) recently announced that its Biologics License Application (BLA)
for its long-acting factor IX (rFIXFc) candidate for hemophilia B
has been accepted by the US Food and Drug Administration (FDA)
for standard review.
Biogen and its partner, Swedish Orphan Biovitrum, had
presented positive phase III top-line results on rFIXFc last
year. Results from the global, open-label, multi-center B-LONG
study showed that rFIXFc was effective in controlling and
preventing bleeding, routine prophylaxis, and perioperative
management. Results showed that a single injection of rFIXFc
helped control 90.4% of bleeding episodes.
A pharmacokinetic (PK) analysis was also conducted. The
approximate terminal half-life of rFIXFc was found to be 82 hours
compared to 34 hours for
The candidate was also found to be well-tolerated with no
inhibitors to rFIXFc being detected or cases of anaphylaxis
(severe allergic reaction) being reported. Patients in the study
had all switched from marketed factor IX products.
Meanwhile, Biogen intends to file for FDA approval of its
hemophilia A candidate, rFVIIIFc, in the first half of 2013.
A convenient dosing schedule (supported by a longer duration
of action and a suitable safety profile) could help rFIXFc and
rFVIIIFc capture share from existing products in the hemophilia
With the FDA granting standard review, a response from the
agency regarding the approval status of rFIXFc should be out in
the fourth quarter of this year.
Meanwhile, Biogen has some other significant pipeline
catalysts coming up, the most important being an update on the
regulatory status of Tecfidera (BG-12). Tecfidera, Biogen's oral
multiple sclerosis candidate, is currently under review in both
the US and the EU. A response in the US should be out this month.
We believe Tecfidera could become a leader in the oral multiple
sclerosis market once launched.
Biogen currently carries a Zacks Rank #3 (Hold). Companies
that currently look interesting include
). Both are Zacks Rank #1 (Strong Buy) stocks.
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