Amgen (NASDAQ: AMGN) today announced that it will present data from several romosozumab and Prolia® (denosumab) studies at the American Society for Bone and Mineral Research (ASBMR) 2013 Annual Meeting in Baltimore from Oct. 4-7, 2013.
Romosozumab data include results from the Phase 2 study that demonstrate significant increases in volumetric bone mineral density. Romosozumab is being developed in collaboration with UCB. Prolia data include 19 abstracts, featuring several on long-term safety and efficacy data from the open-label extension study of the pivotal Phase 3 fracture trial for up to eight years.
"We are very encouraged by the long-term safety and efficacy data with Prolia treatment as well as by the clinical data we see from our pipeline bone-building molecule, romosozumab," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "Amgen has led nearly a decade of clinical work in bone biology and, with fracture rates on the rise, we remain committed to advancing medicines that help treat bone disease."
SELECTED ABSTRACTS OF INTEREST INCLUDE:
Abstracts are available on the ASBMR website at www.asbmr.org and updated data will be presented at the meeting.
Prolia Abstracts of Interest:
Eight Years of Denosumab Treatment in Postmenopausal Women With Osteoporosis: Results From the First Five Years of the FREEDOM Extension
Abstract LB-MO26, Late Breaking Abstract Session, Monday, Oct. 7, 10:35 – 10:40 a.m. EDT (Discovery Hall-Hall C)
Denosumab Significantly Increases Bone Mineral Density Compared With Ibandronate and Risedronate in Postmenopausal Women Previously Treated With an Oral Bisphosphonate Who are at Higher Risk for Fracture
Abstract 1018, Oral Presentation, Saturday, Oct. 5, 8:15 – 8:30 a.m. EDT (Hall A)
Further Reduction in Nonvertebral Fracture Rate Is Observed Following Three Years of Denosumab Treatment: Results With Up to Seven Years in the FREEDOM Extension
Abstract 1017, Oral Presentation, Saturday, Oct. 5, 8:00 – 8:15 a.m. EDT (Hall A)
Romosozumab Abstract of Interest:
Effect of Romosozumab on Lumbar Spine and Hip Volumetric Bone Mineral Density (vBMD) as Assessed by Quantitative Computed Tomography (QCT)
Study 20060326, Oral Presentation, Saturday, Oct. 5, 9:15 – 9:30 a.m. EDT (Hall A)
Postmenopausal osteoporosis (PMO) affects many women after menopause and is a disease that weakens bones over time, making them thinner and more likely to break.
In PMO, bone-removing cells get rid of bone at a rate that is too fast. This puts postmenopausal women with osteoporosis at risk for breaking a bone. Such a break, or fracture, may be a life-changing event. About half of all women over age 50 will have an osteoporosis-related fracture, and once that happens, the chances of another are much higher. According to the National Osteoporosis Foundation, women who have suffered a hip fracture are at a four-times greater risk of a second one.
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.
Osteoporosis-related fractures are responsible for an estimated $19 billion in costs annually in the U.S., and are expected to rise to approximately $25 billion by 2025. 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.