UCB S.A. (UCBJF) - OTCPK - Current
  • 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
  • Fri, Feb. 26, 7:29 AM
    • Belgian biotech UCB S.A. (OTCPK:UCBJF) terminates its May 2006 collaboration deal with Immunomedics (NASDAQ:IMMU) to develop and commercialize epratuzumab for the treatment of all non-cancer indications worldwide. The move was not unexpected since the monoclonal antibody failed two late-stage studies in systemic lupus erythematosus in July.
    • CEO Cynthia Sullivan says, "The return of the worldwide rights of epratuzumab for all non-cancer indications allow us to examine all options to maximize its value, not only in oncology but also in autoimmune diseases. Epratuzumab is being studied in a Phase 3 clinical trial in pediatric patients with acute lymphoblastic leukemia...and Bayer has begun studying epratuzumab as a thorium-227-labeled antibody in patients with advanced non-Hodgkin lymphoma."
    • Epratuzumab is a humanized monoclonal antibody that targets CD22, a protein found on the surface of immune system white blood cells called B-lymphocytes. It is a regulatory molecule that prevents the overactivation of the immune system. Elevated expression of CD22 is associated with blood cancers and autoimmune disorders.
    • Previously: Epratuzumab flunks two Phase 3 studies; Immunomedics plummets 42% premarket (July 28, 2015)
    | Fri, Feb. 26, 7:29 AM | 1 Comment
  • Thu, Feb. 25, 8:10 AM
    • The FDA approves Intellipharmaceutics' (NASDAQ:IPCI) abbreviated New Drug Application (ANDA) for levetiracetam extended-release tablets in 500 mg and 750 mg strengths for the treatment of partial onset seizures associated with epilepsy. The product is the generic equivalent of UCB's (OTCPK:UCBJF) Keppra XR.
    • According to Symphony Health Solutions, the U.S. market for the 500 mg and 750 mg products is ~$170M. Mylan's (NASDAQ:MYL) generic version was cleared in December 2011.
    • Shares are up 14% premarket but only on turnover of 225.
    | Thu, Feb. 25, 8:10 AM | 2 Comments
  • Mon, Feb. 22, 7:43 AM
    • Amgen (NASDAQ:AMGN) and co-developer UCB (OTCPK:UCBJF) announce positive top-line results from a Phase 3 clinical trial assessing the bone-forming monoclonal antibody, romosozumab, in reducing the incidence of new vertebral fracture in postmenopausal women with osteoporosis. The study, called FRAME, met it co-primary endpoints of demonstrating statistically valid reductions in vertebral fracture at months 12 and 24 compared to placebo.
    • The trial also met a secondary endpoint of a statistically valid reduction in the incidence of clinical fracture (composite of vertebral and non-vertebral fracture) through month 12 versus placebo, but fell short of demonstrating a statistically significant reduction in the incidence of non-vertebral fracture through months 12 and 24.
    • Results showed women treated with monthly injections of romosozumab experienced a 73% reduction in the risk of spine fracture through 12 months versus placebo. The beneficial effect persisted after both arms were transitioned to denosumab (XGEVA) from months 12 through 24. Patients treated with romosozumab followed by denosumab showed a 75% reduction in vertebral fracture through month 24 compared to placebo. Patients in the romosozumab arm also experienced a 36% reduction in the risk of clinical fracture through month 12 versus placebo.
    • The most common adverse events (>10%) were arthralgia (joint pain), nasopharyngitis (inflammation of the nose and pharynx) and back pain. Injection site reactions were reported in 5.2% of patients receiving romosozumab compared to 2.9% for placebo.
    • Further analysis of the study results is ongoing and will be reported at a future medical conference and for publication. Global regulatory filings should be made this year.
    • Romosozumab inhibits sclerostin, a protein that has anti-anabolic effects on bone formation.
    | Mon, Feb. 22, 7:43 AM
  • Fri, Feb. 19, 9:42 AM
    • The FDA approves UCB S.A.'s (OTCPK:UCBJF) Briviact (brivaracetam) as adjunctive treatment for partial onset seizures in epileptic patients at least 16 years old.
    • Brivaracetam is an analog of levetiracetam (UCB's Keppra), but much more potent.
    • Briviact was cleared in Europe last month.
    | Fri, Feb. 19, 9:42 AM
  • Sep. 1, 2015, 4:42 PM
    • Amgen (NASDAQ:AMGN) and co-developer UCB (OTCPK:UCBJF) announce positive results from a 436-subject Phase 3 clinical trial, called STRUCTURE, that compared their investigational monoclonal antibody, romosozumab, to teriparatide [Eli Lilly's (NYSE:LLYForteo] in postmenopausal women with osteoporosis at high risk of fracture. The study met its primary endpoint of a statistically significant difference in percent change of total hip bone mineral density through month 12 versus teriparatide.
    • Romosozumab inhibits sclerostin, a protein that has anti-anabolic effects on bone formation. The companies started Phase 3 development for the indication in April 2012.
    • The analysis of the results is ongoing. The data will be presented at a future medical conference and for publication.
    • Previously: Amgen osteoporosis drug increases bone density in Phase II trial (Jan. 2, 2014)
    | Sep. 1, 2015, 4:42 PM
  • Nov. 7, 2014, 7:20 AM
    | Nov. 7, 2014, 7:20 AM
  • 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
Company Description
UCB, Brussels, Belgium is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system.
Sector: Healthcare
Industry: Drug Related Products
Country: Belgium