cc comments:
finally listened to the JP morgan cc in full
1. guidance was 20 M for tyzeka this year, more or less in line w what entecavir did post-launch. This is assuming do get go-ahead in EU and china first half of this year.
This was already discussed here..but briefly,while in absolute terms this number is by no means meaningful to the IDIX coffers, this does imply at least decent performance in terms of marketing prowess imo given that idix had to contend with a more crowded marketplace than entecavir did immediately post-launch. As I have already stated, based on historical uptake, this will likely translate to >100M in 2008..a meaningful though perhaps slightly lower number than some here were hoping for
2. JP did say a head to head with entecavir is either ongoing or imminent..i didn't see anyone mention this previously
Now this is interesting..perhaps a bit risky but interesting. JP really feels telbivudine is best in class. When Yaron Werber projected only 11M in 2007 sales for telbiv he felt it was inferior to entecavir. I posted that this was an impossible conclusion due to lack of head to head, differing populations studied, different endpoints, etc., and in fact, when both were independently compared to lamivudine, the difference between outcomes of treatment and lamivudine controls indicated a greater incremental benefit of telbiv vs lamivudine compared to entecavir vs lamivudine. i was careful to say this does not translate to superiority for telbiv, but by the same token a careful look at the data places werber's conclusion of inferiority in the preposterous category.
now hep b nucleosides did >600M in 2006, with 40% growth year to year 2005-2006 and expected to be >1B by 2010..if the head to head confirms JP's suspicion that telbiv is best in class, then telbiv will be worth a whole lot down the road
3. 48 week nm-283 will be presented at EASL.
I think data will be in worst-case scenario decent (i.e. comparable to SOC) and likely superior. We already know FDA has stated that any non-riba-containing regimen that can achieve non-inferiority to soc is approvable, but i still have solid hopes for superiority, although it will be modest, and in all likelihood lower than vx-950 triple therapy. That's fine because 1. there are plenty of riba-intolerant patients 2. even vertex acknowledged that the next phase in evolution of hep c tx is combo protease-polymerase (and its looking like there will be some wiggle room to improve outcomes and/or shorten tx duration even in naives based on the very good but not exquisite 12 week prove data) 3. non-riba-containing vx-950 trials are likely to at least show inferiority to triple therapy, inwhich case plenty of room for improvement with combo protease-polymerase 4. vx-950 has shown less than stellar results thus far in tx-experienced population, so plenty of room for improvement in this very sizable population
4. No guidance on strategy for refractory pts, no guidance on initiation of trials in non-gen-1 pts..this is somewhat disappointing, but I am guessing any strategy in refractory pts will have to await results of drug interaction study simply because if favorable then there is the option of NOT requiring a major dose increase (i.e. 800mg) of nm-283. Now i know this flies in the face of what the company previously stated, but remember the need for 800mg was based on a non-riba containing nm-283 regimen so things could change if they can add riba concurrently in a triple combo therapy..just a hunch as to why we may be seeing some delay in announcing a strategy for this patient population (although a triple therapy regimen in combination with a strategy to get 800mg nm-283 on board may still be what they shoot for even if interaction studies favorable)
5. IND for a second generation non-nuc polymerase inhib for hep C expected end of this year.. JP mentioned the lead has a 10-100 fold increase in liver-targeting, so i would guess we are seeing the first fruit of the metabasis collaboration
6. HIV go ahead for clinical pk studies starting next week, with Ib/IIa expected Q2
this time frame is on the faster side than i think many expected, and there is solid preclinical data to suggest will be effective in polymerase-resistant strains.. cocrystallization wioht a double resistant mutant indicates very strong target binding, and JP described excellent preclinical efficacy with lack of emerging resistance in the most efavirenz-resistant mutant. This could end up being a major value driver this year, as odds of a successful Ib seems high
In summary, not a whole lot of real news other than perhaps a bad virus and delivery for JP, ?minimal slight delay for phIII nm-283 (although this is arguable), favorable movement on the HIV front, and an outlook for telbivudine that at worst alone likely justifies current valuation with potential for much more if ultimately shown to be best in class..I remain comfortable with my long position here
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