Biotech Values

[ghmm]

Protease inhibitor clinical trial question.

Can anyone tell me how VX-950 went through Phase 1 in terms of time line/trials (when they began/finished/etc). Any articles/links would be greatly appreciated as well.

I am curious because InterMune is doing a 1A trial (Health Volunteers) before proceeding to 1B (infected patients).

Don't know how much board interest there is in InterMune outside of 191 (HCV) but here are a few thoughts on whats happened in the past few weeks and from reviewing some things...
1) After reviewing past calls I would venture to guess the "mystery" HCV preclinical candidate in development is either a Polymerase or a Helix inhibitor. Further more I would venture they start to discuss it perhaps as early as later this year and perhaps in the 2008/2009 time frame it enters the clinic. I don't follow this side of InterMune as well as many posters here so not sure what would make the most sense to pursue. In some of the past calls (InterMune not Array) they seem to be very enthusiastic about it and Array gets a larger royalty so I am sure they are more incentivized.
2) If any took advantage of the market not picking up on the Pirfenidone Shionogi news could have made $6-7 before the afternoon 8K filing on the 22nd. I posted the Shionogi PR before trading and was beginning to question myself but I took advantage and added even more. It is good to know that the "smaller" investor can still get ahead of the market in some instances.
3) Along the lines of #2. In my opinion several of the analysts coming out with comments are either off base or don't fully understand. I think some have their models and don't have any vision at all (I wouldn't mind negative reports if they were well reasoned; always appreciate things I may have missed). There are some good ones who have been touting the promise of their PI program but few seem to have a good grasp of the IPF side.
4) The "financing" was actually something I was wondering about (before they filed). If I understand things correctly they can repurchase the convertible (at 21 and change) if the holders try to redeem. So with the price considerably above the convert value InterMune would need the cash if all the note holders would convert (I think Dan likes to have in the $150 million range on the balance sheet). If I am right in my interpretation the beauty of this would be reducing the dilution by a couple million shares if say they can replace the current convertible with one priced in the $40/share range then you cut the dilution of the past note in half!
5) Also I believe there could be some near-term event drivers that (if favorable) could potentially further drive up the share price giving the company an opportunity to build some additional cash:
a) 191 Phase 1A completion/safety OK
b) Pirfenidone CAPACITY trial enrollment completing early
c) INSPIRE interim efficacy reached (just a guess but I say we have one one of the two interim looks in INSPIRE this quarter)
d) Release info on Preclincal HCV target
e) Pirfenidone partner or plan to develop alone in EU
f) Shionogi filing in Japan. Setting price (would guess US/EU price would be along same lines). Getting decision on it and then finally how quickly the up-take is.
I am not big on companies that issue, but I was thinking of a few things I'd like the company to do with some "extra" cash that could really build some value (one is to go at marketing Pirfenidone alone in EU).

OK I have rambled enough. Since there doesn't seem to be a whole lot of interest in the company outside of HCV, I'll probably wait till after the Q4 call to update the InterMune ReadMeFirst.