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Biogen says Eloctate approval may be delayed, Deutsche talks RDP for Tecfidera

  • "According to EMA documents, a review is going on regarding a potential data exclusivity decision and the agency looks likely to reach a conclusion by November. We expect the decision to be made public on November 22 after CHMP meeting," Deutsche's Robyn Karnauskas says, regarding regulatory data protection for Tecfidera in Europe. The decision will affect when the MS drug could face generic competition in the region.
  • Karnauskas sees fair value of $250/share with EU exclusivity and $238/share without it — if there's no EU launch at all, Karnauskas sees $225/share. Adding in hemophilia estimates, Deutsche has a target of $270 on the shares assuming RDP for Tecfidera.
  • Speaking of hemophilia, CEO George Scangos says approval for BIIB's Eloctate may be delayed. "The matter under discussion does not pertain to the safety or efficacy of the product or any of the clinical trial data," Scangos notes.
  • Some analysts believe Eloctate is bad news for Baxter (BAX +2.1%) in terms of competition in the hemophilia space, although Goldman thinks the concerns are overblown.
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