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DonShimoda

12/15/12 1:48 PM

#154196 RE: mcbio #154195

Well, good luck trying to buy it at $30 five years from now. :)

fwiw, Citi reiterated their $31 price target yesterday (the bolding is my own). The report is appropriately entitled “Seeing The Forest” –Efficacy Provides Most Differentiation

Conclusion - We recognize the “black box” warning for Iclusig (ponatinib) is a negative surprise to the Street. However, as the drug was approved based on a single arm trial the FDA is likely compelled to outline all the prominent toxicities despite if there is evidence they were related to the Iclusig or not. We do not expect these warnings to dramatically impact uptake of ponatinib, as physicians treating these patients are likely broadly familiar with the adverse effects caused by this disease and prior treatment, and will be able to assess these warnings with what they would normally expect. We view the weakness in ARIA as overdone and would be buyers of the stock.

Efficacy Is the Clear Differentiator. Ultimately, we believe the tolerability for Iclusig, Sprycel, and Tasigna will likely be viewed by physicians as unique but generally equivalent, with each agent having their drawbacks. Efficacy on the other hand is a clear differentiator for Iclusig and we believe will not be ignored.

Granting of a Broad Drug Label Signals FDA’s View of Risk/Reward. The FDA granted Iclusig a broader label of “patients that have failed any prior TKI therapy” than those patients enrolled in the approval PACE trial. We note that this nearly doubles the available patients who could receive Iclusig, and all towards patients who are generally healthier than those treated in PACE. We think the willingness of the agency to broaden use of Iclusig to healthier patients than those exposed to the drug to date puts these warnings included in the label in perspective.