Biogen Idec
(
BIIB
) recently submitted a Biologics License Application (BLA)
seeking US Food and Drug Administration (FDA) approval for its
long-acting factor IX (rFIXFc) candidate for hemophilia B.
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
Pfizer's
(
PFE
) BeneFIX.
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, as well 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
market.
Upcoming Catalysts
Meanwhile, Biogen has some other significant pipeline
catalysts coming up, the most important being an update on the
regulatory status of BG-12. BG-12, 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 by March. We believe
BG-12 could become a leader in the oral multiple sclerosis market
once launched.
Another important near-term event is the presentation of
top-line phase III (ADVANCE) results on multiple sclerosis
candidate, PEGylated interferon.
Biotech companies that currently look interesting include
Amgen
(
AMGN
), which carries a Zacks #1 Rank (Strong Buy).
AMGEN INC (AMGN): Free Stock Analysis Report
BIOGEN IDEC INC (BIIB): Free Stock Analysis
Report
PFIZER INC (PFE): Free Stock Analysis Report
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