Biogen Idec
(
BIIB
) and partner Swedish Orphan Biovitrum recently announced that they
are evaluating their hemophilia candidates, long-acting factor VIII
and long-acting factor IX (rFVIIIFc and rFIXFc), in children below
12 years of age.
Last year, Biogen and Swedish Orphan Biovitrum had received
opinions from the EMA's Pediatric Committee (PDCO) agreeing to the
companies' plans to conduct pediatric studies with factor VIII and
factor IX.
We note that both candidates are currently in late-stage studies
being conducted in patients 12 years and above. While factor VIII
moved into a registrational study (A-LONG) for hemophilia A in
December 2010, factor IX entered into a registrational trial
(B-LONG) earlier in 2010 for the treatment of hemophilia B. Results
from both studies are due in the second half of 2012.
Both factor VIII and factor IX enjoy orphan drug and fast track
status in the US as well as the EU. A convenient dosing schedule
(supported by a longer duration of action and a suitable safety
profile) could help these candidates capture share from existing
products in the hemophilia market.
Besides reporting much-awaited data on its hemophilia
candidates, 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.
The US Food and Drug Administration (FDA) has granted standard
review to the candidate, which means a response should be out in
late 2012/early 2013. We believe BG-12 could become a leader in the
oral multiple sclerosis market once launched. BG-12 should help
drive long-term growth.
Biogen has been facing additional competition in the multiple
sclerosis market in the form of
Novartis'
(
NVS
) Gilenya. Moreover, several companies besides Biogen are working
on bringing an oral multiple sclerosis drug to market.
We currently have a Neutral recommendation on Biogen. The stock
carries a Zacks #2 Rank (short-term Buy rating).
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