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Incyte Corporation Message Board

  • ejparchitect1 ejparchitect1 Apr 25, 2013 6:44 PM Flag

    The run north....now we know why! just out on the wires...

    Pfizer announced that the CHMP has adopted a negative opinion for Xeljanz for the treatment of adult patients with moderate-to-severe active rheumatoid arthritis. The committee said it did not believe a consistent reduction in disease activity and structural damage to joints had been sufficiently demonstrated by the treatment, while also raising questions related to infections and gastrointestinal perforations and malignancies observed in Xeljanz trials

    Sentiment: Hold

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    • I see this as more negative than positive. To some extent, Pfizer just messed up, presuming that generally subjective endpoints could carry most of the burden of establishing efficacy. In the world before TNF inhibitors, they would probably have been correct. Regulators are demanding that a new drug class be better than existing drugs, not just alternative to and about as good. One hopes Lilly/Incyte are taking this lesson to heart--FDA figures to demand better evidence of disease modification for bari than they settled for on tofa. The upside for Incyte is that CHMP seem concerned about off-target toxicity of tofa and suspicious about possible immunosuppression. We know that these aren't problems with bari, so that will be a promotable advantage after approval.

      I haven't sweated through overcoming an initial CHMP rejection, so I don't know the processes or time course. I doubt that it's as bad a an FDA rejection.

    • EJ, As you know I am a big bull on this stock,.... I sure hope this is good news. I can see some investors thinking that bari is similar!!!!! Not hoping of course....just keeping it real. Maybe Jacosa can add his view point...

 
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52.08+0.36(+0.70%)Jul 9 4:00 PMEDT

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