) and partner Swedish Orphan Biovitrum AB (Sobi) reported
positive top-line data on their hemophilia A candidate, Eloctate
from a phase III pediatric study (Kids A-LONG).
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The study, which evaluated the safety, efficacy and
pharmacokinetics of Eloctate, showed that twice-weekly
prophylactic dosing with Eloctate maintained low bleeding rates
in previously treated children (aged below 12 years) suffering
from severe hemophilia A. Eloctate was found to be generally
well-tolerated with no inhibitors being detected.
Eloctate is currently under the U.S. Food and Drug Administration
(FDA) review for the treatment of hemophilia A in adults. A
feedback from the FDA should be out by mid-2014.
Meanwhile, Biogen is conducting the phase III Kids B-LONG study
with Alprolix for the treatment of hemophilia B in children below
12 years of age. Results from both these studies will help the
company file for pediatric indications and also support marketing
approval in the EU.
Alprolix is already approved in the U.S. and Canada for the
treatment of hemophilia B in adults (> 17 years). Biogen plans
to launch Alprolix in the U.S. in early May 2014.
We note that Biogen has another candidate, Plegridy, under review
in the U.S. and the EU for the treatment of relapsing-remitting
multiple sclerosis. A response should be out in the second half
We expect 2014 to be a catalyst rich year for Biogen with several
data-readouts expected this year.
Biogen carries a Zacks Rank #3 (Hold). Some better-ranked biotech
ZIOPHARM Oncology, Inc.
Alexion Pharmaceuticals, Inc.
). While Amgen and ZIOPHARM carry a Zacks Rank #1 (Strong Buy),
Alexion holds a Zacks Rank #2 (Buy).