THOUSAND OAKS, Calif., Sept. 10 /PRNewswire-FirstCall/ -- Amgen (Nasdaq: AMGN) today announced that new data will be presented on the burden of osteoporosis, current osteoporosis treatment challenges and Prolia(TM) (denosumab) at the 2009 American Society for Bone and Mineral Research (ASBMR) annual meeting in Denver from Sept. 11-15, 2009. Prolia currently is being evaluated by regulatory bodies in the United States (U.S.), the European Union, Switzerland, Australia and Canada as a potential therapy for postmenopausal osteoporosis and bone loss in patients undergoing hormone ablation for prostate and breast cancer.
"The continued need for new alternatives to treat postmenopausal osteoporosis is reinforced by data that will be presented at this year's ASBMR meeting. These data highlight challenges with adherence to therapy and show the link between adherence and fracture outcomes," said Roger M. Perlmutter, M.D., Ph.D., executive vice president for Research and Development at Amgen. "Clinical data that will be presented at the meeting include a Phase 3 study sub-analysis showing Prolia's effect on fracture reduction in woman at a greater risk for fracture, 6-year efficacy and safety data from a Phase 2 study, and bone histology data."
ASBMR abstracts are available and can be viewed online at www.asbmr.org. Identified below are selected abstracts of interest on Amgen research.
-- Effects of Denosumab on Bone Mineral Density and Biochemical Markers of Bone Turnover: 6 Year Results of a Phase 2 Clinical Trial
Lead Author: Miller P
Abstract No. 1026 (Saturday, Sept. 12, 2009, 10:15am MT)
-- Effects of Denosumab on Bone Histomorphometry: the FREEDOM and STAND Studies Lead Author: Reid IR
Abstract No. 1027 (Saturday, Sept. 12, 2009, 10:30am MT)
-- Effect of Denosumab on the Incidence of Hip, New Vertebral, and Nonvertebral Fractures Over 3 Years Among Postmenopausal Women with Higher Fracture Risk: A Subgroup Analysis From the FREEDOM Study
Lead Author: Boonen S
Abstract No. 1199 (Monday, Sept. 14, 2009, 3:00pm MT)
-- Effects of Denosumab Treatment and Discontinuation on Bone Mineral Density and Bone Turnover Markers in Postmenopausal Women With Low Bone Mass
Lead Author: Bone H
Abstract No. 1243 (Monday, Sept. 14, 2009, 5:30pm MT)
-- Baseline Remodeling Intensity and Greater Suppression by Denosumab Than Alendronate: Effects on HR-pQCT Parameters at the Radius
Lead Author: Seeman SE
Abstract No. 1244 (Monday, Sept. 14, 2009, 5:45pm MT)
-- Evaluation of Health-Related Quality of Life in Postmenopausal Women Who Participated in the FREEDOM Trial
Lead Author: Siris E
Abstract No. 1282 (Tuesday, Sept. 15, 2009, 11:15am MT)
-- Increases in BMD on Denosumab Explains Much of the Reduction in Fracture Risk
Lead Author: Cummings SR
Abstract No. 1284 (Tuesday, Sept. 15, 2009, 11:45am MT)
Osteoporosis Burden and Treatment Challenges
-- Impact of Treatment Satisfaction (Perceived Benefits, Convenience, Side Effects) on Persistence with Postmenopausal Osteoporosis (PMO) Therapy
Lead Author: Do T
Abstract No. SA0317 (Saturday, Sept. 12, 2009, 11:30 am MT)
-- Impact of Adherence to Osteoporosis Medication on Risk of Fracture
Lead Author: Halpern R.
Abstract No. SA0368 (Saturday, Sept. 12, 2009, 11:30 am MT)
-- Association Between Adherence to Osteoporosis Medication and Inpatient Stays and Medical Services Costs
Lead Author: Iqbal SU
Abstract No. SU0387 (Sunday, Sept. 13, 2009, 11:30 am MT)
-- Comorbidities, Bone Loss and Concomitant Medication Use in European Postmenopausal Women: POSSIBLE EU
Lead Author: Freemantle N
Abstract No. MO0369 (Monday, Sept. 14, 2009, 12:00pm MT)
-- Assessment of Patient Preference, Satisfaction, and Bother with Two Treatments For Postmenopausal Bone Loss
Lead Author: Gold DT
Abstract No. MO0369 (Monday, Sept. 14, 2009, 12:00pm MT)
About Prolia(TM) (denosumab)
Prolia is the first fully human monoclonal antibody in late stage clinical development that specifically targets RANK Ligand, an essential regulator of osteoclasts (the cells that break down bone). Prolia is being investigated for its potential to inhibit all stages of osteoclast activity through a targeted mechanism. Prolia is being studied in a range of bone loss conditions including postmenopausal osteoporosis and bone loss in patients undergoing hormone ablation for prostate and breast cancer.
In February 2009, the U.S. Food and Drug Administration (FDA) accepted the Biologics License Application (BLA), submitted by Amgen for Prolia for the treatment and prevention of osteoporosis in postmenopausal women and cancer treatment-induced bone loss in women and men receiving hormone therapy for either breast cancer or prostate cancer based on these studies and a parallel trial in women with breast cancer. The FDA has provisionally approved the trade name Prolia in these proposed indications, for which denosumab is administered twice yearly subcutaneously at a 60mg dose. The trade name is only for these indications and may not apply for other indications of denosumab.
Amgen has also submitted marketing applications for use of Prolia in the European Union, Canada, Switzerland, and Australia.
Osteoporosis: Impact and Prevalence
Often referred to as the "silent epidemic," osteoporosis is a global problem that is increasing in significance as the population of the world both increases and ages. The World Health Organization (WHO) has recently identified osteoporosis as a priority health issue along with other major non-communicable diseases.
The economic burden of osteoporosis is comparable to that of other major chronic diseases; for example, in the U.S., the costs associated with osteoporosis-related fractures are equivalent to those of cardiovascular disease and asthma.(i,ii,iii) It has been reported that osteoporosis results in more hospital bed-days than stroke, myocardial infarction or breast cancer.(iv)
Amgen discovers, develops, manufactures and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe and effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. To learn more about our pioneering science and our vital medicines, visit www.amgen.com.
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i. Burge R, et al. J Bone Miner Res. 2007; 22:465-475
ii. "Osteoporosis Fast Facts." National Osteoporosis Foundation. Accessed on August 19, 2009 at http://www.nof.org/osteoporosis/diseasefacts.htm
iii. "Economic Cost of Cardiovascular Diseases." American Heart Association. Accessed on February 24, 2009 at http://www.americanheart.org/statistics/10econom.html.
iv. Lippuner K, et al. "Incidence and direct medical costs of hospitalisations due to osteoporotic fractures in switzerland." Osteoporosis International.1997;7:414-25.
CONTACT: Amgen, Thousand Oaks Sarah Reines: (805) 447-9783 (U.S. media) Arvind Sood: (805) 447-1060 (investors)
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