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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