Biotech Values

[DonShimoda]

it won't likely get reimbursement for 2nd line until there are data available for that setting

I agree that additional data will be needed (See "D" of my earlier post msg-82507924), however, I don't think head-head trials with sprycel and tasigna will be necessary to obtain 2nd-line re-imbursement. The EPIC trial should be sufficient as it will allow direct comparison with the ENESTnd and DASISION results.

Gleevec going generic will certainly impact front-line pricing, however, it has always been my contention that the 2nd-line is the real opportunity for Iclusig. There is a direct correlation between long-term patient outcome and how quickly/deeply a patient achieves molecular response. As I've pointed out, gleevec, tasigna and sprycel aren't even close to achieving the numbers Ariad just released at ASH. Over time, i suspect the new NCCN guidelines will lead to earlier testing which, in turn, will lead to earlier/more frequent switching which, in turn, will benefit Iclusig at the expense of both sprycel and tasigna. If one of the current therapies fails to produce an MMR in the front-line, which drug are you going to want to take in 2nd-line: iclusig, which is able to achieve a 51% MMR in 3/4-line at 30months, or tasigna with a 28% MMR at 24 months in a 2nd-line setting?

One last point, salvage therapy alone is a $500mm market which means that at todays pps ZERO value for the first/second line opportunity is being priced into the stock let alone the ALK/EGFR inhibitor.