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Re: DonShimoda post# 154199

Saturday, 12/15/2012 10:35:14 PM

Saturday, December 15, 2012 10:35:14 PM

Post# of 252454

B) Tasigna is on track to sell over $1 billion with its black box label. Iclusig is a better drug.



Both Tasigna and Sprycel get large chunk of revenue from Europe, only slightly less than from US. Based on recent CHMP approval trend, I doubt (<50% chance IMO) they would grant ponatinib broad label including second line patients as FDA just did. Even if they do, it won't likely get reimbursement for 2nd line until there are data available for that setting. So, ponatinib revenue would mainly come from US for awhile unlike Tasigna and Sprycel. Even after ponatinib 1st line data, considering gleevec becoming generic at that time, ponatinib will get very little reimbursement for 1st line in Europe.

As of a better drug argument, both Tasigna and Sprycel are considered better drugs than Gleevec, after 5 and 6 years on the market, they are nowhere close to Gleevec revenue in CML even though both cost MUCH more than Gleevec. By the time Gleevec becoming generic, both Tasigna and Sprycel won't come close to Gleevec revenue either.

D) By the time, Ariad is ready to ramp sales into 1/2nd-line, the EPIC trial data will be available which I believe will show that the AE's experienced in the 3/4 line PACE trial won't carry over to a front-line population of younger, healthier patients.



Let's give the benefit of doubt on cardio SAEs to earlier line patient population, why are you so certain on hepatotoxicity? I haven't found any explanation on 3 liver failure cases. Were you aware of these cases before FDA label? I don't think at this point you can exlude the possibility that ponatinib better efficacy but with higher hepatotoxicity. We have to wait and see once it is used in wider patient population.

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