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Amgen Presents Several Sub-Analyses At ASBMR From The Ongoing Open-Label Extension Study Of The Pivotal Phase 3 Prolia Fracture Trial

THOUSAND OAKS, Calif., Oct. 14, 2012 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that it has presented data from several Prolia ® (denosumab) studies, including data from the open-label extension study of the pivotal Phase 3 fracture trial, which showed continued increases in bone mineral density (BMD) and low fracture incidence over six years. These data, and those from several key studies, were presented at the American Society for Bone and Mineral Research (ASBMR) 2012 Annual Meeting in Minneapolis from Oct. 12-15, 2012. 

"The data presented provide additional insight into the long-term clinical profile of Prolia," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "Given the increasing burden of osteoporosis in an aging population, it is important to see that continued Prolia therapy may provide ongoing benefit."

SELECTED ABSTRACTS OF INTEREST INCLUDE:Abstracts are available on the ASBMR website at www.asbmr.org and updated data have been presented at the meeting.

  • Relationship Between Changes in Bone Mineral Density (BMD) and Incidence of Fracture with 6 Years of Denosumab TreatmentLead Author: PD Miller, M.D., University of Colorado Health Science Center and Colorado Center for Bone Research(Abstract No. 1099; Oral Presentation; October 14)
    • Nearly all women who received six years of denosumab treatment showed gains in BMD at the lumbar spine, total hip or femoral neck: 95 percent demonstrated gains of greater than six percent at any of these sites. The risk for new or worsening vertebral fracture and nonvertebral fracture decreased with increasing percentage change in total hip BMD over six years.
  • Long-term Denosumab Treatment Maintains Low Incidence of Fracture in Postmenopausal Women >75 Years with Osteoporosis Lead Author: S. Papapoulos, M.D., Leiden University Medical Center (Abstract No. FR0391; Plenary Poster; October 12)
    • Despite the increase in age of the patients during the pivotal Phase 3 fracture study extension, denosumab treatment continued to be associated with a low incidence of new vertebral, nonvertebral and hip fractures.
    • The incidence of fractures in patients > 75 years in the study extension was similar to what was originally observed in women older than 75 years in the original pivotal Phase 3 fracture study.
  • Effects of 5 Years of Denosumab on Bone Histology and Histomorphometry: FREEDOM Study ExtensionLead Author: JP Brown, M.D., Laval University and CHUQ(Abstract No. 1134; Oral Presentation; October 14)
    • Denosumab treatment through five years resulted in normal bone quality with reduced bone turnover, consistent with its mechanism of action.

About OsteoporosisOsteoporosis, which causes more than 2 million bone breaks each year, is a growing concern among health professionals as more than 40 million people are either living with, or at risk for developing, the disease. The World Health Organization has officially declared osteoporosis a public health crisis, while the International Osteoporosis Foundation urges governments worldwide to make osteoporosis a healthcare priority.

In the United States (U.S.), the number of fractures due to osteoporosis is expected to rise to more than 3 million by 2025. 1 In 2000, the number of osteoporotic fractures in Europe was estimated at 3.79 million, of which 890,000 were hip fractures. 2 Since 2001, the incidence of hip fractures in European countries has risen significantly. 3

In 2005, osteoporosis-related fractures were responsible for an estimated $19 billion in cost in the U.S., and this cost is expected to rise to approximately $25 billion by 2025. 1 The direct medical cost of osteoporotic fractures in Europe is expected to rise from €31.7 billion in 2000 to €76.7 billion in 2050. 2

About ProliaProlia is the first approved therapy that specifically targets RANK Ligand, an essential regulator of osteoclasts (the cells that break down bone).

Prolia is approved in the U.S. for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy.

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