WESTON, Mass. (AP) -- Biogen Idec Inc. on Wednesday reported positive data from a late-stage clinical trial of an experimental hemophilia drug it is developing.
Biogen and its partner Swedish Orphan Biovitrum said their drug rFIXFc was effective at preventing bleeding, controlling bleeding, and managing bleeding after surgery. The trial involved 123 adult men with hemophilia B. Biogen said it will ask the Food and Drug Administration to approve marketing of rFIXFc in the first half of 2013. The companies will file for approval in Europe after they complete a study evaluating the drug in boys.
Hemophilia is a rare, inherited disorder that affects blood clotting. It is diagnosed in approximately one in every 25,000 male births. People with hemophilia B have little or none of a blood clotting protein called factor IX. Biogen said hemophilia is typically treated with IV infusions up to three times a week. In the trial, some patients were treated with rFIXFc once a week. Others started with treatments every 10 days, and over time their treatment decreased to once every 14 days on average.
Biogen and Swedish Orphan Biovitrum are also studying a treatment for hemophilia A, which is more common and is caused by a different deficiency.
UBS analyst Matthew Roden said the data is "impressive" and suggests that rFIXFc could be a strong competitor with Pfizer Inc.'s drug BeneFIX and gain significant market share as a treatment for hemophilia B. Roden maintained a "Neutral" rating on Biogen stock with a price target of $156 per share.
Shares of Biogen Idec rose $1.67 to $154.50 in midday trading. The stock has been trading at all-time highs in 2012, and it peaked at $157.18 Wednesday morning.
- Pharmaceuticals & Drug Trials
- Food and Drug Administration
- Swedish Orphan Biovitrum