo Hall A1)
  • Denosumab (DMAb) and Total Lean Body Mass: Exploratory Analyses from the FREEDOM Study Abstract SU0286, Poster Presentation, Sunday, Sept. 18, 12:30 p.m.-2:30 p.m. ET (ASBMR Discovery Hall – Expo Hall A1)
  • Persistence with Osteoporosis Therapies in Postmenopausal Women in a Large US National Health Plan Abstract SU0296, Poster Presentation, Sunday, Sept. 18, 12:30 p.m.-2:30 p.m. ET (ASBMR Discovery Hall – Expo Hall A1)
  • Long-Term Persistence with Osteoporosis Therapies Among Postmenopausal Women in a Commercially-Insured Population in the United States Abstract SU0293, Poster Presentation, Sunday, Sept. 18, 12:30 p.m.-2:30 p.m. ET (ASBMR Discovery Hall – Expo Hall A1)

Osteoporosis Disease State Abstracts of Interest

  • Estimating the Long-Term Functional Burden of Osteoporosis-Related FracturesAbstract MO0243, Poster Presentation, Monday, Sept. 19, 12:30 p.m.-2:30 p.m. ET (ASBMR Discovery Hall – Expo Hall A1)
  • High Risk of Second Fracture Within 1, 2, 5 Years After Prior Fracture Among Women 65 years or Older Abstract FR0233 and SA0233, Plenary Poster, Friday, Sept. 16, 5:30 p.m.-7 p.m. ET and Saturday, Sept. 17, 12:30 p.m.-2:30 p.m. ET (Room ASBMR Discovery Hall – Expo Hall A1)
  • Prediction of Two-Year Risk of Fracture Among Older US WomenAbstract FR0237 and SA0237, Plenary Poster, Friday, Sept. 16, 5:30 p.m.-7 p.m. ET and Saturday, Sept. 17, 12:30 p.m.-2:30 p.m. ET (ASBMR Discovery Hall – Expo Hall A1)
  • Predictors of Imminent Fracture Risk in Medicare-Enrolled Men and WomenAbstract SU0227, Poster Presentation, Sunday, Sept. 18, 12:30 p.m.-2:30 p.m. ET (ASBMR Discovery Hall – Expo Hall A1)
  • Predictors of Imminent Risk of Non-Vertebral Fracture in Older Women: The Framingham Osteoporosis StudyAbstract MO0232, Poster Presentation, Monday, Sept. 19, 12:30 p.m.-2:30 p.m. ET (ASBMR Discovery Hall – Expo Hall A1)
  • Characteristics of Patients at High One-Year Fracture RiskAbstract MO0223, Poster Presentation, Monday, Sept. 19, 12:30 p.m.-2:30 p.m. ET (ASBMR Discovery Hall – Expo Hall A1)

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, M.D., 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).



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