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UCB-Amgen Reveals Positive Data on Romosozumab for PMO

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UCB SA (UCBJF) and partner Amgen Inc. (AMGN) announced positive results from several exploratory analyses of a phase II study on romosozumab in postmenopausal women with low bone mineral density (:BMD).

Results from one analysis showed that romosozumab led to continued increase in lumbar spine BMD (15.7%) and total hip BMD (6%) during the second year of treatment, following a significant increase in BMD in these areas during the first 12 months of treatment. After two years of romosozumab therapy, patients were either transitioned to Amgen’s Prolia (for 12 months) or placebo. Data showed that Prolia led to further BMD increase in patients, while administration of placebo decreased their BMD toward the initial baseline.

Additionally, an analysis of the phase II study showed that after 12 months of treatment, patients receiving romosozumab achieved significantly greater improvements in cortical parameters of the vertebrae including thickness (11.2%), BMD (1.6%), mass (12.7%) and trabecular BMD (22.2%) compared to those receiving placebo or Eli Lilly’s (LLY) Forteo (open label).

Meanwhile, romosozumab is in an extensive global phase III program comprising two large studies (≥10,000 patients) to evaluate its potential in reducing the risk of fractures in patients suffering from osteoporosis. Results from this program should be out in 2016.

According to the National Osteoporosis Foundation, chances of bone fracture increases in women after menopause, since the rate of bone regeneration fails to counter the rate of bone depletion. Almost 50% of all women above the age of 50 years are prone to suffer an osteoporosis-related fracture, which makes them vulnerable to further fractures. This urgently calls for the development and approval of therapies for postmenopausal osteoporosis (PMO).

The above data were presented at the American Society for Bone and Mineral Research (:ASBMR) 2014 Annual Meeting.

Amgen’s Prolia is already approved in the U.S. for the treatment of PMO in women and for increasing bone mass in men with osteoporosis, who are at a high risk of fracture or are at risk of multiple factors for fracture, or who have failed or are intolerant to other available osteoporosis therapy. Prolia is also approved as a treatment to increase bone mass in women receiving therapy for breast cancer and in men receiving therapy for non-metastatic prostate cancer, who are at a high risk for fracture.

UCB carries a Zacks Rank #3 (Hold), while Amgen holds a Zacks Rank #2 (Buy). A well-placed stock in the biotech sector is Gilead Sciences Inc. (GILD), carrying a Zacks Rank #1 (Strong Buy).

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