Replies to post #273 on Idenix Pharmaceuticals (IDIX)

[DewDiligence]

Re: NM283 timeline

>My reference to Doug D. slide corresponds to Dew’s slide 25 of 103 [from the 10/27/06 analysts’ lunch]. It includes a couple inferences that might have been too large of a leap. 1st I assumed that the stage 4 2009-2010 time frame was for approval (not filing) which I believe the NVS slides address. I also assumed that NM283 was the furthest along of the nucleoside polymerase inhibitors and therefore was most likely to be the first to be used in the Stage 4 combination identified by the plan (2009-2010 time frame).<

Roger—now I understand what you meant in your previous post. Slide #25 from the analysts’ lunch on 10/27/06 is essentially the same graphic as the one in #msg-15438502 (which was used in an earlier IDIX presentation). It ought not to be taken literally! Regards, Dew

[DewDiligence]

>One of the few major NVS missteps I can remember was this type of a test a few years ago ( I beleive it was a hypertension product). Man it's embarrasing when you come up on the short side of your own head to head test data.<

Are you sure it was NVS? The big boo-boo from a Big Pharma head-to-head study was the one BMY ran that tested Pravachol against Lipitor. The study showed that Lipitor was superior and hastened the demotion of Pravachol to also-ran status.

[dewophile]

flatlander

"I also assumed that NM283 was the furthest along of the nucleoside polymerase inhibitors and therefore was most likely to be the first to be used in the Stage 4 combination identified by the plan (2009-2010 time frame)."

it is the furthest along, so in phase IV (postmarketing) it does stand to be the first to be tested in combination with an already approved protease (likely VX). the one wrinkle is that vertex could choose to test VX prior to approval (ala HIV model) with another not-yet approved polymerase (that is behind nm-283 in development)..vertex has signaled an interest in protease-polymerase combinations, but who, when, how, in what HCV population(s) is just not clear

"Thanks for calling attention out on the head to head vs. Barraclude on the HBV front that really caught my attention. I used to think that pharma only ran those tests if they had a pretty good idea of the outcome"

I'm not sure the degree of confidence here, but imo this is a higher risk study. as Dew very nicely illustrated, on the surface outcomes for baraclude and tyzeka, as best as can be assessed from the available data, are very comparable. I seem to recall JP mentioning that the rate of decline of virus in tyzeka studies was faster than baraclude (i really haven't gone back to the data to check this), and i guess he feels this might translate to better durability of clearance when longer-term data is accrued, but I'd have to listen to the cc again to confirm this..he may have dropped another tidbit as well as to why he felt tyzeka is superior - I'm not sure. my take is that with some analysts out there under the impression tyzeka is inferior, an outcome with equal efficacy might serve the product well in the eyes of both wall street and the medical community...that is if there is solid proof of non-inferiority in efficacy, coupled with no food interaction and more competitive pricing, that alone should be enough to garner greater market penetration relative to baraclude..of course superiority would enable tyzeka to take over the nuc market for HBV altogether, but that might be more of a long shot