Patients Transitioned From Fosamax(R) To Denosumab Achieved Greater Gains In Bone Mineral Density Vs Those Continuing On Alendronate

Amgen (NASDAQ:AMGN) announced full data
results from a non-pivotal Phase 3 head-to-head, double-blind trial comparing bone
mineral density (BMD) gains in postmenopausal women with low bone mass who
transitioned from weekly oral alendronate (Fosamax®) to denosumab versus those who
continued alendronate therapy. In addition, patient preference data from another nonpivotal
head-to-head trial comparing denosumab to weekly oral alendronate were
announced today at the 2008 American Society of Bone and Mineral Research
(ASBMR) Annual Meeting in Montreal.



"Data from these trials highlight the potential for a new treatment option for the millions
of postmenopausal women worldwide with osteoporosis," said Roger M. Perlmutter,
M.D., Ph.D., executive vice president of Research and Development at Amgen. "In the
bisphosphonate transition study, it is particularly exciting to see significant bone density
gains in patients on denosumab who previously were treated with alendronate, as this
type of result has not been reported in any previous study transitioning patients from
one bisphosphonate to another. We believe these data coupled with data from a
separate Phase 3 head-to-head trial that reported patient preference for twice-yearly
subcutaneous injections versus a weekly oral therapy suggest denosumab offers the
promise to be a welcome new option for patients."


Effect of Denosumab versus Alendronate on Bone Mineral Density (BMD) and
Bone Turnover Markers (BTM) and Safety in Women Previously Treated with
Alendronate (Abstract # 646)


Data presented from the bisphosphonate transition study, also known as the STAND
(Study of Transitioning from AleNdronate to Denosumab) trial, demonstrated that subcutaneous injections of denosumab every six months achieved significantly greater
increases in BMD versus those achieved with alendronate at all sites measured. For the
primary endpoint, denosumab resulted in significant increases in BMD at the total hip
compared with alendronate (1.9 percent vs. 1.05 percent, p







Preference and Satisfaction with a 6-monthly Subcutaneous Injection Versus a
Weekly Tablet for Treatment of Low Bone Mass (Abstract # 434)



As part of the DECIDE (Determining Efficacy: Comparison of Initiating Denosumab vs.
AlEndronate) trial, patients were given a questionnaire after 12 months of treatment to
gauge preference on mode of administration as well as satisfaction with frequency of
dosing of twice-yearly subcutaneous injections versus weekly oral tablet. More than
three-quarters of patients in both study arms preferred subcutaneous injection over oral
pills (77 percent vs. 23 percent, p