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Biogen, Sobi Offer New Data from Phase 3 Trial of ALPROLIX

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Biogen Idec (NASDAQ: BIIB) and Swedish Orphan Biovitrum AB (publ) (Sobi) (STO: SOBI) today presented new findings for their long-lasting recombinant factor IX candidate ALPROLIX^* for hemophilia B at the XXIV International Society on Thrombosis and Haemostasis (ISTH) Congress in Amsterdam, The Netherlands. Three oral presentations showcase new data that reinforce the potential safety, efficacy and pharmacokinetic profile of ALPROLIX. The data highlight the consistency of results with ALPROLIX across patient types and favorable physician ratings of its efficacy in treating acute bleeding episodes and controlling bleeding during and after major surgery.

“ALPROLIX is the first product candidate in a new class of long-lasting clotting factor therapies, and the data presented today support the potential of the therapy to reduce the frequency of prophylactic infusions for patients with hemophilia B,” said Glenn Pierce, M.D., Ph.D., senior vice president of Global Medical Affairs and chief medical officer of Biogen Idec's hemophilia therapeutic area. “These new data help to build the clinical profile of ALPROLIX by increasing our understanding of its efficacy.”

Treatment of Bleeding

An evaluation of the treatment of acute bleeding episodes across the prophylaxis and episodic (on-demand) treatment arms of the phase 3 B-LONG study showed that more than 90% of bleeds were controlled with a single injection of ALPROLIX and more than 97% were controlled with two or fewer injections. These data were showcased in the e-poster presentation:

* Treatment of Bleeding Episodes in Subjects with Haemophilia B with the Long-Lasting Recombinant Factor IX Fc Fusion Protein (rFIXFc) in the Phase 3 B-LONG Study

Surgery Analysis

Results from an analysis of the phase 3 B-LONG study showed that ALPROLIX consistently controlled bleeding during and after 14 major surgeries in 12 patients with hemophilia B. Physicians reported high efficacy levels of ALPROLIX during surgery, with hemostasis (the stoppage of bleeding) rated as “excellent” for 13/14 surgeries and “good” for 1/14 surgeries. According to investigator analyses, the results were comparable to that for similar surgeries in people without hemophilia. These data were showcased in the e-poster presentation:

* Long-Lasting Recombinant Factor IX Fc Fusion (rFIXFc) for Perioperative Management of Subjects with Haemophilia B in the Phase 3 B-LONG Study

Population Pharmacokinetics (PK) Analysis

Analysis of a population pharmacokinetics (popPK) model developed for ALPROLIX demonstrated that the model accurately predicts peak and trough factor IX activity levels achieved in the B-LONG clinical study at a variety of ALPROLIX doses. These data were showcased in the e-poster presentation:

* Clinical Implications of Population Pharmacokinetics of rFIXFc in Routine Prophylaxis, Control of Bleeding and Perioperative Management for Haemophilia B Patients

“These new data from the B-LONG study support the potential application of Fc fusion technology in hemophilia,” said Birgitte Volck, M.D., Ph.D., senior vice president development and chief medical officer of Sobi. “The results add to the growing body of evidence supporting the potential efficacy and safety of this long-lasting clotting factor candidate for the treatment of hemophilia B.”

ALPROLIX Global Regulatory Status

A Biologics License Application (BLA) for Biogen Idec's long-lasting hemophilia product candidate ALPROLIX is currently under review with the U.S. Food and Drug Administration (FDA) for the treatment of hemophilia B.

Marketing Applications for ALPROLIX have been submitted in Canada and Australia for the treatment of hemophilia B. Additional regulatory filings are planned.

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