Amgen’s (AMGN - Analyst Report) romosozumab (AMG 785/CDP7851) is one of the most promising and interesting candidates in the company’s pipeline. Romosozumab works by inhibiting the protein sclerostin, thereby leading to an increase in bone formation and decrease in bone breakdown in women post-menopause.
Amgen is developing romosozumab for the treatment of low bone mineral density (BMD) in collaboration with UCB.
Amgen and UCB recently released positive data on romosozumab from a multicenter randomized placebo-controlled phase II trial (n=419). The data was published in the New England Journal of Medicine. The data from the trial showed that romosozumab increased BMD at the lumbar spine, total hip and femoral neck region after 12 months of treatment as compared to placebo.
In addition, treatment with romosozumab resulted in greater increases in bone mineral density when compared to current treatments like Merck & Co, Inc.’s (MRK - Analyst Report) Fosamax and Eli Lilly’s (LLY - Analyst Report) Forteo.
Meanwhile, a phase III program for romosozumab is currently under progress for the treatment of BMD post menopause.
The program will evaluate approximately 10,000 postmenopausal osteoporosis patients in two pivotal phase III studies.
We remind investors that UCB and Amgen discontinued their development program on romosozumab for the acceleration of fracture healing in 2013. UCB/Amgen’s decision was based on phase II data and regulatory guidance on fracture healing programs. The safety profile was not an issue where the decision to discontinue the program was concerned.
Amgen carries a Zacks Rank #3 (Hold). At current levels, Isis Pharmaceuticals looks attractive with a Zacks Rank #2 (Buy).