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UCB (UCBJF) and Amgen Inc. (AMGN - Analyst Report) 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 concerned.
However, UCB and Amgen said that they will continue studying CDP7851/AMG785 for the treatment of postmenopausal osteoporosis (PMO).
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 placebo.
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, Targacept, Inc. (TRGT - Snapshot Report) and Salix Pharmaceuticals Ltd. (SLXP - Analyst Report) look more attractive with a Zacks Rank #1 (Strong Buy).