Analyst Research

Report Title Price
Provider: Reuters Investment Profile
$20.00
Provider: Wright Reports
$75.00

NYSE and AMEX quotes delayed by at least 20 minutes. NASDAQ delayed by at least 15 minutes. For a complete list of exchanges and delays, please click here.

Swedish Orphan Biovitrum publ AB and Biogen Idec Inc announce results of phase 3 study of recombinant factor IX and VIII Fc fusion protein candidates


Monday, 9 Dec 2013 11:30am EST 

Swedish Orphan Biovitrum publ AB and Biogen Idec Inc:Say they announce results from Phase 3 studies of investigational long-lasting recombinant factor IX and VIII Fc fusion protein candidates for haemophilia B and A, rFIXFc (ALPROLIX) and rFVIIIFc (ELOCTATE), with interim analysis of pediatric pharmacokinetics (PK) data.Say interim data demonstrate that rFIXFc and rFVIIIFc have consistently prolonged half- lives (a measure of the time therapy circulates in the bloodstream) in children, compared to study participants' prior therapies.Say rFIXFc and rFVIIIFc use a technology called Fc fusion and demonstrate prolonged circulation in the body, which has been shown in studies of adults with haemophilia to extend the time between prophylactic infusions.Say in 43 children treated with rFVIIIFc as of Feb. 8, and 23 children receiving rFIXFc as of Apr. 23, no inhibitors (antibodies that may interfere with the activity of the therapy) were detected.Say the pattern of treatment-emergent adverse events reported was typical of the populations studied, with no unique safety issues identified.Say the final results of the pediatric studies will evaluate the safety and efficacy of rFIXFc and rFVIIIFc, as well as provide further PK information. 

Related Company News

Company Quote

83.5
-0.5 -0.60%
11:29am EST