) recently announced their decision to discontinue a phase III
program being conducted with CDP7851/AMG785 (romosozumab) for the
acceleration of fracture healing. UCB/Amgen's decision was based
on phase II data and regulatory guidance on fracture healing
programs. Full phase II results will be presented shortly.
The companies pointed out that the safety profile was not an
issue where the decision to discontinue the program was
However, UCB and Amgen said that they will continue studying
CDP7851/AMG785 for the treatment of postmenopausal osteoporosis
In Apr 2011, Amgen and UCB had announced positive phase II
top-line results on CDP7851/AMG785. The phase II study compared
CDP7851/AMG785 to placebo in postmenopausal women with low bone
mineral density (BMD) for the treatment of PMO.
CDP7851/AMG785 met its primary endpoint and showed a
significant increase in lumbar spine BMD at month 12 compared to
A phase III program for CDP7851/AMG785 is currently under
progress for the treatment of PMO.
The program will evaluate approximately 10,000 PMO patients in
two pivotal phase III studies. The first study is placebo
controlled and will evaluate the incidence of new vertebral
fractures at 12 and 24 months in 6,000 patients. The second is an
active controlled study versus alendronate that will evaluate the
occurrence of clinical fracture and new vertebral fracture at 12
and 24 months in 4,000 patients. Results from the phase III
program should start coming out by the end of 2015.
We expect investor focus to remain on CDP7851/AMG785 for the
treatment of PMO. Both UCB and Amgen carry a Zacks Rank #3
(Hold). Right now,
Salix Pharmaceuticals Ltd.
) look more attractive with a Zacks Rank #1 (Strong Buy).
AMGEN INC (AMGN): Free Stock Analysis Report
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