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  • Sun, Nov. 13, 7:52 PM
    • Results from a Phase 3 clinical trial, BRIDGE, assessing Amgen (NASDAQ:AMGN) and co-developer UCB's (OTCPK:UCBJF)(OTCPK:UCBJY) romosozumab (AMG 785) in men with osteoporosis showed statistically significant bone mineral density (BMD) gains compared to placebo. The data were presented at the American College of Rheumatology and Association of Rheumatology Health Professionals Annual Meeting in Washington, D.C.
    • The study randomized 245 men 2:1 to receive either 210 mg romosozumab or placebo subcutaneously once per month for 12 months. The primary endpoint, the increase in BMD at the lumbar spine at Month 12 versus placebo, was achieved (12.1%; p<0.01). All secondary endpoints were also met.
    • Romosozumab is a monoclonal antibody that inhibits sclerostin, a protein that has anti-anabolic effects on bone formation. It has a dual effect of increasing bone formation and decreasing bone breakdown.
    • Worldwide, 20% of men over the age of 50 will experience an osteoporosis-related fracture.
    • The companies plan to discuss the data with global regulatory authorities.
    • Previously: Amgen's romosozumab successful in late-stage study in men with osteoporosis (March 21)
    | Sun, Nov. 13, 7:52 PM
  • Fri, Jul. 22, 7:58 AM
    • Amgen (NASDAQ:AMGN) files a Biologics License Application (BLA) with the FDA seeking approval of romosozumab for the treatment of osteoporosis in postmenopausal women at increased risk of fracture.
    • Romosozumab is a monoclonal antibody that inhibits sclerostin, a protein that has anti-anabolic effects on bone formation. It has a dual effect of increasing bone formation and decreasing bone breakdown.
    • The company is co-developing the product with Belgium's UCB (OTCPK:UCBJF)(OTCPK:UCBJY).
    | Fri, Jul. 22, 7:58 AM
  • Mon, Mar. 21, 7:20 AM
    • Amgen (NASDAQ:AMGN) and co-developer UCB (OTCPK:UCBJF)(OTCPK:UCBJY) announce that the Phase 3 study, BRIDGE, assessing romosozumab in men with osteoporosis met its primary endpoint of a statistically significant increase in bone mineral density (BMD) at the lumbar spine compared to placebo at month 12.
    • All secondary endpoints were also met. Subjects receiving romosozumab showed statistically valid increases in BMD at the femoral neck and total hip at month 12 and statistically valid increases in BMD at the lumbar spine, femoral neck and total hip at month 6, both versus placebo.
    • The study enrolled 245 men who were randomized 2:1 to receive either a monthly subcutaneous injection of romosozumab (210 mg) or placebo for 12 months.
    • The incidence of adverse events was comparable between the arms. The most frequent (>5%) were nasopharyngitis, back pain, hypertension, headache and constipation. Injection site reactions were reported in 5.5% of patients in the romosozumab cohort compared to 3.7% in the placebo group. Most were mild in severity. The incidence of confirmed cardiovascular (CV) serious adverse events (SAEs) was 4.9% (n=8/163) for romosozumab and 2.5% (n=2/81) for placebo. Both arms had one confirmed CV death.
    • The results will be submitted for presentation at a future medical conference. The companies intend to discuss the data with global regulators.
    • Romosozumab is a monoclonal antibody that inhibits sclerostin, a protein that has anti-anabolic effects on bone formation. It has a dual effect of increasing bone formation and decreasing bone breakdown.
    • Related ticker: (NASDAQ:RDUS)(NYSE:LLY)
    | Mon, Mar. 21, 7:20 AM | 8 Comments
  • Dec. 28, 2011, 3:02 AM

    Immunomedics (IMMU) and UCB (UCBJF.PK) tweak their pact for developing and marketing epratuzumab, a drug for lupus, cancer and other diseases. The changes predominately concern marketing rights. UCB also gets a five-year warrant to buy 1M Immunomedics shares at $8 apiece; IMMU currently at $3.37.

    | Dec. 28, 2011, 3:02 AM