NVS/IDIX/HCV
"NVS may not have much of an hcv presence but they have invested over $1B into idix and probably another $1B in other companies e.g. albuferon "
there is no doubt that NVS wanted to build a presence in HCV. given the size of the market and the fact (unlike HIV) that drug development for this indication was at its infancy at the time they took the plunge, who can blame them. but it's not an overstatement to say everything they touched turned to crap. albuferon is going to be a commercial loser even if it gets approved. anadys' tlr compound was great conceptually but bombed. nm-283 at the time was the most advanced direct antiviral, and as such, despite having relatively low potency, had potential as first to market. it was a bust.
the HCV landscape now 3 years later has changed so much that it no longer makes much sense imo to bring 184, a more potent version of nm-283, forward. the main change is that there is no first mover advantage, and the future is clearly with combination therapy (particularly for a lower potency drug class). roche's success to date with inform, and gild's decision to move straight to combo therapy highlight this. moreover, about a year ago the FDA still required significant monotherapy data in combination with SOC before initiating combination therapy. that is why inform had to be run overseas (australia if i recall). in such an environment moving the agent forward as single agent to a fairly advanced stage and then pairing it with another company with a complementary agent might make sense. However, the regulatory climate seems to now be moving with the times (eveidence for this is twofold: 1. idix, in response to the same question on where the fda stands re combo therapy, a year ago said it is virtually impossible since they required huge amounts of triple combination with soc before considering combo now says they are "in flux" on this matter 2. GILD can jump straight to combo therapy). so on the issue if NVS is the best company to advance 184 i firmly believe the answer is NO. now could NVS have partnered and then codeveloped with another company with a direct acting agent? possibly - but their ownership of idix still enables them to participate in 184 regardless (albeit with less ownership stake, but also less dollars invested and risk). Lastly, it's kind of tough to negotiate a big partnership when all you have is 3 day data and less than a log efficacy. this last point is the one idix investors should concern themselves with most imo. i do agree with wallstarb that it could be some time before there is any market-moving news since partners may want to see some steady state data - which could be 6+ months down the road. I could be wrong if there is convincing preclinical data, or they manage some partnership with a successful 14 day study as a major milestone event and ink something soon, but if your time horizon is long i don'tthin this is that much of an issue since (and i disagree with wallstarb on this) i think 184 is far from dead - i just think there is a paucity of clinical data plus the fact nvs is not a great fit as the main reasons why nvs took a pass, and not some inherent flaw with the compound
PS: i own a trivial amount of idix so my interest mainly stems from whether or not there is an opportunity here since i do see value in the pipeline. the real issue is how much patience will the market have and how much lower might idix go if there is no real news until midyear 2010 *if* such data is really needed to partner the compound. (the other news event is a milestone on 899 which also i am guessing won't happen until midyear next year). I'm real tempted to go long - it's just a timing issue for me
one wildcard in all this might be how the nuke from roche/VRUS fairs. If tox issues emerge - contrary to popular belief - i think that will be viewed as a net negative. even though it will leave 184 as the most advanced nuke, it will put a cloud over the class in general. however, if it succeeds (particularly in combo with the protease) then 184 will (or should) be viewed as a valuable asset since it has POC for combination therapy and does have differentiating characteristics from R7128 (more potentency and greater potential for coformulation along with a lower systemic level of drug that could theoretically translate to a better tox profile)
